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4. Clinical management of patients with thymic epithelial tumors: the recommendations endorsed by the Italian Association of Medical Oncology (AIOM)

Author

Conforti, F., Marino, M., Vitolo, V., Spaggiari, L., Mantegazza, R., Zucali, P., Ruffini, E., di Tommaso, L., Pelosi, G., Barberis, M., Petrini, I., Palmieri, G., Pasello, G., Galli, G., Berardi, R., Garassino, M., Filosso, P., Alloisio, M., Scorsetti, M., Orecchia, R., Pala, L., Abatedaga, L., Cinieri, S., and De Pas, T.

Published
2021
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6. 101P Primary malignant phyllodes tumors of the breast: A retrospective analysis from a referral center

Author

Valenza, C., primary, De Pas, T.M., additional, Gaeta, A., additional, Castellano, G., additional, Santoro, C., additional, Battaiotto, E., additional, Burroni, M., additional, Chiappini, G., additional, Vivanet, G., additional, Trapani, D., additional, Coppola, S., additional, Conforti, F., additional, Mattar, D., additional, Gandini, S., additional, Veronesi, P., additional, Pennacchioli, E., additional, and Curigliano, G., additional

Published
2024
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8. Outcomes of patients with advanced solid tumors who discontinued immune-checkpoint inhibitors: a systematic review and meta-analysis

Author

Pala, L, Pagan, E, Sala, I, Oriecuia, C, Oliari, M, De Pas, T, Specchia, C, Cocorocchio, E, Zattarin, E, Rossi, G, Catania, C, Ceresoli, G, Laszlo, D, Canzian, J, Valenzi, E, Viale, G, Gelber, R, Mantovani, A, Bagnardi, V, Conforti, F, Pala, Laura, Pagan, Eleonora, Sala, Isabella, Oriecuia, Chiara, Oliari, Matteo, De Pas, Tommaso, Specchia, Claudia, Cocorocchio, Emilia, Zattarin, Emma, Rossi, Giovanna, Catania, Chiara, Ceresoli, Giovanni Luca, Laszlo, Daniele, Canzian, Jacopo, Valenzi, Elena, Viale, Giuseppe, Gelber, Richard D., Mantovani, Alberto, Bagnardi, Vincenzo, Conforti, Fabio, Pala, L, Pagan, E, Sala, I, Oriecuia, C, Oliari, M, De Pas, T, Specchia, C, Cocorocchio, E, Zattarin, E, Rossi, G, Catania, C, Ceresoli, G, Laszlo, D, Canzian, J, Valenzi, E, Viale, G, Gelber, R, Mantovani, A, Bagnardi, V, Conforti, F, Pala, Laura, Pagan, Eleonora, Sala, Isabella, Oriecuia, Chiara, Oliari, Matteo, De Pas, Tommaso, Specchia, Claudia, Cocorocchio, Emilia, Zattarin, Emma, Rossi, Giovanna, Catania, Chiara, Ceresoli, Giovanni Luca, Laszlo, Daniele, Canzian, Jacopo, Valenzi, Elena, Viale, Giuseppe, Gelber, Richard D., Mantovani, Alberto, Bagnardi, Vincenzo, and Conforti, Fabio

Abstract

Background: The outcome of patients with metastatic tumors who discontinued immune checkpoint inhibitors (ICIs) not for progressive disease (PD) has been poorly explored. We performed a meta-analysis of all studies reporting the clinical outcome of patients who discontinued ICIs for reasons other than PD. Methods: We searched PubMed, Embase and Scopus databases, from the inception of each database to December 2023, for clinical trials (randomized or not) and observational studies assessing PD-(L)1 and CTLA-4 inhibitors in patients with metastatic solid tumors who discontinued treatment for reasons other than PD. Each study had to provide swimmer plots or Kaplan–Meier survival curves enabling the reconstruction of individual patient-level data on progression-free survival (PFS) following the discontinuation of immunotherapy. The primary endpoint was PFS from the date of treatment discontinuation overall and according to tumor histotype, type of treatment and reason of discontinuation. The Combersure's method was used to estimate meta-analytical non-parametric summary survival curves assuming random effects at study level. Findings: Thirty-six studies (2180 patients) were included. The pooled median PFS (mPFS) was 24.7 months (95% CI, 18.8–30.6) and the PFS-rate at 12, 24, and 36 months was respectively 69.8% (95% CI, 63.1–77.3), 51.0% (95% CI, 43.4–59.8) and 34.0% (95% CI, 27.0–42.9). Univariable analysis showed that the mPFS was significantly longer for patients with melanoma (43.0 months), as compared with non-small cell lung cancer (NSCLC, 13.5 months) and renal cell carcinoma (RCC, 10.0 months; between-strata comparison test p-value < 0.001); for patients treated with anti-PD-(L)1 + anti-CTLA-4 as compared with anti-PD-(L)1 monotherapy (44.6 versus 19.9 months; p-value < 0.001), and in NSCLC when the reason of treatment discontinuation was elective as compared with toxicity onset (19.6 versus 4.8 months; p-value = 0.003). The multivariable analysis confirme

Published
2024

9. Surrogate endpoints for overall survival in randomized clinical trials testing immune checkpoint inhibitors: a systematic review and meta-analysis

Author

Sala, I, Pagan, E, Pala, L, Oriecuia, C, Musca, M, Specchia, C, De Pas, T, Cortes, J, Giaccone, G, Postow, M, Gelber, R, Bagnardi, V, Conforti, F, Gelber, RD, Sala, I, Pagan, E, Pala, L, Oriecuia, C, Musca, M, Specchia, C, De Pas, T, Cortes, J, Giaccone, G, Postow, M, Gelber, R, Bagnardi, V, Conforti, F, and Gelber, RD

Abstract

Introduction: There is debate on which are the best surrogate endpoint and metric to capture treatment effect on overall survival (OS) in RCTs testing immune-checkpoint inhibitors (ICIs). Methods: We systematically searched for RCTs testing ICIs in patients with advanced solid tumors. Inclusion criteria were: RCTs i) assessing PD-(L)1 and CTLA-4 inhibitors either as monotherapy or in combination with another ICI, and/or targeted therapy, and/or chemotherapy, in patients with advanced solid tumors; ii) randomizing at least 100 patients. We performed a meta-analysis of RCTs to compare the surrogacy value of PFS and modified-PFS (mPFS) for OS in RCTs testing ICIs, when the treatment effect is measured by the hazard ratio (HR) for OS, and by the HR and the ratio of restricted mean survival time (rRMST) for PFS and mPFS. Results: 61 RCTs (67 treatment comparisons and 36,034 patients) were included in the analysis. In comparisons testing ICI plus chemotherapy, HRPFS and HRmPFS both had a strong surrogacy value (R2 = 0.74 and R2 = 0.81, respectively). In comparisons testing ICI as monotherapy, HRPFS was the best surrogate, although having a moderate correlation (R2 = 0.58). In comparisons testing ICI plus other treatment(s), the associations were very weak for all the surrogate endpoints and treatment effect measures, with R2 ranging from 0.01 to 0.22. Conclusion: In RCTs testing ICIs, the value of potential surrogates for HROS was strongly affected by the type of treatment(s) tested. The evidence available supports HRPFS as the best surrogate, and disproves the use of alternative endpoints, such as the mPFS, or treatment effect measures, such as the RMST.

Published
2024

10. 'Heterogeneity of treatment effect on patients' long-term outcome according to pathological response type in neoadjuvant RCTs for breast cancer.'

Author

Pala, L, Sala, I, Pagan, E, De Pas, T, Zattarin, E, Catania, C, Cocorocchio, E, Rossi, G, Laszlo, D, Ceresoli, G, Canzian, J, Valenzi, E, Bagnardi, V, Conforti, F, Pala, Laura, Sala, Isabella, Pagan, Eleonora, De Pas, Tommaso, Zattarin, Emma, Catania, Chiara, Cocorocchio, Emilia, Rossi, Giovanna, Laszlo, Daniele, Ceresoli, Giovanni, Canzian, Jacopo, Valenzi, Elena, Bagnardi, Vincenzo, Conforti, Fabio, Pala, L, Sala, I, Pagan, E, De Pas, T, Zattarin, E, Catania, C, Cocorocchio, E, Rossi, G, Laszlo, D, Ceresoli, G, Canzian, J, Valenzi, E, Bagnardi, V, Conforti, F, Pala, Laura, Sala, Isabella, Pagan, Eleonora, De Pas, Tommaso, Zattarin, Emma, Catania, Chiara, Cocorocchio, Emilia, Rossi, Giovanna, Laszlo, Daniele, Ceresoli, Giovanni, Canzian, Jacopo, Valenzi, Elena, Bagnardi, Vincenzo, and Conforti, Fabio

Abstract

Introduction: To provide evidence explaining the poor association between pCR and patients’ long-term outcome at trial-level in neoadjuvant RCTs for breast cancer (BC), we performed a systematic-review and meta-analysis of all RCTs testing neoadjuvant treatments for early-BC and reporting the hazard ratio of DFS (HRDFS) for the intervention versus control arm stratified by pathological response type (i.e., pCR yes versus no). Methods: The objective was to explore differences of treatment effects on DFS across patients with and without pCR. We calculated the pooled HRDFS in the two strata of pathological response (i.e., pCR yes versus no) using a random-effects model, and assessed the difference between these two estimates using an interaction test. Results: Ten RCTs and 8496 patients were included in the analysis. Patients obtaining pCR in the intervention-arm had a higher, although not statistically significant, risk of DFS-event as compared with patients obtaining pCR in the control-arm: the pooled HRDFS for the experimental versus control arm was 1.23 (95%CI, 0.91–1.65). On the opposite, the risk of DFS-event was higher for control as compared with the intervention-arm in the stratum of patients without pCR: the pooled HRDFS was 0.86 (95%CI, 0.78–0.95). Treatment effect on DFS was significantly different according to pathological response type (interaction test p: 0.014). Conclusion: We reported new evidence that contributes to explaining the poor surrogacy value of pCR at trial-level in neoadjuvant RCTs for early-BC.

Published
2024

12. Safety, hesitancy of coronavirus disease 2019 vaccination and pandemic burden in patients with inflammatory bowel disease: Data of a national study (ESCAPE-IBD)

Author

Principi, M, Macaluso, F, Todeschini, A, Facciotti, F, Contaldo, A, Castiglione, F, Nardone, O, Spagnuolo, R, Doldo, P, Riguccio, G, Conforti, F, Vigano, C, Ascolani, M, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Caprioli, F, Mannino, M, Rizzo, G, Orlando, A, Principi M., Macaluso F. S., Todeschini A., Facciotti F., Contaldo A., Castiglione F., Nardone O. M., Spagnuolo R., Doldo P., Riguccio G., Conforti F. S., Vigano C., Ascolani M., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Caprioli F., Mannino M., Rizzo G., Orlando A., Principi, M, Macaluso, F, Todeschini, A, Facciotti, F, Contaldo, A, Castiglione, F, Nardone, O, Spagnuolo, R, Doldo, P, Riguccio, G, Conforti, F, Vigano, C, Ascolani, M, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Caprioli, F, Mannino, M, Rizzo, G, Orlando, A, Principi M., Macaluso F. S., Todeschini A., Facciotti F., Contaldo A., Castiglione F., Nardone O. M., Spagnuolo R., Doldo P., Riguccio G., Conforti F. S., Vigano C., Ascolani M., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Caprioli F., Mannino M., Rizzo G., and Orlando A.

Abstract

Background and aims The purpose of this study was to present data on the safety of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in a cohort of inflammatory bowel disease (IBD) patients of an ongoing multicenter study (ESCAPE-IBD) sponsored by the Italian Group for the study of Inflammatory Bowel Disease (ClinicalTrials.gov Identifier: NCT04769258). Methods Anti-SARS-CoV-2 vaccination was administrated to 809 IBD patients. Interviews were conducted to report adverse events related to vaccination. Of these 809, 346 patients were surveyed on the pandemic burden and the main reason for hesitancy in coronavirus disease 2019 vaccination. The chi-square test was used to compare categorical variables. Logistic regression was used to assess the relationship between disease-related characteristics and the onset of adverse events. Results About 45% of patients had at least one side effect, following the first dose (10%), the second (15%), and both doses (19%). All the adverse events were mild and lasted only a few days. Logistic regression analysis revealed that female sex (P < 0.001), younger age (P = 0.001), seroconversion (P = 0.002), and comorbidity (P < 0.001) were significantly associated with adverse events. The survey showed that the main concerns were the possibility of adverse event (33%). Almost all patients (99%) felt safer having been vaccinated at their IBD reference center. Conclusion The vaccine reactions experienced in IBD patients were mostly self-limited. We found high acceptance and good safety of SARS-CoV-2 vaccination in our cohort.

Published
2023

13. Tailoring the optimal duration of the extended adjuvant endocrine therapy in patients with early-stage breast cancer. A systematic review and meta-analysis of randomized clinical trials

Author

Pala, L, De Pas, T, Pagan, E, Sala, I, Catania, C, Zattarin, E, Arnone, P, Grassi, M, Colleoni, M, Wolff, A, Cortes, J, Piccart, M, Gelber, R, Viale, G, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Sala I., Catania C., Zattarin E., Arnone P., Grassi M. M., Colleoni M., Wolff A. C., Cortes J., Piccart M., Gelber R. D., Viale G., Bagnardi V., Conforti F., Pala, L, De Pas, T, Pagan, E, Sala, I, Catania, C, Zattarin, E, Arnone, P, Grassi, M, Colleoni, M, Wolff, A, Cortes, J, Piccart, M, Gelber, R, Viale, G, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Sala I., Catania C., Zattarin E., Arnone P., Grassi M. M., Colleoni M., Wolff A. C., Cortes J., Piccart M., Gelber R. D., Viale G., Bagnardi V., and Conforti F.

Abstract

Background: Controversy exists regarding the optimal duration of the extended adjuvant endocrine treatment (ET) in patients with early-stage breast-cancer (eBC). We performed a systematic review and trial-level meta-analysis of all randomized clinical trials (RCTs) comparing a “limited-extended” adjuvant ET (defined as more than 5 but less than 7.5 years of treatment overall) versus a “full-extended” adjuvant ET (defined as more than 7.5 years of treatment overall) in eBC. Methods: To be eligible, RCTs had to i) compare a “limited-extended” adjuvant ET versus a “full-extended” adjuvant ET in patients with eBC; and ii) report disease-free survival (DFS) hazard ratio (HR) according to the disease nodal-status [i.e., nodal-negative (N-ve) versus nodal-positive (N + ve)]. The primary endpoint was to assess the difference in efficacy of full-versus limited-extended ET, measured in terms of the difference in DFS log-HR, according to the disease nodal-status. Secondary endpoint was the difference in efficacy of full-versus limited-extended ET according to tumor size (i.e., pT1 vs pT2/3/4), histological grade (i.e., G1/G2 vs G3), patients’ age (i.e., ≤60 vs > 60 years) and previous type of ET (i.e., aromatase inhibitors vs tamoxifen vs switch strategy). Results: Three phase III RCTs fulfilled the inclusion criteria. A total of 6689 patients were included in the analysis, of which 3506 (53%) had N + ve disease. The full-extended ET provided no DFS-benefit as compared with the limited-extended ET in patients with N-ve disease (pooled DFS-HR = 1.04, 95%CI: 0.89 to 1.22; I2 = 18%). Conversely, in patients with N + ve disease the full-extended ET significantly improved DFS, with a pooled DFS-HR of 0.85 (95%CI: 0.74 to 0.97; I2 = 0%). There was a significant interaction between the disease nodal-status and the efficacy of the full-versus limited-extended ET (p-heterogeneity = 0.048). The full-extended ET provided no significant DFS-benefit as compared with the limited-extended

Published
2023

14. Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study

Author

Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Mannino, M, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Casa, A, Comberlato, M, Conforti, F, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, Rizzuto, G, Macaluso F. S., Principi M., Facciotti F., Contaldo A., Todeschini A., Saibeni S., Bezzio C., Castiglione F., Nardone O. M., Spagnuolo R., Fantini M. C., Riguccio G., Caprioli F., Vigano C., Felice C., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Mannino M., Rizzo G., Orlando A., Amato A., Ascolani M., Calabrese G., Casa A., Comberlato M., Conforti F. S., De Bona M., Demarzo M. G., Doldo P., Dragoni G., Furfaro F., Mulinacci G., Olmo O., O'Sed N. P., Paba S., Radice S., Renna S., Ribaldone D. G., Rizzuto G., Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Mannino, M, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Casa, A, Comberlato, M, Conforti, F, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, Rizzuto, G, Macaluso F. S., Principi M., Facciotti F., Contaldo A., Todeschini A., Saibeni S., Bezzio C., Castiglione F., Nardone O. M., Spagnuolo R., Fantini M. C., Riguccio G., Caprioli F., Vigano C., Felice C., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Mannino M., Rizzo G., Orlando A., Amato A., Ascolani M., Calabrese G., Casa A., Comberlato M., Conforti F. S., De Bona M., Demarzo M. G., Doldo P., Dragoni G., Furfaro F., Mulinacci G., Olmo O., O'Sed N. P., Paba S., Radice S., Renna S., Ribaldone D. G., and Rizzuto G.

Abstract

Background: Patients on immunosuppressive drugs have been excluded from COVID-19 vaccines trials, creating concerns regarding their efficacy. Aims: To explore the humoral response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD) Methods: Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE-IBD) is a prospective, multicentre study promoted by the Italian Group for the study of Inflammatory Bowel Disease. We present data on serological response eight weeks after the second dose of COVID-19 vaccination in IBD patients and healthy controls (HCs). Results: 1076 patients with IBD and 1126 HCs were analyzed. Seropositivity for anti-SARS-CoV-2 IgG was reported for most IBD patients, even if with a lesser rate compared with HCs (92.1% vs. 97.9%; p<0.001). HCs had higher antibody concentrations (median OD 8.72 [IQR 5.2-14-2]) compared to the whole cohort of IBD patients (median OD 1.54 [IQR 0.8-3.6]; p<0.001) and the subgroup of IBD patients (n=280) without any treatment or on aminosalicylates only (median OD 1.72 [IQR 1.0–4.1]; p<0.001). Conclusions: Although most IBD patients showed seropositivity after COVID-19 vaccines, the magnitude of the humoral response was significantly lower than in HCs. Differently from other studies, these findings seem to be mostly unrelated to the use of immune-modifying treatments (ClinicalTrials.govID:NCT04769258).

Published
2023

15. Genetic Alterations of Melanoma Brain Metastases: A Systematic Review and Meta-Analysis

Author

Pala, L, Bagnardi, V, Tettamanzi, F, Barberis, M, Mazzarol, G, Casali, C, De Pas, T, Pennacchioli, E, Coppola, S, Baldini, F, Cocorocchio, E, Ferrucci, P, Patane', D, Saponara, M, Queirolo, P, Conforti, F, Pala L., Bagnardi V., Tettamanzi F., Barberis M., Mazzarol G., Casali C., De Pas T., Pennacchioli E., Coppola S., Baldini F., Cocorocchio E., Ferrucci P., Patane' D., Saponara M., Queirolo P., Conforti F., Pala, L, Bagnardi, V, Tettamanzi, F, Barberis, M, Mazzarol, G, Casali, C, De Pas, T, Pennacchioli, E, Coppola, S, Baldini, F, Cocorocchio, E, Ferrucci, P, Patane', D, Saponara, M, Queirolo, P, Conforti, F, Pala L., Bagnardi V., Tettamanzi F., Barberis M., Mazzarol G., Casali C., De Pas T., Pennacchioli E., Coppola S., Baldini F., Cocorocchio E., Ferrucci P., Patane' D., Saponara M., Queirolo P., and Conforti F.

Abstract

Background: Data on molecular alterations harbored by melanoma brain metastases (MBMs) are limited, and this has hampered the development of more effective therapeutic strategies. We conducted a systematic review and meta-analysis of all the studies reporting DNA sequencing data of MBMs, in order to identify recurrently mutated genes and molecular pathways significantly enriched for genetic alterations. Methods: We searched PubMed, Embase and Scopus for articles published from the inception of each database to June 30, 2021. We included in the analysis all the studies that reported individual patient data on DNA sequencing of MBMs, assessing single nucleotide variants (SNVs) and/or gene copy number variations (CNVs) in at least five tumor samples. Meta-analysis was performed for genes evaluated for SNVs and/or CNVs in at least two studies. Pooled proportions of samples with SNVs and/or CNVs was calculated by applying random-effect models based on the DerSimonian–Laird method. Gene-set enrichment analysis (GSEA) was performed to identify molecular pathways significantly enriched for mutated genes. Results: Ten studies fulfilled the inclusion criteria and were included in the analysis, for a total of 531 samples of MBMs evaluated. Twenty-seven genes were found recurrently mutated with a meta-analytic rate of SNVs higher than 5%. GSEA conducted on the list of these 27 recurrently mutated genes revealed vascular endothelial growth factor-activated receptor activity and transmembrane receptor protein tyrosine kinase activity to be among the top 10 gene ontology (GO) molecular functions significantly enriched for mutated genes, while regulation of apoptosis and cell proliferation were among the top 10 significantly enriched GO biological processes. Notably, a high meta-analytic rate of SNVs was found in several actionable cancer-associated genes, such as all the vascular endothelial growth factor (VEGF) receptor isoforms (i.e., Flt1 and Flt2 genes, for both SNV rate: 0.22

Published
2023

16. Improved outcomes in women with BRAF-mutant melanoma treated with BRAF/MEK-targeted therapy across randomized clinical trials. A systematic review and meta-analysis

Author

Pala, L, De Pas, T, Pagan, E, Minucci, S, Catania, C, Digiacomo, N, Cocorocchio, E, Laszlo, D, Di Muzio, A, Barigazzi, C, Stucchi, E, De Grandi, L, Stucchi, S, Viale, G, Gelber, R, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Minucci S., Catania C., Digiacomo N., Cocorocchio E., Laszlo D., Di Muzio A., Barigazzi C., Stucchi E., De Grandi L., Stucchi S., Viale G., Gelber R. D., Bagnardi V., Conforti F., Pala, L, De Pas, T, Pagan, E, Minucci, S, Catania, C, Digiacomo, N, Cocorocchio, E, Laszlo, D, Di Muzio, A, Barigazzi, C, Stucchi, E, De Grandi, L, Stucchi, S, Viale, G, Gelber, R, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Minucci S., Catania C., Digiacomo N., Cocorocchio E., Laszlo D., Di Muzio A., Barigazzi C., Stucchi E., De Grandi L., Stucchi S., Viale G., Gelber R. D., Bagnardi V., and Conforti F.

Abstract

Available evidence suggests that in patients with advanced BRAF V600-mutant melanoma treated with the combination of BRAF and MEK inhibitors, gender could be associated with survival outcome. We performed a systematic review and meta-analysis of all randomized clinical trials (RCTs) testing the combination of BRAF and MEK inhibitors, to assess the interaction between treatment effect and patients’ gender. We searched PubMed, MEDLINE, Embase, and Scopus, for phase II and III RCTs up to January 30, 2022. We included all RCTs that enrolled patients with BRAF V600-mutant advanced cutaneous melanoma and assessed combinations of BRAF and MEK inhibitors versus BRAF inhibitor monotherapy. Our aim was to assess differences if any in treatment efficacy between men and women, measured in terms of the differences in progression-free survival (PFS) and overall survival (OS) log-hazard ratios (log-HRs). We calculated the pooled PFS- and OS-HRs with 95% confidence intervals (CIs) in men and women using a random-effects model and assessed the heterogeneity between the estimates using an interaction test. Five RCTs that enrolled a total of 2,113 patients were included in the analysis. In women, the combination of BRAF and MEK inhibitors halved the risk of progression or death as compared with BRAF inhibitor monotherapy with a pooled PFS-HR of 0.50 (95%CI 0.41–0.61). In men, the benefit obtained with BRAF and MEK inhibitors was smaller with a pooled PFS-HR of 0.63 (95%CI 0.54–0.74), P-heterogeneity = .05. A similar trend was observed for OS where the pooled OS-HR was 0.62 (95%CI 0.48–0.80) in women and only 0.78, (95%CI 0.67–0.92) in men, P-heterogeneity = 0.11. These results support meaningful gender-based heterogeneity of response to combination of BRAF and MEK inhibitors targeted therapy in patients with advanced BRAF-mutant melanoma, that should be considered in future research to improve treatment effectiveness.

Published
2023

18. P981 Risankizumab, but not ustekinumab or vedolizumab, downregulates IL-23-induced mucosal pathogenic Th17 cells in patients with Crohn’s disease

Author

Noviello, D, primary, Dusetti, I, additional, Pivorunas, V, additional, Lovati, A E, additional, Ciafardini, C, additional, Amoroso, C, additional, Conforti, F, additional, Piazza O Sed, N, additional, Vecchi, M, additional, Facciotti, F, additional, Paroni, M, additional, and Caprioli, F, additional

Published
2024
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19. P908 Real-life effectiveness and safety of tofacitinib and vedolizumab as a second-line therapy in anti-TNFs experienced patients ulcerative colitis: preliminary results of an IGIBD study (VE2TO-UC)

Author

Noviello, D, primary, Savarino, E, additional, Fries, W, additional, Fantini, M C, additional, Conforti, F, additional, Orlando, A, additional, Ribaldone, D G, additional, Mocci, G, additional, Viganò, C, additional, Festa, S, additional, Spagnuolo, R, additional, Campigotto, M, additional, Grossi, L, additional, Gravina, A G, additional, Principi, M, additional, Imperatore, N, additional, Carvalhas, A, additional, Scardino, G, additional, Scaldaferri, F, additional, Ceccarelli, L, additional, Biancone, L, additional, Di Sario, A, additional, De Barba, C, additional, De Francesco, C, additional, Calderone, S, additional, Onali, S, additional, Vecchi, M, additional, Ventimiglia, M, additional, and Caprioli, F, additional

Published
2024
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20. P921 Maintenance of clinical, biochemical and transmural remission in inflammatory bowel disease patients switching from intravenous to subcutaneous infliximab

Author

Piazza O Sed, N, primary, Maregatti, M C, additional, Pessarelli, T, additional, Viganò, C, additional, Conforti, F, additional, Noviello, D, additional, Bezzio, C, additional, Amoroso, C, additional, Molteni, C, additional, Anolli, M P, additional, Pirola, L, additional, Saibeni, S, additional, Fraquelli, M, additional, Vecchi, M, additional, and Caprioli, F, additional

Published
2024
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27. Chemotherapy in patients with localized angiosarcoma of any site: A retrospective european study

Author

Conforti, F, Gronchi, A, Penel, N, Jones, R, Broto, J, Sala, I, Bagnardi, V, Napolitano, A, Pala, L, Pennacchioli, E, Catania, C, Queirolo, P, Grigani, G, Merlini, A, Stacchiotti, S, Comandone, A, Vincenzi, B, Quagliuolo, V, Bertuzzi, A, Boglione, A, Palassini, E, Baldi, G, Blay, J, Ryckewaert, T, Toulmonde, M, Italiano, A, Le Cesne, A, Ray-Coquard, I, Cruz, J, Hernandez-Leon, C, Trufero, J, da Silva Moura, D, Muniz, N, De Pas, T, Conforti F., Gronchi A., Penel N., Jones R. L., Broto J. M., Sala I., Bagnardi V., Napolitano A., Pala L., Pennacchioli E., Catania C., Queirolo P., Grigani G., Merlini A., Stacchiotti S., Comandone A., Vincenzi B., Quagliuolo V., Bertuzzi A., Boglione A., Palassini E., Baldi G. G., Blay J. -Y., Ryckewaert T., Toulmonde M., Italiano A., Le Cesne A., Ray-Coquard I., Cruz J., Hernandez-Leon C. N., Trufero J. M., da Silva Moura D., Muniz N. H., De Pas T., Conforti, F, Gronchi, A, Penel, N, Jones, R, Broto, J, Sala, I, Bagnardi, V, Napolitano, A, Pala, L, Pennacchioli, E, Catania, C, Queirolo, P, Grigani, G, Merlini, A, Stacchiotti, S, Comandone, A, Vincenzi, B, Quagliuolo, V, Bertuzzi, A, Boglione, A, Palassini, E, Baldi, G, Blay, J, Ryckewaert, T, Toulmonde, M, Italiano, A, Le Cesne, A, Ray-Coquard, I, Cruz, J, Hernandez-Leon, C, Trufero, J, da Silva Moura, D, Muniz, N, De Pas, T, Conforti F., Gronchi A., Penel N., Jones R. L., Broto J. M., Sala I., Bagnardi V., Napolitano A., Pala L., Pennacchioli E., Catania C., Queirolo P., Grigani G., Merlini A., Stacchiotti S., Comandone A., Vincenzi B., Quagliuolo V., Bertuzzi A., Boglione A., Palassini E., Baldi G. G., Blay J. -Y., Ryckewaert T., Toulmonde M., Italiano A., Le Cesne A., Ray-Coquard I., Cruz J., Hernandez-Leon C. N., Trufero J. M., da Silva Moura D., Muniz N. H., and De Pas T.

Abstract

Background: We retrospectively investigated the role of (neo)adjuvant chemotherapy in patients with primary, localized angiosarcoma. Methods: We selected all patients with primary, localized angiosarcoma, who had received radical surgery between January 2005 and December 2019 at 33 European sarcoma reference centers. The primary objective was to compare the outcome of patients who received (neo)adjuvant chemotherapy versus those who did not, in terms of overall survival (OS), disease-free survival (DFS) and distant metastasis-free survival (DMFS). To reduce the risk of confounding due to imbalance, a propensity-score matching(PSM) was performed. Finally, subgroups analysis was performed according to tumor site, tumor size (< 50 mm or ≥ 50 mm) and patients predicted 10-years OS according to the nomogram sarculator (two different cutoff-values were applied: ≤ 33% or > 33% and < 60% or ≥ 60%). Results: 362 patients were analyzed: 149 (41.2%; treated group) received (neo) adjuvant chemotherapy and 213 (58.6%; control group) did not. The median follow-up for the OS endpoint was 5.1 years (95% CI: 4.0–5.5). The OS-HR was 0.58 (95%CI: 0.40–0.83; p-value = 0.003) in the univariate analysis and 0.74 (95% CI: 0.38–1.43; p = 0.367) in the PSM analysis. The DFS-HR was 0.75 (95% CI: 0.57–0.98; p-value = 0.036) in the univariate analysis, and 0.91 (95% CI:0.56–1.48; p-value = 0.7) in the PSM analysis. The DMFS-HR was 0.75 (95% CI: 0.55–1.02; p-value = 0.065) in univariate analysis and 0.92 (95% CI: 0.53–1.61; p-value = 0.769) in the PSM analysis. Subgroup analysis revealed no heterogeneity of results in strata of tumor site. On the contrary, there was a trend for heterogeneity according to tumor size and patient's risk of death. For all the endpoints analyzed, patients with tumors smaller than 50 mm or at lower risk of death seem to have no benefit from chemotherapy, while patients with larger tumors or at higher risk of death at 10 years seem to derive substantial benef

Published
2022

28. Avelumab plus axitinib in unresectable or metastatic type B3 thymomas and thymic carcinomas (CAVEATT): a single-arm, multicentre, phase 2 trial

Author

Conforti, F, Zucali, P, Pala, L, Catania, C, Bagnardi, V, Sala, I, Della Vigna, P, Perrino, M, Zagami, P, Corti, C, Stucchi, S, Barberis, M, Guerini-Rocco, E, Di Venosa, B, De Vincenzo, F, Cordua, N, Santoro, A, Giaccone, G, Martino De Pas, T, Conforti F., Zucali P. A., Pala L., Catania C., Bagnardi V., Sala I., Della Vigna P., Perrino M., Zagami P., Corti C., Stucchi S., Barberis M., Guerini-Rocco E., Di Venosa B., De Vincenzo F., Cordua N., Santoro A., Giaccone G., Martino De Pas T., Conforti, F, Zucali, P, Pala, L, Catania, C, Bagnardi, V, Sala, I, Della Vigna, P, Perrino, M, Zagami, P, Corti, C, Stucchi, S, Barberis, M, Guerini-Rocco, E, Di Venosa, B, De Vincenzo, F, Cordua, N, Santoro, A, Giaccone, G, Martino De Pas, T, Conforti F., Zucali P. A., Pala L., Catania C., Bagnardi V., Sala I., Della Vigna P., Perrino M., Zagami P., Corti C., Stucchi S., Barberis M., Guerini-Rocco E., Di Venosa B., De Vincenzo F., Cordua N., Santoro A., Giaccone G., and Martino De Pas T.

Abstract

Background: Patients with advanced type B3 thymoma and thymic carcinoma resistant to chemotherapy have few treatment options. We report the efficacy and safety results of the combination of the anti-PD-L1 inhibitor avelumab with the anti-angiogenesis drug axitinib in patients with advanced type B3 thymoma and thymic carcinoma. Methods: CAVEATT was a single-arm, multicentre, phase 2 trial, conducted in two Italian centres (the European Instituteof Oncology and the Humanitas Institute, Milan) in patients with histologically confirmed type B3 thymoma or thymic carcinoma, with advanced stage of disease who had progressed after at least one line of platinum-based chemotherapy. Previous treatment with an anti-angiogenesis drug was allowed but not with immune checkpoint inhibitors. Other inclusion criteria were age 18 years or older, an Eastern Cooperative Oncology Group performance status of 0–2, progressive disease, and presence of measurable disease according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Patients received avelumab 10 mg/kg intravenously every 2 weeks and axitinib 5 mg orally twice daily until disease progression or unacceptable toxicity. The primary endpoint was the centrally assessed overall response rate according to RECIST version 1.1. Patients who received at least one cycle of treatment and had at least one CT scan after treatment start at scheduled time point by protocol were judged assessable for response and were included in efficacy and safety analyses. This study is registered with EUDRACT, 2017–004048–38; enrolment is completed and follow-up is ongoing. Findings: Between April 22, 2019, and June 30, 2021, 32 patients were enrolled. 27 patients had a thymic carcinoma, three a type B3 thymoma, and two a mixed type B3 thymoma and thymic carcinoma. 29 (91%) of 32 patients had stage IVB disease and 13 (41%) of 32 had been pretreated with an anti-angiogenesis drug. 11 of 32 patients had an overall response; thus the overall

Published
2022

29. Different Response to Immunotherapy According to Melanoma Histologic Subtype

Author

Pala, L, Conforti, F, Pagan, E, Bagnardi, V, De Pas, T, Mazzarol, G, Barberis, M, Pennacchioli, E, Orsolini, G, Prestianni, P, Zagami, P, Nicolo', E, Patane, D, Saponara, M, Queirolo, P, Pala L., Conforti F., Pagan E., Bagnardi V., De Pas T. M., Mazzarol G., Barberis M., Pennacchioli E., Orsolini G., Prestianni P., Zagami P., Nicolo' E., Patane D., Saponara M., Queirolo P., Pala, L, Conforti, F, Pagan, E, Bagnardi, V, De Pas, T, Mazzarol, G, Barberis, M, Pennacchioli, E, Orsolini, G, Prestianni, P, Zagami, P, Nicolo', E, Patane, D, Saponara, M, Queirolo, P, Pala L., Conforti F., Pagan E., Bagnardi V., De Pas T. M., Mazzarol G., Barberis M., Pennacchioli E., Orsolini G., Prestianni P., Zagami P., Nicolo' E., Patane D., Saponara M., and Queirolo P.

Abstract

Superficial spreading melanoma (SSM) and nodular melanoma (NM) are the most common melanoma histologic subtypes and are characterized by different biological features. We retrospectively analyzed all consecutive patients with advanced melanoma, treated with anti-PD-1 and/or anti-CTLA-4 at our center, with data available on primary tumor subtype. The primary objective was to assess the association between histologic subtype and patients' outcomes. In addition, we analyzed whole-exome and whole-transcriptome sequencing data of a cohort of advanced melanoma to identify genes and related pathways, characterized by significant differences between NMs and SSMs. Twenty-one patients with NM and 39 with SSM, treated with anti-PD-1(53/60) as monotherapy or combined with anti-CTLA-4 (7/60), were analyzed. All known clinical-pathologic prognostic factors were well balanced between NM and SSM groups, except for the ECOG-PS score. The overall response rate was 52.4% (95% confidence interval, 29.8-74.3) in the NMs group versus 20.5% (9.3-36.5) in the SSMs group (P-value=0.02). The median progression-free survival and overall survival were, respectively, 13.9 and 44.5 months in the NMs group versus only 3.2 and 12 months in SSMs group (progression-free survival P-value=0.032; overall survival P-value=0.002). Multivariable analysis adjusting for the ECOG-PS, confirmed similar results. Whole-exome and whole-transcriptome data of 28 NMs and 21 SSMs were analyzed. No significant differences were observed in terms of both TMB and frequency of mutation in any gene. A total of 266 genes were overexpressed in NMs as compared with SSMs, and enrichment-analysis revealed a significant enrichment (false discovery rate<0.05) of genes belonging to immune-related pathways involved in antigens presentation mechanisms, response to interferon gamma and neutrophil activation. We provided clinical evidences suggesting a relevant association between melanoma histologic subtype and response to immuno

Published
2022

30. Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study

Author

Mazza, S, Piazza, O, Conforti, F, Fasci, A, Rimondi, A, Marinoni, B, Casini, V, Ricci, C, Munari, F, Pirola, L, Invernizzi, P, Girelli, C, Lupinacci, G, Pastorelli, L, Cavallaro, F, Ferraris, L, Colucci, A, Amato, A, Eugenio Tontini, G, Vecchi, M, Fiorino, G, Caprioli, F, Mazza S., Piazza O. Sed N., Conforti F. S., Fasci A., Rimondi A., Marinoni B., Casini V., Ricci C., Munari F., Pirola L., Invernizzi P., Girelli C., Lupinacci G., Pastorelli L., Cavallaro F., Ferraris L., Colucci A., Amato A., Eugenio Tontini G., Vecchi M., Fiorino G., Caprioli F., Mazza, S, Piazza, O, Conforti, F, Fasci, A, Rimondi, A, Marinoni, B, Casini, V, Ricci, C, Munari, F, Pirola, L, Invernizzi, P, Girelli, C, Lupinacci, G, Pastorelli, L, Cavallaro, F, Ferraris, L, Colucci, A, Amato, A, Eugenio Tontini, G, Vecchi, M, Fiorino, G, Caprioli, F, Mazza S., Piazza O. Sed N., Conforti F. S., Fasci A., Rimondi A., Marinoni B., Casini V., Ricci C., Munari F., Pirola L., Invernizzi P., Girelli C., Lupinacci G., Pastorelli L., Cavallaro F., Ferraris L., Colucci A., Amato A., Eugenio Tontini G., Vecchi M., Fiorino G., and Caprioli F.

Abstract

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 → SB2) were 98% (95% confidence interval [CI] 94%–100%) and 90% (95% CI 81%–99%), respectively. Four patients experienced a total of five AEs, all graded 1–3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.

Published
2022

31. Sex-related differences in patients with coronavirus disease 2019: Results of the Cardio-COVID-Italy multicentre study

Author

Lombardi, C, Specchia, C, Conforti, F, Rovere, M, Carubelli, V, Agostoni, P, Carugo, S, Danzi, G, Guazzi, M, Mortara, A, Piepoli, M, Porto, I, Sinagra, G, Volterrani, M, Ameri, P, Gnecchi, M, Leonardi, S, Merlo, M, Iorio, A, Bellasi, A, Canale, C, Camporotondo, R, Catagnano, F, Dalla Vecchia, L, Di Pasquale, M, Giovinazzo, S, Maccagni, G, Mapelli, M, Margonato, D, Monzo, L, Nuzzi, V, Oriecuia, C, Pala, L, Peveri, G, Pozzi, A, Provenzale, G, Sarullo, F, Adamo, M, Tomasoni, D, Inciardi, R, Senni, M, Metra, M, Lombardi C. M., Specchia C., Conforti F., Rovere M. T. L., Carubelli V., Agostoni P., Carugo S., Danzi G. B., Guazzi M., Mortara A., Piepoli M., Porto I., Sinagra G., Volterrani M., Ameri P., Gnecchi M., Leonardi S., Merlo M., Iorio A., Bellasi A., Canale C., Camporotondo R., Catagnano F., Dalla Vecchia L. A., Di Pasquale M., Giovinazzo S., Maccagni G., Mapelli M., Margonato D., Monzo L., Nuzzi V., Oriecuia C., Pala L., Peveri G., Pozzi A., Provenzale G., Sarullo F., Adamo M., Tomasoni D., Inciardi R. M., Senni M., Metra M., Lombardi, C, Specchia, C, Conforti, F, Rovere, M, Carubelli, V, Agostoni, P, Carugo, S, Danzi, G, Guazzi, M, Mortara, A, Piepoli, M, Porto, I, Sinagra, G, Volterrani, M, Ameri, P, Gnecchi, M, Leonardi, S, Merlo, M, Iorio, A, Bellasi, A, Canale, C, Camporotondo, R, Catagnano, F, Dalla Vecchia, L, Di Pasquale, M, Giovinazzo, S, Maccagni, G, Mapelli, M, Margonato, D, Monzo, L, Nuzzi, V, Oriecuia, C, Pala, L, Peveri, G, Pozzi, A, Provenzale, G, Sarullo, F, Adamo, M, Tomasoni, D, Inciardi, R, Senni, M, Metra, M, Lombardi C. M., Specchia C., Conforti F., Rovere M. T. L., Carubelli V., Agostoni P., Carugo S., Danzi G. B., Guazzi M., Mortara A., Piepoli M., Porto I., Sinagra G., Volterrani M., Ameri P., Gnecchi M., Leonardi S., Merlo M., Iorio A., Bellasi A., Canale C., Camporotondo R., Catagnano F., Dalla Vecchia L. A., Di Pasquale M., Giovinazzo S., Maccagni G., Mapelli M., Margonato D., Monzo L., Nuzzi V., Oriecuia C., Pala L., Peveri G., Pozzi A., Provenzale G., Sarullo F., Adamo M., Tomasoni D., Inciardi R. M., Senni M., and Metra M.

Abstract

IntroductionThe role of sex compared to comorbidities and other prognostic variables in patients with coronavirus disease (COVID-19) is unclear.MethodsThis is a retrospective observational study on patients with COVID-19 infection, referred to 13 cardiology units. The primary objective was to assess the difference in risk of death between the sexes. The secondary objective was to explore sex-based heterogeneity in the association between demographic, clinical and laboratory variables, and patients' risk of death.ResultsSeven hundred and one patients were included: 214 (30.5%) women and 487 (69.5%) men. During a median follow-up of 15-days, deaths occurred in 39 (18.2%) women and 126 (25.9%) men. In a multivariable Cox regression model, men had a nonsignificantly higher risk of death vs. women (P = 0.07).The risk of death was more than double in men with a low lymphocytes count as compared with men with a high lymphocytes count [overall survival hazard ratio (OS-HR) 2.56, 95% confidence interval (CI) 1.72-3.81]. In contrast, lymphocytes count was not related to death in women (P=0.03).Platelets count was associated with better outcome in men (OS-HR for increase of 50-×-103units: 0.88 95% CI 0.78-1.00) but not in women. The strength of association between higher PaO2/FiO2ratio and lower risk of death was larger in women (OS-HR for increase of 50-mmHg/%: 0.72, 95% CI 0.59-0.89) vs. men (OS-HR: 0.88, 95% CI 0.80-0.98; P-=-0.05).ConclusionsPatients' sex is a relevant variable that should be taken into account when evaluating risk of death from COVID-19. There is a sex-based heterogeneity in the association between baseline variables and patients' risk of death.

Published
2022

32. The HFE p.H63D (p.His63Asp) Polymorphism Is a Modifier of ALS Outcome in Italian and French Patients with SOD1 Mutations

Author

Canosa, A, Calvo, A, Mora, G, Moglia, C, Brunetti, M, Barberis, M, Borghero, G, Caponnetto, C, Trojsi, F, Spataro, R, Volanti, P, Simone, I, Salvi, F, Logullo, F, Riva, N, Tremolizzo, L, Giannini, F, Mandrioli, J, Tanel, R, Murru, M, Mandich, P, Conforti, F, Zollino, M, Sabatelli, M, Tarlarini, C, Lunetta, C, Mazzini, L, D'Alfonso, S, Guy, N, Meininger, V, Clavelou, P, Camu, W, Chiò, A, Canosa, Antonio, Calvo, Andrea, Mora, Gabriele, Moglia, Cristina, Brunetti, Maura, Barberis, Marco, Borghero, Giuseppe, Caponnetto, Claudia, Trojsi, Francesca, Spataro, Rossella, Volanti, Paolo, Simone, Isabella Laura, Salvi, Fabrizio, Logullo, Francesco Ottavio, Riva, Nilo, Tremolizzo, Lucio, Giannini, Fabio, Mandrioli, Jessica, Tanel, Raffaella, Murru, Maria Rita, Mandich, Paola, Conforti, Francesca Luisa, Zollino, Marcella, Sabatelli, Mario, Tarlarini, Claudia, Lunetta, Christian, Mazzini, Letizia, D'Alfonso, Sandra, Guy, Nathalie, Meininger, Vincent, Clavelou, Pierre, Camu, William, Chiò, Adriano, Canosa, A, Calvo, A, Mora, G, Moglia, C, Brunetti, M, Barberis, M, Borghero, G, Caponnetto, C, Trojsi, F, Spataro, R, Volanti, P, Simone, I, Salvi, F, Logullo, F, Riva, N, Tremolizzo, L, Giannini, F, Mandrioli, J, Tanel, R, Murru, M, Mandich, P, Conforti, F, Zollino, M, Sabatelli, M, Tarlarini, C, Lunetta, C, Mazzini, L, D'Alfonso, S, Guy, N, Meininger, V, Clavelou, P, Camu, W, Chiò, A, Canosa, Antonio, Calvo, Andrea, Mora, Gabriele, Moglia, Cristina, Brunetti, Maura, Barberis, Marco, Borghero, Giuseppe, Caponnetto, Claudia, Trojsi, Francesca, Spataro, Rossella, Volanti, Paolo, Simone, Isabella Laura, Salvi, Fabrizio, Logullo, Francesco Ottavio, Riva, Nilo, Tremolizzo, Lucio, Giannini, Fabio, Mandrioli, Jessica, Tanel, Raffaella, Murru, Maria Rita, Mandich, Paola, Conforti, Francesca Luisa, Zollino, Marcella, Sabatelli, Mario, Tarlarini, Claudia, Lunetta, Christian, Mazzini, Letizia, D'Alfonso, Sandra, Guy, Nathalie, Meininger, Vincent, Clavelou, Pierre, Camu, William, and Chiò, Adriano

Abstract

Background: Data from published studies about the effect of HFE polymorphisms on ALS risk, phenotype, and survival are still inconclusive. We aimed at evaluating whether the p.H63D polymorphism is a modifier of phenotype and survival in SOD1-mutated patients. Methods: We included 183 SOD1-mutated ALS patients. Mutations were classified as severe or mild according to the median survival of the study population. Patients were screened for the HFE p.H63D polymorphism. Survival was calculated using the Kaplan–Meier modeling, and differences were measured by the log-rank test. Multivariable analysis was performed with the Cox proportional hazards model (stepwise backward). Results: SOD1 severe mutation carriers show more frequent familial history for ALS and shorter survival compared to mild mutation carriers. Carriers and non-carriers of the p.H63D polymorphism did not differ in terms of sex ratio, frequency of positive familial history, age at onset, and bulbar/spinal ratio. In univariate and in Cox multivariable analysis using sex, age at onset, site of onset, family history, country of origin, and mutation severity as covariates, p.H63D carriers had a longer survival (p = 0.034 and p = 0.004). Conclusions: We found that SOD1-mutated ALS patients carrying the p.H63D HFE polymorphism have a longer survival compared to non-carriers, independently of sex, age and site of onset, family history, nation of origin, and severity of mutations, suggesting a possible role as disease progression modifier for the p.H63D HFE polymorphism in SOD1-ALS.

Published
2023

33. OC.14.2 LACK OF SEROCONVERSION FOLLOWING COVID-19 VACCINATION, BUT NOT TREATMENT, IS AN INDEPENDENT RISK FACTOR FOR BREAKTHROUGH SARS-COV-2 INFECTION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: DATA FROM ESCAPE - AN IGIBD STUDY

Author

Macaluso, F.S., primary, Principi, M., additional, Facciotti, F., additional, Contaldo, A., additional, Todeschini, A., additional, Saibeni, S., additional, Bezzio, C., additional, Castiglione, F., additional, Nardone, O., additional, Spagnuolo, R., additional, Fantini, M., additional, Riguccio, G., additional, Conforti, F., additional, Caprioli, F., additional, Vigano, C., additional, Felice, C., additional, Fiorino, G., additional, Correale, C., additional, Bodini, G., additional, Milla, M., additional, Scardino, G., additional, Vernero, M., additional, Desideri, F., additional, Bossa, F., additional, Guerra, M., additional, Ventimiglia, M., additional, Mannino, M., additional, Rizzo, G., additional, and Orlando, A., additional

Published
2023
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36. Correction to: Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial (Journal of Translational Medicine, (2020), 18, 1, (405), 10.1186/s12967-020-02573-9)

Author

Perrone F., Perrone, F, Piccirillo, M, Ascierto, P, Salvarani, C, Parrella, R, Marata, A, Popoli, P, Ferraris, L, Marrocco-Trischitta, M, Ripamonti, D, Binda, F, Bonfanti, P, Squillace, N, Castelli, F, Muiesan, M, Lichtner, M, Calzetti, C, Salerno, N, Atripaldi, L, Cascella, M, Costantini, M, Dolci, G, Facciolongo, N, Fraganza, F, Massari, M, Montesarchio, V, Mussini, C, Negri, E, Botti, G, Cardone, C, Gargiulo, P, Gravina, A, Schettino, C, Arenare, L, Chiodini, P, Gallo, C, Vitale, M, Trojaniello, C, Palla, M, Bianchi, A, De Feo, G, Miscio, L, Chiodiniy, P, Froldi, M, Menicanti, L, Cuppone, M, Gobbo, G, Baldessari, C, Valenti, V, Castelvecchio, S, Poli, F, Giacomazzi, F, Piccinni, R, Annnunziata, M, Biondi, A, Bussolari, C, Mazzoleni, M, Giachi, A, Filtz, A, Manini, A, Poletti, E, Masserini, F, Conforti, F, Gaudiano, G, Favero, V, Moroni, A, Viva, T, Fancoli, F, Ferrari, D, Niro, D, Resta, M, Ballotta, A, Poli, M, Ranucci, M, Tebaldi, A, Gritti, G, Pasulo, L, Gaglio, L, Del Fabbro, R, Alborghetti, L, Giustinetti, G, Columpsi, P, Cazzaniga, M, Capici, S, Sala, L, Di Sciacca, R, Mosca, G, Pirozzi, M, Perrone F., Piccirillo M. C., Ascierto P. A., Salvarani C., Parrella R., Marata A. M., Popoli P., Ferraris L., Marrocco-Trischitta M. M., Ripamonti D., Binda F., Bonfanti P., Squillace N., Castelli F., Muiesan M. L., Lichtner M., Calzetti C., Salerno N. D., Atripaldi L., Cascella M., Costantini M., Dolci G., Facciolongo N. C., Fraganza F., Massari M., Montesarchio V., Mussini C., Negri E. A., Botti G., Cardone C., Gargiulo P., Gravina A., Schettino C., Arenare L., Chiodini P., Gallo C., Vitale M. G., Trojaniello C., Palla M., Bianchi A. A. M., De Feo G., Miscio L., Chiodiniy P., Froldi M., Menicanti L., Cuppone M. T., Gobbo G., Baldessari C., Valenti V., Castelvecchio S., Poli F., Giacomazzi F., Piccinni R., Annnunziata M. L., Biondi A., Bussolari C., Mazzoleni M., Giachi A., Filtz A., Manini A., Poletti E., Masserini F., Conforti F., Gaudiano G., Favero V., Moroni A., Viva T., Fancoli F., Ferrari D., Niro D., Resta M., Ballotta A., Poli M. D., Ranucci M., Tebaldi A., Gritti G., Pasulo L., Gaglio L., Del Fabbro R., Alborghetti L., Giustinetti G., Columpsi P., Cazzaniga M., Capici S., Sala L., Di Sciacca R., Mosca G., Pirozzi M. R., Perrone F., Perrone, F, Piccirillo, M, Ascierto, P, Salvarani, C, Parrella, R, Marata, A, Popoli, P, Ferraris, L, Marrocco-Trischitta, M, Ripamonti, D, Binda, F, Bonfanti, P, Squillace, N, Castelli, F, Muiesan, M, Lichtner, M, Calzetti, C, Salerno, N, Atripaldi, L, Cascella, M, Costantini, M, Dolci, G, Facciolongo, N, Fraganza, F, Massari, M, Montesarchio, V, Mussini, C, Negri, E, Botti, G, Cardone, C, Gargiulo, P, Gravina, A, Schettino, C, Arenare, L, Chiodini, P, Gallo, C, Vitale, M, Trojaniello, C, Palla, M, Bianchi, A, De Feo, G, Miscio, L, Chiodiniy, P, Froldi, M, Menicanti, L, Cuppone, M, Gobbo, G, Baldessari, C, Valenti, V, Castelvecchio, S, Poli, F, Giacomazzi, F, Piccinni, R, Annnunziata, M, Biondi, A, Bussolari, C, Mazzoleni, M, Giachi, A, Filtz, A, Manini, A, Poletti, E, Masserini, F, Conforti, F, Gaudiano, G, Favero, V, Moroni, A, Viva, T, Fancoli, F, Ferrari, D, Niro, D, Resta, M, Ballotta, A, Poli, M, Ranucci, M, Tebaldi, A, Gritti, G, Pasulo, L, Gaglio, L, Del Fabbro, R, Alborghetti, L, Giustinetti, G, Columpsi, P, Cazzaniga, M, Capici, S, Sala, L, Di Sciacca, R, Mosca, G, Pirozzi, M, Perrone F., Piccirillo M. C., Ascierto P. A., Salvarani C., Parrella R., Marata A. M., Popoli P., Ferraris L., Marrocco-Trischitta M. M., Ripamonti D., Binda F., Bonfanti P., Squillace N., Castelli F., Muiesan M. L., Lichtner M., Calzetti C., Salerno N. D., Atripaldi L., Cascella M., Costantini M., Dolci G., Facciolongo N. C., Fraganza F., Massari M., Montesarchio V., Mussini C., Negri E. A., Botti G., Cardone C., Gargiulo P., Gravina A., Schettino C., Arenare L., Chiodini P., Gallo C., Vitale M. G., Trojaniello C., Palla M., Bianchi A. A. M., De Feo G., Miscio L., Chiodiniy P., Froldi M., Menicanti L., Cuppone M. T., Gobbo G., Baldessari C., Valenti V., Castelvecchio S., Poli F., Giacomazzi F., Piccinni R., Annnunziata M. L., Biondi A., Bussolari C., Mazzoleni M., Giachi A., Filtz A., Manini A., Poletti E., Masserini F., Conforti F., Gaudiano G., Favero V., Moroni A., Viva T., Fancoli F., Ferrari D., Niro D., Resta M., Ballotta A., Poli M. D., Ranucci M., Tebaldi A., Gritti G., Pasulo L., Gaglio L., Del Fabbro R., Alborghetti L., Giustinetti G., Columpsi P., Cazzaniga M., Capici S., Sala L., Di Sciacca R., Mosca G., and Pirozzi M. R.

Published
2021

37. Sex-based differences in response to anti-PD-1 or PD-L1 treatment in patients with non-small-cell lung cancer expressing high PD-L1 levels. A systematic review and meta-analysis of randomized clinical trials

Author

Conforti, F, Pala, L, Pagan, E, Corti, C, Bagnardi, V, Queirolo, P, Catania, C, De Pas, T, Giaccone, G, Conforti, F., Pala, L., Pagan, E., Corti, C., Bagnardi, V., Queirolo, P., Catania, C., De Pas, T., Giaccone, G., Conforti, F, Pala, L, Pagan, E, Corti, C, Bagnardi, V, Queirolo, P, Catania, C, De Pas, T, Giaccone, G, Conforti, F., Pala, L., Pagan, E., Corti, C., Bagnardi, V., Queirolo, P., Catania, C., De Pas, T., and Giaccone, G.

Abstract

Background: In our previous works, we demonstrated that patients’ sex affects the efficacy of immune checkpoint inhibitors (ICIs) in patients with several advanced solid tumors. Here, we assessed the sex-based heterogeneity of efficacy of anti-programmed cell death protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) given as monotherapy, for advanced non-small-cell lung cancer (NSCLC) expressing high PD-L1 levels, to evaluate if available evidence supports this therapeutic option for both women and men. Methods: We carried out a systematic review and meta-analysis including all randomized, controlled trials testing anti-PD-1/anti-PD-L1 drugs in monotherapy, as first-line treatment of advanced NSCLC expressing high PD-L1 levels. The primary endpoint was the difference in efficacy of anti-PD-1/anti-PD-L1 drugs versus chemotherapy, between men and women, measured in terms of the difference in overall survival (OS) log [hazard ratio (HR)] reported in male and female study participants. Results: We analyzed four randomized, controlled trials, including 1672 patients, of whom 1224 (73.2%) were men and 448 (26.8%) were women. The pooled OS-HR comparing anti-PD-1/anti-PD-L1 versus chemotherapy was 0.59 [95% confidence interval (CI), 0.50-0.69] for men and only 0.84 (95% CI, 0.64-1.10) for women. The pooled ratio of the OS-HRs reported in men versus women was 0.71 (95% CI, 0.52-0.98; P-heterogeneity: 0.04), indicating a significantly greater effect for men. No heterogeneity among single-study estimates was observed in either male patients (Q = 2.39, P = 0.50, I2 = 0%) or in female patients (Q = 1.13, P = 0.50, I2 = 0%). Conclusion: Evidence available indicates anti-PD-1/anti-PD-L1 monotherapy as highly effective in men but not in women, even in NSCLCs expressing high PD-L1 levels. Prospective trials testing sex-based tailored immunotherapy strategies are needed.

Published
2021

38. Metaplastic breast cancer: Prognostic and therapeutic considerations

Author

Corso, G, Frassoni, S, Girardi, A, De Camilli, E, Montagna, E, Intra, M, Bottiglieri, L, Margherita De Scalzi, A, Fanianos, D, Magnoni, F, Invento, A, Toesca, A, Conforti, F, Bagnardi, V, Viale, G, Colleoni, M, Veronesi, P, Corso G., Frassoni S., Girardi A., De Camilli E., Montagna E., Intra M., Bottiglieri L., Margherita De Scalzi A., Fanianos D. M., Magnoni F., Invento A., Toesca A., Conforti F., Bagnardi V., Viale G., Colleoni M. A., Veronesi P., Corso, G, Frassoni, S, Girardi, A, De Camilli, E, Montagna, E, Intra, M, Bottiglieri, L, Margherita De Scalzi, A, Fanianos, D, Magnoni, F, Invento, A, Toesca, A, Conforti, F, Bagnardi, V, Viale, G, Colleoni, M, Veronesi, P, Corso G., Frassoni S., Girardi A., De Camilli E., Montagna E., Intra M., Bottiglieri L., Margherita De Scalzi A., Fanianos D. M., Magnoni F., Invento A., Toesca A., Conforti F., Bagnardi V., Viale G., Colleoni M. A., and Veronesi P.

Abstract

Introduction: Metaplastic breast cancer (MBC) is a rare condition of breast tumor with different subtypes, considered a disease with worse prognosis; treatments and survival are often unclear and conflicting. Methods: We consecutively collected 153 primary MBCs of different subtypes. Breast surgery, neoadjuvant or adjuvant treatment, clinic-pathological factors, number and type of events during follow-up were considered to evaluate overall survival (OS) and invasive disease-free survival (IDFS). Results: The majority of MBC was triple-negative (TN) subtype (88.7%), G3 (95.3%), pN0 (70.6%), and with high levels of Ki-67 (93.5%). For OS and IDFS, no significant associations were seen between the different MBC subtypes. The matched triple-negative MBC (TNMBC) and ductal TNBC cohorts had similar prognosis both in terms of OS (p =.411) and IDFS (p =.981). We observed a positive trend for TNMBC patients treated in the adjuvant setting with the cyclofosfamide, methotrexate, 5-fluorouracil protocol for better OS (p =.090) and IDFS (p =.087). A poor or absent response rate was observed in the neoadjuvant setting. Conclusion: Our results demonstrate that metaplastic and ductal breast cancers with TN phenotype are similar in terms of overall and disease-free survival. Metaplastic cancers are poorly responsive to neoadjuvant treatment, and in the absence of novel targeted therapies, surgical treatment remains the first choice.

Published
2021

40. Differential toxicity in an alveolar epithelial cell line of fine particulate matter from brakewear, roadwear, and diesel exhaust

Author

Parkin, J, primary, Dean, L, additional, Cooper, D, additional, Ridley, R, additional, Davies, E, additional, Conforti, F, additional, Bell, J, additional, Wang, Y, additional, Downward, J, additional, Gerlofs-Nijland, M, additional, Cassee, F, additional, Davies, D, additional, Cook, R, additional, and Loxham, M, additional

Published
2022
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43. Different Response to Immunotherapy According to Melanoma Histologic Subtype

Author

Pala L., Conforti F., Pagan E., Bagnardi V., De Pas T. M., Mazzarol G., Barberis M., Pennacchioli E., Orsolini G., Prestianni P., Zagami P., Nicolo' E., Patane D., Saponara M., Queirolo P., Pala, L, Conforti, F, Pagan, E, Bagnardi, V, De Pas, T, Mazzarol, G, Barberis, M, Pennacchioli, E, Orsolini, G, Prestianni, P, Zagami, P, Nicolo', E, Patane, D, Saponara, M, and Queirolo, P

Subjects
histologic subtype, Pharmacology, Cancer Research, Skin Neoplasms, Immunology, Immunology and Allergy, Humans, Immunologic Factors, Immunotherapy, Melanoma, Retrospective Studies
Abstract

Superficial spreading melanoma (SSM) and nodular melanoma (NM) are the most common melanoma histologic subtypes and are characterized by different biological features. We retrospectively analyzed all consecutive patients with advanced melanoma, treated with anti-PD-1 and/or anti-CTLA-4 at our center, with data available on primary tumor subtype. The primary objective was to assess the association between histologic subtype and patients' outcomes. In addition, we analyzed whole-exome and whole-transcriptome sequencing data of a cohort of advanced melanoma to identify genes and related pathways, characterized by significant differences between NMs and SSMs. Twenty-one patients with NM and 39 with SSM, treated with anti-PD-1(53/60) as monotherapy or combined with anti-CTLA-4 (7/60), were analyzed. All known clinical-pathologic prognostic factors were well balanced between NM and SSM groups, except for the ECOG-PS score. The overall response rate was 52.4% (95% confidence interval, 29.8-74.3) in the NMs group versus 20.5% (9.3-36.5) in the SSMs group (P-value=0.02). The median progression-free survival and overall survival were, respectively, 13.9 and 44.5 months in the NMs group versus only 3.2 and 12 months in SSMs group (progression-free survival P-value=0.032; overall survival P-value=0.002). Multivariable analysis adjusting for the ECOG-PS, confirmed similar results. Whole-exome and whole-transcriptome data of 28 NMs and 21 SSMs were analyzed. No significant differences were observed in terms of both TMB and frequency of mutation in any gene. A total of 266 genes were overexpressed in NMs as compared with SSMs, and enrichment-analysis revealed a significant enrichment (false discovery rate

Published
2021

44. Androgen receptor blockade promotes response to BRAF/MEK-targeted therapy

Author

Vellano, C, White, M, Andrews, M, Chelvanambi, M, Witt, R, Daniele, J, Titus, M, Mcquade, J, Conforti, F, Burton, E, Lastrapes, M, Ologun, G, Cogdill, A, Morad, G, Prieto, P, Lazar, A, Chu, Y, Han, G, Khan, M, Helmink, B, Davies, M, Amaria, R, Kovacs, J, Woodman, S, Patel, S, Hwu, P, Peoples, M, Lee, J, Cooper, Z, Zhu, H, Gao, G, Banerjee, H, Lau, M, Gershenwald, J, Lucci, A, Keung, E, Ross, M, Pala, L, Pagan, E, Segura, R, Liu, Q, Borthwick, M, Lau, E, Yates, M, Westin, S, Wani, K, Tetzlaff, M, Haydu, L, Mahendra, M, Ma, X, Logothetis, C, Kulstad, Z, Johnson, S, Hudgens, C, Feng, N, Federico, L, Long, G, Futreal, P, Arur, S, Tawbi, H, Moran, A, Wang, L, Heffernan, T, Marszalek, J, Wargo, J, Vellano, Christopher P., White, Michael G., Andrews, Miles C., Chelvanambi, Manoj, Witt, Russell G., Daniele, Joseph R., Titus, Mark, McQuade, Jennifer L., Conforti, Fabio, Burton, Elizabeth M., Lastrapes, Matthew J., Ologun, Gabriel, Cogdill, Alexandria P., Morad, Golnaz, Prieto, Peter, Lazar, Alexander J., Chu, Yanshuo, Han, Guangchun, Khan, M. A. Wadud, Helmink, Beth, Davies, Michael A., Amaria, Rodabe N., Kovacs, Jeffrey J., Woodman, Scott E., Patel, Sapna, Hwu, Patrick, Peoples, Michael, Lee, Jeffrey E., Cooper, Zachary A., Zhu, Haifeng, Gao, Guang, Banerjee, Hiya, Lau, Mike, Gershenwald, Jeffrey E., Lucci, Anthony, Keung, Emily Z., Ross, Merrick I., Pala, Laura, Pagan, Eleonora, Segura, Rossana Lazcano, Liu, Qian, Borthwick, Mikayla S., Lau, Eric, Yates, Melinda S., Westin, Shannon N., Wani, Khalida, Tetzlaff, Michael T., Haydu, Lauren E., Mahendra, Mikhila, Ma, XiaoYan, Logothetis, Christopher, Kulstad, Zachary, Johnson, Sarah, Hudgens, Courtney W., Feng, Ningping, Federico, Lorenzo, Long, Georgina V., Futreal, P. Andrew, Arur, Swathi, Tawbi, Hussein A., Moran, Amy E., Wang, Linghua, Heffernan, Timothy P., Marszalek, Joseph R., Wargo, Jennifer A., Vellano, C, White, M, Andrews, M, Chelvanambi, M, Witt, R, Daniele, J, Titus, M, Mcquade, J, Conforti, F, Burton, E, Lastrapes, M, Ologun, G, Cogdill, A, Morad, G, Prieto, P, Lazar, A, Chu, Y, Han, G, Khan, M, Helmink, B, Davies, M, Amaria, R, Kovacs, J, Woodman, S, Patel, S, Hwu, P, Peoples, M, Lee, J, Cooper, Z, Zhu, H, Gao, G, Banerjee, H, Lau, M, Gershenwald, J, Lucci, A, Keung, E, Ross, M, Pala, L, Pagan, E, Segura, R, Liu, Q, Borthwick, M, Lau, E, Yates, M, Westin, S, Wani, K, Tetzlaff, M, Haydu, L, Mahendra, M, Ma, X, Logothetis, C, Kulstad, Z, Johnson, S, Hudgens, C, Feng, N, Federico, L, Long, G, Futreal, P, Arur, S, Tawbi, H, Moran, A, Wang, L, Heffernan, T, Marszalek, J, Wargo, J, Vellano, Christopher P., White, Michael G., Andrews, Miles C., Chelvanambi, Manoj, Witt, Russell G., Daniele, Joseph R., Titus, Mark, McQuade, Jennifer L., Conforti, Fabio, Burton, Elizabeth M., Lastrapes, Matthew J., Ologun, Gabriel, Cogdill, Alexandria P., Morad, Golnaz, Prieto, Peter, Lazar, Alexander J., Chu, Yanshuo, Han, Guangchun, Khan, M. A. Wadud, Helmink, Beth, Davies, Michael A., Amaria, Rodabe N., Kovacs, Jeffrey J., Woodman, Scott E., Patel, Sapna, Hwu, Patrick, Peoples, Michael, Lee, Jeffrey E., Cooper, Zachary A., Zhu, Haifeng, Gao, Guang, Banerjee, Hiya, Lau, Mike, Gershenwald, Jeffrey E., Lucci, Anthony, Keung, Emily Z., Ross, Merrick I., Pala, Laura, Pagan, Eleonora, Segura, Rossana Lazcano, Liu, Qian, Borthwick, Mikayla S., Lau, Eric, Yates, Melinda S., Westin, Shannon N., Wani, Khalida, Tetzlaff, Michael T., Haydu, Lauren E., Mahendra, Mikhila, Ma, XiaoYan, Logothetis, Christopher, Kulstad, Zachary, Johnson, Sarah, Hudgens, Courtney W., Feng, Ningping, Federico, Lorenzo, Long, Georgina V., Futreal, P. Andrew, Arur, Swathi, Tawbi, Hussein A., Moran, Amy E., Wang, Linghua, Heffernan, Timothy P., Marszalek, Joseph R., and Wargo, Jennifer A.

Abstract

Treatment with therapy targeting BRAF and MEK (BRAF/MEK) has revolutionized care in melanoma and other cancers; however, therapeutic resistance is common and innovative treatment strategies are needed1,2. Here we studied a group of patients with melanoma who were treated with neoadjuvant BRAF/MEK-targeted therapy (NCT02231775, n = 51) and observed significantly higher rates of major pathological response (MPR; ≤10% viable tumour at resection) and improved recurrence-free survival (RFS) in female versus male patients (MPR, 66% versus 14%, P = 0.001; RFS, 64% versus 32% at 2 years, P = 0.021). The findings were validated in several additional cohorts2–4 of patients with unresectable metastatic melanoma who were treated with BRAF- and/or MEK-targeted therapy (n = 664 patients in total), demonstrating improved progression-free survival and overall survival in female versus male patients in several of these studies. Studies in preclinical models demonstrated significantly impaired anti-tumour activity in male versus female mice after BRAF/MEK-targeted therapy (P = 0.006), with significantly higher expression of the androgen receptor in tumours of male and female BRAF/MEK-treated mice versus the control (P = 0.0006 and P = 0.0025). Pharmacological inhibition of androgen receptor signalling improved responses to BRAF/MEK-targeted therapy in male and female mice (P = 0.018 and P = 0.003), whereas induction of androgen receptor signalling (through testosterone administration) was associated with a significantly impaired response to BRAF/MEK-targeted therapy in male and female patients (P = 0.021 and P < 0.0001). Together, these results have important implications for therapy.

Published
2022

45. Association of Anticancer Immune Checkpoint Inhibitors with Patient-Reported Outcomes Assessed in Randomized Clinical Trials: A Systematic Review and Meta-Analysis

Author

Pala, L, Sala, I, Oriecuia, C, De Pas, T, Queirolo, P, Specchia, C, Cocorocchio, E, Ferrucci, P, Patane, D, Saponara, M, Pennacchioli, E, Coppola, S, Viale, G, Giaccone, G, Gelber, R, Bagnardi, V, Conforti, F, Pala, L, Sala, I, Oriecuia, C, De Pas, T, Queirolo, P, Specchia, C, Cocorocchio, E, Ferrucci, P, Patane, D, Saponara, M, Pennacchioli, E, Coppola, S, Viale, G, Giaccone, G, Gelber, R, Bagnardi, V, and Conforti, F

Abstract

Importance: The association of immune checkpoint inhibitors (ICIs) with patient quality of life has been poorly explored. Objective: To evaluate patient-reported outcomes (PROs) assessed in randomized clinical trials (RCTs) of immunotherapy-based treatments. Data Sources: This systematic review and random-effects meta-Analysis used RCTs identified in PubMed, MEDLINE, Embase, and Scopus from database inception to June 1, 2021. Study Selection: A total of 2259 RCTs were identified that assessed ICIs as monotherapy or in combination with chemotherapy or combined with another ICI and/or targeted therapy vs control groups not containing immunotherapy in patients with advanced solid tumors. Studies were reviewed independently by 2 authors. Data Extraction and Synthesis: This meta-Analysis followed the PRISMA guidelines and recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. Main Outcomes and Measures: The coprimary aims of the meta-Analysis were (1) pooled differences between treatment groups in the mean change of PRO score from baseline to 12 and 24 weeks of follow-up and (2) pooled differences between treatment groups in the time to deterioration of PRO score. For each end point, RCTs have been analyzed according to the type of treatment administered in the experimental group: ICIs given as monotherapy, ICIs combined with chemotherapy, or ICIs in association with another ICI and/or with targeted therapies. Results: Of the 2259 identified RCTs, 34 (18709 patients) met the selection criteria and were analyzed. In the group of 19 RCTs testing ICIs as monotherapy, the pooled between-groups difference of mean change from baseline to 12 weeks of follow-up was 4.6 (95% CI, 2.8-6.4), and the mean change from baseline to 24 weeks of follow-up was 6.1 (95% CI, 4.2-8.1), significantly favoring ICIs. The pooled difference was 1.4 (95% CI,-0.4 to 3.2) at week 12 and 2.5 (95% CI,-0.8 to 5.9) at w

Published
2022

46. IL10 secretion endows intestinal human iNKT cells with regulatory functions towards pathogenic T lymphocytes

Author

Burrello, C, Strati, F, Lattanzi, G, Diaz-Basabe, A, Mileti, E, Giuffrè, M, Lopez, G, Cribiù, F, Trombetta, E, Kallikourdis, M, Cremonesi, M, Conforti, F, Botti, F, Porretti, L, Rescigno, M, Vecchi, M, Fantini, M, Caprioli, F, Facciotti, F, Burrello, Claudia, Strati, Francesco, Lattanzi, Georgia, Diaz-Basabe, Angelica, Mileti, Erika, Giuffrè, Maria Rita, Lopez, Gianluca, Cribiù, Fulvia Milena, Trombetta, Elena, Kallikourdis, Marinos, Cremonesi, Marco, Conforti, Francesco, Botti, Fiorenzo, Porretti, Laura, Rescigno, Maria, Vecchi, Maurizio, Fantini, Massimo C, Caprioli, Flavio, Facciotti, Federica, Burrello, C, Strati, F, Lattanzi, G, Diaz-Basabe, A, Mileti, E, Giuffrè, M, Lopez, G, Cribiù, F, Trombetta, E, Kallikourdis, M, Cremonesi, M, Conforti, F, Botti, F, Porretti, L, Rescigno, M, Vecchi, M, Fantini, M, Caprioli, F, Facciotti, F, Burrello, Claudia, Strati, Francesco, Lattanzi, Georgia, Diaz-Basabe, Angelica, Mileti, Erika, Giuffrè, Maria Rita, Lopez, Gianluca, Cribiù, Fulvia Milena, Trombetta, Elena, Kallikourdis, Marinos, Cremonesi, Marco, Conforti, Francesco, Botti, Fiorenzo, Porretti, Laura, Rescigno, Maria, Vecchi, Maurizio, Fantini, Massimo C, Caprioli, Flavio, and Facciotti, Federica

Abstract

BACKGROUND AND AIMS: Invariant natural killer T [iNKT] cells perform pleiotropic functions in different tissues by secreting a vast array of pro-inflammatory and cytotoxic molecules. However, the presence and function of human intestinal iNKT cells capable of secreting immunomodulatory molecules such as IL-10 has never been reported so far. Here we describe for the first time the presence of IL10-producing iNKT cells [NKT10 cells] in the intestinal lamina propria of healthy individuals and of Crohn's disease [CD] patients. METHODS: Frequency and phenotype of NKT10 cells were analysed ex vivo from intestinal specimens of Crohn's disease [n = 17] and controls [n = 7]. Stable CD-derived intestinal NKT10 cell lines were used to perform in vitro suppression assays and co-cultures with patient-derived mucosa-associated microbiota. Experimental colitis models were performed by adoptive cell transfer of splenic naïve CD4+ T cells in the presence or absence of IL10-sufficient or -deficient iNKT cells. In vivo induction of NKT10 cells was performed by administration of short chain fatty acids [SCFA] by oral gavage. RESULTS: Patient-derived intestinal NKT10 cells demonstrated suppressive capabilities towards pathogenic CD4+ T cells. The presence of increased proportions of mucosal NKT10 cells associated with better clinical outcomes in CD patients. Moreover, an intestinal microbial community enriched in SCFA-producing bacteria sustained the production of IL10 by iNKT cells. Finally, IL10-deficient iNKT cells failed to control the pathogenic activity of adoptively transferred CD4+ T cells in an experimental colitis model. CONCLUSIONS: These results describe an unprecedentd IL10-mediated immunoregulatory role of intestinal iNKT cells in controlling the pathogenic functions of mucosal T helper subsets and in maintaining the intestinal immune homeostasis.

Published
2022

48. Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

Author

Perrone, F, Piccirillo, M, Ascierto, P, Salvarani, C, Parrella, R, Marata, A, Popoli, P, Ferraris, L, Marrocco-trischitta, M, Ripamonti, D, Binda, F, Bonfanti, P, Squillace, N, Castelli, F, Muiesan, M, Lichtner, M, Calzetti, C, Salerno, N, Atripaldi, L, Cascella, M, Costantini, M, Dolci, G, Facciolongo, N, Fraganza, F, Massari, M, Montesarchio, V, Mussini, C, Negri, E, Botti, G, Cardone, C, Gargiulo, P, Gravina, A, Schettino, C, Arenare, L, Chiodini, P, Gallo, C, Vitale, M, Trojaniello, C, Palla, M, Bianchi, A, De Feo, G, Miscio, L, Froldi, M, Menicanti, L, Cuppone, M, Gobbo, G, Baldessari, C, Valenti, V, Castelvecchio, S, Poli, F, Giacomazzi, F, Piccinni, R, Annnunziata, M, Biondi, A, Bussolari, C, Mazzoleni, M, Giachi, A, Filtz, A, Manini, A, Poletti, E, Masserini, F, Conforti, F, Gaudiano, G, Favero, V, Moroni, A, Viva, T, Fancoli, F, Ferrari, D, Niro, D, Resta, M, Ballotta, A, Poli, M, Ranucci, M, Tebaldi, A, Gritti, G, Pasulo, L, Gaglio, L, Del Fabbro, R, Alborghetti, L, Giustinetti, G, Columpsi, P, Cazzaniga, M, Capici, S, Sala, L, Di Sciacca, R, Mosca, G, Pirozzi, M, Franceschini, F, Roccaro, A, Salvetti, M, Paini, A, Corda, L, Ricci, C, Tomasoni, L, Nasta, P, Lorenzotti, S, Odolini, S, Foca, E, Roldan, E, Metra, M, Magrini, S, Borghetti, P, Latronico, N, Piva, S, Filippini, M, Tomasoni, G, Zuccala, F, Cattaneo, S, Scolari, F, Bossini, N, Gaggiotti, M, Properzi, M, Del Giudice, E, Marocco, R, Carraro, A, Del Borgo, C, Belvisi, V, Tieghi, T, De Masi, M, Zuccala, P, Fabietti, P, Vetica, A, Mercurio, V, Fondaco, L, Kertusha, B, Curtolo, A, Lubrano, R, Zotti, M, Puorto, A, Ciuffreda, M, Sarni, A, Monteforte, G, Romeo, D, Viola, E, Damiani, C, Barone, A, Mantovani, B, Di Sanzo, D, Gentili, V, Carletti, M, Aiuti, M, Gallo, A, Meliante, P, Martellucci, S, Riggio, O, Cardinale, V, Ridola, L, Bragazzi, M, Gioia, S, Valenzi, E, Graziosi, C, Bina, N, Fasolo, M, Ricci, S, Gioacchini, M, Lucci, A, Corso, L, Tornese, D, Nijhawan, P, Equitani, F, Cosentino, C, Palladino, M, Leonetti, F, Leto, G, Gnessi, C, Campagna, G, Cesareo, R, Marrocco, F, Straface, G, Mecozzi, A, Cerbo, L, Isgro, V, Parrocchia, S, Visconti, G, Casati, G, Ariani, A, Donghi, L, Tacconelli, E, Bertoldi, M, Cattaneo, P, Lambertenghi, L, Motta, L, Omega, L, Albano, G, Scarano, F, De Rosa, A, Buglione, A, Lavoretano, S, Gaglione, G, De Marco, M, Sangiovanni, V, Fusco, F, Viglietti, R, Manzillo, E, Rescigno, C, Pisapia, R, Plamieri, G, Maraolo, A, Calabria, G, Catalano, M, Fiorentino, G, Annunziata, A, Polistina, G, Imitazione, P, Mollica, M, Esposito, V, D'Abraccio, M, Punzi, R, Bianco, V, Sbreglia, C, Del Vecchio, R, Bordonali, A, Franco, A, Salsi, P, Fontana, M, Virzi, G, Ornella, C, Molteni, A, Gennarini, S, Gnudi, U, Ricci, M, Titolo, G, Mensi, G, Vuotto, P, Gasperini, B, Mancini, M, Pasquini, Z, Spanu, P, Clementi, S, Pierini, S, Bokor, D, Gori, D, Ciofetti, M, Caimi, M, Bettazzi, L, Allevi, E, Furiani, S, Capitanio, C, Mastropasqua, B, Fara, C, Pulitano, G, Matsuno, J, Porta, F, Dolfini, V, Beyene, N, Bezzi, M, Novali, M, Viale, P, Tedeschi, S, Pascale, R, Bruno, R, Di Filippo, A, Sachs, M, Oggionni, T, Di Stefano, M, Mengoli, C, Facchini, C, Daniele, D, Frausini, G, Mucci, L, Tedesco, S, Girolimetti, R, Manfredini, E, Di Carlo, A, Espinosa, E, Dennetta, D, Ticinesi, A, Meschi, T, Nouvenne, A, Claudio, N, Vitale, F, Saracco, M, Codeluppi, M, Fronti, E, Ferrante, P, Nespola, G, Francisci, D, Tosti, A, Carbonelli, C, Greco, A, Tinti, M, Stellini, R, Appiani, C, Reghenzi, P, Poletti, V, Ravaglia, C, Tacconi, D, Malcontenti, C, Sainaghi, P, Landi, R, Vassia, V, Rizzi, E, Bellan, M, Rossati, A, Castello, L, Mastroianni, C, Russo, G, Fabio, T, Serino, F, Brollo, L, Momesso, E, Turati, M, Monforte, A, Marchetti, G, Boni, F, Teopompi, E, Trenti, C, Boracchia, L, Minelli, E, Ghidoni, G, Matei, A, Caruso, A, Arcoleo, G, Camarda, G, Catalano, F, Spatafora, M, Bettega, D, Andreoni, M, Teti, E, Sarmati, L, Di Lorenzo, A, Celeste, M, Baratto, F, Monticelli, J, Criveller, P, Andrea, A, Anselmo, R, Castellano, M, Cappelli, C, Corvini, F, Zanini, B, Crippa, M, Ronconi, M, Costa, R, Casella, S, Brentana, L, Bernardi, L, Frascati, A, Panese, S, Presotto, F, Michieletto, L, Bernardi, C, Fusar, M, Agnoletti, V, Farina, M, Russo, Lavorini, F, Ginanni, R, Palmieri, F, Mosti, S, Amaglio, A, Cattaneo, A, Cirri, S, Montisci, A, Gallazzi, C, Cosseta, D, Baronio, B, Rampa, L, Maggi, P, Messina, V, Berlendis, M, Sabatti, M, Palumbo, M, Mazzone, A, Faggioli, P, Bussini, L, Fornaro, G, Volpato, F, Imperiale, D, Manno, E, Ferreri, E, Martelli, D, Verhovez, A, Giorgis, S, Faccio, L, Quadri, R, Negro, C, Converso, M, Bosco, F, Amadasi, S, Prandini, P, Cocchi, S, Manfrin, V, Del Punta, V, Mazzola, G, Sportato, G, Romagnoli, M, Cristini, F, Facondini, F, Perin, T, Boschi, A, Meschiari, M, Guaraldi, G, Modica, S, Moneta, S, Boccalatte, D, Marchetti, V, Ebbreo, G, Dale, M, Tura, P, Rizzoni, D, Boari, G, Bonetti, S, Marini, E, Daniele, I, Grossi, P, Delfrate, N, Bernhart, O, Spizzo, G, Mahlknecht, K, Volkl, T, Di Pietro, M, Trezzi, M, Monacci, C, Peris, A, Bonizzoli, M, Cavanna, L, Moroni, C, Stroppa, E, Savio, M, Gatti, F, Bartolaminelli, C, Petrosillo, N, Donno, D, Taglietti, F, Topino, S, Chinello, P, Galati, V, D'Offizi, G, Taibi, C, Cimolato, B, Moroni, F, Palagano, N, Pelagatti, L, Cristiana, S, Landini, G, Amitrano, M, Raimondo, M, Mangiacapra, S, Romano, A, Atteno, M, Blanc, P, Suardi, L, Pallotto, C, Casinelli, K, Uccella, I, Harari, S, Caminati, A, Lipani, F, Di Perri, G, Calcagno, A, Calleri, G, Montrucchio, C, Caputo, A, Cozzio, S, Donne, L, Bassetti, M, Malgorzata, M, Nicolini, L, Russo, C, Sepulcri, C, Beltramini, S, Mina, F, Puoti, M, Gandino, A, Langer, T, D'Amico, F, Rocchetti, C, Cettolo, F, Gabriele, F, Bocchi, P, Cioni, G, Cappi, C, Corcione, S, De Rosa, F, Scabini, S, Canta, F, Pinna, S, Pensa, A, Rocco, M, Cirasa, M, Spinicci, M, Mencarini, J, Zammarchi, L, Giovanni, C, Sciole, K, Bassi, F, Bianchi, M, Frigerio, S, Spaziani, S, Nucera, A, Rizzardini, G, Cossu, M, Antivalle, M, Carpinteri, G, Macheda, S, Labate, D, Bottiroli, M, Erne, E, Cristina, Z, Di Biase, V, Malberti, F, Montani, G, Poisa, P, Bettini, D, Cauda, R, Ciccullo, A, Riccardi, N, Angheben, A, Turrini, M, Clerici, R, Gardellini, A, Liparulo, L, Rossini, T, Ucciferri, C, Cipollone, F, Vecchiet, J, Nico, A, Marra, L, Leone, A, Sdanganelli, A, Palmiotti, G, D'Alagni, G, Santantonio, T, Caputo, S, Bottalico, I, Ponticiello, A, Di Perna, F, Bernardi, E, Beltrame, A, Bravi, S, David, M, Bernardi, P, Galante, D, Uccelli, M, Prestini, K, Drera, M, Zini, E, Peregrinelli, A, Blanzuoli, L, Benedetti, V, Calvi, R, Scaglione, N, Nallino, G, Bonazzi, M, Crespi, T, Masolin, T, Regazzetti, A, Cerri, M, Maffezzini, E, Piazza, M, Papetti, C, Filippi, C, Roveda, E, Cipolla, G, Scozzafava, M, Crepaldi, M, Henchi, S, Vanoni, N, Repossi, A, Vezzoli, M, Scorletti, E, Perugini, O, Pasini, S, Pacetti, V, Ferrari, L, de Paduanis, G, Del Duca, S, Dell'Ara, F, Brocchieri, A, Minoja, G, Storti, E, Pitagora, L, Costa, I, Delfanti, F, Orlandi, M, Ruggeri, R, Ruggieri, L, Livigni, S, Silengo, D, Ageno, W, Pedrini, L, Artiol, S, Morbidoni, L, De Donno, G, Ravagnani, V, Inglese, F, Scotton, P, Costantini, P, Delucchi, M, Clini, E, Ansuini, A, Marco, B, Giuseppe, L, Vincenzo, B, Rastelli, G, Doria, A, Vianello, A, Cattelan, A, Bindoli, S, Felicietti, M, Canetta, C, Scartabellati, A, Accordino, S, Ferrara, M, Cocco, L, Cirillo, F, Pace, E, De Caro, M, Alberico, M, Benigni, G, Damiano, T, Fusco, P, Iuorio, A, Torretta, G, Racagni, M, Muttini, S, Sala, G, Ghiringhelli, P, Chiumiento, F, Baccari, L, Luca, B, Bocchi, F, Benatti, F, Catellani, J, Coppola, M, Papi, A, Bosco, E, Lazzeri, C, Cesira, N, Puttini, C, Carli, T, Croci, L, Corridi, M, Arlotti, M, Guerrini, G, Cola, L, Romanelli, M, Bonifazi, M, Gasparini, S, Mei, F, Cerutti, E, Lacedonia, D, Santoro, A, Guidelli, G, Greco, S, Castellan, A, Infantino, G, Camici, L, Frigieri, F, Pavoni, V, Migliori, L, Rossetti, B, Montagnini, F, Mauro, I, Genovese, E, Capuozzo, A, Vitiello, L, Sirignano, E, Gnesin, P, Servillo, G, Marinelli, A, Pasero, D, Casadio, L, Babudieri, S, Madeddu, G, De Vito, A, Ranghitta, M, Passalacqua, R, Antonio, F, Gentile, I, Buonomo, A, Scotto, R, Zappulo, E, Dell'Aquila, G, Bianchetti, A, Guerini, F, Vallone, A, Oppedisano, P, Pusterla, L, Giglio, O, Sartori, E, Zanardini, C, Gatti, P, Vincenzo, V, Piconi, S, Molteni, C, Dognini, G, Cosimo, F, Guarneri, L, Pulvirenti, F, Mondino, V, Traballi, G, Iemoli, E, Grisolia, A, Giorgi, R, Nucera, G, Raffaelli, V, Marino, P, Negro, E, Serati, L, Silvia, T, Iacobello, C, Strano, G, Boglione, L, Catania, A, Gipponi, P, Di Cato, L, Panaccione, A, Vitale, G, Crippa, I, Giacomini, M, Basile, A, Andrea, B, Tundo, P, Buzzigoli, S, Palmiero, G, Magnaca, A, Silva, M, Crespi, S, Pasquino, B, Consales, G, Bragantini, D, Mastroianni, F, Righetti, G, Scarafino, A, Bitetto, M, Franzetti, F, Piga, S, Delmonte, V, Carbonara, S, Losappio, R, Dejaco, C, Del Bono, V, Gilioli, F, Barzan, D, De Struppi, S, Carlotto, A, Guadagnin, M, Girardis, M, Bertellini, E, Dentali, F, Foresta, G, Baratta, A, Viviani, R, Agrati, A, Perego, G, Montineri, A, Manuele, R, Bonfante, S, Aquilini, D, Prozzo, A, Santopuoli, D, Di Rosa, Z, Alborghetti, A, Peci, P, Bakhtadze, N, Pandini, C, Ashofarir, N, Casella, G, Spagnolli, W, Urru, S, Marchesoni, I, Caminiti, G, Argilloni, E, Danieli, E, Ghirardi, G, Antonioli, C, Lipari, A, Zavarise, P, Kokaly, F, Polati, E, Gottin, L, Lucernoni, P, De Conti, F, Marcon, E, Pontali, E, Vacca, E, Saffioti, C, Zunino, A, Pognuz, E, Berlot, G, Saltori, M, Tedesco, A, Agostini, C, Di Rosolini, M, Marino, F, Bellinzona, G, Grassi, W, Di Carlo, M, Scimonello, G, Nonini, S, Mondino, M, Mantovani, L, Tenti, E, Tropea, C, Di Stefano, D, Guelfi, P, Dagna, L, Morgana, G, Montemurro, L, Girelli, D, Crisafulli, E, Maroccia, A, Cemuschi, A, Bernasconi, M, Zummo, U, Barbato, V, Bevilacqua, S, Buonfanti, G, Canzanella, G, De Matteis, G, Florio, M, Martino, M, Ribecco, M, Romano, F, Savio, A, Sparavigna, L, Curvietto, M, Citarella, M, Nava, V, Maggioni, P, Magni, M, Iommelli, C, Bianco, A, Corsini, R, Valli, L, Ruggieri, M, Mancini, A, Melica, T, Ferrari, A, Cicognini, D, Delliponti, M, Zuccarini, A, Ciani, S, Raffaeli, D, Donati, L, Cannizzo, S, Lui, S, Santini, L, Roncaglia, E, Mighali, P, Eisendle, F, Cerino, G, Citterio, C, Di Nunzio, C, Lamonica, S, Resimini, S, Sarteschi, G, Pavei, C, Battistini, N, Gazzola, E, Miceli, M, Pontiggia, S, Lonati, V, Giannandrea, G, Sortino, C, Ravani, S, Uggeri, C, Jocolle, G, Bare, C, Baroni, I, De Candia, D, Fiorini, B, Chierico, K, Romeo, F, Bottega, R, Boccasile, L, Corsaro, A, Spadoni, C, Ria, E, Chiari, S, Ercolino, G, Dell'Uomo, V, Viri, S, Minato, M, Gazzola, L, Dorina, B, Gianelli, D, Maspero, S, Farinazzo, M, Zanini, P, Sangiovanni, A, Del Giudice, A, Dragonetti, M, Bordignon, S, Machiavelli, A, Chiodelli, G, Spatarella, M, Zenoni, D, Beretta, F, Santilli, G, Badagliacca, R, Angileri, M, Giannelli, L, Campomori, A, Maimone, P, Fadda, A, Faoro, S, Pisterna, A, Cacopardo, B, Marino, A, Pampaloni, A, Celesia, B, Cinnella, G, Labella, D, Caporusso, R, Danzi, M, Fiscon, M, Malena, M, Fendt, D, Nardi, S, Stobbione, P, Savi, M, De Monte, A, Scala, A, Liberato, N, Luchi, S, Vincenti, A, Cabrini, L, Pinelli, G, Brugioni, L, Potenza, D, Numis, F, Porta, G, D'Amico, M, Iengo, B, Angarano, G, Saracino, A, Blasi, L, De Negri, P, Angelici, S, Farina, A, Martino, G, Bitti, G, Tedeschi, A, De Ponti, S, Agostinone, A, Parruti, G, Consorte, A, Frattari, A, Filippelli, A, Pagliano, P, Masullo, A, Sellitto, C, Reta, M, Rossi, N, Raumer, L, Andreassi, S, Brancaleoni, P, Carai, A, Salerno, A, Marinangeli, F, Mariani, R, Ciccone, A, Meschini, C, Santoboni, G, Angrisani, C, Micarelli, D, Tarquini, G, Fregoni, V, Volta, C, Cherubini, A, Del Prete, M, Ciarrochi, E, Tasca, F, Ballarin, A, Bianchin, A, Flocco, R, Cuzzone, V, Carpinteri, M, Gallotti, P, Torre, F, Zannetti, P, Crapis, M, Venturini, S, Barattini, M, Gori, G, Mastroianni, A, De Stefano, G, Gilio, M, Rapisarda, G, Gulisano, L, Granata, M, Saglimbene, S, Montalto, M, Grasso, I, De Luca, S, Magro, G, Messina, F, Scapino, B, Abrate, P, Francisco, C, Pesce, L, Navarra, M, Agosti, M, Pagani, S, Piluso, M, Ricioppo, A, Tognella, S, Rovere, P, Vincenzi, M, Ghirardi, L, Generali, D, Ingrosso, M, Desiderio, E, Molaro, R, Vitiello, S, Lancione, L, Paone, T, Meli, A, Mainardi, S, Rastellino, V, Ursillo, A, Grigoli, P, Bovetto, E, Stefanetto, I, Mazzola, F, Daniele, A, Bisio, C, Delnero, P, Morando, G, Nava, A, Francesco, L, Fiammengo, F, Regis, M, Roccatello, D, Sabato, E, Liccardi, M, Bretto, C, Lutri, L, Castenetto, E, Roberti, G, Guidi, M, Bini, F, Zappa, M, Trequattrini, T, Rivitti, R, Vigliarolo, R, Succu, A, Lilli, M, Serao, M, Giogre, G, Ruggieri, A, Flores, K, Vairo, G, Satira, R, Lingua, A, Spina, R, Nicastri, E, Maffongelli, G, Barreca, F, Scollet, S, Franchi, F, Fabbri, C, Minuz, P, Dalbeni, A, Zanatta, P, Gelormini, D, Mandelli, A, Galderisi, F, Zoia, E, Marchi, M, Neves, N, Carbone, G, Di Caterino, E, Petrone, A, Usai, C, Bandiera, F, Monti, R, Hofer, A, Castiglione, G, Angeletti, C, Tarsia, P, Veronese, L, Artoni, P, Larussa, D, Fumagalli, R, Brioschi, P, Cerutti, A, Pasquino, P, Gilberto, F, Cantadori, L, Coppola, N, Spolveri, S, Pollastri, C, Fico, L, Principi, T, Pierantozzi, S, Fontana, C, Lubrano, G, Martinelli, L, Navalesi, P, Serra, E, Cogi, E, Manzi, A, Furino, E, Dasseni, N, Gentilini, C, Benatti, E, Pignatti, A, Aiello, G, Milia, M, Covesnon, M, Brianti, A, Francesco, C, Ilaria, B, Pagnozzi, F, Mietta, S, Rossi, A, Maroni, L, Borroni, V, Bellintani, C, Sgarabotto, C, Bizzotto, G, Bucci, L, Spagnuolo, G, Agostini, M, Caria, F, Testa, F, De Palma, R, Murdaca, G, Zanolini, G, Sala, N, Righini, E, Pontremoli, R, Aondio, G, Riccardi, F, De Cristoforo, M, De Michele, F, Storti, A, Perra, R, Deidda, S, Enrica, C, Valastro, F, Pierfranceschi, M, De Gennaro, F, Nardecchia, A, Castellini, M, Buetto, G, Ippoliti, G, Sicheri, D, Bottoli, M, De Arroyabe, B, Versaci, A, Pallotti, G, Civita, M, Grio, M, Liuzzi, N, Molino, P, Pastorelli, M, Ricchiardi, A, Varbella, F, Zeme, A, Sighieri, C, Portale, G, Olivetti, A, Pagnoni, C, Moschini, G, Boni, S, Guerra, A, Scudellari, R, Vella, S, Inchiostro, S, Piazza, O, Guarino, S, Aldegheri, G, Napoli, G, Morettini, A, Caldini, E, Menicacci, L, Pieralli, F, Torrini, M, Poggesi, L, Visetti, E, Mangano, C, Visconti, S, Maietta, P, Banfi, E, Cartella, S, Venturi, B, Nuceri, A, Chiesa, E, Pacentra, E, Panzolato, G, Giannotti, M, Bianchi, C, Pietrangelo, A, Para, O, Rutili, M, Russo, R, Lanfranco, M, Scalabrino, E, Tafuri, A, Chiarello, T, Perfetti, E, Cancanelli, L, Otero, M, Pannella, G, Bellucci, F, Ferrero, G, Vico, C, Stillante, M, D'Andrea, G, Amoroso, F, Arcidiacono, A, Bella, A, Belsito, A, Berte, Y, Carubia, G, Caruso, M, Casella, O, Chiereleson, F, Costa, C, De Franco, D, Germana, G, Messina, A, Musumeci, D, Noto, C, Valenti, M, Sorrentino, C, Panico, R, Schettino, G, Piccoli, J, Pepe, A, Ottaviano, M, Marrazzo, G, Raponi, G, Diberardino, S, Bausi, S, Marini, S, Giubellino, E, Innocenti, G, Gugliemi, G, Maccari, D, Baciu, I, Perrone F., Piccirillo M. C., Ascierto P. A., Salvarani C., Parrella R., Marata A. M., Popoli P., Ferraris L., Marrocco-trischitta M. M., Ripamonti D., Binda F., Bonfanti P., Squillace N., Castelli F., Muiesan M. L., Lichtner M., Calzetti C., Salerno N. D., Atripaldi L., Cascella M., Costantini M., Dolci G., Facciolongo N. C., Fraganza F., Massari M., Montesarchio V., Mussini C., Negri E. A., Botti G., Cardone C., Gargiulo P., Gravina A., Schettino C., Arenare L., Chiodini P., Gallo C., Vitale M. G., Trojaniello C., Palla M., Bianchi A. A. M., De Feo G., Miscio L., Froldi M., Menicanti L., Cuppone M. T., Gobbo G., Baldessari C., Valenti V., Castelvecchio S., Poli F., Giacomazzi F., Piccinni R., Annnunziata M. L., Biondi A., Bussolari C., Mazzoleni M., Giachi A., Filtz A., Manini A., Poletti E., Masserini F., Conforti F., Gaudiano G., Favero V., Moroni A., Viva T., Fancoli F., Ferrari D., Niro D., Resta M., Ballotta A., Poli M. D., Ranucci M., Tebaldi A., Gritti G., Pasulo L., Gaglio L., Del Fabbro R., Alborghetti L., Giustinetti G., Columpsi P., Cazzaniga M., Capici S., Sala L., Di Sciacca R., Mosca G., Pirozzi M. R., Franceschini F., Roccaro A., Salvetti M., Paini A., Corda L., Ricci C., Tomasoni L., Nasta P., Lorenzotti S., Odolini S., Foca E., Roldan E. Q., Metra M., Magrini S., Borghetti P., Latronico N., Piva S., Filippini M., Tomasoni G., Zuccala F., Cattaneo S., Scolari F., Bossini N., Gaggiotti M., Properzi M., Del Giudice E., Marocco R., Carraro A., Del Borgo C., Belvisi V., Tieghi T., De Masi M., Zuccala P., Fabietti P., Vetica A., Mercurio V. S., Fondaco L., Kertusha B., Curtolo A., Lubrano R., Zotti M. G., Puorto A., Ciuffreda M., Sarni A., Monteforte G., Romeo D., Viola E., Damiani C., Barone A., Mantovani B., Di Sanzo D., Gentili V., Carletti M., Aiuti M., Gallo A., Meliante P. G., Martellucci S., Riggio O., Cardinale V., Ridola L., Bragazzi M. 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B., Montineri A., Manuele R., Bonfante S., Aquilini D., Prozzo A., Santopuoli D., Di Rosa Z., Alborghetti A., Peci P., Bakhtadze N., Pandini C. S., Ashofarir N., Casella G., Spagnolli W., Urru S., Marchesoni I., Caminiti G., Argilloni E., Danieli E., Ghirardi G., Antonioli C. M., Lipari A., Zavarise P., Kokaly F., Polati E., Gottin L., Lucernoni P., De Conti F., Marcon E., Pontali E., Vacca E. B., Saffioti C., Zunino A., Pognuz E. R., Berlot G., Saltori M., Tedesco A., Agostini C., Di Rosolini M. A., Marino F., Bellinzona G., Grassi W., Di Carlo M., Scimonello G., Nonini S., Mondino M., Mantovani L. F., Tenti E., Tropea C. M. G., Di Stefano D. E., Guelfi P., Dagna L., Morgana G., Montemurro L., Girelli D., Crisafulli E., Maroccia A., Cemuschi A. M., Bernasconi M., Zummo U., Barbato V., Bevilacqua S., Buonfanti G., Canzanella G., De Matteis G., Florio M., Martino M., Ribecco M. T., Romano F., Savio A., Sparavigna L., Curvietto M., Citarella M., Nava V., Maggioni P., Magni M., Iommelli C., Bianco A., Corsini R., Valli L., Ruggieri M. P., Mancini A., Melica T., Ferrari A., Cicognini D., Delliponti M., Zuccarini A., Ciani S., Raffaeli D., Donati L., Cannizzo S., Lui S., Santini L., Roncaglia E., Mighali P., Eisendle F., Cerino G., Citterio C., Di Nunzio C., Lamonica S., Resimini S., Sarteschi G., Pavei C., Battistini N., Gazzola E., Miceli M., Pontiggia S., Lonati V., Giannandrea G., Sortino C., Ravani S., Uggeri C., Jocolle G., Bare C., Baroni I., De Candia D., Fiorini B., Chierico K., Romeo F., Bottega R., Boccasile L., Corsaro A., Spadoni C., Ria E., Chiari S., Ercolino G., Dell'uomo V., Viri S., Minato M., Gazzola L., Dorina B., Gianelli D., Maspero S., Farinazzo M., Zanini P., Sangiovanni A., Del Giudice A., Dragonetti M. M., Bordignon S., Machiavelli A. M., Chiodelli G., Spatarella M., Zenoni D., Beretta F. N., Santilli G., Badagliacca R., Angileri M., Giannelli L., Campomori A., Maimone P., Fadda A., Faoro S., Pisterna A., Cacopardo B., Marino A., Pampaloni A., Celesia B. M., Cinnella G., Labella D., Caporusso R. R., Danzi M., Fiscon M., Malena M., Fendt D., Nardi S., Stobbione P., Savi M. L., De Monte A., Scala A., Liberato N. L., Luchi S., Vincenti A., Cabrini L., Pinelli G., Brugioni L., Potenza D., Numis F. G., Porta G., D'amico M., Iengo B., Angarano G., Saracino A., Blasi L., De Negri P., Angelici S., Farina A., Martino G. P., Bitti G., Tedeschi A., De Ponti S., Agostinone A., Parruti G., Consorte A., Frattari A., Filippelli A., Pagliano P., Masullo A., Sellitto C., Reta M., Rossi N., Raumer L., Andreassi S., Brancaleoni P., Carai A., Salerno A. M., Marinangeli F., Mariani R., Ciccone A., Meschini C., Santoboni G., Angrisani C., Micarelli D., Tarquini G., Fregoni V., Volta C. A., Cherubini A., Del Prete M. S., Ciarrochi E., Tasca F., Ballarin A., Bianchin A., Flocco R., Cuzzone V., Carpinteri M., Gallotti P., Torre F., Zannetti P., Crapis M., Venturini S., Barattini M., Gori G., Mastroianni A., De Stefano G., Gilio M., Rapisarda G., Gulisano L., Granata M. L., Saglimbene S., Montalto M. T., Grasso I., De Luca S., Magro G., Messina F., Scapino B., Abrate P., Francisco C., Pesce L., Navarra M., Agosti M., Pagani S., Piluso M., Ricioppo A., Tognella S., Rovere P., Vincenzi M., Ghirardi L., Generali D., Ingrosso M., Desiderio E., Molaro R., Vitiello S., Lancione L., Paone T. C., Meli A., Mainardi S., Rastellino V., Ursillo A., Grigoli P. D., Bovetto E., Stefanetto I. M., Mazzola F., Daniele A., Bisio C., Delnero P., Morando G., Nava A., Francesco L., Fiammengo F., Regis M., Roccatello D., Sabato E., Liccardi M. M., Bretto C., Lutri L., Castenetto E., Roberti G., Guidi M. F., Bini F., Zappa M. C., Trequattrini T., Rivitti R., Vigliarolo R., Succu A., Lilli M., Serao M., Giogre G., Ruggieri A., Flores K., Vairo G., Satira R., Lingua A., Spina R., Nicastri E., Maffongelli G., Barreca F., Scollet S., Franchi F., Fabbri C., Minuz P., Dalbeni A., Zanatta P., Gelormini D., Mandelli A., Galderisi F., Zoia E., Marchi M. R., Neves N. D. A., Carbone G., Di Caterino E., Petrone A., Usai C. A., Bandiera F., Monti R., Hofer A., Castiglione G., Angeletti C., Tarsia P., Veronese L., Artoni P. D., Larussa D., Fumagalli R., Brioschi P., Cerutti A., Pasquino P., Gilberto F., Cantadori L., Tomasoni L. R., Coppola N., Spolveri S., Pollastri C., Fico L., Principi T., Pierantozzi S., Fontana C. C., Lubrano G., Martinelli L., Navalesi P., Serra E., Cogi E., Manzi A., Furino E., Dasseni N., Gentilini C., Benatti E., Pignatti A., Aiello G., Milia M., Covesnon M. G., Brianti A., Francesco C., Ilaria B., Pagnozzi F., Mietta S., Rossi A., Maroni L., Borroni V., Bellintani C., Sgarabotto C., Bizzotto G., Bucci L., Spagnuolo G., Agostini M., Caria F. C., Testa F., De Palma R., Murdaca G., Zanolini G., Sala N., Righini E., Pontremoli R., Aondio G., Riccardi F., De Cristoforo M. G., De Michele F., Storti A., Perra R., Deidda S., Enrica C., Valastro F., Pierfranceschi M. G., De Gennaro F., Nardecchia A. L., Castellini M., Buetto G., Ippoliti G., Sicheri D., Bottoli M. G., De Arroyabe B. M. L., Versaci A., Pallotti G., Civita M., Grio M., Liuzzi N., Molino P., Pastorelli M., Ricchiardi A., Varbella F., Zeme A. D., Sighieri C., Portale G., Olivetti A., Pagnoni C., Moschini G., Boni S., Guerra A., Scudellari R., Vella S., Inchiostro S., Piazza O., Guarino S., Aldegheri G., Napoli G., Morettini A., Caldini E., Menicacci L., Pieralli F., Torrini M., Poggesi L., Visetti E. M., Mangano C., Visconti S., Maietta P., Banfi E., Cartella S., Venturi B., Nuceri A., Chiesa E., Pacentra E., Panzolato G., Giannotti M., Bianchi C., Pietrangelo A., Para O., Rutili M. S., Russo R., Lanfranco M., Scalabrino E., Tafuri A., Chiarello T., Perfetti E., Cancanelli L., Otero M., Pannella G., Bellucci F., Ferrero G., Vico C., Stillante M. S., D'andrea G., Amoroso F., Arcidiacono A., Bella A. M., Belsito A., Berte Y., Carubia G., Caruso M. G., Casella O., Chiereleson F., Costa C., De Franco D., Germana G., Messina A., Musumeci D., Noto C., Valenti M., Sorrentino C., Panico R., Schettino G., Piccoli J., Pepe A., De Rosa F., Ottaviano M., Marrazzo G., Raponi G., Diberardino S., Bausi S., Marini S. F., Giubellino E., Innocenti G., Gugliemi G., Maccari D., Baciu I., Perrone, F, Piccirillo, M, Ascierto, P, Salvarani, C, Parrella, R, Marata, A, Popoli, P, Ferraris, L, Marrocco-trischitta, M, Ripamonti, D, Binda, F, Bonfanti, P, Squillace, N, Castelli, F, Muiesan, M, Lichtner, M, Calzetti, C, Salerno, N, Atripaldi, L, Cascella, M, Costantini, M, Dolci, G, Facciolongo, N, Fraganza, F, Massari, M, Montesarchio, V, Mussini, C, Negri, E, Botti, G, Cardone, C, Gargiulo, P, Gravina, A, Schettino, C, Arenare, L, Chiodini, P, Gallo, C, Vitale, M, Trojaniello, C, Palla, M, Bianchi, A, De Feo, G, Miscio, L, Froldi, M, Menicanti, L, Cuppone, M, Gobbo, G, Baldessari, C, Valenti, V, Castelvecchio, S, Poli, F, Giacomazzi, F, Piccinni, R, Annnunziata, M, Biondi, A, Bussolari, C, Mazzoleni, M, Giachi, A, Filtz, A, Manini, A, Poletti, E, Masserini, F, Conforti, F, Gaudiano, G, Favero, V, Moroni, A, Viva, T, Fancoli, F, Ferrari, D, Niro, D, Resta, M, Ballotta, A, Poli, M, Ranucci, M, Tebaldi, A, 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A., Titolo G., Mensi G., Vuotto P., Gasperini B., Mancini M., Pasquini Z., Spanu P., Clementi S., Pierini S., Bokor D., Gori D., Ciofetti M., Caimi M., Bettazzi L., Allevi E., Furiani S., Capitanio C., Mastropasqua B., Fara C., Pulitano G., Matsuno J. S., Porta F. D., Dolfini V., Beyene N. B., Bezzi M., Novali M., Viale P., Tedeschi S., Pascale R., Bruno R., Di Filippo A., Sachs M., Oggionni T., Di Stefano M., Mengoli C., Facchini C., Daniele D. N., Frausini G., Mucci L., Tedesco S., Girolimetti R., Manfredini E., Di Carlo A. M., Espinosa E., Dennetta D., Ticinesi A., Meschi T., Nouvenne A., Claudio N., Vitale F., Saracco M., Codeluppi M., Fronti E., Ferrante P., Nespola G. A., Francisci D., Tosti A., Carbonelli C. M., Greco A., Tinti M. G., Stellini R., Appiani C., Reghenzi P., Poletti V., Ravaglia C., Tacconi D., Malcontenti C., Sainaghi P. P., Landi R., Vassia V., Rizzi E., Bellan M., Rossati A., Castello L., Mastroianni C. M., Russo G., Fabio T., Serino F. 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D., Negro C., Converso M., Bosco F., Amadasi S., Prandini P., Cocchi S., Manfrin V., Del Punta V., Mazzola G., Sportato G., Romagnoli M., Cristini F., Facondini F., Perin T., Boschi A., Meschiari M., Guaraldi G., Modica S., Moneta S., Boccalatte D., Marchetti V., Ebbreo G., Dale M., Tura P., Rizzoni D., Boari G. E. M., Bonetti S., Marini E., Daniele I., Grossi P. A., Delfrate N. W., Bernhart O., Spizzo G., Mahlknecht K., Volkl T., Di Pietro M. A., Trezzi M., Monacci C., Peris A., Bonizzoli M., Cavanna L., Moroni C., Stroppa E. M., Savio M. C., Gatti F., Bartolaminelli C., Petrosillo N., Donno D. R., Taglietti F., Topino S., Chinello P., Galati V., D'offizi G., Taibi C., Cimolato B., Moroni F., Palagano N., Pelagatti L., Cristiana S., Landini G., Amitrano M., Raimondo M., Mangiacapra S., Romano A., Atteno M., Blanc P., Suardi L. R., Pallotto C., Casinelli K., Uccella I., Harari S., Caminati A., Lipani F., Di Perri G., Calcagno A., Calleri G., Montrucchio C., Caputo A. M., Cozzio S., Donne L. D., Bassetti M., Malgorzata M., Nicolini L. A., Russo C., Sepulcri C., Beltramini S., Mina F., Puoti M., Gandino A., Langer T., D'amico F., Rocchetti C., Cettolo F., Gabriele F., Bocchi P., Cioni G., Cappi C., Corcione S., De Rosa F. G., Scabini S., Canta F., Pinna S. M., Pensa A., Rocco M., Cirasa M. T., Spinicci M., Mencarini J., Zammarchi L., Giovanni C., Sciole K., Bassi F., Bianchi M., Frigerio S., Spaziani S., Nucera A., Rizzardini G., Cossu M. V., Antivalle M., Carpinteri G., Macheda S., Labate D., Bottiroli M., Erne E. M., Cristina Z., Di Biase V., Malberti F., Montani G., Poisa P., Bettini D., Cauda R., Ciccullo A., Riccardi N., Angheben A., Turrini M., Clerici R., Gardellini A., Liparulo L., Rossini T., Ucciferri C., Cipollone F., Vecchiet J., Nico A., Marra L., Leone A., Sdanganelli A., Palmiotti G. A., D'alagni G., Santantonio T. A., Caputo S. L., Bottalico I., Ponticiello A., Di Perna F., Bernardi E., Beltrame A., Bravi S., David M., Bernardi P., Galante D., Uccelli M. C., Prestini K., Drera M., Zini E., Peregrinelli A., Blanzuoli L., Benedetti V., Calvi R., Scaglione N., Nallino G., Bonazzi M., Crespi T., Masolin T., Regazzetti A., Cerri M. C., Maffezzini E., Piazza M., Papetti C., Filippi C. D., Roveda E., Cipolla G., Scozzafava M., Crepaldi M., Henchi S., Vanoni N., Repossi A., Vezzoli M., Scorletti E., Perugini O., Pasini S. M., Pacetti V., Ferrari L., de Paduanis G. A., Del Duca S., Dell'ara F., Brocchieri A., Minoja G., Storti E., Pitagora L., Costa I., Delfanti F., Orlandi M., Ruggeri R., Ruggieri L., Livigni S., Silengo D., Ageno W., Pedrini L., Artiol S., Morbidoni L., De Donno G., Ravagnani V., Inglese F., Scotton P. G., Costantini P., Delucchi M., Clini E., Ansuini A., Marco B., Giuseppe L., Vincenzo B., Rastelli G., Doria A., Vianello A., Cattelan A. M., Bindoli S., Felicietti M., Canetta C., Scartabellati A., Accordino S., Ferrara M., Cocco L., Cirillo F., Pace E., De Caro M., Alberico M., Benigni G., Damiano T., Fusco P., Iuorio A., Torretta G., Racagni M., Muttini S., Sala G., Ghiringhelli P., Chiumiento F., Baccari L., Luca B., Bocchi F., Benatti F., Catellani J., Coppola M., Papi A., Bosco E., Lazzeri C., Cesira N., Puttini C., Carli T., Croci L., Corridi M., Arlotti M., Guerrini G., Cola L., Romanelli M., Bonifazi M., Gasparini S., Mei F., Cerutti E., Lacedonia D., Santoro A., Guidelli G. M., Greco S., Castellan A., Infantino G., Camici L., Frigieri F. C., Pavoni V., Migliori L., Rossetti B., Montagnini F., Mauro I., Genovese E., Capuozzo A., Vitiello L., Sirignano E., Gnesin P., Servillo G., Marinelli A., Pasero D., Casadio L., Babudieri S., Madeddu G., De Vito A., Ranghitta M., Passalacqua R., Antonio F., Gentile I., Buonomo A. R., Scotto R., Zappulo E., Dell'aquila G., Bianchetti A., Guerini F., Vallone A., Oppedisano P., Pusterla L., Giglio O., Sartori E., Zanardini C., Gatti P., Vincenzo V., Piconi S., Molteni C., Dognini G., Cosimo F., Guarneri L., Pulvirenti F., Mondino V., Traballi G., Iemoli E., Grisolia A., Giorgi R., Nucera G., Raffaelli V., Marino P., Negro E., Serati L., Silvia T., Iacobello C., Strano G., Boglione L., Catania A., Gipponi P., Di Cato L., Panaccione A., Vitale G., Crippa I. A., Giacomini M., Basile A., Andrea B., Tundo P., Buzzigoli S., Palmiero G., Magnaca A., Silva M., Ricci M., Crespi S., Pasquino B., Consales G., Bragantini D., Mastroianni F., Righetti G., Scarafino A., Bitetto M., Franzetti F., Piga S., Delmonte V., Carbonara S., Losappio R., Dejaco C., Mastroianni C., Del Bono V., Gilioli F., Barzan D., De Struppi S., Carlotto A., Guadagnin M. L., Girardis M., Bertellini E., Dentali F., Foresta G., Baratta A., Viviani R., Agrati A. M., Perego G. B., Montineri A., Manuele R., Bonfante S., Aquilini D., Prozzo A., Santopuoli D., Di Rosa Z., Alborghetti A., Peci P., Bakhtadze N., Pandini C. S., Ashofarir N., Casella G., Spagnolli W., Urru S., Marchesoni I., Caminiti G., Argilloni E., Danieli E., Ghirardi G., Antonioli C. M., Lipari A., Zavarise P., Kokaly F., Polati E., Gottin L., Lucernoni P., De Conti F., Marcon E., Pontali E., Vacca E. B., Saffioti C., Zunino A., Pognuz E. R., Berlot G., Saltori M., Tedesco A., Agostini C., Di Rosolini M. A., Marino F., Bellinzona G., Grassi W., Di Carlo M., Scimonello G., Nonini S., Mondino M., Mantovani L. F., Tenti E., Tropea C. M. G., Di Stefano D. E., Guelfi P., Dagna L., Morgana G., Montemurro L., Girelli D., Crisafulli E., Maroccia A., Cemuschi A. M., Bernasconi M., Zummo U., Barbato V., Bevilacqua S., Buonfanti G., Canzanella G., De Matteis G., Florio M., Martino M., Ribecco M. T., Romano F., Savio A., Sparavigna L., Curvietto M., Citarella M., Nava V., Maggioni P., Magni M., Iommelli C., Bianco A., Corsini R., Valli L., Ruggieri M. P., Mancini A., Melica T., Ferrari A., Cicognini D., Delliponti M., Zuccarini A., Ciani S., Raffaeli D., Donati L., Cannizzo S., Lui S., Santini L., Roncaglia E., Mighali P., Eisendle F., Cerino G., Citterio C., Di Nunzio C., Lamonica S., Resimini S., Sarteschi G., Pavei C., Battistini N., Gazzola E., Miceli M., Pontiggia S., Lonati V., Giannandrea G., Sortino C., Ravani S., Uggeri C., Jocolle G., Bare C., Baroni I., De Candia D., Fiorini B., Chierico K., Romeo F., Bottega R., Boccasile L., Corsaro A., Spadoni C., Ria E., Chiari S., Ercolino G., Dell'uomo V., Viri S., Minato M., Gazzola L., Dorina B., Gianelli D., Maspero S., Farinazzo M., Zanini P., Sangiovanni A., Del Giudice A., Dragonetti M. M., Bordignon S., Machiavelli A. M., Chiodelli G., Spatarella M., Zenoni D., Beretta F. N., Santilli G., Badagliacca R., Angileri M., Giannelli L., Campomori A., Maimone P., Fadda A., Faoro S., Pisterna A., Cacopardo B., Marino A., Pampaloni A., Celesia B. M., Cinnella G., Labella D., Caporusso R. R., Danzi M., Fiscon M., Malena M., Fendt D., Nardi S., Stobbione P., Savi M. L., De Monte A., Scala A., Liberato N. L., Luchi S., Vincenti A., Cabrini L., Pinelli G., Brugioni L., Potenza D., Numis F. G., Porta G., D'amico M., Iengo B., Angarano G., Saracino A., Blasi L., De Negri P., Angelici S., Farina A., Martino G. P., Bitti G., Tedeschi A., De Ponti S., Agostinone A., Parruti G., Consorte A., Frattari A., Filippelli A., Pagliano P., Masullo A., Sellitto C., Reta M., Rossi N., Raumer L., Andreassi S., Brancaleoni P., Carai A., Salerno A. M., Marinangeli F., Mariani R., Ciccone A., Meschini C., Santoboni G., Angrisani C., Micarelli D., Tarquini G., Fregoni V., Volta C. A., Cherubini A., Del Prete M. S., Ciarrochi E., Tasca F., Ballarin A., Bianchin A., Flocco R., Cuzzone V., Carpinteri M., Gallotti P., Torre F., Zannetti P., Crapis M., Venturini S., Barattini M., Gori G., Mastroianni A., De Stefano G., Gilio M., Rapisarda G., Gulisano L., Granata M. L., Saglimbene S., Montalto M. T., Grasso I., De Luca S., Magro G., Messina F., Scapino B., Abrate P., Francisco C., Pesce L., Navarra M., Agosti M., Pagani S., Piluso M., Ricioppo A., Tognella S., Rovere P., Vincenzi M., Ghirardi L., Generali D., Ingrosso M., Desiderio E., Molaro R., Vitiello S., Lancione L., Paone T. C., Meli A., Mainardi S., Rastellino V., Ursillo A., Grigoli P. D., Bovetto E., Stefanetto I. M., Mazzola F., Daniele A., Bisio C., Delnero P., Morando G., Nava A., Francesco L., Fiammengo F., Regis M., Roccatello D., Sabato E., Liccardi M. M., Bretto C., Lutri L., Castenetto E., Roberti G., Guidi M. F., Bini F., Zappa M. C., Trequattrini T., Rivitti R., Vigliarolo R., Succu A., Lilli M., Serao M., Giogre G., Ruggieri A., Flores K., Vairo G., Satira R., Lingua A., Spina R., Nicastri E., Maffongelli G., Barreca F., Scollet S., Franchi F., Fabbri C., Minuz P., Dalbeni A., Zanatta P., Gelormini D., Mandelli A., Galderisi F., Zoia E., Marchi M. R., Neves N. D. A., Carbone G., Di Caterino E., Petrone A., Usai C. A., Bandiera F., Monti R., Hofer A., Castiglione G., Angeletti C., Tarsia P., Veronese L., Artoni P. D., Larussa D., Fumagalli R., Brioschi P., Cerutti A., Pasquino P., Gilberto F., Cantadori L., Tomasoni L. R., Coppola N., Spolveri S., Pollastri C., Fico L., Principi T., Pierantozzi S., Fontana C. C., Lubrano G., Martinelli L., Navalesi P., Serra E., Cogi E., Manzi A., Furino E., Dasseni N., Gentilini C., Benatti E., Pignatti A., Aiello G., Milia M., Covesnon M. G., Brianti A., Francesco C., Ilaria B., Pagnozzi F., Mietta S., Rossi A., Maroni L., Borroni V., Bellintani C., Sgarabotto C., Bizzotto G., Bucci L., Spagnuolo G., Agostini M., Caria F. C., Testa F., De Palma R., Murdaca G., Zanolini G., Sala N., Righini E., Pontremoli R., Aondio G., Riccardi F., De Cristoforo M. G., De Michele F., Storti A., Perra R., Deidda S., Enrica C., Valastro F., Pierfranceschi M. G., De Gennaro F., Nardecchia A. L., Castellini M., Buetto G., Ippoliti G., Sicheri D., Bottoli M. G., De Arroyabe B. M. L., Versaci A., Pallotti G., Civita M., Grio M., Liuzzi N., Molino P., Pastorelli M., Ricchiardi A., Varbella F., Zeme A. D., Sighieri C., Portale G., Olivetti A., Pagnoni C., Moschini G., Boni S., Guerra A., Scudellari R., Vella S., Inchiostro S., Piazza O., Guarino S., Aldegheri G., Napoli G., Morettini A., Caldini E., Menicacci L., Pieralli F., Torrini M., Poggesi L., Visetti E. M., Mangano C., Visconti S., Maietta P., Banfi E., Cartella S., Venturi B., Nuceri A., Chiesa E., Pacentra E., Panzolato G., Giannotti M., Bianchi C., Pietrangelo A., Para O., Rutili M. S., Russo R., Lanfranco M., Scalabrino E., Tafuri A., Chiarello T., Perfetti E., Cancanelli L., Otero M., Pannella G., Bellucci F., Ferrero G., Vico C., Stillante M. S., D'andrea G., Amoroso F., Arcidiacono A., Bella A. M., Belsito A., Berte Y., Carubia G., Caruso M. G., Casella O., Chiereleson F., Costa C., De Franco D., Germana G., Messina A., Musumeci D., Noto C., Valenti M., Sorrentino C., Panico R., Schettino G., Piccoli J., Pepe A., De Rosa F., Ottaviano M., Marrazzo G., Raponi G., Diberardino S., Bausi S., Marini S. F., Giubellino E., Innocenti G., Gugliemi G., Maccari D., and Baciu I.

Abstract

Background: Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods: A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results: In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P = 0.52) and 22.4% (97.5% CI: 17.2-28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions: Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).

Published
2020

49. EGFR-TKI plus anti-angiogenic drugs in EGFR-mutated non–small cell lung cancer: A meta-analysis of randomized clinical trials

Author

Conforti, F, Pala, L, Bagnardi, V, Specchia, C, Oriecuia, C, Marra, A, Zagami, P, Morganti, S, Tarantino, P, Catania, C, de Marinis, F, Queirolo, P, de Pas, T, Conforti F., Pala L., Bagnardi V., Specchia C., Oriecuia C., Marra A., Zagami P., Morganti S., Tarantino P., Catania C., de Marinis F., Queirolo P., de Pas T., Conforti, F, Pala, L, Bagnardi, V, Specchia, C, Oriecuia, C, Marra, A, Zagami, P, Morganti, S, Tarantino, P, Catania, C, de Marinis, F, Queirolo, P, de Pas, T, Conforti F., Pala L., Bagnardi V., Specchia C., Oriecuia C., Marra A., Zagami P., Morganti S., Tarantino P., Catania C., de Marinis F., Queirolo P., and de Pas T.

Abstract

Background: Results of several randomized clinical trials (RCTs) testing the combination of an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) plus an anti-angiogenic drug in advanced EGFR-mutated non–small cell lung cancer were reported. Methods: We first report a systematic review and meta-analysis of all RCTs to estimate effectiveness and toxicity of this new therapeutic approach compared with first-generation EGFR-TKI monotherapy. Subsequently, we present a network meta-analysis comparing the combination of an EGFR-TKI plus an anti-angiogenic drug with 2 new treatment options: combination of an EGFR-TKI plus chemotherapy or new EGFR-TKIs of second or third generation as monotherapy. Results: Five RCTs were included in the first meta-analysis. The progression-free survival (PFS) was statistically significantly larger in patients treated with an EGFR-TKI plus an anti-angiogenic drug compared with EGFR-TKI monotherapy: the pooled PFS–hazard ratio (HR) was 0.59 (95% confidence interval [CI] 1⁄4 0.51 to 0.69). The pooled median-PFS was 17.8 months (95% CI 1⁄4 16.5 to 19.3 months) for the combination vs 11.7 months (95% CI 1⁄4 11.1 to 12.7 months) for EGFR-TKI as monotherapy. No statistically significant differences between the 2 treatment arms were observed in overall survival or objective response rate. The rate of grade equal or higher than 3 adverse events was statistically significantly higher in patients treated with EGFR-TKI plus an anti-angiogenic drug: the pooled-relative risk was 1.72 (95% CI 1⁄4 1.43 to 2.06). Ten RCTs were included in the network meta-analysis. All 3 experimental treatments were associated with a statistically significant improvement in PFS compared with first-generation EGFR-TKIs. When compared to each other, none of the 3 experimental treatments were statistically significantly associated with larger PFS or lower rate of grade 3 or higher adverse events. Conclusion: Patients with EGFR-mutated non small-cell lung c

Published
2020

50. Effectiveness of intensive clinical and radiological follow-up in patients with surgically resected NSCLC. Analysis of 2661 patients from the prospective MAGRIT trial

Author

Conforti, F, Pala, L, Pagan, E, Bagnardi, V, Zagami, P, Spaggiari, L, Catania, C, Vansteenkiste, J, Giaccone, G, De Pas, T, Conforti F., Pala L., Pagan E., Bagnardi V., Zagami P., Spaggiari L., Catania C., Vansteenkiste J., Giaccone G., De Pas T., Conforti, F, Pala, L, Pagan, E, Bagnardi, V, Zagami, P, Spaggiari, L, Catania, C, Vansteenkiste, J, Giaccone, G, De Pas, T, Conforti F., Pala L., Pagan E., Bagnardi V., Zagami P., Spaggiari L., Catania C., Vansteenkiste J., Giaccone G., and De Pas T.

Abstract

Background: Limited evidence is available on effectiveness of clinicoradiological follow-up of early-stage NSCLC patients. MAGRIT was a phase III adjuvant RCT conducted in surgically resected stage IB-IIIA NSCLC patients, in which all participants had a prospectively defined intensive clinicoradiological follow-up. Methods: At patient-level data, we analyzed detection modality of disease recurrences and new primary lung cancer (i.e. detected by clinicoradiological scheduled exams versus by interim unscheduled exams), features associated with higher risk of locoregional and/or distant recurrence, and recurrence rates over time. Results: In the 2261 patients studied, there was a significant association between the type of recurrence and the modality of detection: 88.4% (95% CI, 84%–91%) of the locoregional recurrences and 93.2% (95% CI, 84%–99%) of the new primary lung cancers were detected by scheduled exams, whereas this was only 68.7% (95% CI, 65%–73%) for distant metastases (p < 0.001). Survival of patients with locoregional recurrence or new primary lung cancer detected by scheduled exams was significantly better as compared with those detected by unscheduled exams (HR 0.56, 95% CI 0.36–0.87; p = 0.01). Survival was similarly poor in patients with distant recurrences, both with scheduled and unscheduled detection (3-year survival after recurrence 22.0% and 21.8%, respectively). Recurrence rate was the highest in the first 18 months after surgery—with a peak between month 6 and 12—decreasing thereafter. The hazard of a second primary lung cancer was constant over time. Conclusion: Intensive follow-up is effective in detecting locoregional recurrences and second primary lung cancers, with impact on patients’ survival but did not influence the detection of distant recurrences.

Published
2020

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