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3. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians’ attitudes

Author

Cortellini, A., Leonetti, A., Catino, A., Pizzutillo, P., Ricciuti, B., De Giglio, A., Chiari, R., Bordi, P., Santini, D., Giusti, R., De Tursi, M., Brocco, D., Zoratto, F., Rastelli, F., Citarella, F., Russano, M., Filetti, M., Marchetti, P., Berardi, R., Torniai, M., Cortinovis, D., Sala, E., Maggioni, C., Follador, A., Macerelli, M., Nigro, O., Tuzi, A., Iacono, D., Migliorino, M. R., Banna, G., Porzio, G., Cannita, K., Ferrara, M. G., Bria, E., Galetta, D., Ficorella, C., and Tiseo, M.

Published
2020
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5. In Vitro Biofouling Performance of Boron-Doped Diamond Microelectrodes for Serotonin Detection Using Fast-Scan Cyclic Voltammetry

Author

Gupta, Bhavna, primary, Perillo, Mason L., additional, Siegenthaler, James R., additional, Christensen, Isabelle E., additional, Welch, Matthew P., additional, Rechenberg, Robert, additional, Banna, G M Hasan Ul, additional, Galstyan, Davit, additional, Becker, Michael F., additional, Li, Wen, additional, and Purcell, Erin K., additional

Published
2023
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8. 142P CODAK real-world study: Interim analysis of clinical outcomes in unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy (CRT) in the United Kingdom

Author

Franks, K., primary, Ahmed, M., additional, Smith, D., additional, Shaw, P.H., additional, Banna, G., additional, Cominos, M., additional, Walther, J., additional, Talbot, T., additional, Taylor, P., additional, Blak, B., additional, Lindqvist, L., additional, Paul, S.K., additional, and Vincent, D., additional

Published
2022
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10. Novel cytotoxic chemotherapies in small cell lung carcinoma

Author

Cortinovis, D, Bidoli, P, Canova, S, Colonese, F, Gemelli, M, Lavitrano, M, Banna, G, Liu, S, Morabito, A, Cortinovis D., Bidoli P., Canova S., Colonese F., Gemelli M., Lavitrano M. L., Banna G. L., Liu S. V., Morabito A., Cortinovis, D, Bidoli, P, Canova, S, Colonese, F, Gemelli, M, Lavitrano, M, Banna, G, Liu, S, Morabito, A, Cortinovis D., Bidoli P., Canova S., Colonese F., Gemelli M., Lavitrano M. L., Banna G. L., Liu S. V., and Morabito A.

Abstract

Small cell lung cancer (SCLC) is one of the deadliest thoracic neoplasms, in part due to its fast doubling time and early metastatic spread. Historically, cytotoxic chemotherapy consisting of platinum–etoposide or anthracycline-based regimens has demonstrated a high response rate, but early chemoresistance leads to a poor prognosis in advanced SCLC. Only a fraction of patients with limited-disease can be cured by chemo-radiotherapy. Given the disappointing survival rates in advanced SCLC, new cytotoxic agents are eagerly awaited. Unfortunately, few novel chemotherapy drugs have been developed in the latest decades. This review describes the results and potential application in the clinical practice of novel chemotherapy agents for SCLC.

Published
2021

11. Diagnostic and prognostic biomarkers in oligometastatic non-small cell lung cancer: A literature review

Author

Cortinovis, D, Malapelle, U, Pagni, F, Russo, A, Banna, G, Sala, E, Rolfo, C, Cortinovis D., Malapelle U., Pagni F., Russo A., Banna G. L., Sala E., Rolfo C., Cortinovis, D, Malapelle, U, Pagni, F, Russo, A, Banna, G, Sala, E, Rolfo, C, Cortinovis D., Malapelle U., Pagni F., Russo A., Banna G. L., Sala E., and Rolfo C.

Abstract

Objective: This review aims to summarize the possibilities of recently discovered molecular diagnostic techniques in lung cancer, by evaluating their impact on diagnosis, monitoring, and prognosis in oligometastatic disease. Background: Oligometastatic non-small cell lung cancer (OM-NSCLC) is currently defined based on morphological rather than biological features. Major advances in the detection of molecular biomarkers in cell-free tumoral DNA and the models of oncogene addiction make as feasible an early diagnosis and guide the therapeutic decision-making progress to improve the prognosis. Methods: This narrative review EXAMINES current approaches of diagnosis, monitoring, and prognosis of OM-NSCLC and describes the fast-evolving therapeutic scenario of this disease. We provide an overview of the powerful capability of liquid biopsy techniques applied to blood and fluid and we focus on the technological advancement of circulant biomolecular factors in OM NSCLC pathology, starting from apparently simpler models such as oncogene addicted tumors to evaluate themselves in the light of treatment with immune-checkpoint inhibitors. Conclusions: A better understanding of spatial and temporal evolution of oligometastatic diseases would contribute to a more accurate diagnosis and tailored treatment. Data from prospective clinical trials in the early stage of disease, coupled with knowledge of genetic characteristics of lung tumors, are warranted. These efforts would lead to improving the possibility to eradicate the residual disease in these low burden tumoral settings, thus enhancing the definitive cure perspectives.

Published
2021

13. EP08.02-060 How Do Oncologists Treat Patients With EGFR Exon-20 Mutant NSCLC Outside of Clinical Trials? Updated Analysis From the European EXOTIC Registry

Author

Mountzios, G., primary, Planchard, D., additional, Metro, G., additional, Tsiouda, D., additional, Prelaj, A., additional, Lampaki, S., additional, Shalata, W., additional, Riudavets, M., additional, Christopoulos, P., additional, Girard, N., additional, Albarran, V., additional, Garcia Campelo, R., additional, Samitas, K., additional, Banna, G., additional, Boukovinas, I., additional, Agbarya, A., additional, Koumarianou, A., additional, Perdikouri, E.-I., additional, Kosmidis, P., additional, Reck, M., additional, and Lo Russo, G., additional

Published
2022
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16. COVID-19 in patients with thoracic malignancies (TERAVOLT): first results of an international, registry-based, cohort study

Author

Garassino, M.C., Whisenant, J.G., Huang, L.C., Trama, A., Torri, V., Agustoni, F., Baena, J., Banna, G., Berardi, R., Bettini, A.C., Bria, E., Brighenti, M., Cadranel, J., Toma, A. De, Chini, C., Cortellini, A., Felip, E., Finocchiaro, G., Garrido, P., Genova, C., Giusti, R., Gregorc, V., Grossi, F., Grosso, F., Intagliata, S., Verde, N. La, Liu, S.V., Mazieres, J., Mercadante, E., Michielin, O., Minuti, G., Moro-Sibilot, D., Pasello, G., Passaro, A., Scotti, V., Solli, P., Stroppa, E., Tiseo, M., Viscardi, G., Voltolini, L., Wu, Y.L., Zai, S., Pancaldi, V., Dingemans, A.M., Meerbeeck, J. Van, Barlesi, F., Wakelee, H., Schuurbiers, O.C.J., Peters, S., Horn, L., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Pulmonologie, MUMC+: MA Med Staf Spec Longziekten (9), Pulmonary Medicine, TERAVOLT investigators, and TERAVOLT Investigators

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Aged, Betacoronavirus, Cause of Death, Coronavirus Infections, Cross-Sectional Studies, Female, Hospitalization, Humans, Longitudinal Studies, Middle Aged, Pandemics, Pneumonia, Viral, Registries, Risk Factors, Thoracic Neoplasms, COVID-19, Pneumonia, Viral, SARS-CoV-2, Article, 03 medical and health sciences, 0302 clinical medicine, Disease registry, Intensive care, Internal medicine, medicine, Medical history, Risk factor, Lung cancer, business.industry, Mortality rate, Cancer, Coronavirus Infections/epidemiology, Coronavirus Infections/mortality, Coronavirus Infections/pathology, Hospitalization/statistics & numerical data, Pneumonia, Viral/epidemiology, Pneumonia, Viral/mortality, Pneumonia, Viral/pathology, Registries/statistics & numerical data, Thoracic Neoplasms/epidemiology, Thoracic Neoplasms/mortality, Thoracic Neoplasms/pathology, Thoracic Neoplasms/therapy, medicine.disease, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Human medicine, business, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], Cohort study
Abstract

Contains fulltext : 229846.pdf (Publisher’s version ) (Closed access) BACKGROUND: Early reports on patients with cancer and COVID-19 have suggested a high mortality rate compared with the general population. Patients with thoracic malignancies are thought to be particularly susceptible to COVID-19 given their older age, smoking habits, and pre-existing cardiopulmonary comorbidities, in addition to cancer treatments. We aimed to study the effect of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on patients with thoracic malignancies. METHODS: The Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry is a multicentre observational study composed of a cross-sectional component and a longitudinal cohort component. Eligibility criteria were the presence of any thoracic cancer (non-small-cell lung cancer [NSCLC], small-cell lung cancer, mesothelioma, thymic epithelial tumours, and other pulmonary neuroendocrine neoplasms) and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms. Patients of any age, sex, histology, or stage were considered eligible, including those in active treatment and clinical follow-up. Clinical data were extracted from medical records of consecutive patients from Jan 1, 2020, and will be collected until the end of pandemic declared by WHO. Data on demographics, oncological history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes were collected. Associations between demographic or clinical characteristics and outcomes were measured with odds ratios (ORs) with 95% CIs using univariable and multivariable logistic regression, with sex, age, smoking status, hypertension, and chronic obstructive pulmonary disease included in multivariable analysis. This is a preliminary analysis of the first 200 patients. The registry continues to accept new sites and patient data. FINDINGS: Between March 26 and April 12, 2020, 200 patients with COVID-19 and thoracic cancers from eight countries were identified and included in the TERAVOLT registry; median age was 68.0 years (61.8-75.0) and the majority had an Eastern Cooperative Oncology Group performance status of 0-1 (142 [72%] of 196 patients), were current or former smokers (159 [81%] of 196), had non-small-cell lung cancer (151 [76%] of 200), and were on therapy at the time of COVID-19 diagnosis (147 [74%] of 199), with 112 (57%) of 197 on first-line treatment. 152 (76%) patients were hospitalised and 66 (33%) died. 13 (10%) of 134 patients who met criteria for ICU admission were admitted to ICU; the remaining 121 were hospitalised, but were not admitted to ICU. Univariable analyses revealed that being older than 65 years (OR 1.88, 95% 1.00-3.62), being a current or former smoker (4.24, 1.70-12.95), receiving treatment with chemotherapy alone (2.54, 1.09-6.11), and the presence of any comorbidities (2.65, 1.09-7.46) were associated with increased risk of death. However, in multivariable analysis, only smoking history (OR 3.18, 95% CI 1.11-9.06) was associated with increased risk of death. INTERPRETATION: With an ongoing global pandemic of COVID-19, our data suggest high mortality and low admission to intensive care in patients with thoracic cancer. Whether mortality could be reduced with treatment in intensive care remains to be determined. With improved cancer therapeutic options, access to intensive care should be discussed in a multidisciplinary setting based on cancer specific mortality and patients' preference. FUNDING: None.

Published
2020
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17. Host immune-inflammatory markers to unravel the heterogeneous outcome and assessment of patients with PD-L1 ≥50% metastatic non-small cell lung cancer and poor performance status receiving first-line immunotherapy

Author

Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, Addeo A, Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, and Addeo A

Abstract

Background: Patients with programmed cell death-ligand 1 (PD-L1) ≥50% metastatic non-small cell lung cancer (mNSCLC) and ECOG performance status (PS) of 2 treated with first-line immunotherapy have heterogeneous clinical assessment and outcomes. Methods: To explore the role of immune-inflammatory surrogates by the validated lung immuno-oncology prognostic score (LIPS) score, including the neutrophil-to-lymphocyte ratio (NLR) and the pretreatment use of steroids, alongside other prognostic variables. A retrospective analysis of 128 patients with PS2 and PD-L1 ≥50% mNSCLC treated between April 2018 and September 2019 with first-line pembrolizumab in a real-world setting was performed. Results: With a median follow-up of 15.3 months, the 1-year overall survival (OS) and median progression-free survival (PFS) were 32.3% (95% CI: 30.9–33.9) and 3.3 months (95% CI: 1.8–4.7), respectively. The NLR, lactate dehydrogenase (LDH) and pretreatment steroids results were the only significant prognostic factors on the univariate analysis and independent prognostic factors by the multivariate analysis on both OS and PFS. The LIPS score, including the NLR and pretreatment steroids, identified 29 (23%) favourable-risk patients, with 0 factors, 1-year OS of 67.6% and median PFS of 8.2 months; 57 (45%) intermediate-risk patients, with 1 factor, 1-year OS 32.1% and median PFS 2.7 months; 42 (33%) poor-risk patients, with both factors, 1-year OS of 10.7% and median PFS of 1.2 months. Conclusions: The assessment of pre-existing imbalance of the host immune response by combined blood and clinical immune-inflammatory markers may represent a way to unravel the heterogeneous outcome and assessment of patients with mNSCLC and poor PS in the immune-oncology setting.

Published
2022

18. Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program

Author

Rebuzzi, S. E., Signori, A., Buti, S., Banna, G. L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, Diana, Tortora, Giampaolo, Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, Francesco, Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, Antonio, Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., Fornarini, G., Giannarelli D., Tortora G. (ORCID:0000-0002-1378-4962), Atzori F., Astone A. (ORCID:0000-0001-9572-309X), Rebuzzi, S. E., Signori, A., Buti, S., Banna, G. L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, Diana, Tortora, Giampaolo, Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, Francesco, Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, Antonio, Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., Fornarini, G., Giannarelli D., Tortora G. (ORCID:0000-0002-1378-4962), Atzori F., and Astone A. (ORCID:0000-0001-9572-309X)

Abstract

Background: The Meet-URO score allowed a more accurate prognostication than the International Metastatic RCC Database Consortium (IMDC) for patients with pre-treated metastatic renal cell carcinoma (mRCC) by adding the pre-treatment neutrophil-to-lymphocyte ratio and presence of bone metastases.Materials and methods: A post hoc analysis was carried out to validate the Meet-URO score on the overall survival (OS) of patients with IMDC intermediate-poor-risk mRCC treated with first-line nivolumab plus ipilimumab within the prospective Italian Expanded Access Programme (EAP). We additionally considered progression-free survival (PFS) and disease response rates. Harrell's c-index was calculated to compare the accuracy of survival prediction.Results: Overall the EAP included 306 patients, with a median follow-up of 12.2 months, median OS was not reached, 1-year OS was 66.8% and median PFS was 7.9 months. By univariable analysis, both the IMDC score and the two additional variables of the Meet-URO score were associated with either OS or PFS (P < 0.001 for all comparisons). The four Meet-URO risk groups (G) had 1-year OS of 92%, 72%, 50% and 21% for G2 (29.1% of patients), G3 (28.8%), G4 (33.0%) and G5 (9.1%), respectively. OS was significantly shorter in each consecutive G (P = 0.001 for G3, P < 0.001 for both G4 and G5 compared to G2). Similarly, Meet-URO Gs 2-5 showed decreasing median PFS and response rates. The Meet-URO score showed the highest c-index for both OS (0.73) and PFS (0.67). Limitations include the post hoc nature of this analysis and the lack of a comparative arm to assess predictive value.Conclusion: The Meet-URO score appeared to show better prognostic classification than the IMDC alone in patients with mRCC at IMDC intermediate-poor risk treated with first-line nivolumab and ipilimumab.

Published
2022

19. Get up, stand up: Alongside adolescents and young adults with cancer for their right to be forgotten

Author

Quarello, P, Toss, A, Mascarin, M, Banna, G, Canesi, M, Milano, G, Incorvaia, L, Lambertini, M, Terenziani, M, Clerici, C, Vigevani, G, Beretta, G, Prete, A, Cinieri, S, Peccatori, F, Ferrari, A, Quarello, Paola, Toss, Angela, Mascarin, Maurizio, Banna, Giuseppe Luigi, Canesi, Marta, Milano, Giuseppe Maria, Incorvaia, Lorena, Lambertini, Matteo, Terenziani, Monica, Clerici, Carlo Alfredo, Vigevani, Giulio Enea, Beretta, Giordano Domenico, Prete, Arcangelo, Cinieri, Saverio, Peccatori, Fedro Alessandro, Ferrari, Andrea, Quarello, P, Toss, A, Mascarin, M, Banna, G, Canesi, M, Milano, G, Incorvaia, L, Lambertini, M, Terenziani, M, Clerici, C, Vigevani, G, Beretta, G, Prete, A, Cinieri, S, Peccatori, F, Ferrari, A, Quarello, Paola, Toss, Angela, Mascarin, Maurizio, Banna, Giuseppe Luigi, Canesi, Marta, Milano, Giuseppe Maria, Incorvaia, Lorena, Lambertini, Matteo, Terenziani, Monica, Clerici, Carlo Alfredo, Vigevani, Giulio Enea, Beretta, Giordano Domenico, Prete, Arcangelo, Cinieri, Saverio, Peccatori, Fedro Alessandro, and Ferrari, Andrea

Abstract

Adolescent and young adult cancer survivors may experience various forms of social difficulties years or even decades after completing their cancer treatments. This article will hopefully help the Italian national project dedicated to adolescents and young adults with cancer promoting political and legal solutions to stop discrimination and supporting the right to be forgotten.

Published
2022

20. A prognostic score for patients with malignant pleural mesothelioma (MPM) receiving second-line immunotherapy or chemotherapy in the ETOP 9–15 PROMISE-meso phase III trial

Author

Luigi Banna, G. Addeo, A. Zygoura, P. Tsourti, Z. Popat, S. Curioni-Fontecedro, A. Nadal, E. Shah, R. Pope, A. Fisher, P. Spicer, J. Roy, A. Gilligan, D. Gautschi, O. Janthur, W.-D. López-Castro, R. Roschitzki-Voser, H. Dafni, U. Peters, S. Stahel, R.A.

Abstract

Introduction: Clinical and laboratory parameters associated with response for patients with advanced pre-treated malignant pleural mesothelioma (MPM) are lacking. We aimed to identify prognostic and predictive markers among patients with relapsed MPM who were randomised into the ETOP 9–15 PROMISE-meso phase III trial, evaluating pembrolizumab and chemotherapy. Methods: Baseline clinical and laboratory parameters were investigated for prognostic or predictive value on progression-free survival (PFS) and overall survival (OS) in a retrospective analysis, based on the full cohort of 144 MPM patients. These consisted of immune-inflammatory indexes (neutrophil–lymphocyte ratio [NLR], systemic immune-inflammatory index [SII], lactate dehydrogenase [LDH]) along with other already known prognostic baseline characteristics and laboratory values. Cut-offs were chosen independently of outcome. Based on Cox multivariable analysis for PFS in the whole cohort, a risk factor model was built to illustrate the prognostic stratification of patients by the combination of the derived independent prognostic factors, taking into account the EORTC score, a validated prognostic score in MPM. All models were stratified by histology and adjusted by treatment. Results: In the stratified multivariable analysis in the whole cohort, high SII (hazard ratio (HR) 2.06; 95%CI 1.39–3.05) and low haemoglobin (HR 1.62; 95%CI 1.06–2.50) were associated with worse PFS. Based on these two prognostic factors, a mesothelioma risk score (MRS) was constructed with three PFS risk prognosis categories: favourable, intermediate and poor with 0, 1 and 2 risk factors, respectively (corresponding percent of cohort: 24%, 34% and 42% and median PFS: 5.8, 4.2 and 2.1 months). The derived MRS stratified the prognosis for PFS and OS, overall and within each of the EORTC groups. No significant predictors of treatment benefit were identified. Conclusions: The proposed MRS is prognostic of patient outcome and it fine-tunes the prognosis of patients with pre-treated MPM alone or when used with the already established EORTC score. © 2022

Published
2022

21. Erratum: ☆Corrigendum to “Recommendations for surveillance and follow-up of men with testicular germ cell tumors: A multidisciplinary consensus conference by the Italian Germ cell cancer Group and the Associazione Italiana di Oncologia Medica” (Critical Reviews in Oncology / Hematology (2019) 137 (154–164), (S1040842819300587), (10.1016/j.critrevonc.2019.03.006))

Author

Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., De Giorgi U., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., and De Giorgi U.

Abstract

The authors regret that the affiliation of Drs. Barone and De. Giorgi in the Acknowledgements section is incorrect and should be as follows: Radiology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. Barone and Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. De Giorgi and The authors would like to apologise for any inconvenience caused.

Published
2020

22. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians' attitudes

Author

Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, Tiseo M., Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, and Tiseo M.

Abstract

Background: In most cases, T790M EGFR-positive NSCLC patients receiving osimertinib developed “non-drugable” progression, as the patients with common EGFR-sensitizing mutations were treated with first-line osimertinib. In both settings, chemotherapy represents the standard treatment and local ablative treatments (LATs) are potential useful options in the case of oligo-progression. Methods: We conducted a study on “post-progression” (pp) outcomes of T790M EGFR-positive NSCLC patients treated with osimertinib, according to the therapeutic strategy applied: osimertinib beyond progression (± LATs), “switched therapies” or best supportive care only (BSC). Results: 144 consecutive patients were evaluated: 53 (36.8%) did not received post-progression treatments (BSC), while 91 (63.2%) patients received at least 1 subsequent treatment; 50 patients (54.9%) received osimertinib beyond disease progression [19 (20.9%) of them with adjunctive LATs] and 41 (45.1%) a switched therapy. Median ppPFS (progression-free survival) and median ppOS (overall survival) of patients who received osimertinib beyond progression vs. switched therapies were 6.4 months vs. 4.7 months, respectively [HR 0.57 (95% CI 0.35–0.92), p = 0.0239] and 11.3 months vs 7.8 months, respectively [HR 0.57 (95% CI 0.33–0.98), p = 0.0446]. Among patients who received osimertinib beyond progression with and without LATs median ppPFS was 6.4 months and 5.7 months, respectively [HR 0.90 (95% CI 0.68–1.18), p = 0.4560], while median ppOS was 20.2 months and 9.9 months, respectively [HR 0.73 (95% CI 0.52–1.03), p = 0.0748]. At the univariate analysis, the only factor significantly related to the ppPFS was the therapeutic strategy in favor of osimertinib beyond progression (± LATs). Moreover, the only variable which was significantly related to ppOS at the multivariate analysis was osimertinib beyond progression (± LATs). Conclusion: Our study confirmed that in clinical practice, in case of “non-druggable” disease progre

Published
2020

23. Chemotherapy in non-small cell lung cancer patients after prior immunotherapy: The multicenter retrospective CLARITY study

Author

Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., Tiseo M., Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., and Tiseo M.

Abstract

Objectives: In the most of cases, for non-small cell lung cancer (NSCLC) patients who progressed to previous immune checkpoint inhibitors (CKI) administered as first- or as second-line therapy, chemotherapy (CT) remains the only viable options in the absence of “druggable” mutations. We aimed to explore the efficacy of salvage chemotherapy after immunotherapy (SCAI) in advanced NSCLC patients. Materials and Methods: We designed a retrospective, multicenter study, involving 20 Italian centers, with the primary objective of describing the clinical outcome of advanced NSCLC patients treated with SCAI at the participating institutions from November 2013 to July 2019. The primary endpoint of the study was represented by overall survival (OS), defined as the time from CT initiation to death. Secondary outcome endpoints of the SCAI (progression free survival, PFS, objective response rate, ORR and toxicity) and explorative biomarkers (lactate dehydrogenase, LDH, and neutrophil-to-lymphocyte ratio, NLR during immunotherapy) were also analyzed. Results: In our study population of 342 NSCLC patients, SCAI obtained a median OS of 6.8 months (95 % confidence interval, CI 5.5–8.1), median PFS of 4.1 months (95 % CI 3.4−4.8) and ORR of 22.8 %. A “Post-CKI score” was constructed by combining significant predictors of OS at the multivariate analyses (sex, ECOG PS, disease control with prior immunotherapy), Harrell'C was 0.65, (95 % CI:0.59−0.71). Conclusions: Despite the late-line settings, our findings support the hypothesis that previous immunotherapy might increase the sensitivity of the tumor to the subsequent chemotherapy. The “Post-CKI score” was clinically effective in successfully discriminating three distinct prognostic subgroups of patients after the failure of CKI, representing a possibly useful tool for the tailored decision-making process of advanced treatment-line settings in NSCLC.

Published
2020

24. Erratum: ☆Corrigendum to “Recommendations for surveillance and follow-up of men with testicular germ cell tumors: A multidisciplinary consensus conference by the Italian Germ cell cancer Group and the Associazione Italiana di Oncologia Medica” (Critical Reviews in Oncology / Hematology (2019) 137 (154–164), (S1040842819300587), (10.1016/j.critrevonc.2019.03.006))

Author

Banna G. L., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., De Giorgi U., Banna G. L., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., and De Giorgi U.

Abstract

The authors regret that the affiliation of Drs. Barone and De. Giorgi in the Acknowledgements section is incorrect and should be as follows: Radiology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. Barone and Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. De Giorgi and The authors would like to apologise for any inconvenience caused.

Published
2020

26. Recommendations for surveillance and follow-up of men with testicular germ cell tumors: a multidisciplinary consensus conference by the Italian Germ cell cancer Group and the Associazione Italiana di Oncologia Medica

Author

Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, DA POZZO, L, Di Nardo, D, Fornarini, G, Prayer Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., DA POZZO, LUIGI FILIPPO, Di Nardo D., Fornarini G., Prayer Galetti T., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., De Giorgi U., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, DA POZZO, L, Di Nardo, D, Fornarini, G, Prayer Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., DA POZZO, LUIGI FILIPPO, Di Nardo D., Fornarini G., Prayer Galetti T., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., and De Giorgi U.

Abstract

Background: No compelling evidence is available about surveillance and follow-up of patients with testicular germ cell tumour (TGCT). Methods: In the light of the best clinical evidence, the Italian Germ cell cancer Group (IGG) and the Associazione Italiana di Oncologia Medica (AIOM) set up a multidisciplinary national consensus conference, involving 42 leading experts and 3 TGCT survivors. A minimum of 50% of votes was required in order to achieve a consensus recommendation on 29 questions. Results: Recommendations have been summarized in three tables, divided by stage I seminoma, stage I nonseminoma and the advanced disease, which may be useful for clinicians to appropriately choose the clinical investigation and its timing during the surveillance and follow-up of TGCT patients based on an accurate estimation of their risk of disease relapse. Conclusions: The IGG-AIOM consensus recommendations may help clinicians to choose appropriate clinical investigations for the surveillance and follow-up of TGCT patients.

Published
2019

28. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021

29. Predictive ability of a drug-based score in patients with advanced non-small-cell lung cancer receiving first-line immunotherapy

Author

Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, Cortellini A, Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, and Cortellini A

Abstract

Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This ‘drug score’ was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1–2 and poor risk with score 3–4. Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non–small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy). Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab coh

Published
2021

30. Differential influence of antibiotic therapy and other medications on oncological outcomes of patients with non-small cell lung cancer treated with first-line pembrolizumab versus cytotoxic chemotherapy

Author

Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, Pinato DJ, Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, and Pinato DJ

Abstract

Background Some concomitant medications including antibiotics (ATB) have been reproducibly associated with worse survival following immune checkpoint inhibitors (ICIs) in unselected patients with non-small cell lung cancer (NSCLC) (according to programmed death-ligand 1 (PD-L1) expression and treatment line). Whether such relationship is causative or associative is matter of debate. Methods We present the outcomes analysis according to concomitant baseline medications (prior to ICI initiation) with putative immune-modulatory effects in a large cohort of patients with metastatic NSCLC with a PD-L1 expression >= 50%, receiving first-line pembrolizumab monotherapy. We also evaluated a control cohort of patients with metastatic NSCLC treated with first-line chemotherapy. The interaction between key medications and therapeutic modality (pembrolizumab vs chemotherapy) was validated in pooled multivariable analyses. Results 950 and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Corticosteroid and proton pump inhibitor (PPI) therapy but not ATB therapy was associated with poorer performance status at baseline in both the cohorts. No association with clinical outcomes was found according to baseline statin, aspirin, beta-blocker and metformin within the pembrolizumab cohort. On the multivariable analysis, ATB emerged as a strong predictor of worse overall survival (OS) (HR=1.42 (95% CI 1.13 to 1.79); p=0.0024), and progression free survival (PFS) (HR=1.29 (95% CI 1.04 to 1.59); p=0.0192) in the pembrolizumab but not in the chemotherapy cohort. Corticosteroids were associated with shorter PFS (HR=1.69 (95% CI 1.42 to 2.03); p<0.0001), and OS (HR=1.93 (95% CI 1.59 to 2.35); p<0.0001) following pembrolizumab, and shorter PFS (HR=1.30 (95% CI 1.08 to 1.56), p=0.0046) and OS (HR=1.58 (95% CI 1.29 to 1.94), p<0.0001), following chemotherapy. PPIs were associated with worse OS (HR=1.49 (95% CI 1.26 to 1.77); p<0.0001) with pem

Published
2021

31. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case-control matched analysis from a large multicenter study

Author

Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, Porzio G, Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, and Porzio G

Abstract

Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat

Published
2021

32. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, Addeo A., Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, and Addeo A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

33. Post-progression outcomes of NSCLC patients with PD-L1 expression ≥ 50% receiving first-line single-agent pembrolizumab in a large multicentre real-world study

Author

Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, Porzio G, Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, and Porzio G

Abstract

Background: Treatment sequencing with first-line immunotherapy, followed by second-line chemotherapy, is still a viable option for NSCLC patients with PD-L1 expression ≥50%. Methods: We evaluated post-progression treatment pathways in a large real-world cohort of metastatic NSCLC patients with PD-L1 expression ≥ 50% treated with first-line pembrolizumab monotherapy. Results: Overall, 974 patients were included. With a median follow-up of 22.7 months (95%CI: 21.6–38.2), the median overall survival (OS) of the entire population was 15.8 months (95%CI: 13.5–17.5; 548 events). At the data cutoff, among the 678 patients who experienced disease progression, 379 (55.9%) had not received any further treatment, and 359 patients (52.9%) had died. Patients who did not receive post-progression therapies were older (p = 0.0011), with a worse ECOG-PS (p < 0.0001) and were on corticosteroids prior to pembrolizumab (p = 0.0024). At disease progression, 198 patients (29.2%) received a switched approach and 101 (14.9%) received pembrolizumab ByPD either alone (64 [9.4%]) or in combination with local ablative treatments (37 [5.5%]) (LATs). After a random-case control matching according to ECOG-PS, CNS metastases, bone metastases, and (previous) best response to pembrolizumab, patients receiving pembrolizumab ByPD plus LATs were confirmed to have a significantly longer post-progression OS compared to patients receiving pembrolizumab ByPD alone 13.9 months versus 7.8 months (p = 0.0179) 241 patients (35.5%) among the 678 who had experienced PD, received a second-line systemic treatment (regardless of previous treatment beyond PD). As compared to first-line treatment commencement, patients’ features at the moment of second-line initiation showed a significantly higher proportion of patients aged under 70 years (p = 0.0244), with a poorer ECOG-PS (p < 0.0001) and having CNS (p = 0.0001), bone (p = 0.0266) and liver metastases (p = 0.0148). Conclusions: In the real-world scenario NSC

Published
2021

34. The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

37. Effect of a low glycemic index Mediterranean diet on cardiovascular risk factors in women diagnosed with breast cancer: preliminary data from DEDiCa study

Author

Montagnese, C., primary, Porciello, G., additional, Vitale, S., additional, Palumbo, E., additional, Calabrese, I., additional, Crispo, A., additional, Grimaldi, M., additional, Pica, R., additional, Marotta, V., additional, Esindi, N., additional, Prete, M., additional, Cubisino, S., additional, Falzone, L., additional, De Laurentiis, M., additional, Rinaldo, M., additional, D’Aiuto, M., additional, Cianniello, D., additional, Pacilio, C., additional, Pinto, M., additional, Thomas, G., additional, Catalano, F., additional, Banna, G., additional, Ursino, V., additional, Ferrau’, F., additional, Rossello, R., additional, Serraino, D., additional, Massarut, S., additional, Poletto, L., additional, Martinuzzo, V., additional, Guerra, G., additional, Farina, A., additional, Messina, F., additional, Cavalcanti, E., additional, Minopoli, A., additional, Fiorillo, P., additional, Grilli, B., additional, Cuomo, M., additional, Comegna, C., additional, Cervo, S., additional, Evangelista, C., additional, Bolzicco, D., additional, Steffan, A., additional, Riccardi, G., additional, Jenkins, D.J.A., additional, Gatti, D., additional, Libra, M., additional, Celentano, E., additional, Botti, G., additional, and Augustin, L.S.A., additional

Published
2020
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38. Immune-related Adverse Events of Pembrolizumab in a Large Real-world Cohort of Patients With NSCLC With a PD-L1 Expression ≥ 50% and Their Relationship With Clinical Outcomes

Author

Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, Cannita K., Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, and Cannita K.

Abstract

Background: The role of immune-related adverse events (irAEs), as a surrogate predictor of the efficacy of checkpoint inhibitors, has not yet been described in the setting of first-line, single-agent pembrolizumab for patients with metastatic non-small-cell lung-cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of ≥ 50%. Patients and methods: We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50% receiving first-line pembrolizumab. Here, we report the results of the irAE analysis and the potential correlation between irAEs and clinical outcomes. Results: A total of 1010 patients were included in this analysis; after a 6-week landmark selection, 877 (86.8%) patients were included in the efficacy analysis. Any grade irAEs (P < .0001), grade 3/4 irAEs (P = .0025), leading to discontinuation irAEs (P = .0144), multiple-site and single-site irAEs (P < .0001), cutaneous irAEs (P = .0001), endocrine irAEs (P = .0227), pulmonary irAEs (P = .0479), and rheumatologic irAEs (P = .0018) were significantly related to a higher objective response rate. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0005), cutaneous irAEs (P = .0042), endocrine irAEs (P < .0001), gastrointestinal irAEs (P = .0391), and rheumatologic irAEs (P = .0086) were significantly related to progression-free survival. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0003), cutaneous irAEs (P = .0002), endocrine irAEs (P = .0001), and rheumatologic irAEs (P = .0214) were significantly related to overall survival. Conclusions: This study confirms the feasibility and the safety of first-line, single-agent pembrolizumab, in a large, real-world cohort of patients with NSCLC with PD-L1 expression ≥ 50%. The occurrence of irAEs may be a surrogate of clinical activity and improved outcomes in this setting.

Published
2020

39. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation

Author

Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, Ficorella C., Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, and Ficorella C.

Abstract

Background The association between obesity and outcomes in patients receiving programmed death-1/programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04-2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37-0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45-0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01-1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49-0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.

Published
2020

40. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50

Author

Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, Porzio G., Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, and Porzio G.

Abstract

Background: Single-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%. Methods: We conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%. Results: One thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2–49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9–9.5; 599 events) and 17.2 months (95% CI 15.3–22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis. Conclusion: Pembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effe

Published
2020

41. First-line pembrolizumab in advanced non-small cell lung cancer patients with poor performance status

Author

Facchinetti, F, Mazzaschi, G, Barbieri, F, Passiglia, F, Mazzoni, F, Berardi, R, Proto, C, Cecere, F, Pilotto, S, Scotti, V, Rossi, S, Del Conte, A, Vita, E, Bennati, C, Ardizzoni, A, Cerea, G, Migliorino, M, Sala, E, Camerini, A, Bearz, A, De Carlo, E, Zanelli, F, Guaitoli, G, Garassino, M, Ciccone, L, Sartori, G, Toschi, L, Dall'Olio, F, Landi, L, Pizzutilo, E, Bartoli, G, Baldessari, C, Novello, S, Bria, E, Cortinovis, D, Rossi, G, Rossi, A, Banna, G, Camisa, R, Di Maio, M, Tiseo, M, Cecere, FL, Migliorino, MR, Garassino, MC, Ciccone, LP, Dall'Olio, FG, Pizzutilo, EG, Banna, GL, Facchinetti, F, Mazzaschi, G, Barbieri, F, Passiglia, F, Mazzoni, F, Berardi, R, Proto, C, Cecere, F, Pilotto, S, Scotti, V, Rossi, S, Del Conte, A, Vita, E, Bennati, C, Ardizzoni, A, Cerea, G, Migliorino, M, Sala, E, Camerini, A, Bearz, A, De Carlo, E, Zanelli, F, Guaitoli, G, Garassino, M, Ciccone, L, Sartori, G, Toschi, L, Dall'Olio, F, Landi, L, Pizzutilo, E, Bartoli, G, Baldessari, C, Novello, S, Bria, E, Cortinovis, D, Rossi, G, Rossi, A, Banna, G, Camisa, R, Di Maio, M, Tiseo, M, Cecere, FL, Migliorino, MR, Garassino, MC, Ciccone, LP, Dall'Olio, FG, Pizzutilo, EG, and Banna, GL

Abstract

Background: Pembrolizumab is the first-line standard of care for advanced non–small cell lung cancer (NSCLC) with a PD-L1 tumour proportion score (TPS) ≥ 50%. Eastern Cooperative Oncology Group performance status (PS) 2 patients may receive pembrolizumab, despite the absence of sustaining evidence. Patients and methods: GOIRC-2018-01 is a multicentre, retrospective, observational study. PS 2 NSCLC patients with a PD-L1 TPS ≥50% receiving first-line pembrolizumab from June 2017 to December 2018 at 21 Italian institutions were included. Clinical-pathological characteristics were correlated with disease response and survival outcomes; adverse events were recorded. The primary objective was 6-months progression-free rate (6-months PFR). Results: One hundred fifty-three patients (median age 70 years) were enrolled. At a median follow-up of 18.2 months, median progression-free survival (PFS) and overall survival (OS) were 2.4 (95% confidence interval, 95% CI, 1.6–2.5) and 3.0 months (95% CI 2.4–3.5), respectively. 6-months PFR was 27% (95% CI 21–35%). Patients with a PS 2 determined by comorbidities (n = 41) had significantly better outcomes compared with disease burden-induced PS 2 (n = 112). Indeed, 6-months PFR was 49% versus 19%, median PFS 5.6 versus 1.8 months and OS 11.8 versus 2.8 months, respectively. Additional potential prognostic factors (radiotherapy, antibiotics, steroids received before pembrolizumab) correlated with clinical outcomes. The determinant of PS 2 resulted the only factor independently impacting on both PFS and OS. No toxicity issues emerged. Conclusions: Outcomes of PS 2 NSCLC patients with PD-L1 TPS ≥50% receiving first-line pembrolizumab were globally dismal but strongly dependent on the reason conditioning the poor PS itself.

Published
2020

46. Baseline neutrophil-to-lymphocyte ratio and PD-L1 expression level or LDH value may predict outcome of patients with high PD-L1 advanced non-small cell lung cancer treated with first-line pembrolizumab

Author

Banna, G., primary, Signorelli, D., additional, Metro, G., additional, Galetta, D., additional, De Toma, A., additional, Cantale, O., additional, Banini, M., additional, Friedlaender, A., additional, Pizzutillo, P., additional, Garassino, M., additional, and Addeo, A., additional

Published
2020
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47. P2.01-74 Clinical-Pathological Features and Outcome of Patients with Oral Metastases from Lung Cancer: A Multicenter Retrospective Study

Author

Tagliamento, M., primary, Pignataro, D., additional, Bironzo, P., additional, Tiseo, M., additional, Militello, A.M., additional, Banna, G., additional, Galetta, D., additional, Pesola, F., additional, Del Bene, G., additional, Lupatelli, M., additional, Val, M., additional, Olmetto, E., additional, Capelletto, E., additional, Pentenero, M., additional, and Novello, S., additional

Published
2019
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48. P1.16-09 Post-Progression Outcomes After Pembrolizumab in Patients with NSCLC and High PD-L1 Expression: Real-World Data from a European Cohort

Author

Metro, G., primary, Signorelli, D., additional, Rey-Cobo, J., additional, Banini, M., additional, Economopoulou, P., additional, Lo Russo, G., additional, Baxevanos, P., additional, Roila, F., additional, De Toma, A., additional, Banna, G., additional, Christopoulou, A., additional, Jimenez, B., additional, Collazo-Lorduy, A., additional, Linardou, H., additional, Blanco, A. Calles, additional, Galetta, D., additional, Addeo, A., additional, Camerini, A., additional, Kosmidis, P., additional, Garassino, M., additional, and Mountzios, G., additional

Published
2019
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49. Pembrolizumab frontline monotherapy in patients with NSCLC and high PD-L1 expression: Real-world data from a European Cohort with focus on subgroups of interest

Author

Mountzios, G., primary, Signorelli, D., additional, Cobo, J Rey, additional, Banini, M., additional, Economopoulou, P., additional, Russo, G Lo, additional, Baxevanos, P.T., additional, Roila, F., additional, de Toma, A., additional, Banna, G., additional, Christopoulou, A., additional, Jimenez, B., additional, Linardou, H., additional, Calles, A., additional, Galetta, D., additional, Addeo, A., additional, Camerini, A., additional, Kosmidis, P.A., additional, Garassino, M.C., additional, and Metro, G., additional

Published
2019
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50. P1.01-59 Expanding Access to Large-Scale Genomic Mutational Analyses for Patients with Advanced NSCLC in Italy

Author

Gregorc, V., primary, Lazzari, C., additional, Guida, A., additional, Bucci, G., additional, Graziano, P., additional, Cangi, M.G., additional, Frigè, G., additional, Rossi, A., additional, Ceol, A., additional, Sardina, D., additional, Milella, M., additional, Pallocca, M., additional, Vigneri, P., additional, Fancello, L., additional, Buglioni, S., additional, Motta, G., additional, Biagini, T., additional, Rijavec, E., additional, Bonfiglio, S., additional, Delmonte, A., additional, Toschi, L., additional, Banna, G., additional, Galetta, D., additional, Bearz, A., additional, Tartarone, A., additional, Verderame, F., additional, Daidone, M., additional, Fanciulli, M., additional, Ciliberto, G., additional, Pelicci, P.G., additional, De Maria, R., additional, and Mazzarella, L., additional

Published
2019
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