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8 results on '"Nole' F"'

1. Modeling the Prognostic Impact of Circulating Tumor Cells Enumeration in Metastatic Breast Cancer for Clinical Trial Design Simulation

Author

Gerratana, L, Pierga, J-Y, Reuben, JM, Davis, AA, Wehbe, FH, Dirix, L, Fehm, T, Nole, F, Gisbert-Criado, R, Mavroudis, D, Grisanti, S, Garcia-Saenz, JA, Stebbing, J, Caldas, C, Gazzaniga, P, Manso, L, Zamarchi, R, Bonotto, M, Fernandez de Lascoiti, A, De Mattos-Arruda, L, Ignatiadis, M, Sandri, M-T, Generali, D, De Angelis, C, Dawson, S-J, Janni, W, Caranana, V, Riethdorf, S, Solomayer, E-F, Puglisi, F, Giuliano, M, Pantel, K, Bidard, F-C, Cristofanilli, M, Gerratana, L, Pierga, J-Y, Reuben, JM, Davis, AA, Wehbe, FH, Dirix, L, Fehm, T, Nole, F, Gisbert-Criado, R, Mavroudis, D, Grisanti, S, Garcia-Saenz, JA, Stebbing, J, Caldas, C, Gazzaniga, P, Manso, L, Zamarchi, R, Bonotto, M, Fernandez de Lascoiti, A, De Mattos-Arruda, L, Ignatiadis, M, Sandri, M-T, Generali, D, De Angelis, C, Dawson, S-J, Janni, W, Caranana, V, Riethdorf, S, Solomayer, E-F, Puglisi, F, Giuliano, M, Pantel, K, Bidard, F-C, and Cristofanilli, M

Abstract

Despite the strong prognostic stratification of circulating tumor cells (CTCs) enumeration in metastatic breast cancer (MBC), current clinical trials usually do not include a baseline CTCs in their design. This study aimed to generate a classifier for CTCs prognostic simulation in existing datasets for hypothesis generation in patients with MBC. A K-nearest neighbor machine learning algorithm was trained on a pooled dataset comprising 2436 individual MBC patients from the European Pooled Analysis Consortium and the MD Anderson Cancer Center to identify patients likely to have CTCs ≥ 5/7 mL blood (StageIVaggressive vs StageIVindolent). The model had a 65.1% accuracy and its prognostic impact resulted in a hazard ratio (HR) of 1.89 (Simulatedaggressive vs SimulatedindolentP < .001), similar to patients with actual CTCs enumeration (HR 2.76; P < .001). The classifier's performance was then tested on an independent retrospective database comprising 446 consecutive hormone receptor (HR)-positive HER2-negative MBC patients. The model further stratified clinical subgroups usually considered prognostically homogeneous such as patients with bone-only or liver metastases. Bone-only disease classified as Simulatedaggressive had a significantly worse overall survival (OS; P < .0001), while patients with liver metastases classified as Simulatedindolent had a significantly better prognosis (P < .0001). Consistent results were observed for patients who had undergone CTCs enumeration in the pooled population. The differential prognostic impact of endocrine- (ET) and chemotherapy (CT) was explored across the simulated subgroups. No significant differences were observed between ET and CT in the overall population, both in terms of progression-free survival (PFS) and OS. In contrast, a statistically significant difference, favoring CT over ET was observed among Simulatedaggressive patients (HR: 0.62; P = .030 and HR: 0.60; P = .037, respectively, for PFS and OS).

Published
2022

2. 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

3. Association of quantitative mri-based radiomic features with prognostic factors and recurrence rate in oropharyngeal squamous cell carcinoma

Author

Giannitto, C, Marvaso, G, Botta, F, Raimondi, S, Alterio, D, Ciardo, D, Volpe, S, de Piano, F, Ancona, E, Tagliabue, M, Origgi, D, Chiocca, S, Maffini, F, Ansarin, M, Bagnardi, V, Cattani, F, Nole, F, Preda, L, Orecchia, R, Cassano, E, Cremonesi, M, Starzynska, A, Bellomi, M, Jereczek-Fossa, B, Giannitto C., Marvaso G., Botta F., Raimondi S., Alterio D., Ciardo D., Volpe S., de Piano F., Ancona E., Tagliabue M., Origgi D., Chiocca S., Maffini F. A., Ansarin M., Bagnardi V., Cattani F., Nole F., Preda L., Orecchia R., Cassano E., Cremonesi M., Starzynska A., Bellomi M., Jereczek-Fossa B. A., Giannitto, C, Marvaso, G, Botta, F, Raimondi, S, Alterio, D, Ciardo, D, Volpe, S, de Piano, F, Ancona, E, Tagliabue, M, Origgi, D, Chiocca, S, Maffini, F, Ansarin, M, Bagnardi, V, Cattani, F, Nole, F, Preda, L, Orecchia, R, Cassano, E, Cremonesi, M, Starzynska, A, Bellomi, M, Jereczek-Fossa, B, Giannitto C., Marvaso G., Botta F., Raimondi S., Alterio D., Ciardo D., Volpe S., de Piano F., Ancona E., Tagliabue M., Origgi D., Chiocca S., Maffini F. A., Ansarin M., Bagnardi V., Cattani F., Nole F., Preda L., Orecchia R., Cassano E., Cremonesi M., Starzynska A., Bellomi M., and Jereczek-Fossa B. A.

Abstract

Radiomics focuses on extracting a large number of quantitative imaging features and testing both their correlation with clinical characteristics and their prognostic and predictive values. We propose a radiomic approach using magnetic resonance imaging (MRI) to decode the tumor phenotype and local recurrence in oropharyngeal squamous cell carcinoma (OPSCC). The contrast-enhanced T1-weighted sequences from baseline MRI examinations of OPSCC patients treated between 2008 and 2016 were retrospectively selected. Radiomic features were extracted using the IBEX software, and hiegrarchical clustering was applied to reduce features redundancy. The association of each radiomic feature with tumor grading and stage, HPV status, loco-regional recurrence within 2 years, considered as main endpoints, was assessed by univariate analysis and then corrected for multiple testing. Statistical analysis was performed with SAS/STAT® software. Thirty-two eligible cases were identified. For each patient, 1286 radiomic features were extracted, subsequently grouped into 16 clusters. Higher grading (G3 vs. G1/G2) was associated with lower values of GOH/65Percentile and GOH/85Percentile features (p=0.04 and 0.01, respectively). Positive HPV status was associated with higher values of GOH/10Percentile (p=0.03) and lower values of GOH/90Percentile (p=0.03). Loco-regional recurrence within 2 years was associated with higher values of GLCM3/4-7Correlation (p=0.04) and lower values of GLCM3/2-1InformationMeasureCorr1 (p=0.04). Results lost the statistical significance after correction for multiple testing. T stage was significantly correlated with 9 features, 4 of which (GLCM25/180-4InformationMeasureCorr2, Shape/MeanBreadth, GLCM25/90-1InverseDiffMomentNorm, and GLCM3/6-1InformationMeasureCorr1) retained statistical significance after False Discovery Rate correction. MRI-based radiomics is a feasible and promising approach for the prediction of tumor phenotype and local recurrence in OPSCC. Some r

Published
2020

4. 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

5. Modified-BEP Chemotherapy in Patients With Germ-Cell Tumors Treated at a Comprehensive Cancer Center

Author

Aurilio, G, Verri, E, Frassoni, S, Bagnardi, V, Cossu Rocca, M, Cullura, D, Milani, M, Mascia, R, Curigliano, G, Orsi, F, Jereczek-Fossa, B, Musi, G, Omodeo Sale, E, De Cobelli, O, Nole, F, Aurilio G., Verri E., Frassoni S., Bagnardi V., Cossu Rocca M., Cullura D., Milani M., Mascia R., Curigliano G., Orsi F., Jereczek-Fossa B. A., Musi G., Omodeo Sale E., De Cobelli O., Nole F., Aurilio, G, Verri, E, Frassoni, S, Bagnardi, V, Cossu Rocca, M, Cullura, D, Milani, M, Mascia, R, Curigliano, G, Orsi, F, Jereczek-Fossa, B, Musi, G, Omodeo Sale, E, De Cobelli, O, Nole, F, Aurilio G., Verri E., Frassoni S., Bagnardi V., Cossu Rocca M., Cullura D., Milani M., Mascia R., Curigliano G., Orsi F., Jereczek-Fossa B. A., Musi G., Omodeo Sale E., De Cobelli O., and Nole F.

Abstract

OBJECTIVES: Bleomycin, etoposide, and cisplatin (BEP) is the most common and successful chemotherapy regimen for germ-cell tumor (GCT) patients, accompanied by a bleomycin-induced dose-dependent lung toxicity in certain patients. In an attempt to reduce bleomycin-toxicity, we developed a modified-BEP (mBEP) regimen. MATERIALS AND METHODS: Between August 2008 and February 2018, 182 unselected mainly testicular GCT patients (39 with adjuvant purpose and 143 with curative purpose) received a tri-weekly 5-day hospitalization schedule with bleomycin 15 U intravenous (IV) push on day 1 and 10 U IV continuous infusion over 12 hours on days 1 to 3, cisplatin 20 mg/m IV, and etoposide 100 mg/m IV on days 1 to 5. Pulmonary toxicity was assessed through chest computed tomography scan and clinical monitoring. RESULTS: Median number of mBEP cycles was 3 (range: 1 to 4). In the curative setting, according to the International Germ Cell Cancer Collaborative Group (IGCCCG) prognostic system, 112, 21, and 9 patients had good-risk, intermediate-risk, and poor-risk class, respectively; 66 (46%) patients had complete response (CR), 67 (47%) had partial response (52 of whom became CR afterwards), 6 (4%) had stable disease (that in 3 became CR afterwards), 3 (2%) progressed, and 1 (1%) died of brain stroke. At a median follow-up of 2.67 years (interquartile range: 1.23-5.00 y), 1 and 5-year overall survival and progression-free survival were 99% and 95%, and 90% and 88%, respectively. In the entire patient population, there was grade 3/4 neutropenia in 92 patients (51%), febrile neutropenia in 11 patients (6%), grade 1/2 nausea in 74 patients (41%), and no death due to pulmonary toxicity. CONCLUSION: In GCT patients, our mBEP-schedule would suggest an effective treatment modality without suffering meaningful pulmonary toxicity.

Published
2020

6. 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

7. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study

Author

Burtness, B. Harrington, K.J. Greil, R. Soulières, D. Tahara, M. de Castro, G., Jr Psyrri, A. Basté, N. Neupane, P. Bratland, Å. Fuereder, T. Hughes, B.G.M. Mesía, R. Ngamphaiboon, N. Rordorf, T. Wan Ishak, W.Z. Hong, R.-L. González Mendoza, R. Roy, A. Zhang, Y. Gumuscu, B. Cheng, J.D. Jin, F. Rischin, D. Lerzo, G. Tatangelo, M. Varela, M. Zarba, J.J. Boyer, M. Gan, H. Gao, B. Hughes, B. Mallesara, G. Taylor, A. Burian, M. Barrios, C.H. de Castro Junior, D.O. Castro, G. Franke, F.A. Girotto, G. Lima, I.P.F. Nicolau, U.R. Pinto, G.D.J. Santos, L. Victorino, A.-P. Chua, N. Couture, F. Gregg, R. Hansen, A. Hilton, J. McCarthy, J. Soulieres, D. Ascui, R. Gonzalez, P. Villanueva, L. Torregroza, M. Zambrano, A. Holeckova, P. Kral, Z. Melichar, B. Prausova, J. Vosmik, M. Andersen, M. Gyldenkerne, N. Jurgens, H. Putnik, K. Reinikainen, P. Gruenwald, V. Laban, S. Aravantinos, G. Boukovinas, I. Georgoulias, V. Kwong, D. Al-Farhat, Y. Csoszi, T. Erfan, J. Horvai, G. Landherr, L. Remenar, E. Ruzsa, A. Szota, J. Billan, S. Gluck, I. Gutfeld, O. Popovtzer, A. Benasso, M. Bui, S. Ferrari, V. Licitra, L. Nole, F. Fujii, T. Fujimoto, Y. Hanai, N. Hara, H. Matsumoto, K. Mitsugi, K. Monden, N. Nakayama, M. Okami, K. Oridate, N. Shiga, K. Shimizu, Y. Sugasawa, M. Takahashi, M. Takahashi, S. Tanaka, K. Ueda, T. Yamaguchi, H. Yamazaki, T. Yasumatsu, R. Yokota, T. Yoshizaki, T. Kudaba, I. Stara, Z. Cheah, S.K. Aguilar Ponce, J. Gonzalez Mendoza, R. Hernandez Hernandez, C. Medina Soto, F. Buter, J. Hoeben, A. Oosting, S. Suijkerbuijk, K. Bratland, A. Brydoey, M. Alvarez, R. Mas, L. Caguioa, P. Querol, J. Regala, E.E. Tamayo, M.B. Villegas, E.M. Kawecki, A. Karpenko, A. Klochikhin, A. Smolin, A. Zarubenkov, O. Goh, B.C. Cohen, G. du Toit, J. Jordaan, C. Landers, G. Ruff, P. Szpak, W. Tabane, N. Brana, I. Iglesias Docampo, L. Lavernia, J. Mesia, R. Abel, E. Muratidu, V. Nielsen, N. Cristina, V. Rothschild, S. Wang, H.-M. Yang, M.-H. Yeh, S.-P. Yen, C.-J. Soparattanapaisarn, N. Sriuranpong, V and Burtness, B. Harrington, K.J. Greil, R. Soulières, D. Tahara, M. de Castro, G., Jr Psyrri, A. Basté, N. Neupane, P. Bratland, Å. Fuereder, T. Hughes, B.G.M. Mesía, R. Ngamphaiboon, N. Rordorf, T. Wan Ishak, W.Z. Hong, R.-L. González Mendoza, R. Roy, A. Zhang, Y. Gumuscu, B. Cheng, J.D. Jin, F. Rischin, D. Lerzo, G. Tatangelo, M. Varela, M. Zarba, J.J. Boyer, M. Gan, H. Gao, B. Hughes, B. Mallesara, G. Taylor, A. Burian, M. Barrios, C.H. de Castro Junior, D.O. Castro, G. Franke, F.A. Girotto, G. Lima, I.P.F. Nicolau, U.R. Pinto, G.D.J. Santos, L. Victorino, A.-P. Chua, N. Couture, F. Gregg, R. Hansen, A. Hilton, J. McCarthy, J. Soulieres, D. Ascui, R. Gonzalez, P. Villanueva, L. Torregroza, M. Zambrano, A. Holeckova, P. Kral, Z. Melichar, B. Prausova, J. Vosmik, M. Andersen, M. Gyldenkerne, N. Jurgens, H. Putnik, K. Reinikainen, P. Gruenwald, V. Laban, S. Aravantinos, G. Boukovinas, I. Georgoulias, V. Kwong, D. Al-Farhat, Y. Csoszi, T. Erfan, J. Horvai, G. Landherr, L. Remenar, E. Ruzsa, A. Szota, J. Billan, S. Gluck, I. Gutfeld, O. Popovtzer, A. Benasso, M. Bui, S. Ferrari, V. Licitra, L. Nole, F. Fujii, T. Fujimoto, Y. Hanai, N. Hara, H. Matsumoto, K. Mitsugi, K. Monden, N. Nakayama, M. Okami, K. Oridate, N. Shiga, K. Shimizu, Y. Sugasawa, M. Takahashi, M. Takahashi, S. Tanaka, K. Ueda, T. Yamaguchi, H. Yamazaki, T. Yasumatsu, R. Yokota, T. Yoshizaki, T. Kudaba, I. Stara, Z. Cheah, S.K. Aguilar Ponce, J. Gonzalez Mendoza, R. Hernandez Hernandez, C. Medina Soto, F. Buter, J. Hoeben, A. Oosting, S. Suijkerbuijk, K. Bratland, A. Brydoey, M. Alvarez, R. Mas, L. Caguioa, P. Querol, J. Regala, E.E. Tamayo, M.B. Villegas, E.M. Kawecki, A. Karpenko, A. Klochikhin, A. Smolin, A. Zarubenkov, O. Goh, B.C. Cohen, G. du Toit, J. Jordaan, C. Landers, G. Ruff, P. Szpak, W. Tabane, N. Brana, I. Iglesias Docampo, L. Lavernia, J. Mesia, R. Abel, E. Muratidu, V. Nielsen, N. Cristina, V. Rothschild, S. Wang, H.-M. Yang, M.-H. Yeh, S.-P. Yen, C.-J. Soparattanapaisarn, N. Sriuranpong, V

Abstract

Background: Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response. Methods: KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at l

Published
2019

8. Breast cancer in Hodgkin's disease and non-Hodgkin's lymphoma survivors

Author

Sanna, G, Lorizzo, K, Rotmensz, N, Bagnardi, V, Cinieri, S, Colleoni, M, Nole, F, Goldhirsch, A, Goldhirsch, A., BAGNARDI, VINCENZO, Sanna, G, Lorizzo, K, Rotmensz, N, Bagnardi, V, Cinieri, S, Colleoni, M, Nole, F, Goldhirsch, A, Goldhirsch, A., and BAGNARDI, VINCENZO

Abstract

Background: Better therapeutic approaches for patients with Hodgkin's disease (HD) and non-Hodgkin's lymphomas (NHL) resulted in high cure rates, at cost of serious late side effects. Second primary tumours are a major concern for long-term survivors, and breast cancer (BC) is the most common solid tumour among women treated for HD. Materials and methods: Fifty-three women treated for primary BC with previous history of malignant lymphoma were identified in our institution, 35 with HD (66%), 18 (34%) with NHL. A comparison group was randomly selected from our database matching for each patient with previous lymphoma, two patients with primary BC (rate 1 : 2) for age, stage (pathological tumour size [pT] status and nodal status), year of diagnosis, and estrogen and progesterone status (positive versus negative). The primary end points were disease-free survival (DFS) and overall survival (OS). Results: The two groups of patients were compared for biological features: histopathological diagnosis, grading, lymphatic invasion, c-erbB2 overexpression, and Ki-67. Considering these variables, no significant differences were observed between the two groups with the exception of Ki-67, which was found higher in those with previous HD or NHL (65% versus 49%, respectively, P = 0.0526, borderline significant). Comparing the two groups for treatment approach, no differences were found for surgical and medical therapy (endocrine therapy and chemotherapy). However, regarding patients with node-positive disease (14 versus 35 patients), five patients in the lymphoma group (36%), compared with 24 (69%) in the matched group received anthracycline-based therapy (P = 0.0345). As expected, radiotherapy was used very differently in the two groups, with 36% of patients in the study group undergoing intraoperative radiotherapy with electrons versus 10% in the control group (P = 0.0001). Five-year DFS was 54.5% for the study cohort compared with 91% for controls (P < 0.0001). Five-year OS pe

Published
2007

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