Safety evaluation of nivolumab added concurrently to radiotherapy in a standard first line chemo-radiotherapy regimen in stage III non-small cell lung cancer-The ETOP NICOLAS trial
| العنوان: | Safety evaluation of nivolumab added concurrently to radiotherapy in a standard first line chemo-radiotherapy regimen in stage III non-small cell lung cancer-The ETOP NICOLAS trial |
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| المؤلفون: | Johan Vansteenkiste, Amanda Tufman, M. Guckenberger, Dirk De Ruysscher, Miklos Pless, N. Andratschke, Maarten Lambrecht, Alex Martinez-Marti, Antonio Irigoyen, M. Kassapian, A.-C. Piguet, H. Roschitzki-Voser, Enriqueta Felip, Manuela Rabaglio-Poretti, Rolf A. Stahel, Urania Dafni, Claus Belka, H. Vees, Solange Peters, E. Nadal, A. Becker |
| المساهمون: | CCA - Cancer Treatment and quality of life, Pulmonary medicine, University of Zurich, De Ruysscher, D, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Radiotherapie |
| المصدر: | Peters, S, Felip, E, Dafni, U, Belka, C, Guckenberger, M, Irigoyen, A, Nadal, E, Becker, A, Vees, H, Pless, M, Martinez-Marti, A, Tufman, A, Lambrecht, M, Andratschke, N, Piguet, A C, Kassapian, M, Roschitzki-Voser, H, Rabaglio-Poretti, M, Stahel, R A, Vansteenkiste, J & De Ruysscher, D 2019, ' Safety evaluation of nivolumab added concurrently to radiotherapy in a standard first line chemo-radiotherapy regimen in stage III non-small cell lung cancer—The ETOP NICOLAS trial ', Lung Cancer, vol. 133, pp. 83-87 . https://doi.org/10.1016/j.lungcan.2019.05.001 Lung Cancer, 133, 83-87. Elsevier Ireland Ltd |
| بيانات النشر: | Elsevier Ireland Ltd, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, 0301 basic medicine, Oncology, Cancer Research, Lung Neoplasms, medicine.medical_treatment, Programmed Cell Death 1 Receptor, Platinum Compounds, Cancer immunotherapy, NSCLC, B7-H1 Antigen, Cohort Studies, 0302 clinical medicine, Non-small cell lung cancer, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, 1306 Cancer Research, 610 Medicine & health, Chemoradiotherapy, Middle Aged, 10044 Clinic for Radiation Oncology, Treatment Outcome, Nivolumab, 030220 oncology & carcinogenesis, Female, 2730 Oncology, Adult, Pulmonary and Respiratory Medicine, medicine.medical_specialty, 03 medical and health sciences, Immune checkpoint inhibitors, Internal medicine, medicine, Humans, Chemotherapy, Adverse effect, Aged, Neoplasm Staging, Pneumonitis, Radiotherapy, business.industry, medicine.disease, Survival Analysis, Radiation therapy, Clinical trial, PD-1 inhibitor, Regimen, 030104 developmental biology, 2740 Pulmonary and Respiratory Medicine, Combination treatment, 10032 Clinic for Oncology and Hematology, business |
| الوصف: | Objectives: Chemo-radiotherapy (CRT) and concurrent PD-1 inhibition has shown promising results in preclinical models. So far, the feasibility of delivering concurrent CRT and PD-1/PD-L1 inhibition has never been assessed in a clinical trial.Material and methods: NICOLAS is a phase-II trial evaluating the safety and efficacy of nivolumab combined with CRT in stage III NSCLC. Patients received 3 cycles of platinum-based chemotherapy and concurrent RT (66 Gy/33fractions). Nivolumab started concurrently with RT. The primary endpoint was 6-month post-RT rate of grade- >= 3-pneumonitis. A formal interim safety analysis (IA) was scheduled when the first 21 patients reached 3 months follow-up post-RT. An early positive safety conclusion would be reached at IA if there were no grade >= 3-pneumonitis in those patients. Efficacy evaluation was planned provided the safety conclusion was reached.Results and conclusion: As of 13 December 2018, 82 patients were recruited with median follow-up of 13.4 months. The most frequent adverse events (AEs) were anaemia, fatigue and pneumonitis. No unexpected AEs or increased toxicities were observed. For the first 21 patients, no grade- >= 3-pneumonitis was observed by the end of the 3-month post-RT follow-up period.The early safety IA provides evidence that the addition of nivolumab to concurrent CRT is safe and tolerable regarding the 6-month rate of pneumonitis grade >= 3 at the one-sided significance level of 5%. Following that, the 1-year progression-free survival will be evaluated in an expanded patient cohort NICOLAS trial creates the opportunity for assessing the activity of the combination of checkpoint with concurrent CRT in larger prospective trials for locally advanced NSCLC. |
| اللغة: | English |
| تدمد: | 1872-8332 0169-5002 |
| DOI: | 10.1016/j.lungcan.2019.05.001 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::570cf868996fee0e2e923a6bd8d28c82 https://cris.maastrichtuniversity.nl/en/publications/2a8c0117-7e00-4d83-b7fc-7be4e145c39d |
| Rights: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....570cf868996fee0e2e923a6bd8d28c82 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 18728332 01695002 |
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| DOI: | 10.1016/j.lungcan.2019.05.001 |