Real world data of nivolumab for previously treated non-small cell lung cancer patients: a Galician lung cancer group clinical experience
| Autor: | Natalia Fernández Núñez, Martin Lázaro Quintela, Iria Carou Frieiro, Joaquin Mosquera Martinez, Margarita Amenedo Gancedo, Joaquin Casal Rubio, Jose Muñoz Iglesias, Alexandra Sabela Cortegoso mosquera, Rocio Vilchez Simo, Urbano Anido Herranz, Jesús García Mata, Lucía Santomé Couto, Begoña Campos Balea, Mª Carmen Areses Manrique, Jorge García González, Mª Rosario García Campelo, Guillermo Alonso-Jaudenes Curbera, José Luis Fírvida Pérez, Cristina Azpitarte Raposeiras, F.J. Afonso |
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| Rok vydání: | 2018 |
| Předmět: |
Oncology
medicine.medical_specialty Performance status business.industry Not Otherwise Specified Evaluable Disease medicine.disease Clinical trial 03 medical and health sciences 0302 clinical medicine 030220 oncology & carcinogenesis Internal medicine medicine Adenocarcinoma 030212 general & internal medicine Nivolumab Lung cancer business Progressive disease |
| Zdroj: | Translational Lung Cancer Research. 7:404-415 |
| ISSN: | 2226-4477 2218-6751 |
| DOI: | 10.21037/tlcr.2018.04.03 |
| Popis: | Background Recently, immunotherapy has changed the standard of treatment in non-small cell lung cancer (NSCLC). Outside clinical trials, data of real life is lacking. This is an observational study that represents the real world experience with nivolumab in pretreated NSCLC. Methods Eligibility criteria included, histologically confirmed NSCLC, stage IIIB and IV, evaluable disease and at least one prior therapy. Patients received nivolumab until progressive disease (PD) or unacceptable toxicity. The main aim of the study was to report the efficacy and safety profile of Nivolumab in pretreated patients with advanced NSCLC of our everyday clinical practice. The secondary aim was to perform subgroup analysis by clinical features. Results From August of 2015 to January of 2017, 188 patients were enrolled. The patients demographics were: median age 58 years, 144 male; 17 never smoker and 171 former/current smoker; 112 adenocarcinoma, 66 squamous-cell carcinoma and 10 not otherwise specified (NOS); 61 stage IIIB and 127 stage IV; 15 performance status (PS) 0, 154 PS 1 and 19 PS 2; 5 epidermal growth factor receptor (EGFR) and 1 anaplastic lymphoma kinase (ALK); 42 with central nervous system (CNS) metastases; and 71 received 2 or more prior therapy lines. Of the 188 patients enrolled, 25 (13.3%) were not evaluated, 3 (1.6%) had complete response (CR), 45 (23.9%) partial response (PR), 48 (25.5%) disease stabilization (DS) and 67 (35.6%) PD. The median of progression-free survival (PFS) was 4.83 months (95% CI, 3.6-5.9) and overall survival (OS) was 12.85 months (95% CI, 9.07-16.62). The subgroup analysis revealed statistical significance in OS for patients with CNS metastases 14.8 months (95% CI, 11.5-17.3) vs. 5.09 months (95% CI, 0.3-9.8) and also PS 0 [not reached (NR)] vs. PS 1 11.7 months vs. PS 2 3.4 months (95% CI, 2.3-4.4). The safety profile was in accordance with the literature data. Conclusions This study represents the real word experience with nivolumab and the results are consistent with previously reported in clinical trials. PS 2 and the presence of CNS metastases are associated with poor prognosis. |
| Databáze: | OpenAIRE |
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