Second-line Erlotinib or Intermittent Erlotinib plus Docetaxel in Male Ex-smokers with Squamous NSCLC: The TALISMAN Randomized Trial
| Autor: | Paolo Maione, Antonio Rossi, Antonio Chella, G. Valmadre, Maria Rita Migliorino, Paolo Bidoli, Serena Ricciardi, Matteo Brighenti, Cesare Gridelli, Giacomo Allegrini, Filippo de Marinis |
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| Přispěvatelé: | Gridelli, C, Chella, A, Valmadre, G, Allegrini, G, Brighenti, M, Bidoli, P, Rossi, A, Maione, P, Migliorino, M, Ricciardi, S, De Marinis, F |
| Rok vydání: | 2016 |
| Předmět: |
Male
0301 basic medicine Oncology Cancer Research medicine.medical_specialty Lung Neoplasms Combination therapy Docetaxel NSCLC Disease-Free Survival law.invention Erlotinib Hydrochloride 03 medical and health sciences 0302 clinical medicine Second line Randomized controlled trial law Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Adverse effect neoplasms Aged Smoker business.industry Smoking Ex smokers General Medicine Middle Aged respiratory tract diseases 030104 developmental biology Erlotinib TArceva 030220 oncology & carcinogenesis Second-line treatment Taxoids business medicine.drug |
| Zdroj: | Anticancer Research. 36:6535-6540 |
| ISSN: | 1791-7530 0250-7005 |
| Popis: | Background/Aim: The TArceva and docetaxeL In former-Smokers MAle patients with recurrent non-small cell lung cancer (TALISMAN) phase II, open-label randomized trial evaluates the combination of erlotinib with docetaxel in the second-line therapy of ex-smoker males with advanced squamous non-small cell lung cancer (NSCLC). Patients and Methods: Patients received erlotinib 150 mg/day (arm A; n=36) or docetaxel 75 mg/m2 on day 1 of each 3-week cycle and erlotinib 150 mg/day on days 2-16 of each cycle (arm B; n=38). The primary end-point was progression-free rate (PFR) at 6 months. Results: The study was prematurely interrupted due to slow enrolment. Three (8.3%) patients in arm A and 3 (8.1%) in arm B remained progression-free at 6 months. Median progressionfree survival (PFS) was 2.3 months in arm A and 2.8 months in arm B. Median overall survival (OS) was 5.6 and 8.9 months, respectively. Overall, 77.8% of patients in arm A and 89.2% in arm B experienced treatment-related adverse events (AEs). Conclusion: Results do not support further investigation of the combination of erlotinib and docetaxel in this setting Background/Aim: The TArceva and docetaxeL In former-Smokers MAle patients with recurrent non-small cell lung cancer (TALISMAN) phase II, open-label randomized trial evaluates the combination of erlotinib with docetaxel in the second-line therapy of ex-smoker males with advanced squamous non-small cell lung cancer (NSCLC). Patients and Methods: Patients received erlotinib 150 mg/day (arm A; n=36) or docetaxel 75 mg/m2 on day 1 of each 3-week cycle and erlotinib 150 mg/day on days 2-16 of each cycle (arm B; n=38). The primary end-point was progression-free rate (PFR) at 6 months. Results: The study was prematurely interrupted due to slow enrolment. Three (8.3%) patients in arm A and 3 (8.1%) in arm B remained progression-free at 6 months. Median progressionfree survival (PFS) was 2.3 months in arm A and 2.8 months in arm B. Median overall survival (OS) was 5.6 and 8.9 months, respectively. Overall, 77.8% of patients in arm A and 89.2% in arm B experienced treatment-related adverse events (AEs). Conclusion: Results do not support further investigation of the combination of erlotinib and docetaxel in this setting. |
| Databáze: | OpenAIRE |
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