ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer
| Autor: | Chris Bowden, Vincent A. Miller, Taral Patel, Leonard White, Fairooz F. Kabbinavar, Saifuddin M. Kasubhai, Bruce Kressel, Louis Fehrenbacher, Jonathan Polikoff, John D. Hainsworth, Thomas Marsland, Mark A. Rubin, Chin-Yu Lin, James Chih-Hsin Yang, Bruce E. Johnson |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Lung Neoplasms Bevacizumab Kaplan-Meier Estimate Placebo Antibodies Monoclonal Humanized Disease-Free Survival Maintenance Chemotherapy Erlotinib Hydrochloride Double-Blind Method Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Malignant pleural effusion Humans Lung cancer Aged Proportional Hazards Models Aged 80 and over business.industry Phase IIIb Trial Middle Aged medicine.disease Chemotherapy regimen Surgery Treatment Outcome Quinazolines Female Erlotinib business medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 31(31) |
| ISSN: | 1527-7755 |
| Popis: | Purpose This phase III trial was performed to assess the potential benefit of adding maintenance erlotinib to bevacizumab after a first-line chemotherapy regimen with bevacizumab for advanced non–small-cell lung cancer (NSCLC). Patients and Methods One thousand one hundred forty-five patients with histologically or cytologically confirmed NSCLC (stage IIIB with malignant pleural effusion, stage IV, or recurrent) received four cycles of chemotherapy plus bevacizumab. Seven hundred forty-three patients without disease progression or significant toxicity were then randomly assigned (1:1) to bevacizumab (15 mg/kg, day 1, 21-day cycle) plus either placebo or erlotinib (150 mg per day). The primary end point was progression-free survival (PFS). Results Median PFS from time of random assignment was 3.7 months with bevacizumab/placebo and 4.8 months with bevacizumab/erlotinib (hazard ratio [HR], 0.71; 95% CI, 0.58 to 0.86; P < .001). Median overall survival (OS) times from random assignment were 13.3 and 14.4 months with bevacizumab/placebo and bevacizumab/erlotinib, respectively (HR, 0.92; 95% CI, 0.70 to 1.21; P = .5341). During the postchemotherapy phase, there were more adverse events (AEs) overall, more grade 3 and 4 AEs (mainly rash and diarrhea), more serious AEs, and more AEs leading to erlotinib/placebo discontinuation in the bevacizumab/erlotinib arm versus the bevacizumab/placebo arm. The incidence of AEs leading to bevacizumab discontinuation was similar in both treatment arms. Conclusion The addition of erlotinib to bevacizumab significantly improved PFS but not OS. Although generally well tolerated, the modest impact on survival and increased toxicity associated with the addition of erlotinib to bevacizumab maintenance mean that this two-drug maintenance regimen will not lead to a new postchemotherapy standard of care. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|