Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 6, Issue 1, Pages 103-108Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/JTO.0b013e3181fa8efd
Keywords
Non-small cell lung cancer; Sex differences; Bevacizumab
Categories
Funding
- National Cancer Institute, National Institutes of Health [CA23318, CA66636, CA21115, CA16116, CA21076, CA49957]
- Department of Health and Human Services
- NATIONAL CANCER INSTITUTE [U10CA049957, U10CA021115, U10CA023318, U10CA066636, U10CA016116, U10CA021076] Funding Source: NIH RePORTER
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Introduction: E4599 compared carboplatin and paclitaxel with (PCB) or without (PC) bevacizumab in patients with advanced-stage non-small cell lung cancer. Bevacizumab improved overall survival. However, an unplanned subset analysis did not show a survival benefit for females treated with bevacizumab. Methods: Known prognostic factors and toxicities were compared by sex. Proportional hazards models of survival with multiple factor combinations were used to adjust for treatment effect. Results: The analysis includes 850 patients. The median survival was 8.7 months (PC) versus 11.7 months (PCB) for males (p = 0.001) and 13.1 months (PC) versus 13.3 months (PCB) for females (p = 0.87). Progression-free survival and response rate on the PCB arm were 6.3 months and 29% for males and 6.2 months and 41% for females (p > 0.05). Progression-free survival and response rate on the PC arm were 4.3 months and 16% for males and 5.3 months and 14% for females (p > 0.05). No significant demographic differences were seen between the two arms for males, whereas fewer females on the PCB arm had liver metastasis (PCB 11.7% versus PC 23.2%, p = 0.003). Adverse events with a sex difference on the PCB arm included severe hypertension (males: 4.2%, females: 9.9%, p = 0.02), constipation (males: 1.4%, females: 4.7%, p = 0.05), and abdominal pain (males: 0.9%, females: 5.2%, p = 0.01). In the proportional hazards model adjusting for the other factors, the test for a sex by treatment interaction was not significant (p = 0.09). Conclusions: Multiple factors may contribute to the apparent sex-specific differences in efficacy of bevacizumab noted in this study.
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