Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 9, Issue 8, Pages 1146-1153Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/JTO.0000000000000217
Keywords
Non-small cell lung cancer; Elderly; Nonsquamous histology; Bevacizumab; Survival
Categories
Funding
- NCI NIH HHS [U10 CA037404, U10 CA180821, U10 CA035090, U10 CA063848, U10 CA025224, CA-35269, CA-35415, U10 CA180882, CA-35103, CA-35090, U10 CA035113, CA-35113, UG1 CA189823, CA-25224, CA-63848, U10 CA035415, U10 CA035267, U10 CA063849, CA-63849, CA-35267, CA-37404, U10 CA035269, U10 CA035103] Funding Source: Medline
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Background: We hypothesized that the combination of bevacizumab, carboplatin, and pemetrexed will be an effective first-line regimen in fit, elderly patients with nonsquamous non-small-cell lung cancer. Methods: Treatment-naive, stage IIIB/IV nonsquamous non-smallcell lung cancer patients more than 70 years old with good performance status (Eastern Cooperative Oncology Group performance status 0-1) and adequate organ function were eligible. Carboplatin area under the curve 6, pemetrexed 500 mg/m(2), and bevacizumab 15 mg/kg were administered on day 1 of each 21-day cycle (up to six cycles) followed by maintenance pemetrexed and bevacizumab. The primary end point of 6-month progression-free survival rate of at least 70% was assessed using a one-stage binomial design. Quality of life (QOL) questionnaires were administered. Polymorphisms in genes encoding relevant proteins (drug targets, transport, and metabolism proteins) were correlated with treatment outcome. Results: Fifty-seven eligible patients were enrolled. Median age was 74.5 years. Median treatment cycles received was 6. The most common grade 3 or higher non-hematologic adverse events were fatigue (26%) and hypertension (11%); 16% had grade 4 neutropenia and 6.5% had grade 4 thrombocytopenia. Three patients experienced grade 3/4 hemorrhagic events (one pulmonary, two gastrointestinal). Primary end point of PFS6 was 60% (95% confidence interval [ CI]: 45.9-73%). Median PFS was 7.0 months (95% CI: 5.9-10.1), median overall survival was 13.7 months (95% CI: 9.4-16.8). Polymorphic KDR and VEGFA variants correlated with survival and toxicity, respectively. There was no significant change in overall QOL scores over time. Conclusion: This regimen is feasible and did not decrease the QOL in this study population. However, it did not meet the primary efficacy end point.
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