Phase 2 trial of maintenance bevacizumab alone after bevacizumab plus pemetrexed and carboplatin in advanced, nonsquamous nonsmall cell lung cancer
Stevenson JP et al. – Combined bevacizumab, pemetrexed, and carboplatin followed by maintenance bevacizumab was well tolerated and displayed remarkable activity in patients with previously untreated, advanced, nonsquamous nonsmall cell lung cancer.
Previously untreated patients with advanced, nonsquamous nonsmall cell lung cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1 received bevacizumab 15mg/kg, pemetrexed 500mg/m2 and carboplatin at an area under the concentration-time curve of 6 intravenously on day 1 every 21days.
Responding or stable patients who completed 6 cycles then received bevacizumab maintenance every 21days until disease progression.
In total, 43 patients (40 who were evaluable for response) were entered on the study.
Treatment-related grade 3/4 toxicities were low and included febrile neutropenia (2%), neutropenia (28%), anemia (18%), thrombocytopenia (11%), hypertension (7%), epistaxis (5%), venous thrombosis (8%), dyspnea (7%), rectovaginal fistula (2.3%), infusion reaction (2%), and cerebrovascular event (2%).
One patient died from complications of venous thromboembolism and cerebrovascular accident after Cycle 2.
Minimal clinically significant toxicity occurred during maintenance bevacizumab.
Two complete responses (5%) were observed, and 17 patients (42%) had a partial response.
At a median follow-up of 15.8months, the median progression-free survival was 7.1months (95% confidence interval, 5.9-8.3months), and the median overall survival was 17.1months (95% confidence interval, 8.8-25.5months).
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