Abstract
e17505 Background: Bendamustine is an alkylating agent with a nitrogen mustard group and purine-like benzimidazole group. Bendamustine in combination with carboplatin has shown efficacy as first line therapy in extensive stage SCLC with RR 73%, TTP 5.2 months and OS 8.3 months [Köster W et al. J Tho Onc. 2007;2(4):312-6]. This study aims to examine the safety and efficacy of single agent bendamustine as 2nd or 3rd line therapy in patients (pts) with SCLC. Methods: This is an open-label, multicenter phase II trial. Eligible pts had previously treated SCLC, up to 2 prior regimens, PS 0-2, evaluable/measurable disease, adequate marrow, renal and hepatic function. Pts with stable treated brain metastases were allowed. Pts were treated with bendamustine (120mg/m2 IV days 1 and 2 every 3 weeks) up to 6 cycles and evaluated every 2 cycles. Primary endpoint was TTP; secondary endpoints include RR, PFS, OS, and toxicity. Results: 28 pts have enrolled to date (target accrual 60); 19 pts were evaluable for response; there were 7 PR, 7 SD and 5 PD. Median TTP was 2.5 months. At the time of analysis, 12 pts were alive. Median number of cycles given was 2. 5 pts required dose reductions due to AEs. Grade 3/4 AEs included neutropenia 14.3%, fatigue 10.7%, anemia and diarrhea 7.1% and less commonly, thrombocytopenia, nausea, infection, hyponatremia, pulmonary at 3.6%. Conclusions: These preliminary data indicate that single agent bendamustine appears to be well tolerated and effective in the second or third line setting for patients with SCLC. Accrual is ongoing.
Published Version
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