Phase II trial of irinotecan, carboplatin, and bevacizumab in patients with extensive-stage small cell lung cancer

Abstract

18130 Background: Bevacizumab (B) improves survival when combined with chemotherapy in non-small cell lung cancer treatment. Our center previously studied the role of B as maintenance therapy in patients (pts) with limited-stage small cell lung cancer (SCLC). The present multicenter community-based trial was designed to examine the role of B and chemotherapy in previously untreated pts with extensive- stage SCLC (ES-SCLC). Methods: The primary endpoint is to assess the median time to progression (TTP). Eligibility criteria: untreated ES-SCLC, ECOG PS 0–1, measurable disease, and informed consent. Exclusion criteria: hemoptysis, brain metastases, and therapeutic anticoagulation. Treatment: irinotecan (I) 60 mg/m2 IV D1, 8, 15, and carboplatin (C) AUC=4 IV D1, and B 10 mg/kg IV D1 and 15 every 28D. Pts were restaged every 8 weeks. If no evidence of progressive disease (PD) after 4–6 cycles, pts received B x 6 months. This 2- stage trial was designed to achieve a 40% improvement in historical median TTP of 6 months. Results: 34 pts were enrolled from 2/06 to 12/06 (trial ongoing, n=50 planned). Data are available for 23 pts in this analysis. Baseline characteristics: median age 66 years; male/female, 52%/48%; and ECOG PS 0/1, 35%/65%. The objective response rate was 78% (95% CI 58%-90%), all partial responses. One pt had stable disease and no pts had PD. Four pts were not evaluable due to: comorbidity (off study), 2 pts; too early, 2 pts. With a median follow-up of 7 months, the median TTP and overall survival have not been reached. Grade (G) 3/4 non-hematologic toxicity: diarrhea (26%), hyponatremia, pain, arthralgia, fatigue (13% each), and dehydration, confusion, proteinuria (9% each). G3/4 hematologic toxicity was limited to neutropenia (13%). Other G3/4 toxicities were = 5%. There have been no episodes of G3/4 bleeding or treatment-related deaths. Conclusions: I/C/B appears to be safe and generally well tolerated in pts with ES-SCLC in this preliminary analysis. Further accrual and longer follow-up are necessary to assess median TTP. No significant financial relationships to disclose.