Efficacy and Toxicity of Belotecan for Relapsed or Refractory Small Cell Lung Cancer Patients

IntroductionBelotecan (Camtobell, CKD602) is a new camptothecin-derivative antitumor agent that belongsto the topoisomerase inhibitors. The aim of this study was to evaluate the efficacy and safetyof belotecan monotherapy as a second-line therapy in patients with relapsed or refractory small cell lung cancer (SCLC).MethodsBetween June 2008 and August 2011, a total of 50 patients with relapsed or refractory SCLC were treated with belotecan 0.5mg/m2 for 5 consecutive days, every 3 weeks. We evaluated the overall response rate (ORR), the progression-free survival (PFS), and the overall survival (OS), and toxicity according to sensitivity to initial chemotherapy.ResultsThe median age was 66 years (range, 43–84 years) and Eastern Cooperative Oncology Group performance was 0 or 1 in 34 patients (68%) and 2 in 16 patients (32%). Twenty patients (40%) had sensitive relapse and 30 patients (60%) had refractory disease. The ORR, PFS, and OS for sensitive patients were 20% (95% confidence interval [CI], 8–40), 2.8 months (95% CI, 0.53–5.06), and 6.5 months (95% CI, 1.58–11.42), respectively. In the refractory group, the ORR, PFS, and OS were 10% (95% CI, 1–21), 1.5 months (95% CI, 1.25–1.75), and 4.0 months (95% CI, 3.40–4.60), respectively. Most commonly reported grade-3 or -4 adverse events included neutropenia (54%), thrombocytopenia (38%), and anemia (32%).ConclusionBelotecan showed modest activity with an acceptable safety profile as a second-line therapy in patients with relapsed or refractory SCLC.