1520PD - Comparative study between belotecan/cisplatin and etoposide/cisplatin (COMBAT) in patients with previously untreated, extensive stage small cell lun...

Date 29 September 2012
Event ESMO Congress 2012
Session NSCLC - Immunotherapy, SCLC and Mesothelioma
Topics Anti-Cancer Agents & Biologic Therapy
Small-Cell Lung Cancer
Presenter Young-Chul Kim
Authors Y. Kim1, K. Kim2, I. Oh2, H. Ban2, K. Na2, S. Ahn2, H. Kang1, W. Kim1, C. Park1, S. Yang3
  • 1Pulmonology, Chonnam National University Hwasun Hospital Lung Cancer Clinic, 519-809 - Hwasun Gun/KR
  • 2Lung Cancer Clinic, Chonnam National University Hwasun Hospital, 519763 - Jeonnam/KR
  • 3Pulmonology, Wonkwang University Hospital, Jeonbuk/KR

Abstract

Purpose

Belotecan (camtobell™) is a topoisomerase I inhibitor, and effective in small cell lung cancer (SCLC). The objective of this study is to compare the efficacy and safety of belotecan + cisplatin (BP) and etoposide + cisplatin (EP) in first line setting.

Methods (materials)

This is a multicenter, randomized, prospective controlled trial to prove non-inferiority of BP compared to standard EP regimen. The primary endpoint is overall response rate (ORR), and secondary endpoints are toxicity, overall survival (OS) and progression-free survival (PFS). BP was administrated by belotecan 0.5 mg/m2 for 4 days combined with cisplatin 60 mg/m2 only for first day. Treatment response was evaluated according to version 1.0 of Response Evaluation Criteria in Solid Tumors.

Results

We enrolled 129 (BP: 63, EP: 66) patients, and response evaluation was possible in 111 (BP: 50, EP: 61) patients. In BP group, there were 1 complete response, 32 partial responses (PR), 7 stable diseases (SD), and there were 33 PR and 11 SD in EP group. There were no significant differences in ORR (BP: 66.0%, EP: 54.1%, p = 0.25) and disease control rate (BP: 80.0%, EP: 72.1%, p = 0.38). Median OS (BP: 483, EP: 340 days, p = 0.21) and PFS (BP: 192, EP: 150 days, p = 0.08) were not significantly different. The frequency of grade ≥ 3 anemia (BP: 29.0%, EP: 7.5%, p < 0.01) and thrombocytopenia (BP: 35.5%, EP: 16.4%, p = 0.02) were higher in BP group. Non-hematologic toxicities were not different between two groups.

Conclusions

In this interim analysis, BP and EP have similar ORR, OS and PFS in extensive stage SCLC. Toxicity profiles except anemia and thrombocytopenia were similar between two groups. (ClinicalTrials.gov number, NCT00826644)

Disclosure

All authors have declared no conflicts of interest.