Efficacy and toxicity of belotecan for relapsed or refractory small cell lung cancer patients.

Abstract

INTRODUCTION:

Belotecan (Camtobell, CKD602) is a new camptothecin-derivative antitumor agent that belongs to the topoisomerase inhibitors. The aim of this study was to evaluate the efficacy and safety of belotecan monotherapy as a second-line therapy in patients with relapsed or refractory small cell lung cancer (SCLC).

METHODS:

Between June 2008 and August 2011, a total of 50 patients with relapsed or refractory SCLC were treated with belotecan 0.5 mg/m 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.

RESULTS:

The 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%).

CONCLUSION:

Belotecan showed modest activity with an acceptable safety profile as a second-line therapy in patients with relapsed or refractory SCLC.

• Authors: Gun Min Kim, Young Sam Kim, Young Ae Kang, Jae-Heon Jeong, Sun Mi Kim, Yun Kyoung Hong, Ji Hee Sung, Seung Taek Lim, Joo Hang Kim, Se Kyu Kim, Byoung Chul Cho
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 7 Issue 4 Pg. 731-6 (Apr 2012) ISSN: 1556-1380 [Electronic] United States
• PMID: 22425922 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Topoisomerase I Inhibitors
• belotecan
• Camptothecin

Topics

• Adult
• Aged
• Aged, 80 and over
• Camptothecin (adverse effects, analogs & derivatives, therapeutic use)
• Carcinoma, Small Cell (drug therapy, mortality)
• Disease-Free Survival
• Female
• Humans
• Lung Neoplasms (drug therapy, mortality)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Retrospective Studies
• Topoisomerase I Inhibitors (therapeutic use)