Belotecan for relapsing small-cell lung cancer patients initially treated with an irinotecan-containing chemotherapy: a phase II trial.
BACKGROUND
Belotecan is a topoisomerase I inhibitor. This phase II trial was conducted to evaluate the efficacy and toxicity of belotecan in relapsing small-cell lung cancer (SCLC) patients after irinotecan failure.


METHODS
SCLC patients, who had relapsed at least 3 months after achieving objective response to irinotecan plus platinum chemotherapy, were eligible. Belotecan was administered at a dose of 0.5 mg/m(2)/day for 5 consecutive days every 3 weeks.


RESULTS
Twenty-seven patients were enrolled in this study. Twenty-five patients were evaluated for response, and 27 patients were evaluated for toxicity and survival. The overall response rate was 22%. The median time to progression was 4.7 months (95% CI, 3.6-5.8 months), and the median overall survival was 13.1 months (95% CI, 10.4-15.8 months). The most frequent grade 3/4 toxicities were neutropenia (93%) and thrombocytopenia (48%). There was one treatment-related death due to pneumonia.


CONCLUSIONS
Belotecan showed modest activity and manageable toxicities in relapsing SCLC patients in this study which was conducted in Asia. But further study in Caucasian patients is needed.
Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Jaeheon
J
Jeong
Byoung Chul
BC
Cho
Joo Hyuk
JH
Sohn
Hye Jin
HJ
Choi
Se Hyun
SH
Kim
Young Joo
YJ
Lee
Min Kyu
MK
Jung
Sang Joon
SJ
Shin
Moo-Suk
MS
Park
Se Kyu
SK
Kim
Joon
J
Chang
Joo Hang
JH
Kim
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D016879:Salvage Therapy; D059004:Topoisomerase I Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*
D009944:Organoplatinum Compounds; D059004:Topoisomerase I Inhibitors; C116963:belotecan; D000077146:Irinotecan; D002166:Camptothecin