Phase II study to topotecan and cisplatin in advanced hepatocellular carcinoma.
BACKGROUND
Hepatocellular carcinoma remains a highly chemoresistant neoplasm and is a common malignancy with poor prognosis in Korea. We performed a phase II study to evaluate the efficacy and toxicities of topotecan and cisplatin combination chemotherapy for advanced hepatocellular carcinoma.


METHODS
Between November 1999 and May 2001, ten patients with histologically proven hepatocellular carcinoma were enrolled in this study. The median age was 54 (range: 53-74) years and all were male. Six patients demonstrated stage IV, 1 stage IIIC, 2 stage IIIB and 1 stage IIIA. Six patients showed a ECOG performance status of 1. The treatment regimen consisted of topotecan 1.25 mg/m2 and cisplatin 20 mg/m2 for 5 days. The treatment was repeated every 4 weeks. Toxicities were evaluated according to WHO toxicity criteria.


RESULTS
All ten patients were evaluable for response and toxicity. There was only one patient who achieved partial response. The overall response rate was 10% (95% C.I.) and the response duration was 46 weeks. The median survival of all patients was 21 (range: 17-54+) weeks. During a total of 24 cycles, neutropenia of WHO grade 3 and 4 occurred in 33%, thrombocytopenia in 33% and anemia in 21%. In non-hematologic toxicity, diarrhea and hepatoxicity of grade 3 occurred in 1 and 2 patients, respectively. But there was no treatment-related death.


CONCLUSIONS
When used in this dose and schedule, topotecan and cisplatin combination chemotherapy does not seem to be effective for patients with advanced hepatocellular carcinoma.
Lee
Ga Young
GY
Department of Internal Medicine, Seoul Veterans Hospital, 6-2 DunChon-dong, Seoul 134-791, Korea.
Kim
Bong-Seog
BS
Seo
Yeoung Tae
YT
Choi
Seong Ho
SH
Kim
Hye Jin
HJ
Choi
Dong Seog
DS
Ko
Ji Young
JY
Yang
Soo Hyun
SH
Byun
Jong Hoon
JH
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D019772:Topotecan / Q000008:administration & dosage*; D016896:Treatment Outcome
D019772:Topotecan; D002945:Cisplatin