Document Detail

Efficacy of low-dose topotecan in second-line treatment for patients with epithelial ovarian carcinoma.
MedLine Citation:
PMID:  12365013     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The high incidence of dose-limiting myelosuppresion using the U.S. Food and Drug Administration-approved topotecan dose of 1.5 mg/m(2) for 5 days every 3 weeks may have limited its utility in the treatment of patients with epithelial ovarian carcinoma. The objective of the study was to evaluate the treatment results and toxicity of a low-dose topotecan regimen as second-line treatment for patients with epithelial ovarian carcinoma. METHODS: A retrospective analysis was conducted of 203 consecutive patients with primary epithelial ovarian carcinoma who were referred to the Finsen Center during the period from June, 1996 to June, 2000. Eligibility criteria included histopathologically documented, International Federation of Gynecology and Obstetrics (FIGO) Stage IC-IV epithelial ovarian carcinoma; first-line treatment with paclitaxel and a platinum compound; and second-line treatment with topotecan (1.0 mg/m(2) intravenously for 5 days every 3 weeks). Efficacy and toxicity were compared with published results from pivotal trials using the approved dose of topotecan of 1.5 mg/m(2) for the same indication. RESULTS: A total of 56 patients received second-line treatment with the reduced-dose topotecan regimen because of refractory, persistent, or recurrent disease. In the subgroup of patients with platinum-resistant and paclitaxel-resistant disease (n = 43 patients), the response rate of 11.6% (95% confidence interval [95%CI], 3.9-25.1%) was similar to the response rate of 12.4% (95%CI, 6.9-19.9%) in a pivotal trial using standard-dose topotecan. In patients with platinum-resistant and paclitaxel-resistant disease, the median progression free survival and overall survival from the first day of second-line topotecan treatment were 2.7 months (range, 0.7-19.5 months) and 6.0 months (range, 1.0-32.8 months), respectively. In a multivariate Cox analysis, the initial performance status (0 vs. 1-2; P = 0.040; hazard ratio [HR], 2.05) and the performance status at the time of second-line treatment (0 vs. 1-2; P < 0.001; HR, 4.50) were identified as independent prognostic factors for overall survival from the start of second-line treatment. Grade 4 neutropenia was noted in only 5.1% of reduced-dose topotecan cycles (95%CI, 2.8-8.4%) compared with 33% and 57% of standard-dose cycles in pivotal studies. CONCLUSIONS: Topotecan at a dose of 1.0 mg/m(2) has similar efficacy based on response rate and lower toxicity compared with the approved schedule of 1.5 mg/m(2) for 5 days every 3 weeks in second-line treatment for patients with platinum-resistant and paclitaxel-resistant epithelial ovarian carcinoma. However, a comparison of different topotecan doses and schedules preferably should be made in a randomized setting in well-characterized populations with regard to established prognostic factors.
Bo Gronlund; Heine H Hansen; Claus Høgdall; Svend A Engelholm
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Cancer     Volume:  95     ISSN:  0008-543X     ISO Abbreviation:  Cancer     Publication Date:  2002 Oct 
Date Detail:
Created Date:  2002-10-04     Completed Date:  2002-10-29     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0374236     Medline TA:  Cancer     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1656-62     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2002 American Cancer Society.
Department of Oncology, Finsen Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
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MeSH Terms
Antineoplastic Agents / administration & dosage*,  adverse effects,  pharmacology*
Antineoplastic Agents, Phytogenic / administration & dosage
Carcinoma / drug therapy*,  pathology
Cisplatin / pharmacology
Dose-Response Relationship, Drug
Drug Resistance, Neoplasm
Middle Aged
Ovarian Neoplasms / drug therapy*,  pathology
Paclitaxel / administration & dosage
Retrospective Studies
Survival Analysis
Topotecan / administration & dosage*,  adverse effects,  pharmacology*
Treatment Outcome
Reg. No./Substance:
0/Antineoplastic Agents; 0/Antineoplastic Agents, Phytogenic; 123948-87-8/Topotecan; 15663-27-1/Cisplatin; 33069-62-4/Paclitaxel

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