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A pilot study of topotecan in the treatment of serous carcinoma of the uterus.

Abstract
A pilot study investigated topotecan (Hycamtin, GlaxoSmithKline, Philadelphia, PA), a topoisomerase I inhibitor, in treating uterine serous carcinoma, a typically unresponsive aggressive tumor. Fifteen patients were surgically staged, then treated with topotecan (1.5 mg/m2, Days 1-5 every 21 days) as first-line therapy (n = 12) or secondary to platinum failure (n = 3). Patients received topotecan through six courses, disease progression, or unacceptable toxicity. Grade 3/4 hematologic toxicity prompted dose adjustments. Thirteen patients exhibited no gross evidence of residual disease postoperatively. At topotecan initiation, one patient had 5-cm and one had < 1-cm residual disease. Seventy-eight courses (median, six) were administered; 12 (80%) patients completed the specified protocol. Common serious toxicities included grade 3 neutropenia (33%), anemia (13%), and thrombocytopenia (13%). Eight patients received erythropoietin and/or granulocyte colony-stimulating factor. Median follow-up for 14 evaluable patients was 26 months (range, 13-40). Of 11 evaluable first-line topotecan patients, nine were alive at follow-up; five were disease-free. Of three second-line topotecan patients, two died and one was alive with disease 31 months post-treatment. One patient with measurable disease achieved a complete and one a partial response as assessed by computed tomography scan. Median progression-free survival was 25 months; median survival has not been reached at 26 months. Although topotecan's antitumor activity cannot yet be quantified, disease-free interval and survival outcomes compare favorably with other therapies in uterine serous carcinoma. Further evaluation of topotecan in this population is warranted.
AuthorsJ T Chambers, T J Rutherford, P E Schwartz, M L Carcangiu, S K Chambers, L Baker
JournalInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society (Int J Gynecol Cancer) 2003 Mar-Apr Vol. 13 Issue 2 Pg. 216-22 ISSN: 1048-891X [Print] England
PMID12657127 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents
  • Platinum
  • Topotecan
Topics
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
  • Cystadenocarcinoma, Papillary (drug therapy, mortality, pathology, surgery)
  • Disease-Free Survival
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Staging
  • New York City
  • Pilot Projects
  • Platinum
  • Survival Analysis
  • Topotecan (administration & dosage, adverse effects, therapeutic use)
  • Treatment Outcome
  • Uterine Neoplasms (drug therapy, mortality, pathology, surgery)

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