Phase II evaluation of topotecan in carcinosarcoma of the uterus: a Gynecologic Oncology Group study.
OBJECTIVE
To estimate the antitumor activity of topotecan in patients with persistent or recurrent carcinosarcoma (malignant mixed mullerian tumors) of the uterus and to determine the nature and degree of toxicity of topotecan in this cohort of patients.


METHODS
Eligible patients had measurable advanced or recurrent carcinosarcoma of the uterus. Topotecan at a target dose of 1.5 mg/m(2) was administered IV daily for 5 days, every 3 weeks, until progression of disease or adverse affects prohibited further therapy.


RESULTS
Twenty-seven member institutions entered 51 patients. Of the patients entered, 48 were eligible. Patient characteristics included a median age of 65, with 33% having prior radiation and 92% having prior chemotherapy. Twenty-six patients (54%) had a performance status (PS) of 0, 18 (38%) had a PS of 1, and four (8%) had a PS of 2. Patients received from 1 to 21 (with a median of 2) courses of treatment. The most frequently observed grade 4 toxicities were neutropenia seen in 35 (73%) patients, leukopenia in 14 (29%), and thrombocytopenia in 10 (21%). Three (6%) patients developed neutropenic sepsis and died shortly after their first treatment cycle. There were five (10%) complete responses; 13 (27%) patients maintained stable disease, 26 (54%) experienced increasing disease, and reassessment did not occur in four (8%).


CONCLUSIONS
Topotecan at this dose and schedule does not appear to have major activity in patients with advanced or recurrent uterine carcinosarcoma previously treated with chemotherapy.
Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Texas, Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., J7.124, Dallas, TX 75390-9032, USA. david.miller@utsouthwestern.edu
David Scott
DS
Miller
John A
JA
Blessing
Jeanne
J
Schilder
Adnan
A
Munkarah
Yi Chun
YC
Lee
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002296:Carcinosarcoma / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D018200:Mixed Tumor, Mullerian / Q000188:drug therapy*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*; D014594:Uterine Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D019772:Topotecan