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Thiotepa in combination with cisplatin for primary epithelial ovarian cancer: A phase II study
  1. M. E. Gordinier*,
  2. A. P. Kudelka,
  3. J. J. Kavanagh,
  4. J. T. Wharton and
  5. R. S. Freedman
  1. * Women's Oncology, Providence, Rhode Island
  2. Section of Gynecologic and Medical Therapeutics, The University of Texas M.D. Anderson Cancer Center, Houston, Texas
  3. Department of Gynecologic Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas
  1. Correspondence and reprint requests: Ralph S. Freedman, MD, PhD, Department of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Box 440, Houston, TX 77030.


The objectives of this phase II protocol were: 1) to determine the clinical activity of thiotepa combined with cisplatin in suboptimally debulked advanced epithelial ovarian carcinoma as first-line chemotherapy, 2) to determine by surgery the response after 6 courses of chemotherapy, and 3) to identify the regimen's qualitative and quantitative toxicities. Patients with FIGO stage IIIC or IV epithelial ovarian cancer were eligible to receive cisplatin (50 mg/m2) followed by thiotepa (40 mg/m2) on an every 4-week schedule. Patients showing no evidence of disease after six cycles of chemotherapy underwent surgical reassessment.

Thirty-one patients were evaluable for toxicity and response. Myelosuppression was the major toxicity and hematologic toxicities prompted all dose reductions. No growth factor support was given in this trial. Thirty-nine percent of patients (12/31) had a clinical complete response. Of these, 16% (5/31) had complete pathologic response and 19% (6/31) had partial pathologic response. One long-term survivor declined reassessment laparotomy. Including the 16% of patients with a partial response, the overall response rate was 55% (17/31). Five patients are currently alive 8 years after enrollment. Median survival was 16.8 months for all patients, 21.5 months for patients with partial response, and 60.8 months for patients with complete pathologic response. A normalization or >50% decrease in CA125 level occurred in 93% of patients. This study indicates that first-line treatment with thiotepa and cisplatin produces significant long-term responses when tumors are sensitive. Such treatment is a reasonable option when paclitaxel is not available.

  • chemotherapy
  • cisplatin
  • neoplastic disease
  • ovarian cancer
  • thiotepa

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