Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 27, No 15S (May 20 Supplement), 2009: 5515
© 2009 American Society of Clinical Oncology

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Abstract

A phase II evaluation of paclitaxel and carboplatin in the treatment of carcinosarcoma of the uterus: A Gynecologic Oncology Group (GOG) study

Washington University, St Louis, MO; Gynecologic Oncology Group Statistical Office, Buffalo, NY; Cleveland Clinic Foundation, Cleveland, OH; University of Oklahoma, Oklahoma City, OK; Abington Memorial Hospital, Abington, PA; University of Iowa Hospitals and Clinics, Iowa City, IA; Wake Forest University, Wake Forest, NC; Keio University from GOG Japan institutions, Keio, Japan; University of Kentucky, Lexington, KY

5515

Background: Both platinum and taxane compounds have demonstrated activity in uterine carcinosarcoma (malignant mixed Mullerian tumor). Ifosfamide plus paclitaxel is the regimen supported by randomized phase III trials through the GOG. However, the toxicity, multi-day schedule, and limited activity of this regimen indicate that development of other regimens is still needed. The primary aims of this prospective study were to estimate the antitumor activity and toxicity of paclitaxel plus carboplatin in patients with uterine carcinosarcomas. Methods: Eligible patients had advanced stage (III or IV), persistent, or recurrent measurable disease with histologic confirmation of the primary tumor, no prior chemotherapy, and a GOG Performance Status of 2 or better. At entry hematologic and all other labs were within pre-defined limits. Patients received the combination of paclitaxel 175 mg/m2 IV over 3 hours plus carboplatin (AUC 6) IV over 30 minutes every 3 weeks until disease progression or adverse effects prohibit further therapy. The primary endpoint of confirmed response was assessed by RECIST criteria. CTCAE v3 was used to grade adverse events. This study used an optimal but flexible two-stage design with early stopping guidelines intended to limit patient accrual to inactive treatments. Forty to 47 eligible patients were targeted for accrual. Central pathology review (CPR) is still pending for 5 patients. Results: Fifty-five patients were entered on study with 9 being excluded from analysis; 7 with unconfirmed diagnosis at CPR and 2 were never treated. Treatment was generally tolerated with expected hematologic toxicity and minimal non-hematologic grade 4 toxicity (1 cardiovascular and 2 pain) with 59% of patients completing 6 or more cycles of chemotherapy. The proportion of patients with confirmed complete and partial responses were 11% and 41%, respectively (52%; 95% CI 37%-67%). Additionally 4% experienced an unconfirmed response and 26% had stable disease. Conclusions: Paclitaxel plus carboplatin demonstrates anti-tumor activity against uterine carcinosarcoma with acceptable toxicity and warrants further evaluation in phase III randomized trials.

No significant financial relationships to disclose.

Abstract presentation from the 2009 ASCO Annual Meeting