Abstract
5143 Background: The prognosis of metastatic uterine sarcoma is poor with median survival reported between 4–26 months. The primary objective of this study was to assess the activity of paclitaxel, carboplatin and gemcitabine (GCP) in the treatment of primary, metastatic, or recurrent uterine sarcomas. Methods: This retrospective study was given an exemption by the Institutional Review Board at Robert Wood Johnson University Hospital. The efficacy of the GCP regimen in women with metastatic or recurrent uterine sarcomas was assessed. Patients were treated on a phase II soft tissue sarcoma protocol or off protocol by the gynecologic oncology division. Results: 13 patients were treated, 9 on and 4 off protocol. 4 patients were inevaluable; 3 patients for less than one month of therapy and 1 patient without measurable disease. Histology included 6 leiomyosarcomas (LMS), 1 endometrial stromal sarcoma (ESS), and 2 carcinosarcomas (CS). There was one 9 month complete response (11%) (LMS) pt remains NED, one 10 month partial response (11%) (CS), 4 patients (44%) with stable disease (3 LMS, 1 ESS), and 3 patients with progressive disease (33%) (2 LMS, 1 CS). The overall response rate was 22%. The duration of stable disease ranged 5 to 22.8 months. Median time to progression for all patients was 10 months (95% CI {83 –530 days}). The median overall survival was 36.6 months. GCP was discontinued in one patient for grade 3 GI toxicity and paclitaxel was discontinued in one patient for grade 2 neuropathy. Toxicity included grade 3 neutropenia (5), grade 3 anemia (1), and grade 3 GI toxicity (1). There were no hospitalizations required secondary to toxicity. Conclusions: GCP combination chemotherapy demonstrates moderate activity, with acceptable toxicity, in patients with advanced uterine sarcomas. Given the durable median time to progression and overall survival, this pilot data supports the evaluation of this regimen in a multi-institutional phase II study. No significant financial relationships to disclose.
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