Efficacy of a gemcitabine based multiagent chemotherapy regimen for advanced uterine sarcomas.

Abstract

15047 Background: Advanced stage uterine sarcomas (US) have poor prognosis. Active agents in US are doxorubicin, cisplatin and ifosfamide, with response rates (RR) of 25%, 19%, and 17% respectively. Given the poor response, there remains a need for other drugs. Gemcitabine has shown activity in soft tissue sarcomas. In trials with all subtypes of sarcomas, RR observed with single and multiagent schedules are ranging from 3 to 53%. There is scarce data on the use of gemcitabine in US. Aim of our study was to determine the clinical activity of gemcitabine based regimen in patients with US. METHODS From 2002-2005, data from11 chemotherapy naïve patients diagnosed with advanced stage US was reviewed who were receiving gemcitabine/ifosfomide/platinum (GIP) combination chemotherapy regimen in an adjuvant setting after TAH and surgical staging. Ifosfomide 2gm/m2 and Platinum 20 mg/m2 intravenously on days 1, 2 and 3. Gemcitabine 800 mg/m2 intravenously was administered on day 1 of a 28-day cycle. RESULTS Eleven pts were treated, all stages III and IV. The median age was 49 years. There were 6 carcinosarcomas, 4 LMS, and 1 ESS. Performance status was 0 (6 pts), 1 (5 pts). Four pts (36%) had undergone prior radiotherapy. The site of measurable disease in 10 pts (91%) was in the pelvis. The median number of GIP cycles received per pt was 6 (range 1-9). There were no treatment-related deaths. Hematologic toxicities of > Grade 3 were seen in 82% of pts and consisted of leukopenia and anemia. 36% of pts had an episode of febrile neutropenia. Neurotoxicty (Grade 3 in 2 pts), nausea (Grade 1/2 in 6 pts), and fatigue (Grade 1/2 in 7 pts) were observed. Three (27%) complete responses were observed, four pts had a partial response (36%), for an overall RR of 63%. Four pts had progression of disease (36%). Of the 7 pts demonstrating a response, 4 had previously been irradiated and 3 had not, such that the RR in those previously irradiated was 4/4 = 100% versus 3/7 = 43% in those not previously irradiated. CONCLUSIONS The combination of GIP is well-tolerated and seems to be active in US, yielding RR higher than seen with single agent chemotherapy agents. Pts that received previous adjuvant radiation demonstrated the best responses to this regimen. A randomized trial is needed to evaluate the true value of this regimen in advanced stage US. No significant financial relationships to disclose.

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