Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 5079
© 2005 American Society of Clinical Oncology

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Abstract

A sequential doublet chemotherapy regimen in patients (pts) with advanced endometrial adenocarcinoma (EC) and gynecological mixed müllerian tumors (MMT). Maintaining activity with tolerability?

Royal Marsden Hosp, Sutton, United Kingdom

5079

Background: Carboplatin (C), doxorubicin (D) and paclitaxel (P) have significant activity in advanced EC and MMT. Concurrent 3 drug regimens are associated with high activity but also significant toxicity. Sequential doublet regimens combining all three drugs may retain high levels of efficacy with acceptable levels of toxicity. Methods: Pts with Stage III-IV advanced EC or MMT received first line treatment, from 2001–2004, with 4 cycles of CD (C=AUC5, D=50mg/m², d1q21) followed by 4 cycles of CP (C=AUC5, P=175mg/m², d1q21). The primary endpoint was the % of pts completing all planned treatment. Results: 25 pts have completed treatment (19 EC, 6 MMT, median age 59) of whom 72% competed all 8 cycles of treatment (primary endpoint reached). 86% of all planned cycles of chemotherapy were delivered (172 out of a max possible of 200). Toxicity: 20% of cycles were delayed (85% by 1w, 12% by 2w and 3% by 3w), all for hematological toxicity (90% neutropenia, 10% thrombocytopenia). Non hematological toxicity Gd3 was myalgia (1 pt), parasthesia (2pt) fainting and nausea (1pt). 8 consultations (in 7 pts) resulted in dose reduction (cause; 5 neutropenia, 2 parasthesia, 1 myalgia). Response: Of 18 radiologically evaluable patients; 3 had a complete response (17%), 10 partial response (55%), 1 differential response (5%), 3 progressive disease (17%) and 1 taken off trial due to toxicity (5%). Median duration of response was 5.8 months (1.5–29.4 months). 5 deaths have occurred all due to PD (2 on treatment, 1 after 3m and 2 after 6m follow-up). Conclusions: The sequential doublet as described is a feasible and highly active regimen (72% overall response rate) in the first line treatment of EC and MMT. This schedule should be considered for more formal evaluation using larger studies in both diseases.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting