TAXOTER GEMZAR FOR PEDIATRIC SARCOMAS

J Pediatr Hematol Oncol. 2009 Sep 1. [Epub ahead of print]

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Treatment of Relapsed/Refractory Pediatric Sarcomas With Gemcitabine and Docetaxel.

Mora J, Cruz CO, Parareda A, de Torres C.

Department of Pediatric Oncology, Hospital Sant Joan de Déu (HSJD), Barcelona, Spain.

AIM OF THE STUDY: In this report we describe experience with gemcitabine-docetaxel in pediatric patients with relapsed or refractory sarcomas. PATIENTS AND METHODS: Ten relapsed/refractory pediatric sarcoma patients including 6 Ewing sarcoma, 2 synovial sarcoma, 1 osteosarcoma, and 1 undifferentiated sarcoma, were treated prospectively, in an outpatient setting, with gemcitabine 1000 mg/m over 90 minutes on day 1 and 8, and docetaxel 100 mg/m over 2 to 4 hours on day 8 of a 21-day cycle, as an investigational rescue therapy. RESULTS: The patients (ages 4 to 18) received a total of 70 cycles of therapy (median 6 cycles; range: 4 to 10 y). All symptomatic patients responded clinically to the new regimen. By Response Evaluation Criteria in Solid Tumors criteria, 4 (40%) patients had a complete response (CR), 1 (10%) had a partial response (PR), 3 (30%) had stable disease (SD), and 2 (20%) had a progressive disease (PD), which provides an objective response rate (CR+PR) of 50%. Median duration of response (CR+PR+SD) was 10 months (range: 6 to 32+ mo). Five out of the 10 patients (50%) are alive, with a median follow-up of 48 months from diagnosis. Mild toxicities (no grades 3 to 4) were encountered and managed in the ambulatory setting. CONCLUSIONS: The gemcitabine-docetaxel regimen demonstrated antitumor activity against advanced pediatric (mainly Ewing) sarcomas, allowing for good quality of life. Evaluation in a large, formal phase 2 trials for Ewing patients is ongoing.