Treatment of Relapsed/Refractory Pediatric Sarcomas With Gemcitabine and Docetaxel

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 m/m(2) over 90 minutes on day 1 and 8, and docetaxel 100 mg/m(2) 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 10y). 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.