Treatment of relapsed/refractory pediatric sarcomas with gemcitabine and docetaxel

Abstract

10059 Background: Cure rates for children andadolescent's cancer have improved steadily for most tumor types. However, recurrent disease or progressive-refractory sarcomas remain incurable and most of these patients die within 1 to 2 years after diagnosis. In this report we describe experience with gemcitabine-docetaxel (G+D) in pediatric patients with relapsed or refractory sarcomas. Methods: Ten relapsed/refractory pediatric sarcoma patients including 6 Ewing sarcoma, 2 synovial sarcoma, 1 osteosarcoma, and 1 undifferentiated sarcoma were treated in an outpatient setting with gemcitabine 1000 mg/m2 over 90 minutes on day 1 and 8, and docetaxel 100 mg/m2 ver 3 to 4 hours on day 8 of a 21-day cycle, as an investigational rescue therapy. Results: A median of 7 cycles were given per patient (range, 4 to 10), and a total of 70 cycles were administered. To date, 2 patients continue on treatment. All symptomatic patients responded clinically to this regimen. No grade 3–4 toxicities were encountered. Five patients (50%) had a CR/functional CR, 4 patients (40%) had a PR/SD, and 2 patients (20%) had PD, which provides an overall response rate (CR+PR/SD) of 90%. Prolonged disease stabilization was achieved even for multiple relapsed patients with the G + D regimen, median duration of responses 11 months. Five out of the 10 patients (50%) are alive, median follow-up 48 months from diagnosis. Conclusions: The G + D regimen seems to be active against advanced pediatric sarcomas. It does not exacerbate pre-existing toxicities and allows good quality of life. Evaluation in a large, formal phase II trial for ES patients is ongoing. No significant financial relationships to disclose.