Treatment of relapsed/refractory pediatric sarcomas with gemcitabine and docetaxel.
OBJECTIVE
In this report we describe experience with gemcitabine-docetaxel 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 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.
Mora
Jaume
J
Department of Pediatric Oncology, Hospital Sant Joan de Déu, Barcelona, Spain. Jmora@hsjdbcn.org
Cruz
Cheeu Ofelia
CO
Parareda
Andreu
A
de Torres
Carmen
C
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D012516:Osteosarcoma / Q000188:drug therapy; D010045:Outpatients; D012074:Remission Induction; D016879:Salvage Therapy / Q000379:methods*; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality; D012512:Sarcoma, Ewing / Q000188:drug therapy; D013584:Sarcoma, Synovial / Q000188:drug therapy; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine