Treatment of relapsed/refractory pediatric sarcomas with gemcitabine and docetaxel

J Pediatr Hematol Oncol. 2009 Oct;31(10):723-9. doi: 10.1097/MPH.0b013e3181b2598c.

Abstract

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.

Publication types

  • Clinical Trial

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Child
  • Child, Preschool
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives*
  • Disease Progression
  • Docetaxel
  • Female
  • Humans
  • Male
  • Osteosarcoma / drug therapy
  • Outpatients
  • Remission Induction
  • Salvage Therapy / methods*
  • Sarcoma / drug therapy*
  • Sarcoma / mortality
  • Sarcoma, Ewing / drug therapy
  • Sarcoma, Synovial / drug therapy
  • Survival Analysis
  • Taxoids / administration & dosage*
  • Treatment Outcome

Substances

  • Taxoids
  • Deoxycytidine
  • Docetaxel
  • gemcitabine