Randomized Phase II Study Comparing Gemcitabine Plus Dacarbazine Versus Dacarbazine Alone in Patients With Previously Treated Soft Tissue Sarcoma: A Spanish Group for Research on Sarcomas Study

Abstract

The combination of gemcitabine and DTIC is active and well tolerated in patients with STS, providing in this phase II randomized trial superior progression-free survival and overall survival than DTIC alone. This regimen constitutes a valuable therapeutic alternative for these patients.

Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial

“…5 The only truly new treatment approved for sarcoma failing standard therapy is trabectedin (approved by the European Medicines Agency in 2007). 6,7 Gemcitabine with dacarbazine or docetaxel [8][9][10] and paclitaxel for angiosarcoma 11 seem to improve progression-free and overall survival in non-randomised and adaptively randomised trials.…”

Soft Tissue Sarcoma: An Update on Systemic Treatment Options for Patients with Advanced Disease

“…Not only PFS, but also OS was significantly better in the combination treatment group [28]. Of note, 32 of 109 included patients (29.4%) in this trial had leiomyosarcoma, which is traditionally known to be responsive to both agents.…”

Sirolimus plus gemcitabine: a new therapeutic combination for resistant sarcomas?

“…More recently, García del Muro et al compared treatment with gemcitabine plus dacarbazine versus dacarbazine alone in a randomized Phase II trial. The combination proved to be well tolerated and active: both PFS and OS were found to be clearly superior in the experimental arm [7]. These encouraging data suggest that the combination of gemcitabine with another cytotoxic agent may enhance its activity against sarcomas.…”