Characteristics of Long Term Responders to Gemcitabine and Paclitxel. Katz Daniela 1 , Elyan Firas 1 , Sonneblick Amir 1 , Merimsky Ofer 2 , Ospovat Inna 1 , Cohen Orit 1 , Salmon Asher 1 , Nechushtan Hovav 1 , Edelmann David 1 , Peretz Tamar 1 , Peylan-Ramu Nili 1
The combination of fixed-dose-rate gemcitabine and docetaxel has demonstrated efficacy in advanced uterine leiomyosarcoma and nonleiomyosarcoma sarcomas. We evaluated the tolerability and efficacy of modified taxol-gemcitabine (GemTax) protocol for patient with advanced sarcoma. The protocol was designed on a weekly basis to reduce toxicity. The purpose of this retrospective study was to evaluate the characteristics of long term-responders (≥12 treatments) to weekly GemTax, among pre-treated advanced high-grade sarcoma patients.
From May 2004 to October 2011, 48 advanced sarcoma patients were treated with combination paclitaxel (60-90 mg/m2) and gemcitabine (600-900 mg/m2 over 100 min), on days 1,8 of every 3-week cycle or on days 1, 8 and 15 of every 4-week cycle at a wide-range treatment lines. Two patients are still on the protocol.
Fifteen patients (6 males and 9 females) completed 12 weekly treatments or more (mean 22.3 range 12-37) of which 4 completed >30 treatments. These include 5 leiomyosarcomas (one retroperitoneal), 2 uterine leiomyosarcomas, 3 MFH, 2 spindle sarcoma, 1 osteosarcoma, 1 adamantinoma and 1 pleomorphic rhabdomyosarcoma. GemTax was administered as 1st or 2nd line treatment in 2 and 8 patients, respectively, and as 3rd -6th line in 5. Of these patients, none achieved complete response (CR), 7/15 (47%) achieved a partial response (PR) and 8/15 (53%) had stable disease (SD). Median time to progression was 10.3 months (range 4-22 months) Median overall survival was 51.2 months (range 16-95 months). A lower starting dose of paclitaxel (60-70 mg/m2) and gemcitabine (600-700 mg/m2) characterized the 4 patients with responses >30 cycles. Only five patients required dose reduction ranging between 10-40% due to grade 3 hematological toxicity. None of these patients, however, had febrile neutropenia, or bleeding events, and all non-hematologic toxicities including neurotoxicity were manageable.
GemTax is a reasonable treatment option for patients with advanced pre-treated high-grade sarcomas. The regimen is well tolerated and dose adjustments do not seem to impact response.