Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: A fédération nationale des centres de lutte contre le cancer (FNCLCC) french sarcoma group study (TAXOGEM study)

Background. This study aimed to evaluate the efficacy and toxicity of single-agent gemcitabine versus gemcitabine plus docetaxel as second-line therapy in patients with uterine and nonuterine leiomyosarcoma (LMS). Patients and Methods. Patients had metastatic or unresectable LMS and had received one prior anthracyclinebasedregimen.Atotalof90patientsreceivedeithersingleagent gemcitabine (arm A; gemcitabine, 1,000 mg/m²i.v. for 100 minutes on days 1, 8, and 15 of a 28-day cycle) or a combination of gemcitabine and docetaxel (arm B; gemcitabine, 900 mg/m²i.v. for 90 minutes on days 1 and 8, plus docetaxel, 100 mg/m²i.v. for 1 hour on day 8 of a 21-day cycle with lenograstim). The primary endpoint was the objective response rate. Results.Theobjectiveresponserateswere19%and24% in arm A (gemcitabine) and arm B (gemcitabine plus docetaxel), respectively, for patients with uterine LMS. For patientswithnonuterineLMS,theobjectiveresponserates were14%and5%forarmsAandB,respectively.Themedianprogression-freesurvivaltimesforarmsAandBwere 5.5 months and 4.7 months, respectively, for patients with uterine LMS. For patients with nonuterine LMS, the median progression-free survival times were 6.3 months and 3.8monthsforarmsAandB,respectively.Onetoxicdeath occurred in arm B. Conclusions. Both single-agent gemcitabine and gemcitabine plus docetaxel were found to be effective second-line therapies for leiomyosarcomas, with a 3-month progression-freesurvivalrateof40%forLMSwithboth uterine and nonuterine sites of origin. Single-agent gemcitabine yielded results similar to those of gemcitabine plus docetaxel in this trial, but patients using single-agent gemcitabine experienced less toxicity.