Randomized Multicenter and Stratified Phase II Study of Gemcitabine Alone Versus Gemcitabine and Docetaxel in Patients with Metastatic or Relapsed Leiomyosarcomas: A Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma Group Study (TAXOGEM study).
ABSTRACT 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 anthracycline-based regimen. A total of 90 patients received either single-agent gemcitabine (arm A; gemcitabine, 1,000 mg/m(2) i.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/m(2) i.v. for 90 minutes on days 1 and 8, plus docetaxel, 100 mg/m(2) i.v. for 1 hour on day 8 of a 21-day cycle with lenograstim). The primary endpoint was the objective response rate. Results. The objective response rates were 19% and 24% in arm A (gemcitabine) and arm B (gemcitabine plus docetaxel), respectively, for patients with uterine LMS. For patients with nonuterine LMS, the objective response rates were 14% and 5% for arms A and B, respectively. The median progression-free survival times for arms A and B were 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 3.8 months for arms A and B, respectively. One toxic death 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-free survival rate of 40% for LMS with both 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.
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Article: Treatment options for leiomyosarcoma[Show abstract] [Hide abstract]
ABSTRACT: Introduction: The term “soft-tissue sarcomas” embraces more than 50 different subtypes that are often associated with a poor prognosis. Among them, leiomyosarcomas are one of the most frequently occurring subtypes. In spite of the relatively high incidence of leiomyosarcoma, the overall effectiveness of the currently available systemic treatments is still poor. Therefore, there is an urgent need to find successful therapeutic strategies in order to improve the survival of these patients. Areas covered: This article extensively reviews the most relevant therapeutic options in leiomyosarcoma. From the adjuvant to the advanced setting, it discusses all the relevant studies with classic cytotoxic drugs, new targeted therapies, hormone treatment and combined strategies. Moreover, new clinical trials that are currently ongoing and may determine future treatment guidelines for this malignancy are also highlighted. Expert opinion: The heterogeneity of its biological origin, clinical behaviour and responsiveness to chemotherapy, together with the scarcity of successful clinical trials, makes the treatment of leiomyosarcoma especially challenging. As a result, every therapeutic decision should be made on an individual basis in collaboration with the patient. The results of new specifically histology-designed clinical trials should aid decision making in this complex field.04/2013; 1(5). DOI:10.1517/21678707.2013.783769