We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Randomized Multicenter and Stratified Phase II Study of Gemcitabine Alone Versus Gemcitabine and Docetaxel in Patients with Metastatic or Relapsed Leiomyosarcomas: A Fe´de´ration Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma...
- Authors
Pautier, Patricia; Floquet, Anne; Penel, Nicolas; Piperno-Neumann, Sophie; Isambert, Nicolas; Rey, Annie; Bompas, Emmanuelle; Cioffi, Angela; Delcambre, Corinne; Cupissol, Didier; Collin, Françoise; Blay, Jean-Yves; Jimenez, Marta; Duffaud, Florence
- 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/m² 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/m² i.v. for 90 minutes on days 1 and 8, plus docetaxel, 100 mg/m² 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.
- Publication
Oncologist, 2012, Vol 17, Issue 9, p1213
- ISSN
1083-7159
- Publication type
Journal Article
- DOI
10.1634/theoncologist.2011-0467