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Clinical Trial
. 2012;17(9):1213-20.
doi: 10.1634/theoncologist.2011-0467. Epub 2012 Aug 20.

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)

Patricia Pautier  1 , Anne Floquet, Nicolas Penel, Sophie Piperno-Neumann, Nicolas Isambert, Annie Rey, Emmanuelle Bompas, Angela Cioffi, Corinne Delcambre, Didier Cupissol, Françoise Collin, Jean-Yves Blay, Marta Jimenez, Florence Duffaud
Affiliations
Clinical Trial

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)

Patricia Pautier et al. Oncologist. 2012.

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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Conflict of interest statement

Disclosures: Patricia Pautier: Ipsen, Roche (C/A). The other authors indicated no financial relationships.

Figures

Figure 1.
Figure 1.
Kaplan–Meier curve of progression-free survival for the uterine leiomyosarcoma group.
Figure 2.
Figure 2.
Kaplan–Meier curve of progression-free survival for the nonuterine leiomyosarcoma group.
See this image and copyright information in PMC

Comment in

References

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