Institut Gustave-Roussy, 114 rue Edouard Vaillant, Villejuif, France.
Oncologist. 2012;17(9):1213-20. doi: 10.1634/theoncologist.2011-0467. Epub 2012 Aug 20.
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 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.
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.
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.
本研究旨在评估单药吉西他滨与吉西他滨联合多西他赛作为转移性或不可切除的子宫和非子宫平滑肌肉瘤（LMS）患者二线治疗的疗效和毒性。
患者患有转移性或不可切除的 LMS，且已接受过一种蒽环类药物为基础的治疗方案。共有 90 名患者接受单药吉西他滨（A 组；吉西他滨，1000mg/m²静脉输注 100 分钟，第 1、8 和 15 天，每 28 天为一周期）或吉西他滨联合多西他赛（B 组；吉西他滨，900mg/m²静脉输注 90 分钟，第 1 和 8 天，多西他赛，100mg/m²静脉输注 1 小时，第 8 天，每 21 天为一周期，用粒细胞集落刺激因子）。主要终点是客观缓解率。
在子宫 LMS 患者中，A 组（吉西他滨）和 B 组（吉西他滨联合多西他赛）的客观缓解率分别为 19%和 24%。对于非子宫 LMS 患者，A 组和 B 组的客观缓解率分别为 14%和 5%。A 组和 B 组的子宫 LMS 患者中位无进展生存期分别为 5.5 个月和 4.7 个月。对于非子宫 LMS 患者，A 组和 B 组的中位无进展生存期分别为 6.3 个月和 3.8 个月。B 组有 1 例治疗相关死亡。
单药吉西他滨和吉西他滨联合多西他赛均为 LMS 的有效二线治疗方法，对于子宫和非子宫起源的 LMS，3 个月无进展生存率为 40%。在本试验中，单药吉西他滨的结果与吉西他滨联合多西他赛相似，但使用单药吉西他滨的患者毒性更小。
