Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Pungnap-Dong Songpa-Gu, Seoul, 138-736, Korea.
Cancer Chemother Pharmacol. 2012 Mar;69(3):635-42. doi: 10.1007/s00280-011-1742-5. Epub 2011 Sep 30.
The purpose of this prospective multicenter phase II study was to evaluate the efficacy and toxicity of weekly docetaxel and fixed dose rate gemcitabine in patients with previously treated advanced soft tissue and bone sarcoma.
Patients with advanced soft tissue or bone sarcoma, previously treated with ifosfamide and anthracycline-based chemotherapies, were treated with docetaxel (35 mg/m(2) over 60 min) and gemcitabine (1,000 mg/m(2) over 100 min) on days 1 and 8 of every 3-week cycle.
From September 2008 to August 2010, 30 patients were enrolled; 24 (80.0%) were men and median patient age was 45 years (range 17-70 years). The patients received a total of 136 cycles of therapy (median 4 cycles per patient; range 1-15 cycles). Of these 30 patients, none achieved complete response (CR) and 5 achieved a partial response (PR), making the overall response rate 16.7% (95% CI, 2.5-30.8%). Twelve patients had stable disease (SD), resulting in tumor control (CR or PR or SD) in 17 of 30 patients (56.7%). Median progression-free survival was 2.5 months (range 0.8-15.3 months), and median overall survival was 8.4 months (range 1.4-22.3 months). Grade 3 or 4 neutropenia, thrombocytopenia, and anemia were observed in 17 (56.7%), 13 (43.4%), and 4 (13.3%) patients, respectively. None of these patients, however, had febrile neutropenia or bleeding events, and all non-hematologic toxicities were manageable.
The combination of weekly docetaxel and fixed dose rate gemcitabine was tolerable and may be an active regimen in patients with previously treated advanced sarcoma.
本前瞻性多中心 II 期研究的目的在于评估每周多西他赛和固定剂量率吉西他滨在既往接受过治疗的晚期软组织和骨肉瘤患者中的疗效和毒性。
既往接受过异环磷酰胺和蒽环类化疗的晚期软组织或骨肉瘤患者接受多西他赛（35mg/m²，持续 60 分钟）和吉西他滨（1000mg/m²，持续 100 分钟）治疗，每 3 周为一个周期，于第 1 天和第 8 天给药。
2008 年 9 月至 2010 年 8 月，共纳入 30 例患者；24 例（80.0%）为男性，中位患者年龄为 45 岁（范围 17-70 岁）。患者共接受了 136 个周期的治疗（中位 4 个周期/例患者；范围 1-15 个周期）。在这 30 例患者中，无完全缓解（CR），5 例部分缓解（PR），总缓解率为 16.7%（95%CI，2.5-30.8%）。12 例患者疾病稳定（SD），30 例患者中有 17 例（56.7%）出现肿瘤控制（CR 或 PR 或 SD）。中位无进展生存期为 2.5 个月（范围 0.8-15.3 个月），中位总生存期为 8.4 个月（范围 1.4-22.3 个月）。3 级或 4 级中性粒细胞减少症、血小板减少症和贫血分别发生于 17 例（56.7%）、13 例（43.4%）和 4 例（13.3%）患者中。但这些患者均未发生发热性中性粒细胞减少症或出血事件，所有非血液学毒性均可控制。
每周多西他赛联合固定剂量率吉西他滨的方案可耐受，并且可能是既往接受过治疗的晚期肉瘤患者的一种有效治疗方案。
