Aravantinos G, Bafaloukos D, Fountzilas G, Christodoulou C, Papadimitriou C, Pavlidis N, Kalofonos H P, Gogas H, Kosmidis P, Dimopoulos M A
Hellenic Co-operative Oncology Group, Athens, Greece.
Ann Oncol. 2003 Jul;14(7):1094-9. doi: 10.1093/annonc/mdg292.
This multicenter, prospective phase II study evaluated the safety and efficacy of the combination of docetaxel and vinorelbine in patients with platinum-resistant, paclitaxel-pretreated recurrent ovarian cancer.
Treatment consisted of vinorelbine 25 mg/m(2) as a 20-min i.v. infusion (days 1 and 8), and docetaxel 70 mg/m(2), as a 1-h i.v. infusion (day 8). Granulocyte colony-stimulating factor support was administered prophylactically on days 12-16. Treatment was repeated every 21 days.
Forty-six patients were enrolled. The median number of previous chemotherapeutic regimens was one (range 1-3) with a median treatment-free interval of 4.3 months. Four chemotherapy cycles per patient were administered. Almost 75% of the planned doses for both drugs were given. Forty-one patients are evaluable for response. Three patients (6.5% of all patients; 7.3% of evaluable patients) achieved complete response and eight (17.4% and 19.5%, respectively) a partial response to chemotherapy, leading to overall response rates of 23.9% and 26.8%, respectively. Another 34.8% (39.0%) had stable disease. At a median follow-up of 30 months, the median disease-free survival was 13 months, relapse-free survival was 5 months, time to progression was 4.5 months, and overall survival was 9.3 months. Severe toxicities included leukopenia (31%), neutropenia (35%) and febrile neutropenia (20%).
The combination of docetaxel/vinorelbine is an effective regimen with manageable toxicity for the treatment of platinum-resistant, paclitaxel-pretreated ovarian cancer.
这项多中心前瞻性II期研究评估了多西他赛与长春瑞滨联合用药对铂耐药、紫杉醇预处理的复发性卵巢癌患者的安全性和疗效。
治疗方案为长春瑞滨25mg/m²，静脉输注20分钟（第1天和第8天），多西他赛70mg/m²，静脉输注1小时（第8天）。在第12 - 16天预防性给予粒细胞集落刺激因子支持。每21天重复治疗。
46例患者入组。既往化疗方案的中位数为1种（范围1 - 3种），中位无治疗间期为4.3个月。每位患者接受4个化疗周期。两种药物几乎均给予了计划剂量的75%。41例患者可评估疗效。3例患者（占所有患者的6.5%；占可评估患者的7.3%）达到完全缓解，8例患者（分别占17.4%和19.5%）对化疗部分缓解，总缓解率分别为23.9%和26.8%。另有34.8%（39.0%）疾病稳定。中位随访30个月时，中位无病生存期为13个月，无复发生存期为5个月，疾病进展时间为4.5个月，总生存期为9.3个月。严重毒性包括白细胞减少（31%）、中性粒细胞减少（35%）和发热性中性粒细胞减少（20%）。
多西他赛/长春瑞滨联合用药是治疗铂耐药、紫杉醇预处理的卵巢癌的有效方案，毒性可控。
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