Department of Medicine, Royal Marsden Hospital, Sutton, London, SM25PT, UK.
Br J Cancer. 2012 Jul 24;107(3):435-41. doi: 10.1038/bjc.2012.286. Epub 2012 Jul 5.
Docetaxel and irinotecan chemotherapy have shown good efficacy in the treatment of advanced oesophago-gastric cancer. This randomised phase II study evaluated the efficacy and toxicity profile of two non-platinum docetaxel-based doublet regimens in advanced oesophago-gastric cancer.
Chemotherapy-naïve patients with advanced oesophago-gastric cancer were randomised to receive either 3-weekly DI (docetaxel 60 mg m(-2) plus irinotecan 250 mg m(-2) (Day 1)) or 3-weekly DF (docetaxel 85 mg m(-2) (Day 1) followed by 5-fluorouracil 750 mg m(-2) per day as a continuous infusion (Days 1-5)).
A total of 85 patients received DI (n=42) or DF (n=43). The primary endpoint was overall response rate (ORR). The ORR and time to progression (TTP) in the evaluable population (n=65) were 37.5% (DI) vs 33.3% (DF), and 4.2 months vs 4.4 months, respectively. In the intent-to-treat population, the observed ORR, TTP and median overall survival were similar between the two groups. Grade 3-4 neutropenia, febrile neutropenia and diarrhoea were more frequent in the DI arm as compared with the DF arm (83.3% vs 69.8%, 40.5% vs 18.6%, and 42.9% vs 16.3%, respectively).
Both docetaxel-based doublet regimens show comparable efficacy; however, the DF regimen was associated with a better toxicity profile and is an alternative treatment option for patients in whom platinum-based regimens are unsuitable.
多西紫杉醇和伊立替康化疗在治疗晚期食管胃结合部癌方面显示出良好的疗效。本随机 2 期研究评估了两种非铂类多西紫杉醇为基础的双联方案在晚期食管胃结合部癌中的疗效和毒性特征。
化疗初治的晚期食管胃结合部癌患者被随机分配接受每周 3 次 DI（多西紫杉醇 60mg/m²加伊立替康 250mg/m²（第 1 天））或每周 3 次 DF（多西紫杉醇 85mg/m²（第 1 天），随后 5-氟尿嘧啶 750mg/m²连续输注（第 1-5 天））。
共 85 例患者接受 DI（n=42）或 DF（n=43）治疗。主要终点为总缓解率（ORR）。在可评价人群（n=65）中，ORR 和无进展生存期（TTP）分别为 37.5%（DI）和 33.3%（DF），分别为 4.2 个月和 4.4 个月。在意向治疗人群中，两组之间观察到的 ORR、TTP 和中位总生存期相似。3-4 级中性粒细胞减少症、发热性中性粒细胞减少症和腹泻在 DI 组比 DF 组更为常见（83.3%比 69.8%、40.5%比 18.6%和 42.9%比 16.3%）。
两种多西紫杉醇为基础的双联方案疗效相当；然而，DF 方案的毒性特征更好，是不适合铂类方案治疗的患者的另一种治疗选择。
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