虽然多西他赛/顺铂/5-氟尿嘧啶(DCF)在一线胃腺癌中优于CF,毒性仍然是一个问题。
这项多中心II期试验将未化疗的转移性胃腺癌患者随机分为每周一次的DCF(D40mg/m2,C35mg/m²,F1800mg/m²超过24小时,在每3周的第1天和第8天,臂(1)或每两周DCF(D50mg/m2,C50mg/m²,F2000mg/m²每2周48小时,臂(2)。不允许预防性粒细胞集落刺激因子(G-CSF)。主要终点是前六个治疗周(早期FN)内的发热性中性粒细胞减少率。
总共招募了106名符合条件的患者。在第1组中,早期FN率和总体FN率分别为9.5%和17%,臂2分别为5.9%和8%。1组81%的患者和2组90%的患者发生≥3级毒性,最常见的是中性粒细胞减少症(33%vs.61%),疲劳(27%vs.25%),呕吐(21%vs.12%),厌食症(19%vs.18%),和腹泻(17%vs.10%)。中位无进展生存期和总生存期分别为5.1(95%CI,3.2-6.5)和8.2个月(95%CI,6.0-14.5)。分别,在第1组和5.2组(95%CI,3.0-6.9)和11.9个月(95%CI,7.4-15.9),分别,手臂2
每周一次和每两周一次的DCF方案与早期FN的低风险相关,与历史DCF相比,血液学毒性特征更好,而不影响疗效。两种方案都提供了更大的便利性,无需系统使用预防性G-CSF。
While docetaxel/cisplatin/5-fluorouracil (DCF) outperforms CF in first-line gastric adenocarcinoma, toxicity remains an issue.
This multicenter phase II
trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m2 , C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m2 , C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony-stimulating factor (G-CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN).
A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression-free survival and overall survival were 5.1 (95% CI, 3.2-6.5) and 8.2 months (95% CI, 6.0-14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0-6.9) and 11.9 months (95% CI, 7.4-15.9), respectively, in arm 2.
Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G-CSF.