Lessons learned: Adding docetaxel to the modified FOLFOX7 backbone (DOF) is a feasible three-drug combination therapy for advanced gastric cancer with high activity, providing evidence that leucovorin is not necessary in this setting.The DOF regimen represents an alternative to the FLOT (5-FU 2,600 mg/m2 as 24-hour infusion with leucovorin 200 mg/m2, oxaliplatin 85 mg/m2, and docetaxel 50 mg/m2) regimen that can be considered in select patients with advanced gastric cancer and is a potential choice in the curative setting.
Background: The combination of docetaxel, cisplatin, and 5-fluorouracil (5-FU) demonstrates high response rates in advanced gastric cancer, albeit with increased toxicity. Given the efficacy of platinum-taxane-fluoropyrimidine regimens, this phase II study evaluated the efficacy and toxicity of docetaxel, oxaliplatin, and 5-FU (DOF) for the treatment of metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Methods: Patients with metastatic or unresectable gastric or GEJ adenocarcinoma with no prior therapy for metastatic disease received docetaxel 50 mg/m2 on day 1, oxaliplatin 85 mg/m2 on day 1, and 5-FU 2,400 mg/m2 continuous intravenous infusion over 46 hours; cycles were repeated every 2 weeks. The primary endpoint was overall response rate (ORR).
Results: Forty-four patients were enrolled. Assessment of treatment response and toxicity was feasible in 41 and 43 patients, respectively. ORR was 73.2% (68.3% partial response; 4.9% complete response). Therapy was discontinued for progressive disease in 53%, toxicity in 26%, and death on treatment in 16%. Two patients underwent surgical resection. Thirty-three patients (76.7%) received at least seven cycles (7-34). Grade 3-4 toxicities occurred in 31 patients (72.1%), including neutropenia (23.3%), neurologic (20.9%), and diarrhea (14.0%). Median overall survival was 10.3 months.
Conclusion: DOF demonstrates a high response rate, expected safety profile, and prolonged survival and remains an option for select patients with unresectable or metastatic gastric or GEJ adenocarcinoma.
经验总结
• 对于高活性晚期胃癌，将多西他赛加入改良的 FOLFOX7 (DOF) 主方案中是一种可行的三药联合疗法，并证明在此情况下，无需使用甲酰四氢叶酸。
• DOF 方案是 FLOT(5‐FU 2 600 mg/m2，24 小时输注,甲酰四氢叶酸 200 mg/m2，奥沙利铂 85 mg/m2，及 多西他赛 50 mg/m2)方案的替代之选，可考虑用于经选的晚期胃癌患者，是一种可以选择的潜在治疗方案。
摘要
背景。尽管多西他赛、顺铂联合 5‐氟尿嘧啶 (5‐FU) 会增加毒性，但治疗晚期胃癌有极佳的疗效。鉴于铂类‐紫杉烷‐氟尿嘧啶方案具有显著疗效，所以，此项II期试验对多西他赛、奥沙利铂及 5‐FU (DOF) 治疗转移性或不可切除性胃或胃食管结合部 (GEJ) 腺癌的疗效和毒性进行了评估。
方法。对于既往未接受转移性疾病治疗的转移性和不可切除性胃/GEJ腺癌患者，首日用多西他赛 50 mg/m2、奥沙利铂 85 mg/m2，连续 46 小时静脉输注 5‐FU 2 400 mg/m2；每两周重复一次此周期。主要终点为总缓解率 (ORR)。
结果。共纳入 44 名患者。分别对 41 例和 43 例患者进行了治疗反应和毒性评估。ORR为 73.2%(部分缓解为 68.3%；完全缓解为 4.9%)。因疾病进展而停止治疗的病例占 53%，因毒性而停止治疗的病例占 26%，16% 的患者在治疗后死亡。两名患者接受了手术切除。33 名患者 (76.7%) 至少接受了 7 个疗程 (7–34 周期) 的治疗。31 名患者 (72.1%) 出现了 3‐4 级毒性反应，包括中性粒细胞减少症 (23.3%)、神经系统疾病 (20.9%) 及腹泻 (14.0%)。中位总生存期为 10.3 个月。
结论。DOF 方案显现出较高的缓解率、预期的安全性及延长的生存期，对于经选的不可切除性和转移性胃/GEJ腺癌患者是可选治疗方案。《肿瘤学家》
Trial registration: ClinicalTrials.gov NCT00711243.
© AlphaMed Press; the data published online to support this summary are the property of the authors.