Third Department of Internal Medicine (Hematology/Medical Oncology), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Br J Cancer. 2013 Feb 19;108(3):519-26. doi: 10.1038/bjc.2012.588. Epub 2013 Jan 15.
The aim of this exploratory subgroup analysis of the fluorouracil, oxaliplatin, docetaxel (FLOT)65+ trial was to determine tolerability and feasibility of perioperative chemotherapy in elderly, potentially operable esophagogastric cancer patients.
Patients aged ≥65 with locally advanced esophagogastric adenocarcinoma were randomized to perioperative chemotherapy consisting of four pre- and four postoperative cycles of infusional 5-FU, leucovorin, and oxaliplatin (FLO) without or with docetaxel 50 mg m(-)(2) (FLOT), every 2 weeks.
Forty-four patients with a median age of 70 years were randomized and 43 patients started preoperative chemotherapy (FLO, 22; FLOT, 21). Thirty-eight (86.4%) patients completed four cycles of preoperative chemotherapy and 32 (74.4%) proceeded to surgery, with 67.4% R0 resections on intent-to-treat analysis (90.1% of the 32 patients who underwent resection). Median overall survival was not reached and median progression-free survival (PFS) was 17.3 months. Compared with the FLO group, the FLOT group showed a trend towards an improved median PFS (21.1 vs 12.0 months; P=0.09), however, associated with increased chemotherapy related toxicity. No perioperative mortality was observed. Postoperative morbidity was observed in 46.9% of patients (FLO, 35.3%; FLOT, 60%).
Neoadjuvant FLO or FLOT may offer a reasonable chance of curative surgery in elderly patients with locally advanced resectable gastroesophageal cancer. However, the increase in side effects with the FLOT regimen and postoperative morbidity should be carefully considered when an intensive chemotherapy regimen is planned.
本项氟尿嘧啶、奥沙利铂、多西紫杉醇（FLOT）65+ 试验的探索性亚组分析旨在确定围手术期化疗在老年、潜在可手术食管胃腺癌患者中的耐受性和可行性。
纳入年龄≥65 岁、局部晚期食管胃腺癌患者，随机分为接受术前化疗的两组，化疗方案分别为不含多西紫杉醇的氟尿嘧啶、亚叶酸、奥沙利铂（FLO）4 个周期和含多西紫杉醇 50mg/m2 的 FLOT 方案（4 个周期的术前化疗+4 个周期的术后化疗），每 2 周一次。
44 例患者的中位年龄为 70 岁，其中 43 例患者开始接受术前化疗（FLO，22 例；FLOT，21 例）。38 例（86.4%）患者完成了 4 个周期的术前化疗，32 例（74.4%）患者接受了手术，意向治疗分析中 R0 切除率为 67.4%（32 例接受手术的患者中 90.1%为 R0 切除）。中位总生存时间未达到，中位无进展生存期（PFS）为 17.3 个月。与 FLO 组相比，FLOT 组的中位 PFS 有改善趋势（21.1 比 12.0 个月；P=0.09），但与化疗相关的毒性增加相关。未观察到围手术期死亡。术后发病率为 46.9%（FLO 组为 35.3%；FLOT 组为 60%）。
新辅助 FLO 或 FLOT 方案可能为局部晚期可切除胃食管腺癌的老年患者提供有机会进行根治性手术。然而，当计划使用强化化疗方案时，应仔细考虑 FLOT 方案增加的副作用和术后发病率。
