Department of General, Visceral and Transplant Surgery, Ludwig-Maximilians University, Marchionini Str. 15, 81377, Munich, Germany.
Department of Medical Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, University of Munich, Marchionini Str. 15, 81377, Munich, Germany.
J Gastrointest Surg. 2021 Jan;25(1):58-66. doi: 10.1007/s11605-019-04511-7. Epub 2020 Feb 10.
Perioperative treatment is the standard of care in Western Europe for locally advanced gastric cancer (GC) and adenocarcinoma of the gastroesophageal junction (GEJ). Intensified neoadjuvant treatment within the NeoFLOT trial proved to be safe and effective. Yet, the influence of such intensification with 6 cycles of FLOT in the neoadjuvant setting has not been analyzed regarding its possible impact on perioperative results.
A total of 537 patients were enrolled in this study; of whom, 132 had followed a standard neoadjuvant protocol (CTx), 356 had not received any neoadjuvant treatment (NoCTx), and 49 patients had undergone an intensified chemotherapy within the NeoFLOT trial (IntCTx) with 6 cycles of FLOT (5-FU, leucovorin, oxaliplatin, docetaxel) every 2 weeks.
Our results reveal no significant difference in perioperative morbidity or mortality with regard to the neoadjuvant treatment. Postoperative bleeding and hematoma occurred less frequently in the IntCTx group compared to the NoCTx and the CTx groups (2.0% vs. 5.33% vs. 5.1%). Postoperative lymph fistulas were slightly more frequent in the IntCTx group (4.1% vs. 0.3% vs. 1.6%). Patients treated within the NeoFLOT trial had a higher risk for blood transfusions (OR 5.5; 95%-KI, 2.49-12.19), whereas patients without neoadjuvant therapy had the longest ICU stay (mean 8.3 vs. CTx 4.5 vs. IntCTx 6.7 days).
The results of the current study indicate that also an intensification of neoadjuvant chemotherapy with 6 preoperative cycles of FLOT does not significantly increase perioperative complications. Thus, prolonged neoadjuvant chemotherapy with FLOT is safe for patients with locally advanced GC or GEJ tumors.
在西欧，围手术期治疗是局部晚期胃癌（GC）和胃食管交界处（GEJ）腺癌的标准治疗方法。NeoFLOT 试验中的强化新辅助治疗已被证明是安全有效的。然而，在新辅助环境中使用 6 个周期的 FLOT 进行这种强化治疗对围手术期结果的影响尚未进行分析。
这项研究共纳入了 537 名患者；其中，132 名患者接受了标准新辅助方案（CTx），356 名患者未接受任何新辅助治疗（NoCTx），49 名患者在 NeoFLOT 试验中接受了强化化疗（IntCTx），使用每 2 周一次的 6 个周期的 FLOT（5-FU、亚叶酸、奥沙利铂、多西他赛）。
我们的研究结果显示，新辅助治疗对围手术期发病率或死亡率没有显著影响。与 NoCTx 和 CTx 组相比，IntCTx 组术后出血和血肿的发生率较低（2.0% vs. 5.33% vs. 5.1%）。IntCTx 组术后淋巴瘘的发生率略高（4.1% vs. 0.3% vs. 1.6%）。接受 NeoFLOT 试验治疗的患者输血风险较高（OR 5.5；95%CI，2.49-12.19），而未接受新辅助治疗的患者 ICU 停留时间最长（平均 8.3 天 vs. CTx 4.5 天 vs. IntCTx 6.7 天）。
本研究结果表明，用 6 个周期的术前 FLOT 强化新辅助化疗也不会显著增加围手术期并发症。因此，FLOT 的延长新辅助化疗对局部晚期 GC 或 GEJ 肿瘤患者是安全的。
