Sah Birendra Kumar, Xu Wei, Zhang Benyan, Zhang Huan, Yuan Fei, Li Jian, Liu Wentao, Yan Chao, Li Chen, Yan Min, Zhu Zhenggang
Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Pathology, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Front Oncol. 2021 Jan 18;10:567529. doi: 10.3389/fonc.2020.567529. eCollection 2020.
Neoadjuvant fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) has shown significant benefits for gastric cancer patients. However, it has not been well accepted in Asian countries. We conducted a prospective study on the safety and feasibility of the FLOT regimen in Chinese patients.
Patients with adenocarcinoma of the stomach or esophagogastric junction received four cycles of neoadjuvant chemotherapy (NAC) and four cycles of adjuvant chemotherapy (AC) with the FLOT regimen. The completion status of chemotherapy, adverse events, postoperative morbidities, and pathological tumor regression were analyzed. The 2-year overall survival (OS) and relapse-free survival are presented.
Altogether, 10 patients were enrolled, and all patients completed four cycles of neoadjuvant chemotherapy. There were no severe hematological adverse events (grade 3 or above), except for a case of grade 3 anemia. All 10 patients underwent radical gastrectomy. Nine patients had R0 resection, and three patients had complete or subtotal pathological tumor regression. Nine patients completed four cycles of adjuvant chemotherapy, but only one patient completed the full dose of adjuvant chemotherapy. The dose of adjuvant chemotherapy was reduced by 25% or less in the other patients. The median follow-up time was 23.13 months, eight patients achieved the overall survival endpoint, and seven patients had relapse-free survival for this period. Two patients died of disease progression.
Our study demonstrates that the neoadjuvant FLOT regimen is safe and effective for Chinese patients. Dose adjustment is necessary for adjuvant chemotherapy. The pathological regression and survival rates need reevaluation in a larger cohort. The trial is registered with ClinicalTrials.gov (number NCT03646591).
新辅助氟尿嘧啶联合亚叶酸钙、奥沙利铂和多西他赛（FLOT）方案已显示出对胃癌患者有显著益处。然而，该方案在亚洲国家尚未被广泛接受。我们对中国患者进行了一项关于FLOT方案安全性和可行性的前瞻性研究。
胃或食管胃交界腺癌患者接受四个周期的新辅助化疗（NAC）和四个周期的辅助化疗（AC），采用FLOT方案。分析化疗完成情况、不良事件、术后并发症及病理肿瘤退缩情况。呈现2年总生存期（OS）和无复发生存期。
共纳入10例患者，所有患者均完成四个周期的新辅助化疗。除1例3级贫血外，无严重血液学不良事件（3级及以上）。所有10例患者均接受了根治性胃切除术。9例患者实现R0切除，3例患者病理肿瘤完全或部分退缩。9例患者完成了四个周期的辅助化疗，但只有1例患者完成了全剂量的辅助化疗。其他患者辅助化疗剂量减少25%或更少。中位随访时间为23.13个月，8例患者达到总生存终点，7例患者在此期间无疾病复发。2例患者死于疾病进展。
我们的研究表明，新辅助FLOT方案对中国患者安全有效。辅助化疗需要进行剂量调整。病理退缩和生存率需要在更大队列中重新评估。该试验已在ClinicalTrials.gov注册（编号NCT03646591）。
