Total neoadjuvant therapy for locally advanced gastric cancer: an interim study of phase Ⅱ clinical trial
10.3760/cma.j.cn113030-20201216-00607
- VernacularTitle:局部晚期胃癌全新辅助治疗Ⅱ期临床研究中期分析
- Author:
Jinming SHI
1
;
Ning LI
;
Dongbing ZHAO
;
Liming JIANG
;
Lin YANG
;
Hua REN
;
Shulian WANG
;
Yongwen SONG
;
Yueping LIU
;
Hui FANG
;
Yong YANG
;
Ningning LU
;
Yu TANG
;
Shunan QI
;
Bo CHEN
;
Hao JING
;
Yexiong LI
;
Yuan TANG
;
Jing JIN
Author Information
1. 国家癌症中心/国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院放疗科 100021
- Keywords:
Gastric neoplasm/chemoradiotherapy;
Gastric neoplasm/chemotherapy;
Treatment outcome;
Safety
- From:
Chinese Journal of Radiation Oncology
2021;30(10):1025-1029
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the safety and preliminary efficacy of total neoadjuvant therapy (TNT) model of" neoadjuvant chemoradiotherapy plus consolidation neoadjuvant chemotherapy (CNCT) followed by surgery" for locally advanced gastric cancer.Methods:From 2018 to 2020, 28 patients clinically diagnosed with locally advanced gastric adenocarcinoma or Siewert Ⅱ/Ⅲ adenocarcinoma gastroesophageal junction cancer were prospectively enrolled. The neoadjuvant chemoradiotherapy (NCRT) was delivered with a total dose of 45 Gy, 1.8 Gy/f. Concurrent chemotherapy was S-1 at a dose of 40-60 mg twice daily. Then, patients received four to six cycles of CNCT of SOX regimen at three weeks after neoadjuvant chemoradiotherapy. D 2 lymphadenectomy was performed at 4-6 weeks after CNCT. Results:A total of 28 patients completed the whole therapy. Grade 3 or above adverse events occurred in 3 cases (11%) during CCRT, including thrombocytopenia, leukopenia and anorexia; 2 cases (7%) developed leukopenia and 3 cases (11%) of thrombocytopenia during CNCT. Twenty patients (71%) completed the surgery. The proportion of patients with pathological complete remission (pCR) was 50%. Three patients experienced surgical complications including anastomotic leak, anastomotic stenosis and intra-abdominal sepsis. All were recovered after symptomatic treatment.Conclusion:Interim analysis results demonstrate that TNT can yield significant down-staging for patients with locally advanced gastric cancer, which causes tolerable adverse events and postoperative complications.
