Total neoadjuvant therapy for locally advanced gastric cancer:an interim study of phase Ⅱ clinical trial
Shi Jinming1, Li Ning1, Zhao Dongbing2, Jiang Liming3, Yang Lin4, Ren Hua1, Wang Shulian1, Song Yongwen1, Liu Yueping1, Fang Hui1, Yang Yong1, Lu Ningning1, Tang Yu1, Qi Shunan1, Chen Bo1, Jing Hao1, Li Yexiong1, Tang Yuan1, Jin Jing1,5
1Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 2Department of Pancreatic and Gastric Surgery, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 3Department of Imaging, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 4Department of Internal Medicine, National Cancer Center/National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 5Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, China
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 45Gy,1.8Gy/f. Concurrent chemotherapy was S-1 at a dose of 40-60mg twice daily. Then, patients received four to six cycles of CNCT of SOX regimen at three weeks after neoadjuvant chemoradiotherapy. D2 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.
Shi Jinming,Li Ning,Zhao Dongbing et al. Total neoadjuvant therapy for locally advanced gastric cancer:an interim study of phase Ⅱ clinical trial[J]. Chinese Journal of Radiation Oncology, 2021, 30(10): 1025-1029.
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