Xin Wang1, Yongyang Yu2, Wenjian Meng2, Dan Jiang3, Xiangbing Deng2, Bing Wu4, Hua Zhuang5, Cun Wang2, Yali Shen1, Lie Yang2, Hong Zhu6, Ke Cheng6, Yaqin Zhao6, Zhiping Li1, Memg Qiu6, Hongfeng Gou1, Feng Bi6, Feng Xu7, Rrenmin Zhong8, Sen Bai8, Ziqiang Wang9, Zongguang Zhou10. 1. Department of Abdominal Cancer, Cancer Center, West China Hospital, Sichuan University, Chengdu, China; State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China. 2. Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China. 3. Department of Pathology, West China Hospital, Sichuan University, Chengdu, China. 4. Department of Radiology, West China Hospital, Sichuan University, Chengdu, China. 5. Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China. 6. Department of Abdominal Cancer, Cancer Center, West China Hospital, Sichuan University, Chengdu, China. 7. Department of Lung Cancer Center, West China Hospital, Sichuan University, Chengdu, China. 8. Radiation Physics Center, Cancer Center, West China Hospital, Sichuan University, Chengdu, China. 9. Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China. Electronic address: wangzqzyh@163.com. 10. Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China. Electronic address: zhou767@163.com.
Abstract
BACKGROUND AND PURPOSE: To evaluate the safety and efficacy of Total neoadjuvant treatment (TNT) in patients with rectal cancer with high risk factors. METHODS AND MATERIALS: We did this phase 2 trial in patients who were diagnosed with stage II-III rectal cancer with at least one of the high risk factors. Three cycles of induction CAPOX were followed by pelvic radiotherapy of 50.4 Gy/28 fractions and two cycles of concurrent CAPOX. Three cycles of consolidation CAPOX were delivered after radiotherapy. Primary endpoints were pathological complete response (pCR) and R0 resection. RESULTS: Fifty patients were enrolled and 47 patients were evaluable. A total of 34 patients (72.3%) completed 6 to 8 cycles of chemotherapy and 46 patients (98%) completed the planned radiotherapy. 17 patients (36%) achieved a pCR or clinical complete response (cCR). Three cCR patients (6.4%) refused the operation and selected a watch-and-wait approach. The most common grade 3 or worse adverse events were leucopenia (10.6%) and radiation dermatitis (6.4%). The major surgical complications included pelvic abscesses/infection in 2 patients (4.3%), anastomotic leakage and hemorrhage in1 patient (2.2%), respectively, which were all addressed with conservative management. CONCLUSIONS: TNT is effective and safe in patients with locally advanced rectal cancer with high risk factors. Long-term efficacies of TNT need to be further evaluated. This trial is registered with Chinese Clinical Trial Registry, number ChiCTR-OIN-17012284.
BACKGROUND AND PURPOSE: To evaluate the safety and efficacy of Total neoadjuvant treatment (TNT) in patients with rectal cancer with high risk factors. METHODS AND MATERIALS: We did this phase 2 trial in patients who were diagnosed with stage II-III rectal cancer with at least one of the high risk factors. Three cycles of induction CAPOX were followed by pelvic radiotherapy of 50.4 Gy/28 fractions and two cycles of concurrent CAPOX. Three cycles of consolidation CAPOX were delivered after radiotherapy. Primary endpoints were pathological complete response (pCR) and R0 resection. RESULTS: Fifty patients were enrolled and 47 patients were evaluable. A total of 34 patients (72.3%) completed 6 to 8 cycles of chemotherapy and 46 patients (98%) completed the planned radiotherapy. 17 patients (36%) achieved a pCR or clinical complete response (cCR). Three cCR patients (6.4%) refused the operation and selected a watch-and-wait approach. The most common grade 3 or worse adverse events were leucopenia (10.6%) and radiation dermatitis (6.4%). The major surgical complications included pelvic abscesses/infection in 2 patients (4.3%), anastomotic leakage and hemorrhage in1 patient (2.2%), respectively, which were all addressed with conservative management. CONCLUSIONS: TNT is effective and safe in patients with locally advanced rectal cancer with high risk factors. Long-term efficacies of TNT need to be further evaluated. This trial is registered with Chinese Clinical Trial Registry, number ChiCTR-OIN-17012284.
Authors: Anita Nguyen; David R James; Eric J Dozois; Scott R Kelley; Kellie L Mathis Journal: J Gastrointest Surg Date: 2019-02-06 Impact factor: 3.452
Authors: Laila Babar; Veli Bakalov; Stephen Abel; Obaid Ashraf; Gene Grant Finley; Moses S Raj; Kristina Lundeen; Dulabh K Monga; Alexander V Kirichenko; Rodney E Wegner Journal: World J Gastrointest Oncol Date: 2019-10-15