1. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR)
- Author
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Jing Jin, Yuan Tang, Chen Hu, Li-Ming Jiang, Jun Jiang, Ning Li, Wen-Yang Liu, Si-Lin Chen, Shuai Li, Ning-Ning Lu, Yong Cai, Yong-Heng Li, Yuan Zhu, Guang-Hui Cheng, Hong-Yan Zhang, Xin Wang, Su-Yu Zhu, Jun Wang, Gao-Feng Li, Jia-Lin Yang, Kuan Zhang, Yihebali Chi, Lin Yang, Hai-Tao Zhou, Ai-Ping Zhou, Shuang-Mei Zou, Hui Fang, Shu-Lian Wang, Hai-Zeng Zhang, Xi-Shan Wang, Li-Chun Wei, Wen-Ling Wang, Shi-Xin Liu, Yuan-Hong Gao, and Ye-Xiong Li
- Subjects
Cancer Research ,Oncology ,Rectal Neoplasms ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Neoplasms, Second Primary ,Chemoradiotherapy ,Fluorouracil ,Neoplasm Recurrence, Local ,Capecitabine ,Neoadjuvant Therapy ,Neoplasm Staging - Abstract
PURPOSE To ascertain if preoperative short-term radiotherapy followed by chemotherapy is not inferior to a standard schedule of long-term chemoradiotherapy in patients with locally advanced rectal cancer. MATERIALS AND METHODS Patients with distal or middle-third, clinical primary tumor stage 3-4 and/or regional lymph node–positive rectal cancer were randomly assigned (1:1) to short-term radiotherapy (25 Gy in five fractions over 1 week) followed by four cycles of chemotherapy (total neoadjuvant therapy [TNT]) or chemoradiotherapy (50 Gy in 25 fractions over 5 weeks, concurrently with capecitabine [chemoradiotherapy; CRT]). Total mesorectal excision was undertaken 6-8 weeks after preoperative treatment, with two additional cycles of CAPOX (intravenous oxaliplatin [130 mg/m2, once a day] on day 1 and capecitabine [1,000 mg/m2, twice a day] from days 1 to 14) in the TNT group and six cycles of CAPOX in the CRT group. The primary end point was 3-year disease-free survival (DFS). RESULTS Between August 2015 and August 2018, a total of 599 patients were randomly assigned to receive TNT (n = 302) or CRT (n = 297). At a median follow-up of 35.0 months, 3-year DFS was 64.5% and 62.3% in TNT and CRT groups, respectively (hazard ratio, 0.883; one-sided 95% CI, not applicable to 1.11; P < .001 for noninferiority). There was no significant difference in metastasis-free survival or locoregional recurrence, but the TNT group had better 3-year overall survival than the CRT group (86.5% v 75.1%; P = .033). Treatment effects on DFS and overall survival were similar regardless of prognostic factors. The prevalence of acute grade III-V toxicities during preoperative treatment was 26.5% in the TNT group versus 12.6% in the CRT group ( P < .001). CONCLUSION Short-term radiotherapy with preoperative chemotherapy followed by surgery was efficacious with acceptable toxicity and could be used as an alternative to CRT for locally advanced rectal cancer.
- Published
- 2022
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