Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). Issue 15 (20th May 2022)

• Record Type: Journal Article
• Authors: Jin, Jing; Tang, Yuan; Hu, Chen; Jiang, Li-Ming; Jiang, Jun; Li, Ning; Liu, Wen-Yang; Chen, Si-Lin; Li, Shuai; Lu, Ning-Ning; Cai, Yong; Li, Yong-Heng; Zhu, Yuan; Cheng, Guang-Hui; Zhang, Hong-Yan; Wang, Xin; Zhu, Su-Yu; Wang, Jun; Li, Gao-Feng; Yang, Jia-Lin; Zhang, Kuan; Chi, Yihebali; Yang, Lin; Zhou, Hai-Tao; Zhou, Ai-Ping; Zou, Shuang-Mei; Fang, Hui; Wang, Shu-Lian; Zhang, Hai-Zeng; Wang, Xi-Shan; Wei, Li-Chun; Wang, Wen-Ling; Liu, Shi-Xin; Gao, Yuan-Hong; Li, Ye-Xiong;
• Is Part Of: Journal of clinical oncology. Volume 40:Issue 15(2022)
• Page Start: 1681
• Page End: 1692
• Publication Date: 2022-05-20
• Subjects: Oncology -- Periodicals; Cancer -- Periodicals; Oncology; Medical Oncology; Cancérologie -- Périodiques; Cancer -- Périodiques; Cancérologie; Cancer; Oncology; Oncologia; Càncer; Periodicals; 616.994
• DOI: 10.1200/JCO.21.01667
• Languages: English
• ISSNs: 0732-183X

Abstract

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/m 2, once a day] on day 1 and capecitabine [1, 000 mg/m 2, 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. Abstract :