Laura Kairevičė1, Tadas Latkauskas2, Algimantas Tamelis2, Aleksandras Petrauskas3, Henrikas Paužas2, Tadas Žvirblis4, Laimonas Jaruševičius5, Žilvinas Saladžinskas2, Dainius Pavalkis2, Rasa Jančiauskienė5. 1. Department of Oncology and Hematology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania. Electronic address: laurakairev@yahoo.com. 2. Department of Surgery, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania. 3. Department of Chemotherapy with Day Care Unit, National Cancer Institute, Vilnius, Lithuania. 4. Vilnius University Hospital Santariškių Klinikos, Vilnius, Lithuania. 5. Department of Oncology and Hematology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.
Abstract
BACKGROUND AND OBJECTIVE: At present, there are common recommendations for treatment for stage II-III resectable rectal cancer patients: preoperativeconventional chemoradiotherapy (CRT) with delayed surgery in 6-8 weeks or preoperative short-course radiotherapy (SCRT) followed by immediate surgery. The aim of this study was to compare overall survival (OS) and disease-free survival (DFS) in two treatment groups: preoperative SCRT and CRT both with delayed surgery plus adjuvant chemotherapy in CRT arm. MATERIALS AND METHODS:A total of 150 patients were randomly assigned to two groups: 75 to CRT (preoperative conventional CRT, 50Gy/25 fr with fluorouracil and leucovorin on the 1st and the 5th week of RT followed by TME surgery in 6-8 weeks and 4 cycles of adjuvant fluorouracil/leucovorin every 4 weeks; then follow-up) and 75 to SCRT (preoperative short-course RT, 25Gy/5 fr followed by TME surgery in 6-8 weeks; then follow-up). The data of 140 patients (72 in CRT and 68 in SCRT group) were included in statistical analysis. Primary end points were OS and DFS. RESULTS: Median follow-up was 60.5 (range, 5-108) months. The 5-year DFS was 67% in the CRT group (n=72) and 45% in the SCRT group (n=68) (P=0.013; HR=1.88; 95% CI, 1.13-3.12; P=0.015). The 5-year OS was 79% and 62% in the CRT and SCRT groups, respectively (P=0.015; HR=2.05; 95% CI, 1.13-3.70; P=0.017). The 5-year OS for intent-to-treat (ITT) population (n=150) was 78% in the CRT and 58% in the SCRT group (P=0.003; HR=2.28; 95% CI, 1.30-4.00; P=0.004). CONCLUSIONS: The 5-year DFS and OS were significantly better in the CRT than the SCRT group. For ITT population, OS was also significantly better after CRT versus SCRT.
RCT Entities:
BACKGROUND AND OBJECTIVE: At present, there are common recommendations for treatment for stage II-III resectable rectal cancerpatients: preoperative conventional chemoradiotherapy (CRT) with delayed surgery in 6-8 weeks or preoperative short-course radiotherapy (SCRT) followed by immediate surgery. The aim of this study was to compare overall survival (OS) and disease-free survival (DFS) in two treatment groups: preoperative SCRT and CRT both with delayed surgery plus adjuvant chemotherapy in CRT arm. MATERIALS AND METHODS: A total of 150 patients were randomly assigned to two groups: 75 to CRT (preoperative conventional CRT, 50Gy/25 fr with fluorouracil and leucovorin on the 1st and the 5th week of RT followed by TME surgery in 6-8 weeks and 4 cycles of adjuvant fluorouracil/leucovorin every 4 weeks; then follow-up) and 75 to SCRT (preoperative short-course RT, 25Gy/5 fr followed by TME surgery in 6-8 weeks; then follow-up). The data of 140 patients (72 in CRT and 68 in SCRT group) were included in statistical analysis. Primary end points were OS and DFS. RESULTS: Median follow-up was 60.5 (range, 5-108) months. The 5-year DFS was 67% in the CRT group (n=72) and 45% in the SCRT group (n=68) (P=0.013; HR=1.88; 95% CI, 1.13-3.12; P=0.015). The 5-year OS was 79% and 62% in the CRT and SCRT groups, respectively (P=0.015; HR=2.05; 95% CI, 1.13-3.70; P=0.017). The 5-year OS for intent-to-treat (ITT) population (n=150) was 78% in the CRT and 58% in the SCRT group (P=0.003; HR=2.28; 95% CI, 1.30-4.00; P=0.004). CONCLUSIONS: The 5-year DFS and OS were significantly better in the CRT than the SCRT group. For ITT population, OS was also significantly better after CRT versus SCRT.
Authors: Wang Qiaoli; Huang Yongping; Xiong Wei; Xu Guoqiang; Ju Yunhe; Liu Qiuyan; Li Cheng; Guo Mengling; Li Jiayi; Xiong Wei; Yang Yi Journal: Int J Colorectal Dis Date: 2019-11-19 Impact factor: 2.571