Junichi Nishimura1,2, Junichi Hasegawa3, Takeshi Kato4, Shinichi Yoshioka5, Shingo Noura3, Yoshinori Kagawa6, Masayoshi Yasui7, Masakazu Ikenaga8, Kohei Murata6, Taishi Hata9, Chu Matsuda9, Tsunekazu Mizushima9, Hirofumi Yamamoto9, Yuichiro Doki9, Masaki Mori9. 1. Department of Gastroenterological Surgery, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan. jnishimura@gesurg.med.osaka-u.ac.jp. 2. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. jnishimura@gesurg.med.osaka-u.ac.jp. 3. Department of Surgery, Osaka Rosai Hospital, Sakai, Japan. 4. Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan. 5. Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan. 6. Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan. 7. Department of Gastroenterological Surgery, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan. 8. Department of Surgery, Higashiosaka City Medical Center, Higashiōsaka, Japan. 9. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Abstract
PURPOSE: The standard strategy for locally advanced lower rectal cancer is chemoradiotherapy followed by total mesorectal excision (TME) in Western countries and TME followed by adjuvant chemotherapy without preoperative treatment in Japan. METHODS: This phase II trial evaluated the efficacy of a preoperative CAPOX chemotherapy regimen without radiation therapy for patients with locally advanced rectal cancer. The primary endpoint was 2-year disease-free survival. RESULTS: The trial enrolled 45 patients from 9 institutions between 2012 and 2014. The mean age was 63.5 (29-74) years; 31 patients were male. Most patients (n = 41) received preoperative chemotherapy (CTx), and the preoperative CTx completion rate was 95.2%. R0 resection after CTx was performed in 41 patients. The pathological complete response rate was 7.3% (3/41). After surgery, 35 patients (85.3%) received adjuvant CTx, and 22 of 35 completed the protocol treatment. The follow-up period ranged from 0.71 to 4.68 years (median 2.86 years). There was recurrence in 13 of 40 patients who underwent R0 resection, and the 2-year disease-free survival rate and overall survival rate were 71.6 and 92.7%, respectively. CONCLUSIONS: Here we report the completion rates for neoadjuvant CTx and adjuvant CTx, the pathological complete response rate, and the mid-term prognosis. The results indicate that CAPOX followed by TME may be a safe treatment strategy for locally advanced rectal cancer.
RCT Entities:
PURPOSE: The standard strategy for locally advanced lower rectal cancer is chemoradiotherapy followed by total mesorectal excision (TME) in Western countries and TME followed by adjuvant chemotherapy without preoperative treatment in Japan. METHODS: This phase II trial evaluated the efficacy of a preoperative CAPOX chemotherapy regimen without radiation therapy for patients with locally advanced rectal cancer. The primary endpoint was 2-year disease-free survival. RESULTS: The trial enrolled 45 patients from 9 institutions between 2012 and 2014. The mean age was 63.5 (29-74) years; 31 patients were male. Most patients (n = 41) received preoperative chemotherapy (CTx), and the preoperative CTx completion rate was 95.2%. R0 resection after CTx was performed in 41 patients. The pathological complete response rate was 7.3% (3/41). After surgery, 35 patients (85.3%) received adjuvant CTx, and 22 of 35 completed the protocol treatment. The follow-up period ranged from 0.71 to 4.68 years (median 2.86 years). There was recurrence in 13 of 40 patients who underwent R0 resection, and the 2-year disease-free survival rate and overall survival rate were 71.6 and 92.7%, respectively. CONCLUSIONS: Here we report the completion rates for neoadjuvant CTx and adjuvant CTx, the pathological complete response rate, and the mid-term prognosis. The results indicate that CAPOX followed by TME may be a safe treatment strategy for locally advanced rectal cancer.
Entities:
Keywords:
Adjuvant chemotherapy; CAPOX; Neoadjuvant chemotherapy; Rectal cancer
Authors: Hamid Nasrolahi; Sepideh Mirzaei; Mohammad Mohammadianpanah; Ali Mohammad Bananzadeh; Maral Mokhtari; Mohammad Reza Sasani; Ahmad Mosalaei; Shapour Omidvari; Mansour Ansari; Niloofar Ahmadloo; Seyed Hasan Hamedi; Nezhat Khanjani Journal: Ann Coloproctol Date: 2019-10-31
Authors: Juan Francisco Olivos Gonzáles; Rodrigo Arroyo-Gárate; Miguel Angel Leon Estrella; Gustavo Cerrillo; Stefanie Campos Medinae Journal: Ecancermedicalscience Date: 2022-06-13