Wenju Chang1, Ye Wei, Li Ren, Yunshi Zhong, Yiyi Yu, Jingwen Chen, Dexiang Zhu, Lechi Ye, Chunzhi Qin, Naiqing Zhao, Weixin Niu, Xinyu Qin, Jianmin Xu. 1. *Department of General Surgery Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China †Colorectal Cancer Diagnosis and Treatment Center Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China ‡Endoscopy Center Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China §Medical Oncology Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China ¶Statistics, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Abstract
OBJECTIVES: The optimal time to initiate adjuvant chemotherapy after surgery in patients with colon cancer is not clear. We investigated the benefit of combined intraportal chemotherapy administered during radical surgery with adjuvant chemotherapy for treating stage II and III colon cancer. METHODS: Patients were randomly assigned to OCTREE arm (intraportal chemotherapy plus mFOLFOX6) or a standard adjuvant chemotherapy arm (mFOLFOX6). The primary study endpoint was disease-free survival. The secondary endpoints included metastasis-free survival, overall survival, and safety. RESULTS: The intent-to-treat population comprised 237 patients. With a median follow-up of 44 months, the hazard ratio (OCTREE vs mFOLFOX6) was 0.66 (95% confidence interval, 0.43-0.90), a 34% risk reduction in favor of OCTREE (P = 0.016). The 3-year disease-free survival rate was 85.2% for OCTREE and 75.6% for mFOLFOX6 alone (P = 0.030). The 3-year metastasis-free survival rates were 87.6% for OCTREE and 78.0% for mFOLFOX6 (P = 0.035). Patients had lower distant metastatic rate in the OCTREE arm (12.7% vs 22.7%; P = 0.044), when compared with the mFOLFOX6 arm. The 3-year overall survival was no significant difference between 2 arms (P = 0.178). Neutropenia occurred in 12.7% of the patients receiving OCTREE and in 2.5% of the patients receiving mFOLFOX6 (P = 0.003) within 2 weeks of surgery, and grade 3 or 4 toxicity event was no difference between 2 regimens. CONCLUSIONS: Combination of intraoperative intraportal chemotherapy with mFOLFOX6 reduced the occurrence of distant metastases and improved disease-free survival in patients with stage II and stage III colon cancer.
RCT Entities:
OBJECTIVES: The optimal time to initiate adjuvant chemotherapy after surgery in patients with colon cancer is not clear. We investigated the benefit of combined intraportal chemotherapy administered during radical surgery with adjuvant chemotherapy for treating stage II and III colon cancer. METHODS:Patients were randomly assigned to OCTREE arm (intraportal chemotherapy plus mFOLFOX6) or a standard adjuvant chemotherapy arm (mFOLFOX6). The primary study endpoint was disease-free survival. The secondary endpoints included metastasis-free survival, overall survival, and safety. RESULTS: The intent-to-treat population comprised 237 patients. With a median follow-up of 44 months, the hazard ratio (OCTREE vs mFOLFOX6) was 0.66 (95% confidence interval, 0.43-0.90), a 34% risk reduction in favor of OCTREE (P = 0.016). The 3-year disease-free survival rate was 85.2% for OCTREE and 75.6% for mFOLFOX6 alone (P = 0.030). The 3-year metastasis-free survival rates were 87.6% for OCTREE and 78.0% for mFOLFOX6 (P = 0.035). Patients had lower distant metastatic rate in the OCTREE arm (12.7% vs 22.7%; P = 0.044), when compared with the mFOLFOX6 arm. The 3-year overall survival was no significant difference between 2 arms (P = 0.178). Neutropenia occurred in 12.7% of the patients receiving OCTREE and in 2.5% of the patients receiving mFOLFOX6 (P = 0.003) within 2 weeks of surgery, and grade 3 or 4 toxicity event was no difference between 2 regimens. CONCLUSIONS: Combination of intraoperative intraportal chemotherapy with mFOLFOX6 reduced the occurrence of distant metastases and improved disease-free survival in patients with stage II and stage III colon cancer.
Authors: Romain Cohen; Dewi Vernerey; Carine Bellera; Aurélia Meurisse; Julie Henriques; Xavier Paoletti; Benoît Rousseau; Steven Alberts; Thomas Aparicio; Ioannis Boukovinas; Sharlene Gill; Richard M Goldberg; Axel Grothey; Tetsuya Hamaguchi; Timothy Iveson; Rachel Kerr; Roberto Labianca; Sara Lonardi; Jeffrey Meyerhardt; James Paul; Cornelis J A Punt; Leonard Saltz; Marck P Saunders; Hans-Joachim Schmoll; Manish Shah; Alberto Sobrero; Ioannis Souglakos; Julien Taieb; Atsuo Takashima; Anna Dorothea Wagner; Marc Ychou; Franck Bonnetain; Sophie Gourgou; Takayuki Yoshino; Greg Yothers; Aimery de Gramont; Qian Shi; Thierry André Journal: Eur J Cancer Date: 2020-03-12 Impact factor: 9.162
Authors: Berk Aykut; Markus Ochs; Praveen Radhakrishnan; Adrian Brill; Hermine Höcker; Sandra Schwarz; Daniel Weissinger; Roland Kehm; Yakup Kulu; Alexis Ulrich; Martin Schneider Journal: BMC Cancer Date: 2017-08-22 Impact factor: 4.430