Abstract 3059
Background
Whether colorectal cancer patients who undergo radical resection can benefit from intraoperative chemotherapy is still under debate. Therefore, we aimed to compare the results of intraoperative chemotherapy combined with radical surgical resection with surgical resection alone in colorectal cancer patients.
Methods
This is a multicenter, open-label, randomized, non-inferiority, phase 3 trial. All patients who had been histologically confirmed and could receive radical resection with no sign of distance metastasis, were enrolled. The patients were randomized to receive intraoperative chemotherapy with radical surgical resection, or radical surgery resection alone (1:1). Intraoperative chemotherapy included portal vein chemotherapy (200 mg/m2 5-FU), intraluminal chemotherapy (1000 mg/m2 5-FU), and intraperitoneal chemotherapy (300mg/m2 5-FU). The primary endpoint was 3-year disease-free survival (DFS) analyzed on an intention-to-treat basis with an α of 0.05 and a power of 80%.
Results
From January 2011 to January 2016, 685 colorectal cancer patients were enrolled and randomly assigned to intraoperative chemotherapy with radical surgical resection (n = 341), or surgical resection alone (control group, n = 344). After a median follow-up of 65.1 months, 21 patients in the intraoperative chemotherapy group and 26 patients in the control group had died. 39 patients in the intraoperative chemotherapy group and 47 patients in the control group experienced distance metastasis or local recurrence. Intraoperative chemotherapy showed no significant benefit for colorectal cancer patients who underwent radical resection (p = 0.334). Subgroup analyses showed that patients with pre-treatment abnormal CEA level (> 5ng/ml) could benefit from intraoperative chemotherapy (p = 0.026, HR:0.516). The patients with pre-treatment normal CEA level (< 5ng/ml) still did not benefit from intraoperative chemotherapy (p = 0.298).
Conclusions
Intraoperative chemotherapy could improve 3-years DFS of colorectal cancer patients whose pre-treatment serum CEA level was higher than 5ng/ml.
Clinical trial identification
NCT01465451.
Editorial acknowledgement
Legal entity responsible for the study
Zhizhong Pan.
Funding
Sun Yat-sen University 5010 funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3006 - Nal-iri/lv5-fu versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI-PRODIGE 62): A FFCD multicenter, randomized, phase II study.
Presenter: Violaine Randrian
Session: Poster Display session 2
Resources:
Abstract
3697 - The expression of Versican and its role in pancreatic neuroendocrine tumor
Presenter: Zhao Sun
Session: Poster Display session 2
Resources:
Abstract
6073 - Characteristics of patients with thyroid carcinoma in the united states
Presenter: Dina El-Habashy
Session: Poster Display session 2
Resources:
Abstract
2124 - The discrimination of pituitary adenomas and craniopharyngioma on MRI: from image features to texture features
Presenter: Hanyue Xu
Session: Poster Display session 2
Resources:
Abstract
3786 - Proportion of Peripheral Lymphocyte Subsets Correlates with the Progression-free Survival and Metastatic Status of Pancreatic Neuroendocrine Tumor Patients
Presenter: Yitao Gong
Session: Poster Display session 2
Resources:
Abstract
2263 - Immunohistochemical expression of ER-α and PR in papillary thyroid carcinoma
Presenter: Enas Elkhouly
Session: Poster Display session 2
Resources:
Abstract
4386 - SILVELUL Project: Immunohistochemical panel analyses as potential predictive and prognostic factors in Pancreatic Neuroendocrine Tumors (PanNET) Treated with CAPTEM or Everolimus
Presenter: Ana De Jesus-Acosta
Session: Poster Display session 2
Resources:
Abstract
2302 - Carcinoid heart disease (CHD): the CRUSOE-NETs, a prospective cohort study from the French Group of Endocrine Tumors (GTE)
Presenter: Kathleen Dekeister Geoffroy
Session: Poster Display session 2
Resources:
Abstract
5749 - Safety of high doses of somatostatin analogs in well differentiated NENs in elderly
Presenter: Massimiliano Cani
Session: Poster Display session 2
Resources:
Abstract
3931 - Differences in multikinase inhibitors (MKI) toxicity profile according to gender. A pooled analysis of three phase II trials with lenvatinib, pazopanib and sorafenib in patients (pts) with advanced gastroenteropancreatic (GEP) neuroendocrine tumors (NETs).
Presenter: Jorge Hernando Cubero
Session: Poster Display session 2
Resources:
Abstract