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Treatment of locally advanced rectal cancer with chemotherapy, radiotherapy, surgery, and adjuvant chemotherapy can control local disease progression, but distant metastasis is still common.
The study is an open-label, randomized phase 3 trial conducted in 35 hospitals in France, recruiting 18-75-year-old newly diagnosed, histologically confirmed, cT3 or cT4 M0 patients with rectal adenocarcinoma (WHO performance status 0-1 points).
PFS and OS
PFS and OSFrom June 5, 2012 to June 26, 2017, a total of 461 patients were randomly divided into two groups: 231 in the neoadjuvant chemotherapy group and 230 in the standard treatment group.
After a median follow-up of 46.
Adverse events
Adverse eventsDuring neoadjuvant chemotherapy, the most common grade 3-4 adverse events were neutropenia (17%) and diarrhea (11%).
During the entire treatment period, 63 of the 231 patients in the neoadjuvant chemotherapy group (27%) had serious adverse events, while 50 of the 230 patients in the standard treatment group (22%; p=0.
One treatment-related death (sudden death) occurred in the neoadjuvant chemotherapy group, and two treatment-related deaths (1 sudden death and 1 myocardial infarction ) occurred in the standard treatment group .
Myocardial infarction
In summary, for patients with cT3 or cT4 M0 stage rectal cancer, FOLFIRINOX intensive chemotherapy before preoperative radiotherapy can significantly improve their survival prognosis.
For patients with cT3 or cT4 M0 stage rectal cancer, FOLFIRINOX intensive chemotherapy before preoperative radiotherapy can significantly improve their survival prognosis.
Original source:
Thierry Conroy, et al.
org/10.
1016/S1470-2045(21)00079-6" target="_blank" rel="noopener">Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial in this message