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This article is from NEJM Journal Watch (NEJM Journal Watch) Total Neoadjuvant Therapy in Rectal Cancer Increases Pathologic Complete Response.
The whole course of neoadjuvant treatment can improve the pathological complete remission rate of patients with rectal cancer.
Comment by David H.
Ilson, MD, PhD and standard treatment In contrast, the whole course of neoadjuvant therapy also improved the patient's 3-year disease-free survival rate.
Preoperative chemoradiation, total mesorectal resection and adjuvant chemotherapy are the standard treatments for locally advanced rectal cancer.
There is increasing attention to improving drug delivery through neoadjuvant therapy throughout the course, so that patients in remission can receive non-surgical treatment and preserve organs, while improving survival rates.
The researchers reported the results of the UNICANCER-PRODIGE 23 trial, which is an open-label, multi-center, randomized phase 3 trial comparing conventional treatment with neoadjuvant treatment.
Conventional treatment includes preoperative capecitabine treatment/radiotherapy, surgery and 6 months of adjuvant chemotherapy (FOLFFOX or capecitabine), neoadjuvant therapy including 3 months of FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil infusion) treatment, followed by capecitabine treatment /Radiotherapy, surgery and 3 months FOLFFOX adjuvant therapy.
Among the 416 patients who underwent randomization, the median age was 61 years, and most of them suffered from MRI clinical stage T3 (82%) and N1-2 (90%) disease.
At a median follow-up of 47 months, the primary endpoint of 3-year disease-free survival (76% vs.
69%; hazard ratio, 0.
69; P=0.
034), neoadjuvant therapy was better than standard treatment, and the former had no metastasis in 3 years The survival rate is also better than the latter (79% vs.
72%).
The three-year overall survival rates of the two groups were similar (88% and 91%).
The pathological complete remission rate was higher in the neoadjuvant treatment group (28% vs.
12%), and the pathological lymph node negative rate was also higher (83% vs.
67%).
The proportion of R0 resection (95% and 94%) and the proportion of combined abdominal and perineal resection (14%) were similar in the two groups.
The incidence of adverse events is also similar.
Comment UNICANCER-PRODIGE 23 adds new evidence to the ever-increasing evidence, proving that neoadjuvant therapy and full-course neoadjuvant therapy are feasible for rectal cancer, may increase the remission rate of patients, and may increase the remission of patients receiving non-surgical treatment and organ preservation possibility.
The relative benefits of FOLFIRINOX compared to conventional FOLFOX are uncertain, and we need to use randomized trials to determine the best neoadjuvant chemotherapy.
Questions to be resolved include whether chemotherapy or radiotherapy should be given first, and the role of short-term radiotherapy.
Conroy T et al.
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.
Lancet Oncol 2021 May; 22:702 (https://doi.
org/10.
1016/S1470-2045(21)00079-6) Related reading NEJM Journal Watch The NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field.
Help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
The whole course of neoadjuvant treatment can improve the pathological complete remission rate of patients with rectal cancer.
Comment by David H.
Ilson, MD, PhD and standard treatment In contrast, the whole course of neoadjuvant therapy also improved the patient's 3-year disease-free survival rate.
Preoperative chemoradiation, total mesorectal resection and adjuvant chemotherapy are the standard treatments for locally advanced rectal cancer.
There is increasing attention to improving drug delivery through neoadjuvant therapy throughout the course, so that patients in remission can receive non-surgical treatment and preserve organs, while improving survival rates.
The researchers reported the results of the UNICANCER-PRODIGE 23 trial, which is an open-label, multi-center, randomized phase 3 trial comparing conventional treatment with neoadjuvant treatment.
Conventional treatment includes preoperative capecitabine treatment/radiotherapy, surgery and 6 months of adjuvant chemotherapy (FOLFFOX or capecitabine), neoadjuvant therapy including 3 months of FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil infusion) treatment, followed by capecitabine treatment /Radiotherapy, surgery and 3 months FOLFFOX adjuvant therapy.
Among the 416 patients who underwent randomization, the median age was 61 years, and most of them suffered from MRI clinical stage T3 (82%) and N1-2 (90%) disease.
At a median follow-up of 47 months, the primary endpoint of 3-year disease-free survival (76% vs.
69%; hazard ratio, 0.
69; P=0.
034), neoadjuvant therapy was better than standard treatment, and the former had no metastasis in 3 years The survival rate is also better than the latter (79% vs.
72%).
The three-year overall survival rates of the two groups were similar (88% and 91%).
The pathological complete remission rate was higher in the neoadjuvant treatment group (28% vs.
12%), and the pathological lymph node negative rate was also higher (83% vs.
67%).
The proportion of R0 resection (95% and 94%) and the proportion of combined abdominal and perineal resection (14%) were similar in the two groups.
The incidence of adverse events is also similar.
Comment UNICANCER-PRODIGE 23 adds new evidence to the ever-increasing evidence, proving that neoadjuvant therapy and full-course neoadjuvant therapy are feasible for rectal cancer, may increase the remission rate of patients, and may increase the remission of patients receiving non-surgical treatment and organ preservation possibility.
The relative benefits of FOLFIRINOX compared to conventional FOLFOX are uncertain, and we need to use randomized trials to determine the best neoadjuvant chemotherapy.
Questions to be resolved include whether chemotherapy or radiotherapy should be given first, and the role of short-term radiotherapy.
Conroy T et al.
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.
Lancet Oncol 2021 May; 22:702 (https://doi.
org/10.
1016/S1470-2045(21)00079-6) Related reading NEJM Journal Watch The NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field.
Help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
