PRODIGE 24 | CCTG PA6 clinical trial in the New England Journal of Medicine

A new standard of care for patients with pancreatic cancer
Wednesday, January 2, 2019

The results of the Unicancer and Canadian Cancer Trials Group (CCTG) PRODIGE 24 | CCTG PA6 clinical trial have been published in the New England Journal of Medicine. This practice-changing research demonstrated a significant improvement in the survival of pancreatic cancer patients treated with the mFOLFIRINOX chemotherapy regimen compared to the current standard treatment with gemcitabine.

The incidence of pancreatic cancer has been steadily increasing over the past decade and, for patients who are candidates for surgical removal of their disease, the standard of care following surgery has been six months of adjuvant chemotherapy with gemcitabine to reduce the risk of recurrence.

The ground-breaking PRODIGE 24/PA.6 study shows that the number of patients whose disease relapses after surgery is reduced by half. After surgery, two out of five patients treated with mFOLFIRINOX did not experience disease relapse compared to one out of five in those treated with gemcitabine. In addition, the survival of patients was significantly improved; about two out of three patients were alive in the mFOLFIRINOX arm versus one in two in the gemcitabine arm after three years.

“These results demonstrate that resected pancreatic adenocarcinoma patients who receive this treatment after surgery are almost twice as likely to survive,” says Dr. Jim Biagi, Researcher and Oncologist at the Cancer Centre of South Eastern Ontario and the CCTG Canadian study co-chair. “I have been asked; “How significant was the impact of this research?” The day after results of PA.6 were presented, a new standard was set and practice changed overnight.”

“The results of the PRODIGE-24/CCTG PA.6 trial represents the most exciting change in a generation in the treatment of pancreas cancer. The study shows that mFOLFIRINOX is significantly more effective than any prior treatment reported. It has established a new standard of care for patients with pancreatic cancer that have surgery and brings hope for patients who have this disease,” says the CCTG Canadian study co-chair Dr. Alice Wei, Hepato-pancreato-biliary Surgical Oncologist at Princess Margaret Cancer Centre.

Today, mFOLFIRINOX is the new adjuvant standard of care for patients with resected pancreatic adenocarcinoma who are in good general health.

About the trial

From April 2012 to October 2016, 77 hospitals in France and Canada enrolled 493 post-operative pancreatic ductal adenocarcinoma patients in the PRODIGE 24 / CCTG PA.6 study. This was achieved through the collaboration of three French research groups organized under the umbrella of the PRODIGE Intergroup: Unicancer Gastrointestinal (UCGI), la Fédération Francophone de Cancérologie Digestive (FFCD) and the Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), and the Canadian Cancer Trials Group (CCTG)

The international study was coordinated by Prof. Thierry Conroy (Institut de Cancérologie de Lorraine, Nancy) in collaboration with Prof. Jean-Baptiste Bachet (Hôpital La Pitié-Salpêtrière, AP-HP, Paris), and Prof. Patrick Rat (CHU de Dijon) in France, and by Dr. Jim Biagi (Kingston Health Sciences Centre, Kingston) and Dr. Alice Wei (University Health Network, Toronto) in Canada. This important research was funded by the French Ministry of Health and The French league against cancer with additional support from 7 Days in May Foundation and the Canadian Cancer Society.

The results published in the New England Journal of Medicine were previously presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

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