December 20, Paris, France and Kingston, Ontario – The results of the Unicancer and the Canadian Cancer Trials Group (CCTG) PRODIGE 24 | CCTG PA.6 study have been published in the New England Journal of Medicine. The practice changing results indicate a significant improvement in the survival of pancreatic cancer patients treated with the mFOLFIRINOX chemotherapy compared to the current standard treatment with gemcitabine
The incidence of pancreatic cancer has been steadily increasing and for more than 10 years, the standard of care following surgery was a six month adjuvant chemotherapy (to reduce the risk of recurrence) with gemcitabine.
This ground breaking research shows that the number of patients with disease relapse is reduced by half at three years. 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 threeyear survival of the patients is significantly improved; about two out of three patients alive in the mFOLFIRINOX arm versus one in two in the gemcitabine arm.
Severe adverse events, in particular diarrhea (19% versus 4%) and tingly in hands and feet: (9% versus 0%), although more important in the mFOLFIRINOX arm remain manageable by the medical teams. These toxicities require a dose reduction in some patients, but this does not resulted in loss of clinical benefit.
Today, mFOLFIRINOX is the new adjuvant standard of care for patients with resected pancreatic adenocarcinoma and in good general health. These results published in the New England Journal of Medicine were previously presented at the American Society of Clinical Oncology (ASCO) conference in June 2018.
From April 2012 to October 2016, 77 hospitals 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 and the Canadian Cancer Society.
About pancreatic cancer
In 2017, the “Santé publique France” Agency (formerly “Institut de Veille Sanitaire”) estimated at about 14 200 the number of new pancreatic cancer diagnosed in France. The pancreatic ductal adenocarcinoma accounts for 90-95% of all forms of exocrine pancreatic cancers. The vast majority of patient diagnosed are 60 years or older. Due to late clinical expression of the disease, advanced stage are the most frequent form of the cancer at diagnostic. When possible, surgery is the first line of treatment for pancreatic cancer, but only 15% to 20% of patients are amenable to tumor resection.
Across all stages, the 5-year survival is 6 to 7% in France (data for 1989-2010). In patients with tumor resection, adjuvant chemotherapy with gemcitabine prolongs survival compared to surgery alone and significantly increases the proportion of patients without cancer relapse.
About the New England Journal of Medicine
The “New England Journal of Medicine” is the world’s leading medical journal and website. Published since 1812, it is the most widely read, cited, and influential general medical periodical in the world. Dedicated to major innovations, it is widely recognized as the gold standard for research and best medical practice. According to the “Journal Citation Reports”, in 2017 with its highest impact factor (79,258) of all general medical journals, the “New England Journal of Medicine” is the periodical whose articles are the most cited in the scientific and medical literature
Source: FOLFIRINOX versus Gemcitabine as Adjuvant Therapy for Pancreatic Cancer
Authors: Thierry Conroy, M.D., Pascal Hammel, M.D., Ph.D., Mohamed Hebbar, M.D., Ph.D., Meher Ben Abdelghani, M.D., Alice C. Wei, M.D., C.M., M.Sc., F.R.C.S.C., F.A.C.S.,
Jean-Luc Raoul, M.D., Ph.D., Laurence Choné, M.D., Eric Francois, M.D., Pascal Artru, M.D., James Joseph Biagi, M.D., F.R.C.P.C., Thierry Lecomte, M.D., Ph.D., Eric Assenat, M.D., Ph.D., Roger Faroux, M.D., Marc Ychou, M.D., Ph.D., Julien Volet, M.D., Alain Sauvanet, M.D., Gilles Breysacher, M.D., Frédéric Di Fiore, M.D., Ph.D., Christine Cripps, M.D., F.R.C.P.C., Petr Kavan, M.D., Ph.D., Patrick Texereau, M.D., Karine Bouhier Leporrier, M.D., Faiza Khemissa-Akouz, M.D., Jean-Louis Legoux, M.D., Béata Juzyna, Eng, Sophie Gourgou, M.Sc., Christopher J. O’Callaghan, D.V.M., Ph.D., Claire Jouffroy-Zeller, Pharm.D, Patrick Rat, M.D., David Malka, M.D., Ph.D., Florence Castan, M.Sc., Jean- Baptiste Bachet, M.D., Ph.D., for the Canadian Cancer Trials Group and the UNICANCER- GI /PRODIGE Group
Affiliations: From Institut de Cancérologie de Lorraine and Université de Lorraine, Nancy, France (T.C.); Hôpital Beaujon, Clichy, France and Université Paris VII (P.H., A.S.); Hôpital Huriez, Lille, France (M.H.); Centre Paul Strauss, Strasbourg, France (M.B.A.); Princess Margaret Cancer Centre, Toronto, Canada (A.C.W.); Institut Paoli-Calmettes, Marseille, France (J-L.R.); Centre Hospitalier Universitaire, Nancy, France (L.C.); Centre Antoine- Lacassagne, Nice, France (E.F.); Hôpital Jean-Mermoz, Lyon, France (P.A.); Kingston General Hospital, Kingston, Canada (J.J.B.); Hôpital Trousseau, Tours, France (T.L.); Centre Hospitalier Universitaire de Saint-Eloi, Montpellier, France (E.A.); Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France (R.F.); Institut du Cancer Montpellier – Val d’Aurelle, Université de Montpellier, Montpellier, France (M.Y., S.G., F.C.); Centre.
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The Cancer Institute of Lorraine (ICL)
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The French league against cancer
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Canadian Cancer Trials Group
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