MedicalResearch.com Interview with:
Prof. Thierry Conroy MD, Director
Department of Medical Oncology
Institut de Cancérologie de Lorraine
MedicalResearch.com: What is the background for this study?
Response: Surgery of pancreatic cancer offers the only chance of cure. Despite the low response rate (5% – 9%) of gemcitabine in metastatic disease, a 6-month regimen of adjuvant therapy with gemcitabine increases 5-year survival from 10% to 20% and is recognized as standard of care. However, recurrence rate remain high despite adjuvant treatment with 69-75% of patients relapsing within 2 years.
– The combination of bolus and continuous infusion Fluorouracil, Folinic Acid, Irinotecan and Oxaliplatin (Folfirinox) was shown to increase response rate (31.6% versus 9.4%) in metastatic disease as compared to Gemcitabine and increase survival (11.1 versus 6.8 months).
– Deletion of bolus Fluorouracil in the Folfirinox regimen (mFOLFIRINOX) decreased toxicity and do not reduce efficacy in advanced disease.
– We performed a randomized trial in patients with good performance status, ECOG 0-1 CA 19.9 ≤ 180 U/L and no cardiac contraindication to fluorouracil.
MedicalResearch.com: What are the main findings?
Response: The four endpoints of the trial are significantly in favor of mFolfirinox as compared to gemcitabine
– There is a significant increase in DFS with FOLFIRINOX, it almost doubled the DFS rate at 3 years: disease-free survival rates at 3 years were 39.7% in the modified-FOLFIRINOX group, as compared with 21.4%, in the gemcitabine group.The benefit for Folfirinox is observed in all the predefined subgroups regardless of resection margins, TNM stage, sex, and performance status. There is a trend for a benefit over 70 years, but it is not significant.
– The overall survival was significantly increased in the FOLFIRINOX arm. The overall survival rate at 3 years was 63.4% in the modified-FOLFIRINOX group and 48.6% in the gemcitabine group.
– There is also a 15% increase in the cancer-specific survival at 3 years, from 51.2% with gemcitabine to 66.2% with mfolfirinox.
– The metastasis-free survival rate at 3 years was 48.2% in the modified-FOLFIRINOX group and 30.9% in the gemcitabine group. This means a significant reduction of 41% in the risk of metastatic relapse.
– The safety profile of the modified FOLFIRINOX regimen was less favorable than that of gemcitabine but appeared to be manageable in carefully informed patients and doses adaptations.
MedicalResearch.com: What should readers take away from your report?
Response: This trial demonstrated that patients who receive mFOLFIRINOX after surgery are almost twice as likely to survive. mFOLFIRINOX is more toxic than Gem, but it is a safe regimen with manageable toxicities. mFOLFIRINOX should now be considered a new standard of care for fit patients with resected pancreatic cancer
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
– To plan a central quality control of of surgical reports, pathology reports, and preinclusion imaging (CT and MRI) to check prognostic factors
– To test in a future trial neoadjuvant mFolfirinox versus upfront surgery and adjuvant mFolfirinox
FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer
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., Jean-Luc Raoul, M.D., Ph.D., Laurence Choné, M.D., Eric Francois, M.D., Pascal Artru, M.D., James J. Biagi, M.D., Thierry Lecomte, M.D., Ph.D., Eric Assenat, M.D., Ph.D.,
for the Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group*
December 20, 2018
N Engl J Med 2018; 379:2395-2406
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