About this episode
In this JCO Article Insights episode, host Joseph Mathew summaries Pancreatic Adenocarcinoma: Long-Term Outcomes of Adjuvant Therapy in the ESPAC4 Phase III Trial, by Palmer, et al published December 5, 2024. Transcript Joseph Mathew: Hello and welcome to the Journal of Clinical Oncology Article Insights. I'm your host, Joseph Mathew, and today we will be discussing the article "Long-Term Survival in Resected Pancreatic Ductal Adenocarcinoma with Adjuvant Gemcitabine plus Capecitabine Compared to Modified FOLFIRINOX from the ESPAC-4 and the PRODIGE 24 Trials" by Dr. Palmer et al. To summarize the relevant evidence, the ESPAC-4 was a European phase 3 multicenter randomized clinical trial published in 2017 comparing adjuvant gemcitabine and capecitabine (GemCap) with gemcitabine monotherapy following macroscopic margin-negative resections for operable pancreatic ductal adenocarcinoma (PDAC). The trial had included non-metastatic patients aged 18 years or older, World Health Organization (WHO) performance scores of 2 or less, creatinine clearance of at least 50 mL/min, and a life expectancy of over three months who had not received any prior anticancer treatment. Patients who had undergone R2 resections were selectively excluded. Eligible participants were randomized 1:1 within 12 weeks of pancreatectomy to one of the two treatment arms, with chemotherapy initiated within two weeks from the date of randomization. The regimens involved six cycles, each lasting four weeks, for an overall duration of 24 weeks. In the monotherapy arm, gemcitabine dosed at 1 g/m² was given as an intravenous infusion once a week for three weeks, followed by one week off. In the GemCap arm, capecitabine dosed at 1660 mg/m² was added to gemcitabine, given daily for three weeks, followed by one week off. Patients were followed up every three months, with the primary endpoint being overall survival (OS). The study showed that at a median follow-up of 43.2 months, GemCap was associated with a significantly longer OS than gemcitabine alone. Subsequently, in 2018, the Phase 3 randomized PRODIGE 24 trial was conducted in centers across France and Canada, comparing adjuvant modified FOLFIRINOX (mFOLFIRINOX) with gemcitabine in a similar subset of patients with resected PDAC and reported longer OS with the mFOLFIRINOX regimen. This study, however, had more restrictive eligibility criteria when compared to ESPAC-4, including patients aged u
