ArticleEClinicalMedicine2026
Sequential alternation of nal-IRI/5-FU and gemcitabine/nab-paclitaxel versus nal-IRI/5-FU versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer: results of the randomized phase II PRODIGE 61-FUNGEMAX trial (France).
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: New chemotherapeutic approaches are still needed to improve survival and quality of life in metastatic pancreatic ductal adenocarcinoma (mPDAC). In the absence of validated predictive biomarkers, first-line sequential treatment strategies may allow to delay chemoresistance and reduce cumulative side effects. Methods: PRODIGE 61-FUNGEMAX was an open-label, multicentre, randomised phase II trial conducted in 31 centres in France. Between November 2018 and January 2024, chemotherapy-naive patients aged 18-75 years with histologically confirmed metastatic pancreatic ductal adenocarcinoma (mPDAC) and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 were randomly assigned (1:1:1) to receive either nal-IRI (nanoliposomal irinotecan; 70 mg/m Findings: Between 16 November 2018 and 25 January 2024, 288 patients were enrolled in 31 French centres. Baseline characteristics were well balanced between the three arms. With a median follow-up of 39.2 months, median treatment durations were 6.3/3.3/5.3 months, for sequential, NAPOLI and MPACT arms, respectively. The 6-month PFS rates were 51.6%, 32.3% and 45.3% in the sequential, NAPOLI and MPACT arms, respectively. Neither sequential (HR = 0.76, p = 0.072) nor NAPOLI regimens (HR = 1.20, p = 0.22) lead to a statistically significant improvement of PFS over the MPACT regimen. The 12-month PFS rates were 20·3%, 12·7%, and 11·9%, and the 24-month OS rates were 23·8%, 9·5%, and 12·5% in the sequential, NAPOLI, and MPACT arms, respectively; these differences were not statistically significant. Safety profiles were consistent with previous publications for each regimen and QoL (QLQ-C30 and EQ5D) was preserved in the sequential arm. Interpretation: The sequential NAPOLI/MPACT regimen seems feasible and tolerable, with higher rates of 12-month PFS and 24-month OS compared with standard MPACT, despite no improvement in median PFS or OS. Future trials should be adequately powered, integrate predictive biomarkers, and include contemporary first-line standards as comparators. Funding: This trial was sponsored by the Fédération Francophone de Cancérologie Digestive (FFCD) and supported by a grant from Servier, France.
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