{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T19:17:59Z","timestamp":1793733479075,"version":"4.6.1"},"reference-count":19,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"31","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>To assess modified folinic acid\/leucovorin, fluorouracil, irinotecan, oxaliplatin (FOLFIRINOX [mFFX]) versus gemcitabine\/nab-paclitaxel (GnP) in de novo metastatic pancreatic ductal adenocarcinoma (PDAC) and explore predictive biomarkers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>\n                      Patients were randomly assigned 1:1 to mFFX or GnP with exclusion of germline pathogenic variants in\n                      <jats:italic toggle=\"yes\">BRCA1\/2<\/jats:italic>\n                      or\n                      <jats:italic toggle=\"yes\">PALB2<\/jats:italic>\n                      . The primary end point was progression-free survival (PFS) between arms with 0.3 significance. The per-protocol (PP) population included patients who received one dose of chemotherapy. Pretreatment biopsies underwent whole-genome\/transcriptome sequencing and patient-derived organoid (PDO) development, providing correlate recommendations at a molecular tumor board and outcomes assessed according to RNA signatures (basal-like\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      classical).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Of 160 patients randomly assigned (80 mFFX, 80 GnP), 140 patients were in the PP population (71 mFFX, 69 GnP), with median follow-up of 8.3 months. The median PFS was 4.0 months for mFFX versus 5.3 months for GnP (hazard ratio [HR], 1.37 [95% CI, 0.97 to 1.92];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .069) in intention-to-treat. Median overall survival (OS) was 8.5 months with mFFX and 9.7 months with GnP (HR, 1.57 [95% CI, 1.08 to 2.28];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .017). Genomic data were generated in 94%, transcriptomes in 74%, and PDOs in 50%. The median PFS for those with basal-like was 3.0 (mFFX) and 5.5 (GnP) months (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .17), and classical PDAC was 6.3 (mFFX) versus 5.4 (GnP) months (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .36). The median OS in basal-like was 7.5 (mFFX) and 8.9 (GnP) months (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .75) versus in classical OS was 9.7 (mFFX) and 13.9 (GnP) months (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .047). Overall, 75 (54%) of patients received second-line treatment, 33\/75 (44%) correlate-guided. The median time on second-line treatment was only 2.1 months with a median OS of 5.4 months for a correlate-guided choice versus 4.4 months on a standard chemotherapy approach (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .45).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>In the phase II Pancreatic Adenocarcinoma Signature Stratification for Treatment-01 (PASS-01) trial population, PFS was similar between GnP and mFFX; however, OS and safety trends favored GnP. The second-line setting appears inadequate to offer precision choices, given the short survival observed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-00436","type":"journal-article","created":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T19:59:13Z","timestamp":1757534353000},"page":"3355-3368","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":46,"title":["PASS-01: Randomized Phase II Trial of Modified FOLFIRINOX Versus Gemcitabine\/Nab-Paclitaxel and Molecular Correlatives for Previously Untreated Metastatic Pancreatic Cancer"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct04469556","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3474-6647","authenticated-orcid":true,"given":"Jennifer J.","family":"Knox","sequence":"first","affiliation":[{"name":"McCain Centre for Pancreatic Cancer, Princess Margaret Cancer Centre, 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