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PASS-01: Randomized Phase II Trial of Modified FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel and Molecular Correlatives for Previously Untreated Metastatic Pancreatic Cancer

叶黄素 医学 吉西他滨 奥沙利铂 叶酸 内科学 伊立替康 危险系数 胰腺癌 人口 胃肠病学 紫杉醇 肿瘤科 临床终点 无进展生存期 粘膜炎 癌症 氟尿嘧啶 随机对照试验 化疗 置信区间 结直肠癌 环境卫生
作者
Jennifer J. Knox,Grainne M. O’Kane,Daniel A. King,Daniel A. Laheru,Amber N. Habowski,Kenneth H. Yu,Kimberly Perez,Andrew J. Aguirre,Zachary L. Coyne,Harry Harvey,Ronan Andrew McLaughlin,Raymond Jang,Robert C. Grant,Elena Elimova,Daniel J. Renouf,Sandra E. Fischer,Kai Duan,Stephanie Ramotar,Gun Ho Jang,Amy X. Zhang
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
标识
DOI:10.1200/jco-25-00436
摘要

PURPOSE 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. PATIENTS AND METHODS Patients were randomly assigned 1:1 to mFFX or GnP with exclusion of germline pathogenic variants in BRCA1/2 or PALB2 . 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 v classical). RESULTS 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]; P = .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]; P = .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 ( P = .17), and classical PDAC was 6.3 (mFFX) versus 5.4 (GnP) months ( P = .36). The median OS in basal-like was 7.5 (mFFX) and 8.9 (GnP) months ( P = .75) versus in classical OS was 9.7 (mFFX) and 13.9 (GnP) months ( P = .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 ( P = .45). CONCLUSION 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.
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