{"doi":"10.1016/j.ejca.2021.03.028","title":"First-line liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) in pancreatic ductal adenocarcinoma: A phase I/II study","abstract":"BACKGROUND: This open-label, phase I/II study evaluated safety and efficacy for first-line liposomal irinotecan + oxaliplatin + 5-fluorouracil + leucovorin (NALIRIFOX). METHODS: Patients (aged ≥18 years) had locally advanced/metastatic pancreatic ductal adenocarcinoma (mPDAC), with an Eastern Cooperative Oncology Group performance status score of 0/1 and adequate organ function. Primary objectives were to determine the maximum tolerated dose (MTD) and to evaluate safety and tolerability. Treatment-emergent adverse events (TEAEs) were graded using National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. Efficacy end-points included progression-free survival (PFS) and overall survival (OS); disease assessments used Response Evaluation Criteria in Solid Tumors 1.1. RESULTS: every 2 weeks) was based on dose-limiting toxicities and cumulative safety data in four dose-exploration cohorts. The MTD was received by 32 of 56 patients, seven during dose exploration and 25 during dose expansion (median age 58.0 years [range, 39-76], 28 [87.5%] with metastatic disease at diagnosis [29 at study entry], and one receiving study treatment at data cutoff [26 February 2020]). Of these patients, 22 of 32 had grade ≥3 treatment-related TEAEs, most commonly neutropenia (31.3%), febrile neutropenia (12.5%) and hypokalaemia (12.5%); ten had serious treatment-related TEAEs; and three died from TEAEs considered unrelated to treatment. Median PFS and OS were 9.2 (95% CI: 7.69-11.96) and 12.6 (8.74-18.69) months, respectively. CONCLUSION: First-line NALIRIFOX for patients with locally advanced/mPDAC was generally manageable and tolerable. A randomised, controlled phase III study is underway.","journal":"European Journal of Cancer","year":2021,"id":156237,"datarank":0.6038027536102726,"base_score":4.02535169073515,"endowment":4.02535169073515,"self_citation_contribution":0.6038027536102726,"citation_network_contribution":0.0,"self_endowment_contribution":0.6038027536102726,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":55,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9538,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02551991"],"EudraCT":["2015-003086-28"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":105140,"name":"Tanios Bekaii‐Saab","orcid":"0000-0001-7721-1699","position":1,"is_corresponding":false},{"id":555418,"name":"Patrick M. Boland","orcid":"0000-0002-4213-8847","position":2,"is_corresponding":false},{"id":531649,"name":"Farshid Dayyani","orcid":"0000-0002-4970-5189","position":3,"is_corresponding":false},{"id":289281,"name":"Teresa Macarulla","orcid":"0000-0002-5856-4082","position":4,"is_corresponding":false},{"id":246673,"name":"Kabir Mody","orcid":"0000-0003-3254-2990","position":5,"is_corresponding":false},{"id":661132,"name":"Bruce Belanger","orcid":null,"position":6,"is_corresponding":false},{"id":660348,"name":"Fiona Maxwell","orcid":"0000-0002-0985-2870","position":7,"is_corresponding":false},{"id":660349,"name":"Yan Moore","orcid":"0000-0002-8589-5346","position":8,"is_corresponding":false},{"id":660350,"name":"Arunthathi Thiagalingam","orcid":"0000-0001-6666-2427","position":9,"is_corresponding":false},{"id":660351,"name":"Tiffany Wang","orcid":"0000-0001-6444-4020","position":10,"is_corresponding":false},{"id":234884,"name":"Bin Zhang","orcid":"0000-0002-6286-6227","position":11,"is_corresponding":false},{"id":406833,"name":"Andrew Dean","orcid":"0000-0001-6632-2799","position":12,"is_corresponding":false},{"id":226651,"name":"Zev A. Wainberg","orcid":"0000-0002-7142-1246","position":0,"is_corresponding":true}],"reference_count":21,"raw_metadata":null,"created_at":"2026-07-18T23:44:08.368845Z","pmid":"33957442","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}