{"doi":"10.1016/j.redox.2024.103375","title":"A randomized trial of pharmacological ascorbate, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer","abstract":"Patients with metastatic pancreatic ductal adenocarcinoma (PDAC) have poor 5-year survival. Pharmacological ascorbate (P-AscH - , high dose, intravenous, vitamin C) has shown promise as an adjunct to chemotherapy. We hypothesized adding P-AscH - to gemcitabine and nab -paclitaxel would increase survival in patients with metastatic PDAC. Patients diagnosed with stage IV pancreatic cancer randomized 1:1 to gemcitabine and nab -paclitaxel only (SOC, control) or to SOC with concomitant P-AscH − , 75 g three times weekly (ASC, investigational). The primary outcome was overall survival with secondary objectives of determining progression-free survival and adverse event incidence. Quality of life and patient reported outcomes for common oncologic symptoms were captured as an exploratory objective. Thirty-six participants were randomized; of this 34 received their assigned study treatment. All analyses were based on data frozen on December 11, 2023. Intravenous P-AscH - increased serum ascorbate levels from micromolar to millimolar levels. P-AscH - added to the gemcitabine + nab -paclitaxel (ASC) increased overall survival to 16 months compared to 8.3 months with gemcitabine + nab -paclitaxel (SOC) (HR = 0.46; 90 % CI 0.23, 0.92; p = 0.030). Median progression free survival was 6.2 (ASC) vs. 3.9 months (SOC) (HR = 0.43; 90 % CI 0.20, 0.92; p = 0.029). Adding P-AscH - did not negatively impact quality of life or increase the frequency or severity of adverse events. P-AscH − infusions of 75 g three times weekly in patients with metastatic pancreatic cancer prolongs overall and progression free survival without detriment to quality of life or added toxicity ( ClinicalTrials.gov number NCT02905578).","journal":"Redox Biology","year":2024,"id":420515,"datarank":0.881449588903628,"base_score":3.5553480614894135,"endowment":3.5553480614894135,"self_citation_contribution":0.5333022092234121,"citation_network_contribution":0.34814737968021586,"self_endowment_contribution":0.5333022092234121,"citer_contribution":0.34814737968021586,"corpus_percentile":null,"corpus_rank":null,"citation_count":34,"citer_count":32,"citers_with_citation_signal":17,"citers_with_endowment":17,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9601,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02905578"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":557249,"name":"Brian J. 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Lorack","orcid":"0009-0004-2309-932X","position":9,"is_corresponding":false},{"id":1212636,"name":"Stacy McMichael","orcid":null,"position":10,"is_corresponding":false},{"id":1047571,"name":"Jared S. Wulfekuhle","orcid":"0009-0003-8077-7177","position":11,"is_corresponding":false},{"id":297600,"name":"Brett A. Wagner","orcid":"0000-0002-0094-7259","position":12,"is_corresponding":false},{"id":297603,"name":"Garry R. Buettner","orcid":"0000-0002-5594-1903","position":13,"is_corresponding":false},{"id":393437,"name":"Bryan G. Allen","orcid":"0000-0002-4893-7105","position":14,"is_corresponding":false},{"id":407721,"name":"Joseph M. Caster","orcid":"0000-0001-6880-6770","position":15,"is_corresponding":false},{"id":1212637,"name":"Barbara Dion","orcid":null,"position":16,"is_corresponding":false},{"id":469422,"name":"Mandana Kamgar","orcid":"0000-0001-9364-2712","position":17,"is_corresponding":false},{"id":14569,"name":"John M. 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