biostudies-literatureBhatia AKNCATS NIH HHSNCINCI NIH HHS4653-4662https://www.ebi.ac.uk/biostudies/studies/S-EPMC5693641biostudies-literatureUnknown123(23)<h4>Background</h4>13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS).<h4>Methods</h4>In total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups.<h4>Results</h4>13-CCancerDouble-blind, randomized phase 3 trial of low-dose 13-cis retinoic acid in the prevention of second primaries in head and neck cancer: Long-term follow-up of a trial of the Eastern Cooperative Oncology Group-ACRIN Cancer Research Group (C0590).PMC5693641U10 CA035199U10 CA016116UL1 TR001863U10 CA017145U10 CA180790U10 CA011083U10 CA025224U10 CA021661U10 CA037417U10 CA180816UG1 CA232760U10 CA037404U10 CA035103U10 CA013650U10 CA037403U10 CA052667U10 CA180882UG1 CA189862U10 CA180801U10 CA180868U10 CA180802U10 CA067753U10 CA180821U10 CA180822UG1 CA189828UG1 CA189805U10 CA180826UG1 CA189825Reiner SARubin PJacobs CDBurtness BAPandya KJLee JWCelano PLi YDunphy EPBaez-Diaz LLi SKhandekar JDArusell RMAdams GLBhatia AKLimburg PJPinto HAfalseDouble-blind, randomized phase 3 trial of low-dose 13-cis retinoic acid in the prevention of second primaries in head and neck cancer: Long-term follow-up of a trial of the Eastern Cooperative Oncology Group-ACRIN Cancer Research Group (C0590).<h4>Background</h4>13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS).<h4>Methods</h4>In total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups.<h4>Results</h4>13-C2017-01-01T00:00:00Z2017 Dec2025-04-25T18:19:22.503Z2019-03-27T00:09:11ZS-EPMC56936412878610510.1002/cncr.30920