Abstract
12; Table 1 Adjusted outcomes for head and neck cancer patients according to health insurance status Insured Medicaid Uninsured HR 95% CI HR 95% CI HR 95% CI Overall mortality 1.00 – 1.55 1.49-1.62 1.48 1.38-1.58 Cause-specific mortality 1.00 – 1.60 1.55-1.69 1.65 1.52-1.79 Abbreviations: CI Z confidence interval; HR Z hazard ratio. International Journal of Radiation Oncology Biology Physics 870 mg x 7 wks (nZ4); 90 mg x 6 weeks (nZ4); 90 mg x 7 wks (nZ6). Efficacy: SOM duration, incidence through 6 wks/60 Gy, severity, and onset appeared markedly improved from historical controls (Table 1); overall SOM incidence (50% vs 70%) was also reduced. GC4419 efficacy was related to treatment duration (Table 1), but not absolute daily dose. Safety: A true maximum tolerated dose was not reached. Gr 3 gastroenteritis and Gr 3 nausea/vomiting (1 each, 112 mg/d x 3 or 6 wks) were considered dose-limiting. Dose-related Gr 1-2 peri-infusional facial tingling was attributable to GC4419. Other AEs were consistent with known effects of IMRT/CDDP. PK: Dose-related Cmax and AUC; plasma t1/2 approximately 2 hours. Biomarkers: Cy levels were associated with GC4419 dose and WHO severity, consistent with known OM pathogenesis. Conclusion: When GC4419 was given throughout IMRT, SOM was less frequent, briefer, delayed, and less severe than expected. GC4419-related toxicity was mild-to-moderate and acceptable in combination with IMRT/ CDDP. Doses of 30 and 90 mg/d were chosen for a future randomized, placebo-controlled trial. Author Disclosure: C.M. Anderson: Employee; University of Iowa Hospitals & Clinics. Uncompensated, involved in design of randomized Phase 2 trial of GC4419; Galera Therapeutics, Inc. B.G. Allen: Physician scientist, employed and self-funded through grants; University of Iowa Hospitals & Clinics. Research Grant; ASTRO. W. Sun: None. C.M. Lee: Partner; Cancer Care Northwest, Gamma Knife of Spokane. Speaker’s Bureau; Bayer Pharmaceuticals, Bristal Myers Squibb. Partnership; Kobold Medical Devices, Provenir Publishing. Committee Member; Sacred Heart Medical Center. S. Agarwala: None. M. Venigalla: None. L. Greenberg: None. D. Adkins: None. Y. Chen: None. W. Zhen: None. D. Mould: President; Projections Research Inc. Consultant; Projections Research Inc. J. Holmlund: Independent Contractor; Galera Therapeutics, Inc. Consultant; Baxalta, Prometheus Labs. Stock Options; Galera Therapeutics, Inc. Ad-hoc reviewer; Aspire IRB. J. Brill: Employee; Incyte Corporation. Stock Options; Galera Therapeutics, Inc, Incyte Corporation. S. Sonis: Senior Surgeon; Brigham and Women’s Hospital. Consultant; Clinical Assistance Programs. Stock; Inform Genomics. Partnership; BioInsight Diagnostics. Advisor; Galera. Board Member; Inform Genomics. J. Buatti: Research Grant; NIH.
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