Journal article
Two-Year Tumor Outcomes of a Phase 2B, Randomized, Double-Blind Trial of Avasopasem Manganese (GC4419) Versus Placebo to Reduce Severe Oral Mucositis Owing to Concurrent Radiation Therapy and Cisplatin for Head and Neck Cancer
International journal of radiation oncology, biology, physics, Vol.114(3), pp.416-421
11/01/2022
DOI: 10.1016/j.ijrobp.2022.06.063
PMID: 35724774
Abstract
Purpose: Avasopasem manganese (GC4419), an investigational selective dismutase mimetic radioprotector, reduced duration, incidence, and severity of severe oral mucositis (World Health Organization grade 3-4) in a phase 2b, randomized, double-blind trial of patients receiving concurrent cisplatin (cis) and radiation therapy (RT) for head and neck cancer. We report the secondary endpoints of final 1-and 2-year tumor outcomes and exploratory data on trismus and xerostomia.Methods and Materials: Patients with locally advanced oral cavity or oropharynx cancer to be treated with definitive or postop cis and RT were randomized to 1 of 3 arms: 30 mg avasopasem, 90 mg avasopasem, or placebo. Pairwise comparisons of Kaplan-Meier estimates (each active arm separately vs placebo) were made for overall survival, progression-free survival, locoregional control, and distant metastasis-free survival. Xerostomia and trismus data were collected at each follow-up visit and analyzed for trends by post-RT timepoint and treatment group.Results: At a median follow-up for the entire cohort of 25.5 months (25th-75th percentile, 24.6-26.2 months; range, 0.2-31.9 months), Kaplan-Meier estimates of 1-and 2-year overall survival, progression-free survival, locoregional control, and distant metastasis-free survival were not statistically different. No trends were apparent in xerostomia or trismus data.Conclusions: Avasopasem does not lead to statistically different tumor control outcomes when used concurrently with cis and RT for head and neck cancer. There was no detectable effect on trismus or xerostomia. (c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
Details
- Title: Subtitle
- Two-Year Tumor Outcomes of a Phase 2B, Randomized, Double-Blind Trial of Avasopasem Manganese (GC4419) Versus Placebo to Reduce Severe Oral Mucositis Owing to Concurrent Radiation Therapy and Cisplatin for Head and Neck Cancer
- Creators
- Carryn M. Anderson - Univ Iowa Hosp & Clin, Radiat Oncol, Iowa City, IA 52242 USAChristopher M. Lee - Canc Care Northwest, Radiat Oncol, Spokane, WA USADeborah Saunders - Northeast Canc Ctr Hlth Sci North, Dent Oncol, Sudbury, ON, CanadaAmarinthia E. Curtis - Spartanburg Med Ctr, Radiat Oncol, Spartanburg, SC USANeal E. Dunlap - Univ Louisville, James Graham Brown Canc Ctr, Radiat Oncol, Louisville, KY USAChaitali Nangia - Univ Calif Irvine, Med Ctr, Hematol Oncol, Orange, CA USAArielle S. Lee - Univ Texas Hlth Sci Ctr Tyler, HOPE Canc Ctr, Hematol Oncol, Tyler, TX USAPhilip Kovoor - Texas Oncol, Oncol, Plano, TX USAVoichita Bar-Ad - Thomas Jefferson Univ, Radiat Oncol, Philadelphia, PA USAAbhinand V. PedaddaJon Holmlund - Galera Therapeut Inc, Clin Dev, Malvern, PA USAMatt Downs - Stat Collaborat Inc, Biostat, Washington, DC USAStephen T. Sonis - Primary Endpoint Solut, Clin Dev, Waltham, MA USA
- Resource Type
- Journal article
- Publication Details
- International journal of radiation oncology, biology, physics, Vol.114(3), pp.416-421
- DOI
- 10.1016/j.ijrobp.2022.06.063
- PMID
- 35724774
- NLM abbreviation
- Int J Radiat Oncol Biol Phys
- ISSN
- 0360-3016
- eISSN
- 1879-355X
- Publisher
- Elsevier
- Number of pages
- 6
- Language
- English
- Date published
- 11/01/2022
- Academic Unit
- Radiation Oncology
- Record Identifier
- 9984312980402771
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