دورية أكاديمية
Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer.
| العنوان: | Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer. |
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| المؤلفون: | Anderson, Carryn M., Lee, Christopher M, Saunders, Deborah P., Curtis, Amarinthia, Dunlap, Neal, Nangia, Chaitali, Lee, Arielle S., Gordon, Sharon M., Kovoor, Philip, Arevalo-Araujo, Roberto, Bar-Ad, Voichita, Peddada, Abhinand, Colvett, Kyle, Miller, Douglas, Jain, Anshu K., Wheeler, James, Blakaj, Dukagjin, Bonomi, Marcelo, Agarwala, Sanjiv S., Garg, Madhur, Worden, Francis, Holmlund, Jon, Brill, Jeffrey M., Downs, Matt, Sonis, Stephen T., Katz, Sanford, Buatti, John M. |
| المصدر: | Department of Radiation Oncology Faculty Papers |
| بيانات النشر: | Jefferson Digital Commons |
| سنة النشر: | 2019 |
| المجموعة: | Jefferson Digital Commons (Thomas Jefferson University, Philadelphia) |
| مصطلحات موضوعية: | Medicine and Health Sciences, Oncology, Radiation Medicine |
| الوصف: | PURPOSE: Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM). PATIENTS AND METHODS: A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading. RESULTS: Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced (P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing. CONCLUSION: GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712) has begun. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://jdc.jefferson.edu/radoncfp/126Test; https://jdc.jefferson.edu/cgi/viewcontent.cgi?article=1131&context=radoncfpTest |
| الإتاحة: | https://jdc.jefferson.edu/radoncfp/126Test https://jdc.jefferson.edu/cgi/viewcontent.cgi?article=1131&context=radoncfpTest |
| حقوق: | http://creativecommons.org/licenses/by-nc-nd/4.0Test/ |
| رقم الانضمام: | edsbas.A78D9B07 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |