Phase 2 Study of a Temozolomide-Based Chemoradiation Therapy Regimen for High-Risk, Low-Grade Gliomas: Long-Term Results of Radiation Therapy Oncology Group 0424
| Autor: | Jean Paul Bahary, John B. Fiveash, Glenn J. Lesser, Daniel R. Wahl, Young Kwok, Maria Werner-Wasik, C. Leland Rogers, Jon Strasser, Minesh P. Mehta, Minhee Won, Thomas J. Doyle, Steven P. Howard, David D'Souza, David R. Macdonald, Sherry Fox, Igor J. Barani, Stephanie L. Pugh, Hsiang Hsuan Michael Yu, Joseph Bovi, Barbara Fisher, Nadia N. Laack, Arnab Chakravatri |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty medicine.medical_treatment Population Kaplan-Meier Estimate Article 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Internal medicine Glioma Temozolomide medicine Clinical endpoint Humans Radiology Nuclear Medicine and imaging Progression-free survival education education.field_of_study Radiation Brain Neoplasms business.industry Chemoradiotherapy medicine.disease Progression-Free Survival Radiation therapy Regimen 030220 oncology & carcinogenesis Female Neoplasm Grading business medicine.drug |
| Zdroj: | Int J Radiat Oncol Biol Phys |
| ISSN: | 0360-3016 |
| Popis: | PURPOSE: To report the long-term outcomes of the RTOG 0424 study of a high-risk, low-grade glioma population treated with concurrent and adjuvant temozolomide (TMZ) and radiation therapy (RT). METHODS AND MATERIALS: For this single-arm, phase 2 study, patients with low-grade gliomas with ≥3 risk factors (age ≥40 years, astrocytoma, bihemispheric tumor, size ≥6 cm, or preoperative neurologic function status >1) received RT (54 Gy in 30 fractions) with TMZ and up to 12 cycles of post-RT TMZ. The initial primary endpoint P was overall survival (OS) at 3 years after registration. Secondary endpoints included progression-free survival (PFS) and the association of survival outcomes with methylation status. The initial 3-year report of this study was published in 2015. RESULTS: The study accrued 136 patients, of whom 129 were analyzable. The median follow-up for surviving patients was 9.0 years. The 3-year OS was 73.5% (95% confidence interval, 65.8%−81.1%), numerically superior to the 3-year OS historical control of 54% (P < .001). The median survival time was 8.2 years (95% confidence interval, 5.6–9.1). Five- and 10-year OS rates were 60.9% and 34.6%, respectively, and 5- and 10-year PFS rates were 46.8% and 25.5%, respectively. CONCLUSIONS: The long-term results confirmed the findings from the initial report for efficacy, suggesting OS and PFS outcomes with the RT-TMZ regimen exceeded historical control groups treated with radiation alone. Toxicity was acceptable. |
| Databáze: | OpenAIRE |
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