1. 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.
- Author
-
Fisher, Barbara J., Pugh, Stephanie L., Macdonald, David R., Chakravatri, Arnab, Lesser, Glenn J., Fox, Sherry, Rogers, C. Leland, Werner-Wasik, Maria, Doyle, Thomas, Bahary, Jean-Paul, Fiveash, John B., Bovi, Joseph A., Howard, Steven P., Michael Yu, Hsiang-Hsuan, D'Souza, David, Laack, Nadia N., Barani, Igor J., Kwok, Young, Wahl, Daniel R., and Strasser, Jon F.
- Subjects
- *
GROUP psychotherapy , *GLIOMAS , *RADIOTHERAPY , *CHEMORADIOTHERAPY , *PROGRESSION-free survival , *GLIOMA treatment , *BRAIN tumor treatment , *RESEARCH , *CLINICAL trials , *RESEARCH methodology , *EVALUATION research , *MEDICAL cooperation , *BRAIN tumors , *COMPARATIVE studies , *KAPLAN-Meier estimator , *RESEARCH funding , *TUMOR grading - Abstract
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. [ABSTRACT FROM AUTHOR]- Published
- 2020
- Full Text
- View/download PDF