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NRG oncology RTOG 9006: a phase III randomized trial of hyperfractionated radiotherapy (RT) and BCNU versus standard RT and BCNU for malignant glioma patients
- Source :
- Journal of Neuro-Oncology. 137:39-47
- Publication Year :
- 2018
- Publisher :
- Springer Science and Business Media LLC, 2018.
-
Abstract
- PURPOSE: From 1990 to 1994, patients with newly diagnosed malignant gliomas were enrolled and randomized between hyperfractionated radiation (HFX) of 72.0 Gy in 60 fractions given twice daily and 60.0 Gy in 30 fractions given once daily. All patients received 80 mg/m(2) of 1,3 bis (2 chloroethyl)-1 nitrosourea on days 1–3 q8 weeks for 1 year. METHODS: Patients were stratified by age, KPS, and histology. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS) and toxicity. RESULTS: Out of the 712 patients accrued, 694 (97.5%) were analyzable cases (350 HFX, 344 standard arm). There was no significant difference between the arms on overall acute or late treatment-related toxicity. No statistically significant effect for HFX, as compared to standard therapy, was found on either OS, with a median survival time (MST) of 11.3 mo vs. 13.1 mo (p=0.20) or PFS, with a median PFS time of 5.7 mo vs. 6.9 mo (p=0.18). The treatment effect on OS remained insignificant based on the multivariate analysis (hazard ratio=1.16; p=0.0682). When OS was analyzed by histology subgroup there was also no significant difference between the two arms for patients with glioblastoma multiforme (MST: 10.3 mo vs. 11.2 mo; p=0.34), anaplastic astrocytoma (MST: 69.8 mo vs 50.0 mo; p=0.91) or anaplastic oligodendroglioma (MST: 92.1 mo vs. 66.5 mo; p=0.33). CONCLUSION: Though this trial provided many invaluable secondary analyses, there was no trend or indication of a benefit to HFX radiation to 72.0 Gy in any subset of malignant glioma patients.
- Subjects :
- Adult
Male
Oncology
Cancer Research
medicine.medical_specialty
Adolescent
Article
Young Adult
03 medical and health sciences
0302 clinical medicine
Internal medicine
Glioma
Clinical endpoint
Humans
Medicine
Antineoplastic Agents, Alkylating
Survival analysis
Aged
Aged, 80 and over
Carmustine
Brain Neoplasms
business.industry
Hazard ratio
Dose fractionation
Middle Aged
medicine.disease
Combined Modality Therapy
Survival Analysis
Treatment Outcome
Neurology
030220 oncology & carcinogenesis
Female
Dose Fractionation, Radiation
Neurology (clinical)
Oligodendroglioma
business
030217 neurology & neurosurgery
medicine.drug
Anaplastic astrocytoma
Subjects
Details
- ISSN :
- 15737373 and 0167594X
- Volume :
- 137
- Database :
- OpenAIRE
- Journal :
- Journal of Neuro-Oncology
- Accession number :
- edsair.doi.dedup.....11628c299983308479a6b3abf41c0d40