Are three weeks hypofractionated radiation therapy (HFRT) comparable to six weeks for newly diagnosed glioblastoma patients? Results of a phase II study

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Abstract

BACKGROUND: The current standard of care for newly diagnosed glioblastoma (GBM) is surgical resection, followed by radiation therapy (RT) with concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT). The patients outcome is still poor. In this study we evaluated hypofractionated radiation therapy (HFRT), instead of standard fractionated radiation therapy, with concomitant and adjuvant TMZ chemotherapy, in terms of safety and effectiveness.

METHODS: Patients with newly diagnosed GBM, Karnofsky performance scale (KPS) ≥70, and tumor up to 10 cm underwent maximal feasible surgical resection were treated. HFRT consisted of 60 Gy, in daily fractions of 4 Gy given 5 days per week for 3 weeks. The primary endpoints were overall survival (OS), progression free survival (PFS), and incidence of radiation induced brain toxicity. Secondary endpoint was the evaluation of neurocognitive function.

RESULTS: A total of 97 patients were included in this phase II study. The median age was 60.5 years (range 23-77 years). Debulking surgery was performed in 83.5% of patients, HFRT was completed in all 97 patients, concurrent and adjuvant TMZ in 93 (95.9%). The median number of TMZ cycles was six (range 1-12 cycles). No severe toxicity occurred and the neuropsychological evaluation remained stable. At a median follow up time of 15.2 months the median OS time, 1,2-year OS rate were 15.9 months (95% CI 14-18), 72.2% (95% CI 62.1-80) and 30.4% (95% CI 20.8-40.6). Age, KPS, MGMT methylation status, and extent of surgical resection were significant factors influencing the outcome.

CONCLUSION: HFRT with concomitant and adjuvant TMZ chemotherapy is an effective and safe treatment.

Original languageEnglish
Pages (from-to)67696-67708
Number of pages13
JournalOncotarget
Volume8
Issue number40
DOIs
Publication statusPublished - Sep 15 2017

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Glioblastoma
Radiotherapy
Adjuvant Chemotherapy
Karnofsky Performance Status
temozolomide
Survival
Standard of Care
Methylation
Disease-Free Survival
Survival Rate
Radiation
Safety
Incidence
Brain
Neoplasms

Keywords

  • Journal Article

Cite this

@article{cf60e290dbb54f25b4e491d21482905e,
title = "Are three weeks hypofractionated radiation therapy (HFRT) comparable to six weeks for newly diagnosed glioblastoma patients?: Results of a phase II study",
abstract = "BACKGROUND: The current standard of care for newly diagnosed glioblastoma (GBM) is surgical resection, followed by radiation therapy (RT) with concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT). The patients outcome is still poor. In this study we evaluated hypofractionated radiation therapy (HFRT), instead of standard fractionated radiation therapy, with concomitant and adjuvant TMZ chemotherapy, in terms of safety and effectiveness.METHODS: Patients with newly diagnosed GBM, Karnofsky performance scale (KPS) ≥70, and tumor up to 10 cm underwent maximal feasible surgical resection were treated. HFRT consisted of 60 Gy, in daily fractions of 4 Gy given 5 days per week for 3 weeks. The primary endpoints were overall survival (OS), progression free survival (PFS), and incidence of radiation induced brain toxicity. Secondary endpoint was the evaluation of neurocognitive function.RESULTS: A total of 97 patients were included in this phase II study. The median age was 60.5 years (range 23-77 years). Debulking surgery was performed in 83.5{\%} of patients, HFRT was completed in all 97 patients, concurrent and adjuvant TMZ in 93 (95.9{\%}). The median number of TMZ cycles was six (range 1-12 cycles). No severe toxicity occurred and the neuropsychological evaluation remained stable. At a median follow up time of 15.2 months the median OS time, 1,2-year OS rate were 15.9 months (95{\%} CI 14-18), 72.2{\%} (95{\%} CI 62.1-80) and 30.4{\%} (95{\%} CI 20.8-40.6). Age, KPS, MGMT methylation status, and extent of surgical resection were significant factors influencing the outcome.CONCLUSION: HFRT with concomitant and adjuvant TMZ chemotherapy is an effective and safe treatment.",
keywords = "Journal Article",
author = "Pierina Navarria and Federico Pessina and Stefano Tomatis and Riccardo Soffietti and Marco Grimaldi and Egesta Lopci and Arturo Chiti and Antonella Leonetti and Alessandra Casarotti and Marco Rossi and Luca Cozzi and Ascolese, {Anna Maria} and Matteo Simonelli and Simona Marcheselli and Armando Santoro and Elena Clerici and Lorenzo Bello and Marta Scorsetti",
year = "2017",
month = "9",
day = "15",
doi = "10.18632/oncotarget.18809",
language = "English",
volume = "8",
pages = "67696--67708",
journal = "Oncotarget",
issn = "1949-2553",
publisher = "Impact Journals LLC",
number = "40",

}

TY - JOUR

T1 - Are three weeks hypofractionated radiation therapy (HFRT) comparable to six weeks for newly diagnosed glioblastoma patients?

T2 - Results of a phase II study

AU - Navarria, Pierina

AU - Pessina, Federico

AU - Tomatis, Stefano

AU - Soffietti, Riccardo

AU - Grimaldi, Marco

AU - Lopci, Egesta

AU - Chiti, Arturo

AU - Leonetti, Antonella

AU - Casarotti, Alessandra

AU - Rossi, Marco

AU - Cozzi, Luca

AU - Ascolese, Anna Maria

AU - Simonelli, Matteo

AU - Marcheselli, Simona

AU - Santoro, Armando

AU - Clerici, Elena

AU - Bello, Lorenzo

AU - Scorsetti, Marta

PY - 2017/9/15

Y1 - 2017/9/15

N2 - BACKGROUND: The current standard of care for newly diagnosed glioblastoma (GBM) is surgical resection, followed by radiation therapy (RT) with concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT). The patients outcome is still poor. In this study we evaluated hypofractionated radiation therapy (HFRT), instead of standard fractionated radiation therapy, with concomitant and adjuvant TMZ chemotherapy, in terms of safety and effectiveness.METHODS: Patients with newly diagnosed GBM, Karnofsky performance scale (KPS) ≥70, and tumor up to 10 cm underwent maximal feasible surgical resection were treated. HFRT consisted of 60 Gy, in daily fractions of 4 Gy given 5 days per week for 3 weeks. The primary endpoints were overall survival (OS), progression free survival (PFS), and incidence of radiation induced brain toxicity. Secondary endpoint was the evaluation of neurocognitive function.RESULTS: A total of 97 patients were included in this phase II study. The median age was 60.5 years (range 23-77 years). Debulking surgery was performed in 83.5% of patients, HFRT was completed in all 97 patients, concurrent and adjuvant TMZ in 93 (95.9%). The median number of TMZ cycles was six (range 1-12 cycles). No severe toxicity occurred and the neuropsychological evaluation remained stable. At a median follow up time of 15.2 months the median OS time, 1,2-year OS rate were 15.9 months (95% CI 14-18), 72.2% (95% CI 62.1-80) and 30.4% (95% CI 20.8-40.6). Age, KPS, MGMT methylation status, and extent of surgical resection were significant factors influencing the outcome.CONCLUSION: HFRT with concomitant and adjuvant TMZ chemotherapy is an effective and safe treatment.

AB - BACKGROUND: The current standard of care for newly diagnosed glioblastoma (GBM) is surgical resection, followed by radiation therapy (RT) with concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT). The patients outcome is still poor. In this study we evaluated hypofractionated radiation therapy (HFRT), instead of standard fractionated radiation therapy, with concomitant and adjuvant TMZ chemotherapy, in terms of safety and effectiveness.METHODS: Patients with newly diagnosed GBM, Karnofsky performance scale (KPS) ≥70, and tumor up to 10 cm underwent maximal feasible surgical resection were treated. HFRT consisted of 60 Gy, in daily fractions of 4 Gy given 5 days per week for 3 weeks. The primary endpoints were overall survival (OS), progression free survival (PFS), and incidence of radiation induced brain toxicity. Secondary endpoint was the evaluation of neurocognitive function.RESULTS: A total of 97 patients were included in this phase II study. The median age was 60.5 years (range 23-77 years). Debulking surgery was performed in 83.5% of patients, HFRT was completed in all 97 patients, concurrent and adjuvant TMZ in 93 (95.9%). The median number of TMZ cycles was six (range 1-12 cycles). No severe toxicity occurred and the neuropsychological evaluation remained stable. At a median follow up time of 15.2 months the median OS time, 1,2-year OS rate were 15.9 months (95% CI 14-18), 72.2% (95% CI 62.1-80) and 30.4% (95% CI 20.8-40.6). Age, KPS, MGMT methylation status, and extent of surgical resection were significant factors influencing the outcome.CONCLUSION: HFRT with concomitant and adjuvant TMZ chemotherapy is an effective and safe treatment.

KW - Journal Article

U2 - 10.18632/oncotarget.18809

DO - 10.18632/oncotarget.18809

M3 - Article

C2 - 28978064

VL - 8

SP - 67696

EP - 67708

JO - Oncotarget

JF - Oncotarget

SN - 1949-2553

IS - 40

ER -