Research Papers:
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
Pierina Navarria1,*, Federico Pessina2,*, Stefano Tomatis1, Riccardo Soffietti3, Marco Grimaldi4, Egesta Lopci5, Arturo Chiti5,7, Antonella Leonetti9, Alessandra Casarotti2, Marco Rossi2, Luca Cozzi1, Anna Maria Ascolese1, Matteo Simonelli6,7, Simona Marcheselli8, Armando Santoro6,7, Elena Clerici1, Lorenzo Bello2 and Marta Scorsetti1,7
1Radiotherapy and Radiosurgery Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy
2Neurosurgical Oncology Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy
3Consultant of Neurosurgical Oncology Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy
4Neuroradiology Unit, Radiology Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy
5Nuclear Medicine Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy
6Hematology and Oncology Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy
7Department of Biomedical Sciences, Humanitas University, Rozzano, Italy
8Department of Neurology, Humanitas Cancer Center and Research Hospital, Rozzano, Italy
9Laboratory of Motor Control, Department of Medical Biotechnology and Translational Medicine, Milan University, Milan, Italy
*These authors have contributed equally to this work
Correspondence to:
Pierina Navarria, email: [email protected]
Keywords: glioblastoma, hypofractionated radiation therapy, temozolomide, phase II, surgery
Received: May 01, 2017 Accepted: May 14, 2017 Published: June 28, 2017
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.
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