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 language | English |
|---|---|
| Pages (from-to) | 67696-67708 |
| Number of pages | 13 |
| Journal | Oncotarget |
| Volume | 8 |
| Issue number | 40 |
| DOIs | |
| Publication status | Published - Sep 15 2017 |
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Are three weeks hypofractionated radiation therapy (HFRT) comparable to six weeks for newly diagnosed glioblastoma patients? Results of a phase II study. / Navarria, Pierina; Pessina, Federico; Tomatis, Stefano; Soffietti, Riccardo; Grimaldi, Marco; Lopci, Egesta; Chiti, Arturo; Leonetti, Antonella; Casarotti, Alessandra; Rossi, Marco; Cozzi, Luca; Ascolese, Anna Maria; Simonelli, Matteo; Marcheselli, Simona; Santoro, Armando; Clerici, Elena; Bello, Lorenzo; Scorsetti, Marta.
In: Oncotarget, Vol. 8, No. 40, 15.09.2017, p. 67696-67708.Research output: Contribution to journal › Article
}
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
VL - 8
SP - 67696
EP - 67708
JO - Oncotarget
JF - Oncotarget
SN - 1949-2553
IS - 40
ER -