TY - JOUR
T1 - Single-arm phase ii study of conformal radiation therapy and temozolomide plus fractionated stereotactic conformal boost in high-grade gliomas
T2 - Final report
AU - Balducci, Mario
AU - Apicella, Giuseppina
AU - Manfrida, Stefania
AU - Mangiola, Annunziato
AU - Fiorentino, Alba
AU - Azario, Luigi
AU - D'Agostino, Giuseppe Roberto
AU - Frascino, Vincenzo
AU - Dinapoli, Nicola
AU - Mantini, Giovanna
AU - Albanese, Alessio
AU - De Bonis, Pasquale
AU - Chiesa, Silvia
AU - Valentini, Vincenzo
AU - Anile, Carmelo
AU - Cellini, Numa
PY - 2010/10
Y1 - 2010/10
N2 - Purpose: To assess survival, local control and toxicity using fractionated stereotactic conformal radiotherapy (FSCRT) boost and temozolomide in high-grade gliomas (HGGs). Patients and Methods: Patients affected by HGG, with a CTV 1(clinical target volume, representing tumor bed ± residual tumor + a margin of 5 mm) ≤ 8 cm were enrolled into this phase II study. Radiotherapy (RT, total dose 6,940 cGy) was administered using a combination of two different techniques: three-dimensional conformal radiotherapy (3D-CRT, to achieve a dose of 5,040 or 5,940 cGy) and FSCRT boost (19 or 10 Gy) tailored by CTV1diameter (≤ 6 cm and > 6 cm, respectively). Temozolomide (75 mg/m2) was administered during the first 2 or 4 weeks of RT. After the end of RT, temozolomide (150-200 mg/m2) was administered for at least six cycles. The sample size of 41 patients was assessed by the single proportion-powered analysis. Results: 41 patients (36 with glioblastoma multiforme [GBM] and five with anaplastic astrocytoma [AA]) were enrolled; RTOG neurological toxicities G1-2 and G3 were 12% and 3%, respectively. Two cases of radionecrosis were observed. At a median follow-up of 44 months (range 6-56 months), global and GBM median overall survival (OS) were 30 and 28 months. The 2-year survival rate was significantly better compared to the standard treatment (63% vs. 26.5%; p <0.00001). Median progression-free survival (PFS) was 11 months, in GBM patients 10 months. Conclusion: FSCRT boost plus temozolomide is well tolerated and seems to increase survival compared to the standard treatment in patients with HGG.
AB - Purpose: To assess survival, local control and toxicity using fractionated stereotactic conformal radiotherapy (FSCRT) boost and temozolomide in high-grade gliomas (HGGs). Patients and Methods: Patients affected by HGG, with a CTV 1(clinical target volume, representing tumor bed ± residual tumor + a margin of 5 mm) ≤ 8 cm were enrolled into this phase II study. Radiotherapy (RT, total dose 6,940 cGy) was administered using a combination of two different techniques: three-dimensional conformal radiotherapy (3D-CRT, to achieve a dose of 5,040 or 5,940 cGy) and FSCRT boost (19 or 10 Gy) tailored by CTV1diameter (≤ 6 cm and > 6 cm, respectively). Temozolomide (75 mg/m2) was administered during the first 2 or 4 weeks of RT. After the end of RT, temozolomide (150-200 mg/m2) was administered for at least six cycles. The sample size of 41 patients was assessed by the single proportion-powered analysis. Results: 41 patients (36 with glioblastoma multiforme [GBM] and five with anaplastic astrocytoma [AA]) were enrolled; RTOG neurological toxicities G1-2 and G3 were 12% and 3%, respectively. Two cases of radionecrosis were observed. At a median follow-up of 44 months (range 6-56 months), global and GBM median overall survival (OS) were 30 and 28 months. The 2-year survival rate was significantly better compared to the standard treatment (63% vs. 26.5%; p <0.00001). Median progression-free survival (PFS) was 11 months, in GBM patients 10 months. Conclusion: FSCRT boost plus temozolomide is well tolerated and seems to increase survival compared to the standard treatment in patients with HGG.
KW - Boost
KW - Malignant glioma
KW - Stereotactic radiotherapy
KW - Temozolomide
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U2 - 10.1007/s00066-010-2101-x
DO - 10.1007/s00066-010-2101-x
M3 - Article
C2 - 20936460
AN - SCOPUS:78650174731
VL - 186
SP - 558
EP - 564
JO - Strahlentherapie und Onkologie
JF - Strahlentherapie und Onkologie
SN - 0179-7158
IS - 10
ER -