Single-Arm Phase II Study of Conformal Radiation Therapy and Temozolomide plus Fractionated Stereotactic Conformal Boost in High-Grade Gliomas: Final Report

• Published in: Strahlentherapie und Onkologie 2010-10, Vol.186 (10), p.558-564
• Main Authors: Balducci, Mario, Apicella, Giuseppina, Manfrida, Stefania, Mangiola, Annunziato, Fiorentino, Alba, Azario, Luigi, D’Agostino, Giuseppe Roberto, Frascino, Vincenzo, Dinapoli, Nicola, Mantini, Giovanna, Albanese, Alessio, de Bonis, Pasquale, Chiesa, Silvia, Valentini, Vincenzo, Anile, Carmelo, Cellini, Numa
• Format: Article
• Language: English
• Subjects: Actuarial Analysis; Adult; Aged; Antineoplastic Agents, Alkylating - adverse effects; Antineoplastic Agents, Alkylating - therapeutic use; Combined Modality Therapy - adverse effects; Combined Modality Therapy - methods; Dacarbazine - adverse effects; Dacarbazine - analogs & derivatives; Dacarbazine - therapeutic use; Female; Follow-Up Studies; Glioma - drug therapy; Glioma - mortality; Glioma - pathology; Glioma - radiotherapy; Glioma - surgery; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Staging; Oncology; Original Article; Radiosurgery - adverse effects; Radiosurgery - methods; Radiotherapy; Radiotherapy, Conformal - adverse effects; Radiotherapy, Conformal - methods; Survival Rate
• ISSN: 0179-7158; 1439-099X
• DOI: 10.1007/s00066-010-2101-x

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 CTV 1 diameter (≤ 6 cm and > 6 cm, respectively). Temozolomide (75 mg/m 2 ) was administered during the first 2 or 4 weeks of RT. After the end of RT, temozolomide (150–200 mg/m 2 ) 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.