Scoccianti Silvia, Krengli Marco, Marrazzo Livia, Magrini Stefano Maria, Detti Beatrice, Fusco Vincenzo, Pirtoli Luigi, Doino Daniela, Fiorentino Alba, Masini Laura, Greto Daniela, Buglione Michela, Rubino Giovanni, Lonardi Federico, Migliaccio Fernanda, Marzano Salvino, Santoni Riccardo, Ricardi Umberto, Livi Lorenzo
Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, Florence, Italy.
Radiotherapy Unit, Department of Translation Medicine, University of Piemonte Orientale, Novara, Italy.
Radiol Med. 2018 Jan;123(1):48-62. doi: 10.1007/s11547-017-0806-y. Epub 2017 Sep 6.
A multicenter phase II study for assessing the efficacy and the toxicity of hypofractionated radiotherapy with SIB plus temozolomide in patients with glioblastoma was carried out by the Brain Study Group of the Italian Association of Radiation Oncology.
Twenty-four patients with newly diagnosed glioblastoma belonging to Recursive Partitioning Analysis classes III and IV were enrolled. The prescribed dose was 52.5 Gy in 15 fractions of 3.5 Gy and 67.5 in 15 fractions of 4.5 Gy to the SIB volume. Dose constraints for the hypofractionated schedule were provided. Radiotherapy was associated with concomitant and sequential temozolomide.
Median overall survival (OS) was 15.1 months, while median progression-free survival (PFS) was 8.6 months. Actuarial OS at 12 months was 65.6% ± 0.09, whereas actuarial PFS at 12 months was 41.2% ± 0.10. Status of methylation of MGMT promoter resulted to be a significant prognostic factor for OS. Radiotherapy-related acute toxicity was not relevant. Three patients (12.5%) had G3 myelotoxicity that required temozolomide temporary interruption or dose reduction during the chemotherapy. However, chemotherapy was not definitely discontinued for toxicity in any case. One patient out of 24 (4.2%) developed radionecrosis that required surgical resection with no evidence of disease in the surgical specimen.
This trial confirms that hypofractionated radiotherapy with SIB and association with temozolomide may be a reasonable and feasible option for good prognosis patients with GBM.
意大利放射肿瘤学协会脑研究小组开展了一项多中心II期研究，以评估同步整合加量调强放疗联合替莫唑胺治疗胶质母细胞瘤患者的疗效和毒性。
招募了24例新诊断的属于递归分区分析III级和IV级的胶质母细胞瘤患者。给予同步整合加量调强放疗体积52.5 Gy，分15次，每次3.5 Gy，以及67.5 Gy，分15次，每次4.5 Gy的处方剂量。给出了调强放疗方案的剂量限制。放疗联合同步及序贯替莫唑胺治疗。
中位总生存期（OS）为15.1个月，而中位无进展生存期（PFS）为8.6个月。12个月时的精算总生存率为65.6%±0.09，而12个月时的精算无进展生存率为41.2%±0.10。MGMT启动子甲基化状态是总生存期的一个重要预后因素。放疗相关的急性毒性不显著。3例患者（12.5%）出现3级骨髓毒性，化疗期间需要暂时中断替莫唑胺或降低剂量。然而，在任何情况下化疗均未因毒性而明确停药。24例患者中有1例（4.2%）发生放射性坏死，需要手术切除，手术标本中无疾病证据。
该试验证实，同步整合加量调强放疗联合替莫唑胺对预后良好的胶质母细胞瘤患者可能是一种合理可行的选择。
