Navarria Pierina, Pessina Federico, Cozzi Luca, Tomatis Stefano, Reggiori Giacomo, Simonelli Matteo, Santoro Armando, Clerici Elena, Franzese Ciro, Carta Giulio, Conti Nibali Marco, Bello Lorenzo, Scorsetti Marta
1 Radiotherapy and Radiosurgery Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy.
2 Neurosurgical Oncology Department, Humanitas Cancer Center and Research Hospital, Rozzano, Italy.
Tumori. 2019 Feb;105(1):47-54. doi: 10.1177/0300891618792483. Epub 2018 Aug 22.
: To evaluate hypofractionated radiation therapy (HFRT) given at therapeutic effective doses in a phase II study. Endpoints were progression-free survival (PFS) rate, overall survival (OS), and incidence of toxicity.
: Patients with newly diagnosed glioblastoma, age ⩾70 years, Karnofsky performance scale (KPS) score ⩽60, were enrolled. The total dose of HFRT was 52.5 Gy/15 fractions, corresponded to a biological effective dose to the tumor of 70.88 Gy.
: Thirty patients were treated, with a median age of 75 years. Concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT) was administered in 7 (23.3%) and 11 (40.7%) patients received only adjuvant TMZ-CHT. The median, 6-month PFS, and 12-month PFS were 5.0 months, 43.3%, and 20%, respectively. The median, 6-month OS, and 12-month OS were 8 months, 90%, and 30%, respectively. At the last observation time, 26 patients (86.7%) were dead and 4 (13.3%) were alive. No increase in steroid drugs was required during radiotherapy treatment and a reduction was possible in 12 (40%). Patients with KPS=60, RPA V, MGMT methylated status, neurological status stable or improved after surgery and who underwent HFRT with concurrent and adjuvant CHT, had the better outcome.
: HFRT has proven to be feasible and effective, with limited morbidity, for selected elderly and frail patients with newly diagnosed glioblastoma. The primary objective of this study was not reached in the whole cohort but only in selected patients, who need more aggressive treatment.
在一项II期研究中评估给予治疗有效剂量的大分割放射治疗（HFRT）。观察终点为无进展生存期（PFS）率、总生存期（OS）和毒性发生率。
纳入新诊断的胶质母细胞瘤患者，年龄≥70岁，卡诺夫斯基功能状态量表（KPS）评分≤60分。HFRT的总剂量为52.5 Gy/15次分割，相当于肿瘤的生物等效剂量为70.88 Gy。
30例患者接受治疗，中位年龄为75岁。7例（23.3%）患者接受同步和辅助替莫唑胺化疗（TMZ-CHT），11例（40.7%）患者仅接受辅助TMZ-CHT。中位PFS、6个月PFS率和12个月PFS率分别为5.0个月、43.3%和20%。中位OS、6个月OS率和12个月OS率分别为8个月、90%和30%。在最后一次观察时，26例（86.7%）患者死亡，4例（13.3%）患者存活。放疗期间无需增加类固醇药物，12例（40%）患者有可能减少用药。KPS=60、RPA V级、MGMT甲基化状态、术后神经状态稳定或改善且接受同步和辅助CHT的HFRT患者预后较好。
对于选定的新诊断胶质母细胞瘤的老年体弱患者，HFRT已被证明是可行且有效的，发病率有限。本研究的主要目标在整个队列中未实现，但仅在选定的需要更积极治疗的患者中实现。
