短程放疗联合替莫唑胺治疗老年胶质母细胞瘤患者。
Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma.
机构信息
From Odette Cancer Centre, Sunnybrook Health Sciences Centre (J.R.P., A.S.) and Princess Margaret Cancer Centre (N.L., W.P.M.), Toronto, the Canadian Cancer Trials Group, Queens University, Kingston, ON (C.J.O., C.W., K.D.), University of Calgary, Calgary, AB (J.G.C.), University of Alberta, Edmonton (W.R.), Quality of Life Consulting, West Vancouver, BC (D.O.), Queen's University, Kingston General Hospital, Kingston, ON (J.P.R.), and Juravinski Cancer Centre, Hamilton, ON (H.H.) - all in Canada; Azienda Unità Sanitaria Locale- Istituto di Ricovero e Cura a Carattere Scientifico Istituto delle Scienze Neurologiche, Bologna (A.A.B., E.F.), and Fondazione Istituto Neurologico Carlo Besta, Milan (L. Fariselli) - both in Italy; University Hospital Gasthuisberg, Leuven, Belgium (J.M.); Peter MacCallum Cancer Centre, Melbourne, VIC (C.P.), University of Newcastle, Newcastle, NSW (M.F.), University of Queensland, Brisbane (M.F.), and Royal North Shore Hospital, Sydney (M.B.) - all in Australia; Saitama Medical University International Medical Center, Saitama, Japan (R.N.); Hôpital de la Pitié-Salpêtrière (F.L.-D., L. Feuvret), Paris, and Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille, Centre Hospitalier Universitaire Timone, Marseilles (O.C.) - both in France; the European Organization for Research and Treatment of Cancer, Brussels (V.G.); the Neurology Clinic, University of Heidelberg, Heidelberg, Germany (A.W., W.W.); Tauranga Hospital, Tauranga, New Zealand (M.T.); and Maastricht University Medical Center and School for Oncology and Developmental Biology, Maastricht, the Netherlands (B.G.B.).
出版信息
N Engl J Med. 2017 Mar 16;376(11):1027-1037. doi: 10.1056/NEJMoa1611977.
BACKGROUND
Glioblastoma is associated with a poor prognosis in the elderly. Survival has been shown to increase among patients 70 years of age or younger when temozolomide chemotherapy is added to standard radiotherapy (60 Gy over a period of 6 weeks). In elderly patients, more convenient shorter courses of radiotherapy are commonly used, but the benefit of adding temozolomide to a shorter course of radiotherapy is unknown.
METHODS
We conducted a trial involving patients 65 years of age or older with newly diagnosed glioblastoma. Patients were randomly assigned to receive either radiotherapy alone (40 Gy in 15 fractions) or radiotherapy with concomitant and adjuvant temozolomide.
RESULTS
A total of 562 patients underwent randomization, 281 to each group. The median age was 73 years (range, 65 to 90). The median overall survival was longer with radiotherapy plus temozolomide than with radiotherapy alone (9.3 months vs. 7.6 months; hazard ratio for death, 0.67; 95% confidence interval [CI], 0.56 to 0.80; P<0.001), as was the median progression-free survival (5.3 months vs. 3.9 months; hazard ratio for disease progression or death, 0.50; 95% CI, 0.41 to 0.60; P<0.001). Among 165 patients with methylated O-methylguanine-DNA methyltransferase (MGMT) status, the median overall survival was 13.5 months with radiotherapy plus temozolomide and 7.7 months with radiotherapy alone (hazard ratio for death, 0.53; 95% CI, 0.38 to 0.73; P<0.001). Among 189 patients with unmethylated MGMT status, the median overall survival was 10.0 months with radiotherapy plus temozolomide and 7.9 months with radiotherapy alone (hazard ratio for death, 0.75; 95% CI, 0.56 to 1.01; P=0.055; P=0.08 for interaction). Quality of life was similar in the two trial groups.
CONCLUSIONS
In elderly patients with glioblastoma, the addition of temozolomide to short-course radiotherapy resulted in longer survival than short-course radiotherapy alone. (Funded by the Canadian Cancer Society Research Institute and others; ClinicalTrials.gov number, NCT00482677 .).
背景
胶质母细胞瘤与老年人预后不良相关。在接受替莫唑胺化疗联合标准放疗（6 周内 60 Gy）的 70 岁及以下患者中，生存时间有所延长。在老年患者中，更常用更方便的短疗程放疗，但添加替莫唑胺到短疗程放疗的获益尚不清楚。
方法
我们进行了一项涉及新诊断为胶质母细胞瘤的 65 岁及以上患者的试验。患者被随机分配接受单独放疗（40 Gy，15 次分割）或放疗联合辅助替莫唑胺治疗。
结果
共有 562 名患者接受了随机分组，每组 281 名。中位年龄为 73 岁（范围，65 岁至 90 岁）。与单独放疗相比，放疗联合替莫唑胺治疗的中位总生存期更长（9.3 个月 vs. 7.6 个月；死亡风险比为 0.67；95%置信区间[CI]，0.56 至 0.80；P<0.001），无进展生存期也更长（5.3 个月 vs. 3.9 个月；疾病进展或死亡的风险比为 0.50；95%CI，0.41 至 0.60；P<0.001）。在 165 名甲基化 O-甲基鸟嘌呤-DNA 甲基转移酶（MGMT）状态的患者中，放疗联合替莫唑胺治疗的中位总生存期为 13.5 个月，而单独放疗为 7.7 个月（死亡风险比为 0.53；95%CI，0.38 至 0.73；P<0.001）。在 189 名未甲基化 MGMT 状态的患者中，放疗联合替莫唑胺治疗的中位总生存期为 10.0 个月，而单独放疗为 7.9 个月（死亡风险比为 0.75；95%CI，0.56 至 1.01；P=0.055；P=0.08 交互作用）。两组试验的生活质量相似。
结论
在老年胶质母细胞瘤患者中，替莫唑胺联合短疗程放疗的生存时间长于单纯短疗程放疗。（由加拿大癌症协会研究所以及其他机构资助；临床试验.gov 编号，NCT00482677）。
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