Lessons learned: Results suggest that the combination of bevacizumab plus temozolomide is active in terms of response rate, survival, performance, quality of life, and cognition in elderly patients with glioblastoma multiforme with poor performance status.Whether this combination is superior to temozolomide alone remains to be demonstrated by a randomized study.
Background: The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) <70 is not established. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS <70.
Materials and methods: Patients aged ≥70 years with a KPS <70 and biopsy-proven GBM were eligible for this multicenter, prospective, nonrandomized, phase II trial of older patients with impaired performance status. Treatment consisted of TMZ administered at 130-150 mg/m2 per day for 5 days every 4 weeks plus Bev administered at 10 mg/kg every 2 weeks.
Results: The trial included 66 patients (median age of 76 years; median KPS of 60). The median overall survival (OS) was 23.9 weeks (95% confidence interval [CI], 19-27.6), and the median progression-free survival (PFS) was 15.3 weeks (95% CI, 12.9-19.3). Twenty-two (33%) patients became transiently capable of self-care (i.e., KPS >70). Cognition and quality of life significantly improved over time during treatment. Grade ≥3 hematological adverse events occurred in 13 (20%) patients, high blood pressure in 16 (24%), venous thromboembolism in 3 (4.5%), cerebral hemorrhage in 2 (3%), and intestinal perforation in 2 (3%).
Conclusion: This study suggests that TMZ + Bev treatment is active in elderly patients with GBM with low KPS and has an acceptable tolerance level.
经验总结
结果表明, 对于患多形性恶性胶质瘤且体能状态欠佳的老年患者, 贝伐单抗+替莫唑胺联合治疗在缓解率、生存期、体能、生活质量和认知方面有效。
此联合治疗是否优于替莫唑胺单药治疗有待通过随机研究证明。
摘要
背景.尚未确定Karnofsky体能状态评分（KPS）<70、年龄≥70岁的多形性恶性胶质瘤（GBM）患者的最佳治疗。本临床试验评价了替莫唑胺（TMZ）和贝伐单抗（Bev）初期治疗在年龄≥70岁、KPS<70的患者中的疗效和安全性。
材料和方法.年龄≥70岁、KPS<70且患有经活检证实GBM的患者有资格参加本项针对体能状态受损年长患者的多中心、前瞻性、非随机、II期试验。治疗包括每4周一次、为期5天的TMZ 130–150mg/m2/天给药+每2周一次Bev 10mg/kg给药。
结果.该试验包括66例患者（中位年龄为76岁, 中位KPS为60）。中位总生存期（OS）为23.9周[95%置信区间（CI）：19–27.6], 中位无进展生存期（PFS）为15.3周（95% CI：12.9–19.3）。22例（33%）患者暂时能够自我护理（即KPS>70）。治疗期间认知和生活质量得到显著改善。13例（20%）患者发生≥3级血液学不良事件, 16例（24%）患者发生高血压, 3例（4.5%）患者发生静脉血栓栓塞, 2例（3%）患者发生脑出血, 2例（3%）患者发生肠穿孔。
结论.本研究表明TMZ+Bev治疗在KPS较低的GBM老年患者中有效, 且耐受程度可接受。
Trial registration: ClinicalTrials.gov NCT02898012.
©AlphaMed Press; the data published online to support this summary is the property of the authors.