1Department of Neurology 2, Pitié-Salpêtrière University Hospital, APHP, Sorbonne University, Paris.
2Department of Neurosurgery, Clairval Private Hospital, Marseille.
J Neurosurg. 2022 Oct 14;138(5):1199-1205. doi: 10.3171/2022.8.JNS221068. Print 2023 May 1.
The role of surgery in the treatment of malignant gliomas in the elderly is not settled. The authors conducted a randomized trial that compared tumor resection with biopsy only-both followed by standard therapy-in such patients.
Patients ≥ 70 years of age with a Karnofsky Performance Scale (KPS) score ≥ 50 and presenting with a radiological suspicion of operable glioblastoma (GBM) were randomly assigned between tumor resection and biopsy groups. Subsequently, they underwent standard radiotherapy during the first years of the trial (2008-2017), with the addition of adjunct therapy with temozolomide when this regimen became standard (2017-2019). The primary endpoint was survival, and secondary endpoints were progression-free survival (PFS), cognitive status (Mini-Mental State Examination), autonomy (KPS), quality of life (European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 and QLQ-BN20), and perioperative morbidity and mortality.
Between 2008 and 2019, 107 patients from 9 centers were enrolled in the study; 101 were evaluable for analysis because a GBM was histologically confirmed (50 in the surgery arm and 51 in the biopsy arm). There was no statistically significant difference in median survival between the surgery (9.37 months) and the biopsy (8.96 months, p = 0.36) arms (adjusted HR 0.79, 95% CI 0.52-1.21, p = 0.28). However, the surgery group had an increased PFS (5.06 vs 4.02 months; p = 0.034) (adjusted HR 0.50, 95% CI 0.32-0.78, p = 0.002). Less deterioration of quality of life and KPS score evolution than in the biopsy group was observed. Surgery was not associated with increased mortality or morbidity.
This study suggests that debulking surgery is safe, and-compared to biopsy-is associated with a less severe deterioration of quality of life and autonomy, as well as a significant although modest improvement of PFS in elderly patients suffering from newly diagnosed malignant glioma. Although resection does not provide a significant survival benefit in the elderly, the authors believe that the risk/benefit analysis favors an attempt at optimal tumor resection in this population, provided there is careful preoperative geriatric evaluation. Clinical trial registration no.: NCT02892708 (ClinicalTrials.gov).
在老年人中，手术在恶性神经胶质瘤治疗中的作用尚未确定。作者进行了一项随机试验，比较了肿瘤切除术与仅活检的疗效，且两种治疗方式都遵循标准治疗。
纳入了年龄≥ 70 岁、Karnofsky 表现状态（KPS）评分≥ 50 分且影像学提示可手术治疗的胶质母细胞瘤（GBM）患者，这些患者被随机分配到肿瘤切除术组和活检组。随后，他们在试验的前几年接受标准放疗（2008-2017 年），当该方案成为标准治疗时，附加替莫唑胺辅助治疗（2017-2019 年）。主要终点是生存，次要终点是无进展生存期（PFS）、认知状态（简易精神状态检查）、自主能力（KPS）、生活质量（欧洲癌症研究与治疗组织 [EORTC] QLQ-C30 和 QLQ-BN20）和围手术期发病率和死亡率。
在 2008 年至 2019 年间，9 个中心共纳入了 107 名患者；由于组织学证实为 GBM，101 名患者可进行分析（手术组 50 名，活检组 51 名）。手术组（9.37 个月）与活检组（8.96 个月，p=0.36）的中位生存期无统计学差异（调整后 HR 0.79，95%CI 0.52-1.21，p=0.28）。然而，手术组的 PFS 更高（5.06 个月 vs 4.02 个月；p=0.034）（调整后 HR 0.50，95%CI 0.32-0.78，p=0.002）。与活检组相比，手术组的生活质量和 KPS 评分的恶化程度较低。手术与死亡率或发病率增加无关。
本研究表明，肿瘤切除术是安全的，与活检相比，它与生活质量和自主能力的恶化程度较低有关，并且在新诊断的恶性神经胶质瘤老年患者中，PFS 有显著但适度的改善。尽管在老年人中，切除手术并不能显著提高生存率，但作者认为，在进行仔细的术前老年评估的前提下，风险/获益分析支持对该人群进行最佳肿瘤切除术。临床试验注册号：NCT02892708（ClinicalTrials.gov）。
