Brugel Lydia, Laurent Marie, Caillet Philippe, Radenne Anne, Durand-Zaleski Isabelle, Martin Michel, Baron Melany, de Kermadec Héloïse, Bastuji-Garin Sylvie, Canouï-Poitrine Florence, Paillaud Elena
AP-HP, hôpital Henri-Mondor, Département de Médecine Interne et Gériatrie, Unité d'Onco-Gériatrie, Créteil F-94010, France.
BMC Cancer. 2014 Jun 13;14:427. doi: 10.1186/1471-2407-14-427.
Survival is poorer in elderly patients with head and neck squamous cell carcinomas [HNSCCs] than in younger patients. Possible explanations include a contribution of co-morbidities to mortality, frequent refusal of standard therapy, and the use of suboptimal treatments due to concern about toxicities. The Comprehensive Geriatric Assessment [CGA] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans. The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer. Our aim here was to assess the impact of the CGA on overall survival, function, and nutritional status of elderly patients with HNSCC.
METHODS/DESIGN: EGeSOR is an open-label, multicentre, randomised, controlled, parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC. The intervention includes four components: the CGA conducted by a geriatrician before cancer treatment, participation of the same geriatrician in cancer treatment selection, a standardised geriatric therapeutic intervention designed by the same geriatrician; and geriatric follow-up for 24 months. The primary endpoint, assessed after 6 months, is a composite criterion including death, functional impairment [Activities of Daily Living score decrease ≥ 2], and weight loss ≥ 10%. Secondary endpoints include progression-free survival, unscheduled admissions, quality of life, treatment toxicities, costs, and completion of the planned cancer treatment. A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre, age, T and N stages, and tumour site [oral, oropharyngeal, hypopharyngeal, or laryngeal]. The estimated sample size is 704 patients, who are being recruited by 14 centres in 9 French cities.
EGeSOR is the first randomised trial of the CGA in elderly cancer patients. We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC. If this expectation is fulfilled, the trial may lead to modifications of the management model for elderly patients with cancer.
Trial registration: NCT02025062.
老年头颈部鳞状细胞癌（HNSCC）患者的生存率低于年轻患者。可能的解释包括合并症对死亡率的影响、频繁拒绝标准治疗以及因担心毒性而采用次优治疗。综合老年评估（CGA）是对总体健康状况的多维度评估，有助于定制治疗和随访计划。CGA已在多种健康环境中被证明有效，但尚未在癌症患者的随机研究中进行评估。我们在此的目的是评估CGA对老年HNSCC患者总生存期、功能和营养状况的影响。
方法/设计：EGeSOR是一项开放标签、多中心、随机、对照、平行组试验，针对70岁及以上且接受HNSCC标准治疗的患者。干预包括四个部分：由老年病医生在癌症治疗前进行CGA、同一位老年病医生参与癌症治疗选择、由同一位老年病医生设计的标准化老年治疗干预；以及为期24个月的老年随访。6个月后评估的主要终点是一个综合标准，包括死亡、功能障碍（日常生活活动评分下降≥2）和体重减轻≥10%。次要终点包括无进展生存期、非计划住院、生活质量、治疗毒性、成本以及计划癌症治疗的完成情况。使用集中在线系统进行1:1随机分组，采用最小化算法按中心、年龄、T和N分期以及肿瘤部位（口腔、口咽、下咽或喉）进行。估计样本量为704例患者，由法国9个城市的14个中心招募。
EGeSOR是CGA在老年癌症患者中的首个随机试验。我们预计CGA对老年HNSCC患者的管理有直接临床益处。如果这一预期得以实现，该试验可能会导致老年癌症患者管理模式的改变。
试验注册编号：NCT02025062。
