综合老年评估指导下的局部晚期直肠癌老年患者放疗——一项多中心前瞻性研究非手术队列的探索性结果
Comprehensive geriatric assessment guided radiotherapy in elderly patients with locally advanced rectal cancer-exploratory results on nonoperative cohort of a multicenter prospective study.
作者信息
Yang Yue-Xin, Tang Yuan, Li Ning, Tang Yu, Cheng Yun-Jie, Yang Lin, Fang Hui, Lu Ning-Ning, Qi Shu-Nan, Chen Bo, Wang Shu-Lian, Song Yong-Wen, Liu Yue-Ping, Li Ye-Xiong, Liu Zheng, Liang Jian-Wei, Zhang Hai-Zeng, Zhou Hai-Tao, Wang Jun, Liu Wen-Yang, Jin Jing
机构信息
Department of Radiation Oncology, National Cancer Center/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
出版信息
Ther Adv Med Oncol. 2024 Nov 19;16:17588359241296386. doi: 10.1177/17588359241296386. eCollection 2024.
BACKGROUND
Chemoradiotherapy (CRT) is the main treatment for elderly patients with non-metastatic rectal cancer who are ineligible for or decline surgery, but the optimal modality remains unclear.
OBJECTIVES
This study was to validate the safety and efficacy of comprehensive geriatric assessment (CGA) guided radiotherapy in older patients.
DESIGN
An exploratory analysis of a single-arm, multicenter, Phase II trial.
METHODS
Patients aged over 70 and diagnosed with rectal cancer were enrolled and evaluated by CGA. CGA-guided radiotherapy was individually conducted in a multidisciplinary setting. Patients in fit, intermediate, and frail groups were scheduled to receive CRT, long-course radiotherapy, and short-course radiotherapy (SCRT) alone respectively. Patients who were unfit for or refused surgery were analyzed for acute toxicities and survival outcomes.
RESULTS
In a total of 109 enrolled patients, 47 individuals who did not undergo surgery were included, with 26, 9, and 12 categorized into fit, intermediate, and frail groups. Only 11 (23.4%) grade 3 or above toxicities were observed overall. Within a median follow-up of 69.0 months, the 3-year overall survival (OS), progression-free survival (PFS), and cancer-specific survival (CSS) rates were 44.3% (95% CI: 32.1%-61.2%), 25.5% (95% CI: 15.7%-41.6%) and 61.0% (95% CI: 47.8%-77.6%) in total. The 5-year OS, PFS, and CSS reached 15.0% (95% CI: 7.4%-30.3%), 14.6% (95% CI: 7.3%-29.4%), and 36.2% (95% CI: 22.0%-59.4%), with no significant difference among the three subgroups. SCRT ( < 0.001) and dose boost ( = 0.045) contributed to lower tumor-related death rates in multiple competing risk regressions.
CONCLUSION
Radiotherapy guided by CGA was effective and well-tolerated in non-surgical elderly patients. SCRT alone seemed to achieve similar clinical outcomes as CRT in corresponding subgroups. However, given the limited size of this study, further investigation in a larger population is still needed for this strategy.
背景
对于不适合或拒绝手术的老年非转移性直肠癌患者，放化疗（CRT）是主要治疗方法，但最佳治疗模式仍不明确。
目的
本研究旨在验证综合老年评估（CGA）指导下的放疗在老年患者中的安全性和有效性。
设计
一项单臂、多中心II期试验的探索性分析。
方法
纳入年龄超过70岁且诊断为直肠癌的患者，并通过CGA进行评估。在多学科环境中单独进行CGA指导下的放疗。健康、中等和虚弱组的患者分别计划单独接受CRT、长程放疗和短程放疗（SCRT）。对不适合或拒绝手术的患者分析急性毒性和生存结局。
结果
总共109例纳入患者中，47例未接受手术的患者被纳入分析，其中26例、9例和12例分别归类为健康、中等和虚弱组。总体仅观察到11例（23.4%）3级及以上毒性反应。在中位随访69.0个月时，3年总生存（OS）率、无进展生存（PFS）率和癌症特异性生存（CSS）率分别为44.3%（95%CI：32.1%-61.2%）、25.5%（95%CI：15.7%-41.6%）和61.0%（95%CI：47.8%-77.6%）。5年OS、PFS和CSS分别达到15.0%（95%CI：7.4%-30.3%）、14.6%（95%CI：7.3%-29.4%）和36.2%（95%CI：22.0%-59.4%），三个亚组之间无显著差异。在多因素竞争风险回归中，SCRT（<0.001）和剂量增加（=0.045）导致较低的肿瘤相关死亡率。
结论
CGA指导下的放疗在非手术老年患者中有效且耐受性良好。单独SCRT在相应亚组中似乎能取得与CRT相似的临床结局。然而，鉴于本研究规模有限，该策略仍需在更大规模人群中进一步研究。
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