Presley Carolyn J, Mohamed Mostafa R, Culakova Eva, Flannery Marie, Vibhakar Pooja H, Hoyd Rebecca, Amini Arya, VanderWalde Noam, Wong Melisa L, Tsubata Yukari, Spakowicz Daniel J, Mohile Supriya G
Division of Medical Oncology, Department of Internal Medicine, The Ohio State University, Columbus, OH, United States.
Department of Medicine, University of Rochester Medical Center, Rochester, NY, United States.
Front Oncol. 2022 Mar 31;12:835582. doi: 10.3389/fonc.2022.835582. eCollection 2022.
More older adults die from lung cancer worldwide than breast, prostate, and colorectal cancers combined. Current lung cancer treatments may prolong life, but can also cause considerable treatment-related toxicity.
This study is a secondary analysis of a cluster-randomized clinical trial which evaluated whether providing a geriatric assessment (GA) summary and GA-guided management recommendations can improve grade 3-5 toxicity among older adults with advanced lung cancer.
We analyzed participants aged ≥70 years(y) with stage III & IV (advanced) lung cancer and ≥1 GA domain impairment starting a new cancer treatment with high-risk of toxicity within the National Cancer Institute's Community Oncology Research Program. Community practices were randomized to the intervention arm (oncologists received GA summary & recommendations) versus usual care (UC: no summary or recommendations given). The primary outcome was grade 3-5 toxicity through 3 months post-treatment initiation. Secondary outcomes included 6-month (mo) and 1-year overall survival (OS), treatment modifications, and unplanned hospitalizations. Outcomes were analyzed using generalized linear mixed and Cox proportional hazards models with practice site as a random effect. NCT02054741.
RESULTS & CONCLUSION: Among 180 participants with advanced lung cancer, the mean age was 76.3y (SD 5.1), 39.4% were female and 82.2% had stage IV disease. The proportion of patients who experienced grade 3-5 toxicity was significantly lower in the intervention arm vs UC (53.1% vs 71.6%, P=0.01). More participants in the intervention arm received lower intensity treatment at cycle 1 (56.3% vs 35.3%; P<0.01). Even with a cycle 1 dose reduction, OS at 6mo and 1 year was not significantly different (adjusted hazard ratio [HR] intervention vs. UC: 6mo HR=0.90, 95% CI: 0.52-1.57, P=0.72; 1 year HR=0.89, 95% CI: 0.58-1.36, P=0.57). Frequent toxicity checks, providing education and counseling materials, and initiating direct communication with the patient's primary care physician were among the most common GA-guided management recommendations. Providing a GA summary and management recommendations can significantly improve tolerability of cancer treatment among older adults with advanced lung cancer.
在全球范围内，死于肺癌的老年人比死于乳腺癌、前列腺癌和结直肠癌的老年人的总和还要多。目前的肺癌治疗方法可能会延长生命，但也会导致相当大的与治疗相关的毒性。
本研究是一项整群随机临床试验的二次分析，该试验评估了提供老年评估（GA）总结和GA指导的管理建议是否可以改善晚期肺癌老年患者的3-5级毒性。
我们分析了年龄≥70岁、患有III期和IV期（晚期）肺癌且至少有1个GA领域受损的参与者，这些参与者在国家癌症研究所的社区肿瘤学研究项目中开始接受具有高毒性风险的新癌症治疗。社区医疗机构被随机分为干预组（肿瘤学家收到GA总结和建议）和常规治疗组（UC：未提供总结或建议）。主要结局是治疗开始后3个月内的3-5级毒性。次要结局包括6个月和1年的总生存期（OS）、治疗调整和非计划住院。使用广义线性混合模型和Cox比例风险模型分析结局，并将医疗机构作为随机效应。NCT02054741。
在180名晚期肺癌参与者中，平均年龄为76.3岁（标准差5.1），39.4%为女性，82.2%患有IV期疾病。干预组经历3-5级毒性的患者比例显著低于常规治疗组（53.1%对71.6%，P=0.01）。干预组更多参与者在第1周期接受了较低强度的治疗（56.3%对35.3%；P<0.01）。即使在第1周期降低了剂量，6个月和1年时的总生存期也没有显著差异（干预组与常规治疗组的调整风险比[HR]：6个月时HR=0.90，95%置信区间：0.52-1.57，P=0.72；1年时HR=0.89，95%置信区间：0.58-1.36，P=0.57）。频繁的毒性检查、提供教育和咨询材料以及与患者的初级保健医生开始直接沟通是最常见的GA指导的管理建议。提供GA总结和管理建议可以显著提高晚期肺癌老年患者癌症治疗的耐受性。
