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医生报告的老年人未参加癌症临床试验的原因。

Physician-reported reasons for non-enrollment of older adults in cancer clinical trials.

作者信息

Lackman Miki, Vickers Michael M, Hsu Tina

机构信息

University of Ottawa Roger Guindon Hall, 451 Smyth Rd, Ottawa, ON K1H 8M5, Canada.

University of Ottawa Roger Guindon Hall, 451 Smyth Rd, Ottawa, ON K1H 8M5, Canada; Ottawa Hospital Cancer Centre, 501 Smyth Rd, Ottawa, ON K1H 8L6, Canada.

出版信息

J Geriatr Oncol. 2020 Jan;11(1):31-36. doi: 10.1016/j.jgo.2019.01.019. Epub 2019 Feb 21.

DOI:10.1016/j.jgo.2019.01.019
PMID:30799176
Abstract

OBJECTIVES

Older adults (OA) are under-represented in cancer clinical trials. We sought to identify the proportion of OA(age > 65) vs. younger adults offered clinical trial and identify reasons patients were not offered a trial.

METHODS

Consecutive patients with cancer (n = 503) seen by medical oncology in consultation were included. Oncologists provided reasons for not offering a study to patients who were offered and accepted systemic therapy. Comparison between older and younger adults was done using the Chi square test or Fisher exact test. Logistic regression was used to determine the association between age and being offered clinical trial participation.

RESULTS

OA had worse performance status (PS) (ECOG 3+ 15.1% vs 5.2%, p < 0.0001) and more comorbidities (Charlson Comorbidity Index ≥2 24.7% vs 10.0%, p < 0.0001) than younger adults. OA were less likely to be offered systemic treatment (68.3% vs 82.1%, p < 0.001), but were as likely as younger adults to accept (86.6% vs 92.2%, p = 0.07). Of patients who accepted systemic treatment, 24.5% were offered trial enrollment. Taking into account patient factors and stage, increased age by decade was associated with a decreased likelihood of being offered a trial [OR 0.74 (95% CI 0.6-0.9), p < 0.001]. Reasons for not offering a trial included no available trial (75.4%), poor PS (7.8%) and ineligibility (6.3%). Poor PS (11.8% vs 3.9%) was more commonly cited for not offering a study to OA.

CONCLUSIONS

Lack of clinical trials is the most common reason patients are not offered a trial. OA remain less likely to be offered a trial than younger adults.

摘要

目的

老年成年人(OA,年龄>65岁)在癌症临床试验中的代表性不足。我们试图确定提供给OA与年轻成年人的临床试验比例,并找出未向患者提供试验的原因。

方法

纳入连续就诊于肿瘤内科会诊的癌症患者(n = 503)。肿瘤学家为那些接受了全身治疗的患者提供不提供研究的原因。使用卡方检验或Fisher精确检验对老年人和年轻人进行比较。采用逻辑回归分析确定年龄与被提供参与临床试验之间的关联。

结果

与年轻成年人相比,OA的体能状态(PS)更差(东部肿瘤协作组[ECOG] 3级及以上:15.1% 对5.2%,p < 0.0001),合并症更多(Charlson合并症指数≥2:24.7% 对10.0%,p < 0.0001)。OA接受全身治疗的可能性较小(68.3% 对82.1%,p < 0.001),但接受的可能性与年轻成年人相似(86.6% 对92.2%,p = 0.07)。在接受全身治疗的患者中,24.5% 被提供了试验入组机会。考虑到患者因素和分期,每增加十岁,被提供试验的可能性就降低[比值比(OR)0.74(95% 置信区间0.6 - 0.9),p < 0.001]。不提供试验的原因包括没有可用试验(75.4%)、PS差(7.8%)和不符合条件(6.3%)。因PS差而不向OA提供研究的情况更为常见(11.8% 对3.9%)。

结论

缺乏临床试验是未向患者提供试验的最常见原因。与年轻成年人相比,OA被提供试验的可能性仍然较小。

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