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美国转移性结直肠癌白种人和黑种人医疗保险患者中生物制剂的比较疗效。

Comparative Effectiveness of Biologic Agents Among Black and White Medicare Patients in the US With Metastatic Colorectal Cancer.

机构信息

Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.

Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.

出版信息

JAMA Netw Open. 2021 Dec 1;4(12):e2136378. doi: 10.1001/jamanetworkopen.2021.36378.

Abstract

IMPORTANCE

Randomized clinical trials have defined the survival benefit provided by the addition of biologic drugs to chemotherapy in patients with metastatic colorectal cancer (mCRC). However, Black patients may be underrepresented in trial populations, and outcomes in this group remain poorly defined.

OBJECTIVE

To determine whether the real-world benefit of biologic drugs in Black patients is consistent with the real-world benefit of biologic drugs in White patients using a comparative effectiveness research approach.

DESIGN, SETTING, AND PARTICIPANTS: Population-based retrospective comparative effectiveness analysis of a cohort of patients aged 65 years or older with mCRC diagnosed between 2004 and 2011 who had received at least 1 dose of chemotherapy and had complete Medicare claims data using the Surveillance, Epidemiology, and End Result (SEER)-Medicare linked database. Data were analyzed from August 1, 2020, to March 31, 2021.

INTERVENTIONS

Patient data were classified according to whether patients received chemotherapy (oxaliplatin, irinotecan, and 5-fluorouracil or capecitabine) or biochemotherapy (bevacizumab, cetuximab, panitumumab, ramucirumab, or aflibercept, started within 3 months of chemotherapy).

MAIN OUTCOMES AND MEASURES

Overall survival (OS) defined as the time from starting chemotherapy to death or last follow-up. A weighted Cox regression model was used to assess differences in survival.

RESULTS

A total of 5617 patients with mCRC were identified in the SEER-Medicare linked database, and 4542 patients were included in the main analysis. Of the 5617 patients, 3969 (70.7%) received biologic agents at any point between 2004 and 2011; biologic agent therapy was started within 3 months of chemotherapy in 2894 patients (72.9%). Among 4542 patients with data on race and ethnicity, the median age was 72 years (IQR, 68-78 years), 2365 (52.0%) were female, 3445 (75.8%) had colon as the primary site, 552 (12.2%) were Black patients, and 3990 (87.8%) were White patients. There was no difference in the receipt of 1 (76.7% and 74.8%) vs 2 or more (23.3% and 25.2%: P = .92) lines of therapy, and in the receipt of biologic agents (63.6% vs 64.3% P = .33), among White patients and Black patients, respectively. Biochemotherapy was associated with a significant survival benefit compared with chemotherapy alone in the overall population (biochemotherapy median OS, 17.9 [95% CI, 17.3-18.7] months vs chemotherapy median OS, 8.3 [95% CI, 9.1-9.9] months; P < .001). The survival benefit was similar among White patients (17.8 vs 9 months; average hazard ratio, 0.59; 95% CI, 0.55-0.64; P < .001) and Black patients (18.6 vs 9.9; average hazard ratio, 0.58; 95% CI, 0.47-0.71; P < .001).

CONCLUSIONS AND RELEVANCE

In this comparative effectiveness analysis of a cohort of Medicare recipients with mCRC, biochemotherapy was associated with an improvement in OS with a similar rate of reduction in mortality among Black and White patients. Clinicians may offer biochemotherapy therapy to all patients to maximize clinical benefit, factoring in clinical variables, but not their race.

摘要

重要性

随机临床试验已经确定了生物药物在转移性结直肠癌(mCRC)患者中联合化疗的生存获益。然而,黑人患者在试验人群中的代表性可能不足,并且该人群的结果仍不清楚。

目的

通过比较有效性研究方法,确定在接受化疗的黑人患者中,生物药物的实际获益是否与在白人患者中一致。

设计、设置和参与者:对 2004 年至 2011 年间诊断为 mCRC 且至少接受过 1 剂化疗且完整的医疗保险索赔数据的队列进行基于人群的回顾性比较有效性分析,该队列患者年龄在 65 岁或以上,使用监测、流行病学和最终结果(SEER)-医疗保险链接数据库。数据于 2020 年 8 月 1 日至 2021 年 3 月 31 日进行分析。

干预措施

根据患者是否接受化疗(奥沙利铂、伊立替康和氟尿嘧啶或卡培他滨)或生物化学疗法(贝伐单抗、西妥昔单抗、帕尼单抗、雷莫芦单抗或阿柏西普,在化疗后 3 个月内开始)对患者数据进行分类。

主要结局和测量

总生存期(OS)定义为从开始化疗到死亡或最后一次随访的时间。使用加权 Cox 回归模型评估生存差异。

结果

在 SEER-医疗保险链接数据库中确定了 5617 例 mCRC 患者,其中 4542 例患者纳入主要分析。在 5617 例患者中,3969 例(70.7%)在 2004 年至 2011 年间任何时候接受过生物制剂治疗;2894 例患者(72.9%)在化疗后 3 个月内开始使用生物制剂治疗。在 4542 例有种族和民族数据的患者中,中位年龄为 72 岁(IQR,68-78 岁),2365 例(52.0%)为女性,3445 例(75.8%)为结肠原发部位,552 例(12.2%)为黑人患者,3990 例(87.8%)为白人患者。白人患者中接受 1 线(76.7%和 74.8%)与 2 线或更多线(23.3%和 25.2%:P = .92)治疗的比例以及接受生物制剂的比例(63.6%和 64.3%:P = .33)没有差异。在整个人群中,与单独化疗相比,生物化学疗法与显著的生存获益相关(生物化学疗法中位 OS,17.9 [95%CI,17.3-18.7] 个月 vs 化疗中位 OS,8.3 [95%CI,9.1-9.9] 个月;P < .001)。在白人患者(17.8 与 9 个月;平均危险比,0.59;95%CI,0.55-0.64;P < .001)和黑人患者(18.6 与 9.9 个月;平均危险比,0.58;95%CI,0.47-0.71;P < .001)中,生存获益相似。

结论和相关性

在这项对医疗保险接受者转移性结直肠癌队列的比较有效性分析中,生物化学疗法与 OS 改善相关,并且在黑人和白人患者中死亡率降低的速度相似。临床医生可以为所有患者提供生物化学疗法,以最大限度地提高临床获益,同时考虑临床变量,但不考虑其种族。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c365/8674750/3ac1e7716c53/jamanetwopen-e2136378-g001.jpg

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