Lack of Cardiotoxicity Endpoints in Prospective Trials Involving Chest Radiation Therapy: A Review of Registered, Latter-Phase Studies.
Lack of Cardiotoxicity Endpoints in Prospective Trials Involving Chest Radiation Therapy: A Review of Registered, Latter-Phase Studies.
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DOI：
10.3389/fonc.2022.808531
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发表时间：
2022
影响因子：
4.7
通讯作者：
Bazan JG
中科院分区：
文献类型：
--
作者：
Prasad RN;Miller ED;Addison D;Bazan JG
许多研究表明，胸部放射治疗 (RT) 与心脏发病率和死亡率增加有关，其中包括 2013 年发表的具有里程碑意义的 Darby 研究，该研究表明心脏死亡率随着平均心脏辐射剂量的增加而线性增加。然而，心脏毒性在多大程度上被纳入前瞻性 RT 研究的终点仍然未知。我们查询了 clincaltrials.gov，以确定 2006 年 1 月 1 日至 2021 年 2 月 1 日期间，针对肺癌、食管癌、淋巴瘤、间皮瘤、胸腺瘤或乳腺癌的 II/III 期试验，招募了超过 100 名患者，其中至少一个治疗组接受了胸部放疗。主要终点是使用卡方检验（p<0.05 认为显着）的前（2014 年 1 月 1 日之前开始入组）与后达比时代将心脏毒性纳入特定主要或次要终点的比率。我们还使用逻辑回归分析分析了与将心脏毒性作为终点相关的临床试验因素。总共确定了 1,822 项试验，其中 256 项值得纳入。分别有 32% 为食管癌、31% 为肺癌、28% 为乳腺癌、7% 为淋巴瘤/胸腺瘤/间皮瘤。 5% (N=13) 将心脏毒性作为终点：6 项乳腺癌、3 项肺癌、3 项食道癌和 1 项淋巴瘤研究。达比之前和达比之后的心脏毒性终点的纳入没有差异（3.9% vs. 5.9%，P=0.46）。将心脏毒性作为终点的绝对增加最大的是肺癌（0% vs. 6%，p=0.17）和乳腺癌（5.7% vs. 10.8%，p=0.43）研究，尽管这些增加在统计上仍然不显着。我们没有发现与将心脏毒性作为终点相关的临床试验因素。在涉及胸部放疗的前瞻性试验中，心脏毒性仍然是一个不常见的终点，尽管它是治疗后毒性的主要来源。为了更好地表征心脏毒性，未来涉及胸部放疗的前瞻性研究应包括心脏毒性终点。
Chest radiation therapy (RT) has been associated with increased cardiac morbidity and mortality in numerous studies including the landmark Darby study published in 2013 demonstrating a linear increase in cardiac mortality with increasing mean heart radiation dose. However, the extent to which cardiotoxicity has been incorporated as an endpoint in prospective RT studies remains unknown. We queried clincaltrials.gov to identify phase II/III trials in lung, esophageal, lymphoma, mesothelioma, thymoma, or breast cancer from 1/1/2006-2/1/2021 enrolling greater than 100 patients wherein chest RT was delivered in at least one treatment arm. The primary endpoint was the rate of inclusion of cardiotoxicity as a specific primary or secondary endpoint in the pre- (enrollment started prior to 1/1/2014) versus post-Darby era using the Chi-square test (p<0.05 considered significant). We also analyzed clinical trial factors associated with the inclusion of cardiotoxicity as an endpoint using logistic regression analysis. In total, 1,822 trials were identified, of which 256 merited inclusion. 32% were for esophageal, 31% lung, 28% breast, and 7% lymphoma/thymoma/mesothelioma cancers, respectively. 5% (N=13) included cardiotoxicity as an endpoint: 6 breast cancer, 3 lung cancer, 3 esophageal cancer, and 1 lymphoma study. There was no difference in the inclusion of cardiotoxicity endpoints in the pre-Darby versus post-Darby era (3.9% vs. 5.9%, P=0.46). The greatest absolute increase in inclusion of cardiotoxicity as an endpoint was seen for lung cancer (0% vs. 6%, p=0.17) and breast cancer (5.7% vs. 10.8%, p=0.43) studies, though these increases remained statistically non-significant. We found no clinical trial factors associated with the inclusion of cardiotoxicity as an endpoint. Among prospective trials involving chest RT, cardiotoxicity remains an uncommon endpoint despite its prevalence as a primary source of toxicity following treatment. In order to better characterize cardiac toxicities, future prospective studies involving chest RT should include cardiotoxicity endpoints.
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