Few patients with cancer, including those with acute myeloid leukemia and high-grade myeloid neoplasms, participate in clinical trials. Broadening standard eligibility criteria may increase clinical trial participation. In this retrospective single-center analysis, we identified 442 consecutive newly diagnosed patients from 2014 to 2016. Patients were considered eligible if they had performance status 0-2, normal renal and hepatic function, no recent solid tumor, left ventricular ejection fraction (EF) ≥ 50%, and no history of congestive heart failure (CHF) or myocardial infarction (MI); ineligible patients failed to meet one or more of these criteria. We included 372 patients who received chemotherapy. Ineligible patients represented 40% of the population and had a 1-79-fold greater risk of death (95% CI 1.37, 2.33) than eligible patients. Very few patients had cardiac co-morbidities, including 2% with low EF, 4% with prior CHF, and 5% with prior MI. In multivariable analysis, ineligibility was associated with decreased survival [HR 1-44 (95% CI 1-07, 1-93)]. Allogeneic transplantation, performed in 150 patients (40%), was associated with improved survival [HR 0-66, 95% CI (0-48, 0-91)]. Therefore, standard eligibility characteristics identify a patient population with improved survival. Further treatment options are needed for patients considered ineligible for clinical trials.

译文

:很少有癌症患者,包括患有急性髓性白血病和高级别髓样肿瘤的患者参加临床试验。扩大标准资格标准可能会增加临床试验的参与度。在这项回顾性单中心分析中,我们确定了2014年至2016年连续442例新诊断的患者。如果患者的表现状态为0-2,肾和肝功能正常,没有新的实体瘤,左心室射血分数(EF),则认为该患者合格)≥50%,无充血性心力衰竭(CHF)或心肌梗塞(MI)的病史;不符合条件的患者未达到这些标准中的一项或多项。我们纳入了372例接受化疗的患者。不合格的患者占总人口的40%,死亡风险比合格的患者高1-79倍(95%CI 1.37,2.33)。极少数患者有心脏合并症,包括2%的低EF,4%的先前CHF和5%的先前MI。在多变量分析中,不合格与生存率降低相关[HR 1-44(95%CI 1-07,1-93)]。在150例患者中进行了同种异体移植(40%),与存活率提高相关[HR 0-66,95%CI(0-48,0-91)]。因此,标准的资格特征确定了具有改善生存率的患者人群。对于认为不适合进行临床试验的患者,需要进一步的治疗选择。

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