The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: characteristics of patients enrolled and not enrolled. COMS Report No. 17.
The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: characteristics of patients enrolled and not enrolled. COMS Report No. 17.
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COMS 碘 125 近距离放射治疗脉络膜黑色素瘤随机试验，II：入组和未入组患者的特征。
DOI：
10.1001/archopht.119.7.951
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发表时间：
2001
期刊：
影响因子：
--
通讯作者：
CollaborativeOcularMelanomaStudyGroup
中科院分区：
文献类型：
--
作者：
Diener-West,M;Earle,JD;Fine,SL;Hawkins,BS;Moy,CS;Reynolds,SM;Schachat,AP;Straatsma,BR;CollaborativeOcularMelanomaStudyGroup
目的描述眼黑色素瘤合作研究（COMS）随机临床试验中评估的患者特征，该试验通过招募状态进行碘125近距离放射治疗脉络膜黑色素瘤，并将入选患者的特征与未入选的具有合格大小肿瘤的患者的特征进行比较，以评估临床试验的结果可推广到未来患者的程度。从1986年11月到1998年7月31日，在COMS中心对诊断为脉络膜黑色素瘤并进行临床试验评估的患者，选择的数据被传送到COMS协调中心，巴尔的摩，MD，在那里对它们进行整合和分析。数据包括眼科和病史，检查结果，视力测量记录前登记，标准化的A和B扫描超声检查结果，和广角眼底照片和荧光血管造影。其中，2882例（57%）符合入组条件，1317例（46%符合条件的患者，26%肿瘤大小符合条件的患者）入组。合格和不合格患者之间的大部分差异与合格性和排除标准一致。然而，不合格的患者年龄较大，肿瘤较厚。入组的合格患者年龄稍大，肿瘤比未入组的患者更大。近一半（48%）的入组患者脉络膜黑色素瘤与顶点位于颞部的中央凹，相比，40%的合格患者未登记和29%的不合格patients.ConclusionsThis试验的目的是产生内部有效的治疗比较，通过随机分配到治疗时登记。本研究和其他研究的信息记录了入组患者与接受125 I近距离放射治疗的其他脉络膜黑色素瘤患者相似。这些结果支持试验的外部有效性和治疗结果对所有符合用于判断试验合格性标准的患者的适用性。
ObjectivesTo describe characteristics of patients evaluated for the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy for choroidal melanoma by enrollment status, and to compare characteristics of patients enrolled with those of patients with tumors of eligible size who did not enroll in order to assess the extent to which findings from the clinical trial can be generalized to future patients.MethodsFor all patients diagnosed with choroidal melanoma and evaluated for the clinical trial at COMS centers from November 1986 through July 31, 1998, selected data were transmitted to the COMS Coordinating Center, Baltimore, Md, where they were integrated and analyzed. Data included ophthalmic and medical history, examination findings, and visual acuity measurements recorded prior to enrollment; standardized A-and B-scan echographic examination findings; and wide-angle fundus photographs and fluorescein angiograms.ResultsOf 8712 patients with choroidal melanoma, 5046 had tumors of eligible size; of these, 2882 (57%) were eligible for enrollment, and 1317 (46% of eligible patients, 26% of patients with tumors of eligible size) enrolled. Most differences between eligible and ineligible patients corresponded to eligibility and exclusion criteria. However, ineligible patients were older and had thicker tumors than eligible patients. Eligible patients who enrolled were slightly older and had larger tumors than those who did not enroll. Nearly half (48%) of enrolled patients had choroidal melanoma with the apex located temporal to the fovea, compared with 40% of eligible patients not enrolled and 29% of ineligible patients.ConclusionsThis trial was designed to yield internally valid treatment comparisons through random assignment to treatment at time of enrollment. Information from this and other studies document that enrolled patients were similar to other patients with choroidal melanoma who were treated with 125I brachytherapy. These findings support the external validity of the trial and applicability of treatment findings to all patients who meet the criteria used to judge eligibility for the trial.