Quality of life after iodine 125 brachytherapy vs enucleation for choroidal melanoma: 5-year results from the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3.
Quality of life after iodine 125 brachytherapy vs enucleation for choroidal melanoma: 5-year results from the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3.
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DOI：
10.1001/archopht.124.2.226
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发表时间：
2006-02
影响因子：
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通讯作者：
M. Melia;C. Moy;S. Reynolds;J. Hayman;T. Murray;K. R. Hovland;J. Earle;N. Kurinij;L. Dong;Päivi H. Miskala;C. Fountain;D. Cella;C. Mangione
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文献类型：
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作者：
M. Melia;C. Moy;S. Reynolds;J. Hayman;T. Murray;K. R. Hovland;J. Earle;N. Kurinij;L. Dong;Päivi H. Miskala;C. Fountain;D. Cella;C. Mangione
目的描述在一项大型随机临床试验中接受前瞻性治疗和观察的脉络膜黑色素瘤患者中，125碘近距离放射治疗和眼球摘除治疗后的健康和视力目标生活质量。主要结果衡量驾驶困难、近视活动、使用立体视觉或双目视觉的活动、焦虑和抑郁。参与者299名患者在1995年3月至1998年7月期间参加了中等大小肿瘤的合作眼部黑色素瘤研究试验，并在随机之前给予知情同意，以参与一项生活质量的辅助研究。方法由合作眼黑色素瘤研究协调中心的一位训练有素的采访者在基线(随机前)、6个月和每年的登记周年纪念日通过电话采访患者。问卷组合包括医学结局研究简表36、日常视力活动量表、国家眼科研究所视功能问卷和医院焦虑和抑郁量表。关于治疗后外观的满意度和对癌症复发的担忧的其他问题也包括在治疗后访谈中。结果治疗6个月后，两组患者在大多数视觉导向活动的报告困难程度以及躯体和眼睛疼痛方面均有显著增加。在随访期间，治疗组之间的视功能差异相对较小，但在第一年的随访中，发现接受近距离放射治疗的患者在驾驶方面存在显著差异，在前两年的随访中观察到周边视力方面的差异。治疗后，两组患者的焦虑水平都显著下降，但与接受眼球摘除治疗的焦虑症状患者相比，接受有焦虑症状的近距离放射治疗的患者报告症状较晚缓解的可能性较小。这项研究无法评估治疗对治疗后第一年的外观满意度和对癌症复发的担忧的影响，但在两年及以后的随访时间中，这些指标没有发现与治疗相关的差异。结论接受近距离放射治疗的患者在治疗后长达2年的时间内，在驾驶和周边视力方面的视觉功能明显优于眼球摘除患者。治疗3到5年后，治疗之间在视觉功能上的差异缩小，与接受近距离放射治疗的眼睛的视力下降平行。接受近距离放射治疗的患者在随访期间比接受眼球摘除的患者更有可能出现焦虑症状。临床应用由于尚未发现眼球摘除和近距离放射治疗在存活率上的显著差异，此处显示的驾驶和焦虑的差异将使个别患者和医生能够根据个人喜好做出明智的治疗选择。
OBJECTIVE To describe health- and vision-targeted quality of life following treatment with iodine 125 brachytherapy vs enucleation for choroidal melanoma in a subgroup of patients who were treated and observed prospectively as part of a large randomized clinical trial. MAIN OUTCOME MEASURES Difficulty with driving, near vision activities, and activities using stereopsis or binocularity; anxiety; and depression. PARTICIPANTS Two hundred nine patients who enrolled in the Collaborative Ocular Melanoma Study trial for medium-sized tumors between March 1995 and July 1998 and gave informed consent prior to randomization to participation in an ancillary study of quality of life. METHODS Patients were interviewed by telephone by a trained interviewer from the Collaborative Ocular Melanoma Study Coordinating Center at baseline (prior to randomization), at 6 months, and on annual anniversaries of enrollment. The questionnaire battery included the Medical Outcomes Study Short Form 36, the Activities of Daily Vision Scale, the National Eye Institute Visual Function Questionnaire, and the Hospital Anxiety and Depression Scale. Additional questions concerning satisfaction with posttreatment appearance and concerns about cancer recurrence also were included in posttreatment interviews. RESULTS There was a significant increase in both treatment groups in levels of reported difficulty for most vision-oriented activities, and in bodily and ocular pain, 6 months following treatment. Differences in visual function between treatment groups reported during follow-up were relatively small, but significant differences favoring brachytherapy-treated patients were observed for driving during the first year of follow-up and for peripheral vision during the first 2 years of follow-up. Anxiety levels in both groups decreased significantly following treatment, but patients treated with brachytherapy with symptoms of anxiety were less likely to report later resolution of symptoms than patients with symptoms of anxiety who were treated with enucleation. This study was unable to assess impact of treatment on satisfaction with appearance and concern about cancer recurrence during the first year after treatment, but no treatment-related differences were found on these measures at 2 years and later follow-up times. CONCLUSIONS Patients treated with brachytherapy reported significantly better visual function than patients treated with enucleation with respect to driving and peripheral vision for up to 2 years following treatment. Differences between treatments in visual function diminished by 3 to 5 years posttreatment, paralleling decline in visual acuity in brachytherapy-treated eyes. Patients treated with brachytherapy were more likely to have symptoms of anxiety during follow-up than patients treated with enucleation. APPLICATION TO CLINICAL PRACTICE Given that no significant differences in survival between enucleation and brachytherapy have been found, the differences demonstrated here for driving and anxiety will allow the individual patient and physician to make informed choices regarding treatment based on personal preferences.