Quality of life in advanced prostate cancer: results of a randomized therapeutic trial.
Quality of life in advanced prostate cancer: results of a randomized therapeutic trial.
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晚期前列腺癌的生活质量：随机治疗试验的结果。
DOI：
10.1093/jnci/90.20.1537
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发表时间：
1998
期刊：
影响因子：
--
通讯作者：
MeyskensJr,FL
中科院分区：
文献类型：
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作者：
Moinpour,CM;Savage,MJ;Troxel,A;Lovato,LC;Eisenberger,M;Veith,RW;Higgins,B;Skeel,R;Yee,M;Blumenstein,BA;Crawford,ED;MeyskensJr,FL
背景对于转移性前列腺癌患者，治疗主要是姑息性的，主要依赖于抑制全身雄激素水平。为了帮助记录缓解的成就并描述治疗的积极和消极影响，我们评估了转移性前列腺癌患者的生活质量（QOL）参数，这些患者被随机分配到两种雄激素剥夺方法。M1期患者（n = 739）（骨或软组织转移）前列腺癌患者入组QOL方案，该方案是西南肿瘤组INT-0105的配套方案，一项随机双盲试验，比较双侧睾丸切除术（手术阉割）加氟他胺或安慰剂的治疗。患者在随机分配到治疗组和1、3、6个月后完成了一系列全面的QOL问卷。收集了三种治疗特异性症状（腹泻，气体疼痛和身体形象），身体功能和情绪功能的数据。结果：本研究的问卷返回率从未低于80%，只有2%的患者没有提交基线QOL评估。横断面分析（经多重检验校正）发现，在5个主要QOL参数中的2个参数上，睾丸切除术+安慰剂组存在统计学显著差异，如下：接受氟替卡松治疗的患者在3个月时报告腹泻更多（P= .001），在3个月和6个月时报告情绪功能更差（均P <.003）。纵向分析重复了这些发现。其他分析的生活质量参数有利于组接受安慰剂，但没有统计学显着调整后的多重testing.Conclusions：我们发现了一个一致的模式，更好的生活质量的结果在每个后续评估在前6个月的治疗睾丸切除术转移性前列腺癌患者接受安慰剂与氟西汀。两个治疗组随时间的改善都很明显，但接受安慰剂的患者更明显。[J Nall Cancer Inst 1998;90：1537-44]
Background. For patients with metastatic prostate cancer, treatment is primarily palliative, relying mainly on the suppression of systemic androgen hormone levels. To help document the achievement of palliation and to characterize positive and negative effects of treatment, we evaluated qualityof-life (QOL) parameters in patients with metastatic prostate cancer who were randomly assigned to two methods of androgen deprivation.Methods: Patients (n = 739) with stage M1(bone or soft tissue metastasis) prostate cancer were enrolled in a QOL protocol that was a companion to Southwest Oncology Group INT-0105, a randomized doubleblind trial comparing treatment with bilateral orchiectomy (surgical castration) plus either flutamide or placebo. Patients completed a comprehensive battery of QOL questionnaires at random assignment to treatment and at 1, 3, and 6 months later. Data were collected on three treatment-specific symptoms (diarrhea, gas pain, and body image), on physical functioning, and on emotional functioning. AllPvalues are two-sided.Results: Questionnaire return rates for this study never dropped below 80%; only 2% of the patients did not submit baseline QOL assessments. Cross-sectional analyses (corrected for multiple testing) identified statistically significant differences that favored orchiectomy plus placebo for two of the five primary QOL parameters as follows: patients receiving flutamide reported more diarrhea at 3 months (P= .001) and worse emotional functioning at 3 and 6 months (bothP<.003). Longitudinal analyses replicated these findings. Other analyzed QOL parameters favored the group receiving placebo but were not statistically significant after adjustment for multiple testing.Conclusions: We found a consistent pattern of better QOL outcomes at each follow-up assessment during the first 6 months of treatment for orchiectomized patients with metastatic prostate cancer who received placebo versus flutamide. Improvement over time was evident in both treatment groups but more so for patients receiving placebo. [J Nall Cancer Inst 1998;90:1537-44]