Curran D, van Dongen J P, Aaronson N K, Kiebert G, Fentiman I S, Mignolet F, Bartelink H
European Organization for Research and Treatment of Cancer (EORTC), Data Center, Brussels, Belgium.
Eur J Cancer. 1998 Feb;34(3):307-14. doi: 10.1016/s0959-8049(97)00312-2.
In 1980 the EORTC-BCCG initiated a multicentre randomised clinical trial comparing modified radical mastectomy (MRM) with breast-conserving therapy (BCT) in stage I and II breast cancer. The main endpoint of the trial was survival. A brief quality of life (QoL) questionnaire consisting of two multi-item scales (body image and fear of recurrence) and two single items (satisfaction with treatment and cosmetic result) was included in the trial. A cosmetic evaluation of the breast after conservative surgery was also performed. This report concentrates on the results of the QoL study and the cosmetic evaluation. Multitrait scaling analysis was employed to verify the hypothesised scale structure of the questionnaire. Treatment comparison of the QoL scores at 2 years post-treatment was performed using a stratified Wilcoxon rank sum test. Both patients' and doctors' ratings of the cosmetic result were documented on the clinical follow-up form. A multivariate analysis was performed to identify which factors influenced the cosmetic outcome. In total, 127 patients in the MRM arm and 151 in the BCT arm completed a QoL questionnaire at approximately 2 years after randomisation (months 25-36). The Cronbach's alpha coefficients were 0.79 and 0.73 for the body image and fear of recurrence scales, respectively. Significant benefit in body image and satisfaction with treatment was observed in the BCT patients. No significant difference was observed in fear of recurrence between the two groups. Ratings of cosmetic results decreased with time, in line with clinical observations of long-term side-effects of radiotherapy. Wide excision appeared to be the most important predictive factor for poor cosmetic result. In this multicentre randomised study, BCT helped to maintain the patients' body image, resulted in higher satisfaction with treatment and yielded no significant difference from MRM with respect to fear of recurrence.
1980年，欧洲癌症研究与治疗组织-乳腺癌协作组（EORTC-BCCG）发起了一项多中心随机临床试验，比较I期和II期乳腺癌改良根治术（MRM）与保乳治疗（BCT）。该试验的主要终点是生存率。试验中纳入了一份简短的生活质量（QoL）问卷，包括两个多项目量表（身体形象和对复发的恐惧）以及两个单项（对治疗的满意度和美容效果）。还对保乳手术后的乳房进行了美容评估。本报告重点关注生活质量研究和美容评估的结果。采用多特质量表分析来验证问卷假设的量表结构。使用分层Wilcoxon秩和检验对治疗后2年的生活质量评分进行治疗组间比较。在临床随访表上记录了患者和医生对美容效果的评分。进行多变量分析以确定哪些因素影响美容结果。在随机分组后约2年（第25 - 36个月），MRM组有127例患者，BCT组有151例患者完成了生活质量问卷。身体形象量表和对复发恐惧量表的Cronbach's alpha系数分别为0.79和0.73。在BCT患者中观察到身体形象和对治疗的满意度有显著改善。两组在对复发的恐惧方面未观察到显著差异。美容效果评分随时间下降，这与放疗长期副作用的临床观察结果一致。广泛切除似乎是美容效果不佳的最重要预测因素。在这项多中心随机研究中，BCT有助于维持患者的身体形象，使患者对治疗的满意度更高，并且在对复发的恐惧方面与MRM没有显著差异。
