Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.

中文翻译：

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来自加拿大癌症试验组 MA.17R 的生活质量：一项将辅助来曲唑延长至 10 年的随机试验

目的 MA.17R 是加拿大癌症试验组牵头的 III 期随机对照试验，在芳香酶抑制剂作为激素受体阳性乳腺癌的辅助治疗后 5 年，比较来曲唑与安慰剂。生活质量 (QOL) 是该研究的次要结果指标，我们在此报告这些分析的结果。方法 使用 Short Form-36（SF-36；两个总分和八个域）和更年期特定 QOL（MENQOL；四个症状域）在基线和每 12 个月至 60 个月测量 QOL。QOL 评估对于加拿大癌症试验组中心是强制性的，但对于其他组的中心是可选的。计算从基线的平均变化分数。结果 1,918 名女性被随机分配，1,428 名女性完成了基线 QOL 评估。对 QOL 措施的依从性 > 85%。SF-36 身体成分总结（来曲唑为 47.5，安慰剂为 47.9）和精神成分总结（来曲唑为 55.5，安慰剂为 54.8）的基线总结得分接近于 50 的人口标准。 各组之间的平均值没有差异SF-36 身体和心理成分总结和其他八个 QOL 领域的变化分数，除了角色 - 身体分量表。在 MENQOL 的四个领域中的任何一个领域均未发现差异 结论 通过 SF-36 汇总测量和 MENQOL 测量的总体 QOL 在来曲唑组和安慰剂组之间未见有临床显着差异。