MAP.3（乳腺预防 3）试验中的生活质量：一项评估依西美坦用于预防乳腺癌的随机、安慰剂对照试验。
Quality of life in MAP.3 (Mammary Prevention 3): a randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer.
机构信息
Elizabeth Maunsell, Centre de recherche du Centre hospitalier universitaire (CHU) de Québec, (Axe Oncologie), Québec; Pierre Dubé, Hôpital Maisonneuve-Rosemont, Montreal, QC; Andrew L. Cooke, CancerCare Manitoba, Winnipeg, MB; Silvana Spadafora, Algoma District Cancer Program, Sault Ste. Marie, ON; Lavina Lickley, Women's College Hospital; Angela M. Cheung, University Health Network, University of Toronto, Toronto; Dianne Johnston, Andrea Hiltz, Michael Brundage, Dongsheng Tu, and Harriet Richardson, National Cancer Institute of Canada Clinical Trials Group; Joseph Pater, Queens University, Kingston, ON; Susan L. Ellard, British Columbia Cancer Agency-Southern Interior, Kelowna; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, BC, Canada; Paul E. Goss, Massachusetts General Hospital, Boston, MA; Rowan T. Chlebowski, University of California at Los Angeles Medical Centre, Torrance, CA; James N. Ingle and Sandhya Pruthi, Mayo Clinic, Rochester, MN; José E. Alés Martínez, Hospital N. S. Sonsoles, Ávila; Amparao Ruiz, Instituto Valenciano de Oncologia, Valencia, Spain; Gloria E. Sarto, Center for Women's Health & Health Research, University of Wisconsin, Madison, WI; Carol J. Fabian, University of Kansas Medical Center, Kansas City, KS; Pascal Pujol, CHU-Hôpital Arnaud de Villeneuve, Montpellier, France; Susan Hendrix, Hutzel Women's Health Specialists, Detroit, MI; Debra W. Thayer, MedStar Health Research Institute, Hyattsville, MD; Kendrith M. Rowland, Carle Cancer Centre/Mills Breast Cancer Institute, Urbana, IL; and Jean Wactawski-Wende, State University of New York at Buffalo, Buffalo, NY.
出版信息
J Clin Oncol. 2014 May 10;32(14):1427-36. doi: 10.1200/JCO.2013.51.2483. Epub 2014 Apr 7.
PURPOSE
Exemestane, a steroidal aromatase inhibitor, reduced invasive breast cancer incidence by 65% among 4,560 postmenopausal women randomly assigned to exemestane (25 mg per day) compared with placebo in the National Cancer Institute of Canada (NCIC) Clinical Trials Group MAP.3 (Mammary Prevention 3) trial, but effects on quality of life (QOL) were not fully described.
PATIENTS AND METHODS
Menopause-specific and health-related QOL were assessed by using the four Menopause-Specific Quality of Life Questionnaire (MENQOL) domains and the eight Medical Outcomes Study Short Form Health Survey (SF-36) scales at baseline, 6 months, and yearly thereafter. MENQOL questionnaire completion was high (88% to 98%) in both groups at each follow-up visit. Change scores for each MENQOL and SF-36 scale, calculated at each assessment time relative to baseline, were compared by using the Wilcoxon rank-sum test. Clinically important worsened QOL was defined as a MENQOL change score increase of more than 0.5 (of 8) points and an SF-36 change score decrease of more than 5 (of 100) points from baseline.
RESULTS
Exemestane had small negative effects on women's self-reported vasomotor symptoms, sexual symptoms, and pain, which occurred mainly in the first 6 months to 2 years after random assignment. However, these changes represented only a small excess number of women being given exemestane with clinically important worsening of QOL at one time or another; specifically, 8% more in the vasomotor domain and 4% more each in the sexual domain and for pain. No other between-group differences were observed. Overall, slightly more women in the exemestane arm (32%) than in the placebo arm (28%) discontinued assigned treatment.
CONCLUSION
Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer.
目的
在加拿大国家癌症研究所（NCIC）临床试验组 MAP.3（乳房预防 3）试验中，与安慰剂相比，阿那曲唑（每天 25 毫克）可使 4560 名随机分配至阿那曲唑组的绝经后妇女的浸润性乳腺癌发病率降低 65%，但对生活质量（QOL）的影响并未完全描述。
患者和方法
采用 4 个绝经特异性生活质量问卷（MENQOL）领域和 8 个医疗结局研究短表健康调查（SF-36）量表，在基线、6 个月和此后每年评估绝经特异性和与健康相关的 QOL。在每次随访时，两组的 MENQOL 问卷完成率均较高（88%至 98%）。与基线相比，在每个评估时间计算的每个 MENQOL 和 SF-36 量表的变化评分，使用 Wilcoxon 秩和检验进行比较。临床意义上 QOL 恶化定义为 MENQOL 变化评分增加超过 0.5（8 分）点和 SF-36 变化评分降低超过 5（100 分）点。
结果
阿那曲唑对女性报告的血管舒缩症状、性功能障碍和疼痛有轻微的负面影响，这些副作用主要发生在随机分组后的前 6 个月至 2 年内。然而，这些变化仅代表小部分接受阿那曲唑治疗的女性在某一时间点或另一时间点的 QOL 出现临床意义上的恶化；具体而言，血管舒缩症状恶化的女性多 8%，性功能障碍和疼痛恶化的女性各多 4%。未观察到其他组间差异。总体而言，阿那曲唑组（32%）略多于安慰剂组（28%）的女性停止了指定的治疗。
结论
对于有乳腺癌风险的健康绝经后妇女，阿那曲唑用于预防对绝经特异性和与健康相关的 QOL 仅有有限的负面影响。
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