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前情提要：1992年4月14日～2001年3月30日，国际乳腺癌干预研究（IBIS-I）在澳大利亚、新西兰、英国以及其他欧洲国家入组35～70岁乳腺癌高危女性7154例，随机分配口服5年他莫昔芬（20mg/天）或安慰剂，调查了他莫昔芬对乳腺癌高危女性降低乳腺癌风险的有效性。结果发现，经过中位随访50个月、8年、16年，乳腺癌风险减少大约三分之一（32%、27%、29%）。虽然他莫昔芬预防乳腺癌的效果显而易见，但是大约二至四成女性无法坚持5年口服他莫昔芬。 国际乳腺癌干预研究参与者报告的 他莫昔芬与安慰剂所致症状及其对 乳腺癌预防疗法长期依从性的影响 2017年6月29日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表英国利兹大学、伦敦玛丽王后大学、曼彻斯特大学、澳大利亚纽卡斯尔医院的IBIS-I英国样本研究报告，评定了英国参与者报告的症状对乳腺癌预防疗法长期依从性的影响，结果发现他莫昔芬与安慰剂所致症状对依从性的影响程度相似。 该研究入组IBIS-I的4279例英国女性，排除456例不符合分析要求的女性后，对其余3823例女性进行分析。使用每6个月的临床随访数据计算依从性（＜4.5年或≥4.5岁）。根据年龄、Tyrer-Cuzick风险、吸烟、使用激素替代疗法、绝经状态、基线绝经症状、治疗情况进行校正。 结果发现，他莫昔芬组与安慰剂组相比：
因此，在IBIS-I研究中，症状使长期依从性降低，而且对两组的影响相似，表明女性往往将年龄相关症状归咎于预防疗法，故需进行干预以帮助症状控制。 相关阅读 J Clin Oncol. 2017 Jun 29. [Epub ahead of print] Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I). Smith SG, Sestak I, Howell A, Forbes J, Cuzick J. Leeds Institute of Health Science, University of Leeds, Leeds; Wolfson Institute of Preventive Medicine, Queen Mary University of London, London; Institute of Cancer Sciences, University of Manchester, Manchester, United Kingdom; Calvary Mater Newcastle Hospital, Newcastle, Australia. PURPOSE: To assess the role of participant-reported symptoms on long-term adherence to preventive therapy in the United Kingdom sample of the International Breast Cancer Intervention Study (IBIS-I). IBIS-I was a randomized controlled trial that investigated the effectiveness of tamoxifen in reducing the risk of breast cancer among women at increased risk of the disease. PARTICIPANTS AND METHODS: Women were randomly assigned to tamoxifen versus placebo (20 mg/day; n = 4,279). After 456 exclusions, 3,823 women were included in this analysis. Adherence (< 4.5 years or ≥ 4.5 years) was calculated using data from six monthly clinical visits. Analyses were adjusted for age, Tyrer-Cuzick risk, smoking, use of hormone replacement therapy, menopausal status, baseline menopausal symptoms, and treatment. RESULTS: Overall, 69.7% of women were adherent for at least 4.5 years (tamoxifen: 65.2% v placebo: 74.0%; P < .001). Differences in adherence between treatment arms were observed from 12 months onward (all P < .01) and were largest at 54 months. Dropout rates were highest in the first 12 to 18 months and decreased thereafter. Women reporting nausea/vomiting were less likely to be adherent in both the tamoxifen (odds ratio [OR], 0.57; 95% CI, 0.37 to 0.86; P = .007) and placebo (OR, 0.58; 95% CI, 0.37 to 0.93; P = .023) arms. Headaches were associated with adherence only in the placebo arm (OR, 0.62; 95% CI, 0.42 to 0.91; P = .016), whereas gynecologic symptoms were significant only in the tamoxifen arm (OR, 0.77; 95% CI, 0.62 to 0.97; P = .024). Effect sizes for each symptom on adherence were not significantly different between the treatment groups (P > .05). In both treatment arms, we observed significant trends for lower adherence with increasing severity for all symptoms (P < .01) except headaches (P = .054). CONCLUSION: In the IBIS-I trial, experiencing predefined symptoms in the first 6 months reduced long-term adherence. Effects were similar between treatment arms, suggesting that women were attributing age-related symptoms to preventive therapy. Interventions were required to support symptom management. PMID: 28661758 DOI: 10.1200/JCO.2016.71.7439
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