2016年5月23日，美国临床肿瘤学会（ASCO）官方期刊《临床肿瘤学杂志》在线发表美国、澳大利亚、丹麦、法国、意大利、英国、瑞士、比利时、匈牙利的乳腺国际组织（BIG）1-98研究报告，发现在6193例绝经后激素受体阳性早期乳腺癌女性5年他莫昔芬和来曲唑单独和序贯治疗中，持久性和依从性均与无病生存相关。毒性管理，尤其对于序贯治疗，患者和医生的关注可改善依从性。
J Clin Oncol. 2016 May 23. [Epub ahead of print]
Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence.
Jacquie H. Chirgwin, Anita Giobbie-Hurder, Alan S. Coates, Karen N. Price, Bent Ejlertsen, Marc Debled, Richard D. Gelber, Aron Goldhirsch, Ian Smith, Manuela Rabaglio, John F. Forbes, Patrick Neven, István Láng, Marco Colleoni, Beat Thürlimann.
University of Newcastle; Calvary Mater Newcastle, Newcastle; University of Sydney School of Public Health, Sydney, New South Wales; Box Hill Hospital; Maroondah Hospital; Monash University, Melbourne, Victoria, Australia; International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Frontier Science and Technology Research Foundation; Harvard Medical School, Boston, MA; Rigshospitalet, Copenhagen, Denmark; Institut Bergonié, Bordeaux, France; European Institute of Oncology, Milan, Italy; The Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; Inselspital, Bern; Kantonsspital, St. Gallen, Switzerland; University of Leuven; University Hospitals Leuven, Leuven, Belgium; National Institute of Oncology, Budapest, Hungary.
PURPOSE: To investigate adherence to endocrine treatment and its relationship with disease-free survival (DFS) in the Breast International Group (BIG) 1-98 clinical trial.
METHODS: The BIG 1-98 trial is a double-blind trial that randomly assigned 6,193 postmenopausal women with hormone receptor-positive early breast cancer in the four-arm option to 5 years of tamoxifen (Tam), letrozole (Let), or the agents in sequence (Let-Tam, Tam-Let). This analysis included 6,144 women who received at least one dose of study treatment. Conditional landmark analyses and marginal structural Cox proportional hazards models were used to evaluate the relationship between DFS and treatment adherence (persistence [duration] and compliance with dosage). Competing risks regression was used to assess demographic, disease, and treatment characteristics of the women who stopped treatment early because of adverse events.
RESULTS: Both aspects of low adherence (early cessation of letrozole and a compliance score of < 90%) were associated with reduced DFS (multivariable model hazard ratio, 1.45; 95% CI, 1.09 to 1.93; P = .01; and multivariable model hazard ratio, 1.61; 95% CI, 1.08 to 2.38; P = .02, respectively). Sequential treatments were associated with higher rates of nonpersistence (Tam-Let, 20.8%; Let-Tam, 20.3%; Tam 16.9%; Let 17.6%). Adverse events were the reason for most trial treatment early discontinuations (82.7%). Apart from sequential treatment assignment, reduced adherence was associated with older age, smoking, node negativity, or prior thromboembolic event.
CONCLUSION: Both persistence and compliance are associated with DFS. Toxicity management and, for sequential treatments, patient and physician awareness, may improve adherence.
DOI: 10.1200/JCO.2015.63.8619
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