To the Editor Sledge and colleagues1 conducted a global, randomized clinical trial of abemaciclib plus fulvestrant vs placebo plus fulvestrant for treating hormone receptor–positive, ERBB2-negative advanced breast cancer. The trial enrolled 669 women, and 446 and 223 patients were assigned to the abemaciclib and placebo arms, respectively. At the interim analysis, 338 deaths were observed. The median overall survival (OS) times were 46.7 and 37.3 months for the abemaciclib and placebo arms. The hazard ratio (abemaciclib vs placebo) was 0.757 (95% CI, 0.606-0.945; P = .01). However, in Figure 2,1 the 2 Kaplan-Meier curves for OS clearly overlapped until month 27, and so the proportional hazards assumption is obviously not valid. Therefore, the estimated hazard ratio of 0.757 is difficult, if not impossible, to interpret clinically.2
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
Sun R, Kim DH, Wei L. Analysis of Overall Survival Benefit of Abemaciclib Plus Fulvestrant in Hormone Receptor–Positive, ERBB2-Negative Breast Cancer. JAMA Oncol. 2020;6(7):1121–1122. doi:10.1001/jamaoncol.2020.1513
Coronavirus Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: