临床试验经常包括在不同时间成熟的多个终点。当关键计划的联合主要或次要分析尚未可用时，通常基于主要终点的初始报告可能会发布。临床试验更新提供了传播在 JCO 或其他地方发表的研究的更多结果的机会，这些研究的主要终点已经报告。 在激素受体阳性、人表皮生长因子受体 2 阴性的晚期乳腺癌患者中， STIC CTC 试验表明，在内分泌治疗 (ET) 或化疗之间进行选择时，循环肿瘤细胞 (CTC) 计数的使用在无进展生存期方面并不劣于研究者的选择。在这里，我们报告总体生存 (OS) 结果，这是次要终点。患者以 1:1 的比例随机分配，由研究人员或 CTC 计数决定一线治疗（ET 或化疗）（如果 CTC ≥ 5 个/7.5 mL，则化疗；如果 CTC 计数低，则进行 ET；CellSearch）。在随访终止时评估 OS。经过中位随访 4.7 年，755 名患者中有 382 人死亡（50.6%）。 CTC 组的中位 OS 为 51.3 个月（95% CI，46.8 至 55.1），标准组为 45.5 个月（95% CI，40.9 至 51.1）（死亡风险比 [HR]，0.85；95% CI，0.69）至 1.03；P = .11）。在临床医生推荐接受 ET 且 CTC 计数较高的 189 名患者 (25.0%) 中，化疗优于 ET（死亡 HR，0.53；95% CI，0.36 至 0.78；P = 0.001）。如果估计值不一致，OS 数据可证明 CTC 计数的临床实用性。

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.In patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer, the STIC CTC trial established that, for choosing between endocrine therapy (ET) or chemotherapy, the use of circulating tumor cell (CTC) count is noninferior to the investigator's choice in terms of progression-free survival. Here, we report overall survival (OS) results, a secondary end point. Patients were randomly assigned in a 1:1 ratio to have their first-line treatment (ET or chemotherapy) determined by investigators or CTC count (chemotherapy if ≥ 5 CTCs/7.5 mL; ET if low CTC count; CellSearch). OS was assessed at the discontinuation of follow-up. After a median follow-up of 4.7 years, 382 deaths (50.6%) had occurred among 755 patients. Median OS was 51.3 months (95% CI, 46.8 to 55.1) in the CTC arm and 45.5 months (95% CI, 40.9 to 51.1) in the standard arm (hazard ratio [HR] for death, 0.85; 95% CI, 0.69 to 1.03; P = .11). Among 189 patients (25.0%) with ET recommended by clinicians and high CTC count, chemotherapy was superior to ET (HR for death, 0.53; 95% CI, 0.36 to 0.78; P = .001). In case of a discordant estimate, OS data demonstrate the clinical utility of CTC count.