Patient-reported outcomes in the SERENA-6 trial of camizestrant plus CDK4/6 inhibitor in patients with advanced breast cancer and emergent ESR1 mutations during first-line endocrine-based therapy.

Here we report additional data from patient-reported outcomes (PROs).

这里我们报告了来自患者报告结果（PROs）的额外数据。

patients_and_methods

Patients completed PRO questionnaires at pre-specified timepoints, including the European Organisation for Research and Treatment of Cancer (EORTC) oncology-specific EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) and breast cancer-specific (QLQ-BR23) and Patient Global Impression of Treatment Tolerability (PGI-TT).

患者在预定的时间点完成了患者报告的结果（PRO）问卷，包括欧洲癌症研究与治疗组织（EORTC）的肿瘤特异性EORTC生活质量核心问卷30（QLQ-C30）和乳腺癌特异性问卷（QLQ-BR23）以及患者对治疗耐受性的总体印象（PGI-TT）问卷。

All PRO endpoints and analyses were pre-defined, including secondary endpoints of time to deterioration (TTD) in pain, physical functioning, breast symptoms and arm symptoms.

所有PRO终点和分析都是预先定义的，包括次要终点，即在疼痛、身体功能、乳腺症状和手臂症状方面的恶化时间（TTD）。

Results

EORTC QLQ-C30 and EORTC QLQ-BR23 baseline scores were similar between treatment arms.

EORTC QLQ-C30和EORTC QLQ-BR23的基线评分在不同治疗组之间相似。

Switching to camizestrant-CDK4/6i delayed TTD and reduced the risk of deterioration in patient-reported cancer symptoms [pain (hazard ratio0.57, 95% confidence interval0.37-0.86), fatigue (0.75, 0.46-1.24), shortness of breath/dyspnoea (0.52, 0.28-0.93), breast symptoms (0.59, 0.28-1.24) and arm symptoms (0.69, 0.34-1.39)] and functioning [physical (0.74, 0.44-1.24), role (0.73, 0.48-1.10) and emotional (0.51, 0.29-0.87)] compared with AI-CDK4/6i.

转用camizestrant-CDK4/6i延迟了TTD，并降低了患者报告的癌症症状[疼痛(风险比0.57, 95%置信区间0.37-0.86),疲劳(0.75, 0.46-1.24),呼吸急促/呼吸困难(0.52, 0.28-0.93),乳房症状(0.59, 0.28-1.24)和手臂症状(0.69, 0.34-1.39)]以及功能[身体(0.74, 0.44-1.24),角色(0.73, 0.48-1.10)和情绪(0.51, 0.29-0.87)]恶化的风险，与AI-CDK4/6i相比。

Most patients reported they were 'not at all' or 'a little bit' bothered by the side effects of cancer therapy across timepoints (e.g. week 2: 86% camizestrant-CDK4/6i versus 82% AI-CDK4/6i).

大多数患者报告称，他们在各个时间点（例如第2周：86%的camizestrant-CDK4/6i组与82%的AI-CDK4/6i组）对癌症治疗的副作用感到'一点也不'或'有一点'困扰。

Conclusions

Together with the clinical efficacy and manageable safety profile of camizestrant-CDK4/6i, and reduced risk of GHS/QoL deterioration, the PROs from the SERENA-6 trial support switching to this combination as a potential new treatment strategy to optimise and improve outcomes in patients with HR-positive/HER2-negative ABC and ESR1-mut emergence, ahead of disease progression, during first-line AI-CDK4/6i.

结合camizestrant-CDK4/6i的临床疗效和可控的安全性，以及降低的全球健康状况/生活质量恶化的风险，SERENA-6试验中的患者报告结果支持在疾病进展前，作为一线AI-CDK4/6i治疗期间，将此组合作为潜在的新治疗策略，以优化和改善HR阳性/HER2阴性晚期乳腺癌和ESR1突变出现的患者的治疗结果。