Harbeck N, Dieras V, Gelmon K A, Finn R S, Martin M, Neven P, Kim S, Ma J, Gauthier E, Broughton E, Doan J, Rugo H S
Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany.
Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.
ESMO Open. 2025 Apr;10(4):104497. doi: 10.1016/j.esmoop.2025.104497. Epub 2025 Mar 18.
Metastatic breast cancer (mBC) remains incurable, highlighting the importance of patient-reported outcomes (PROs) in treatment decision making. In the randomized phase III PALOMA-2 trial, health-related quality of life (HRQoL) was maintained in patients receiving first-line palbociclib plus letrozole compared with placebo plus letrozole after a median follow-up of 22.3 months. However, little is known about HRQoL for patients taking palbociclib for an extended period of time. Here, we report the PRO results from the PALOMA-2 trial after a median follow-up time of 90 months.
Women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) mBC were randomly assigned 2 : 1 to receive palbociclib plus letrozole (n = 444) or placebo plus letrozole (n = 222). HRQoL was assessed with the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQoL five-dimensions three-level (EQ-5D-3L) questionnaires, administered on site on day 1 of cycles 1, 2, and 3 and then every other cycle from cycle 5 until study end. Treatment arm comparisons were made for change from baseline in QoL and time to deterioration in FACT-B (definitive definition, TTDD).
After a median follow-up of 90 months, no significant differences between treatments were observed for overall change from baseline in FACT-B total, FACT-B subscales, and EQ-5D-3L scores. While TTDD did not differ between treatment arms, TTDD was shorter for patients with disease progression versus those without disease progression (hazard ratio 0.644, P < 0.001). Individual items assessing side-effects and hair loss favored the palbociclib plus letrozole arm versus the letrozole arm; no treatment difference was observed for items assessing pain.
This extended follow-up analysis of PROs in PALOMA-2 shows continued QoL maintenance for patients with ER+/HER2- mBC receiving long-term palbociclib plus letrozole treatment.
转移性乳腺癌（mBC）仍然无法治愈，这凸显了患者报告结局（PROs）在治疗决策中的重要性。在随机III期PALOMA-2试验中，接受一线哌柏西利加来曲唑治疗的患者在中位随访22.3个月后，与接受安慰剂加来曲唑治疗的患者相比，其健康相关生活质量（HRQoL）得以维持。然而，对于长期服用哌柏西利的患者的HRQoL了解甚少。在此，我们报告了PALOMA-2试验在中位随访时间90个月后的PRO结果。
雌激素受体阳性/人表皮生长因子受体2阴性（ER+/HER2-）的mBC女性患者按2:1随机分组，分别接受哌柏西利加来曲唑（n = 444）或安慰剂加来曲唑（n = 222）治疗。采用癌症治疗功能评估-乳腺癌（FACT-B）问卷和欧洲五维健康量表三级版（EQ-5D-3L）对HRQoL进行评估，在第1、2和3周期的第1天现场进行评估，然后从第5周期开始每隔一个周期评估一次，直至研究结束。对治疗组在生活质量方面相对于基线的变化以及FACT-B恶化时间（明确定义，TTDD）进行比较。
中位随访90个月后，在FACT-B总分、FACT-B子量表和EQ-5D-3L评分相对于基线的总体变化方面，各治疗组之间未观察到显著差异。虽然治疗组之间的TTDD没有差异，但疾病进展患者的TTDD短于无疾病进展患者（风险比0.644，P < 0.001）。评估副作用和脱发的单项指标显示，哌柏西利加来曲唑组优于来曲唑组；在评估疼痛的指标方面未观察到治疗差异。
PALOMA-2试验中对PROs的这一延长随访分析表明，接受长期哌柏西利加来曲唑治疗的ER+/HER2- mBC患者的生活质量持续得到维持。
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