British Columbia Cancer Agency, Vancouver, BC, Canada.
Cancer Trials Ireland, Dublin, Ireland.
Breast. 2021 Oct;59:321-326. doi: 10.1016/j.breast.2021.07.017. Epub 2021 Jul 28.
In the PALOMA-2 trial, palbociclib in combination with letrozole prolonged progression-free survival (PFS) and exhibited an acceptable safety profile in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ABC). This post hoc analysis of PALOMA-2 evaluated the efficacy and safety of palbociclib plus letrozole in patients with preexisting conditions grouped by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC).
Postmenopausal patients without prior treatment for ABC were randomized 2:1 to receive palbociclib (125 mg/d on a 3 weeks on/1 week off schedule) plus letrozole (2.5 mg/d, continuous) or placebo plus letrozole. Patients were grouped by the following MedDRA SOC preexisting conditions: gastrointestinal, musculoskeletal, metabolic, and vascular/cardiac. Median PFS was estimated by the Kaplan-Meier method, and treatment emergent adverse events (AEs) were compared between treatment arms within each preexisting condition subgroup.
At baseline, 276 (41.4 %) patients had preexisting gastrointestinal disorders, 390 (58.6 %) had musculoskeletal disorders, 259 (38.9 %) had metabolic disorders, and 382 (57.4 %) had vascular/cardiac disorders. Baseline characteristics were similar between subgroups and between each arm within subgroups. Regardless of baseline preexisting condition, palbociclib plus letrozole prolonged PFS compared with placebo plus letrozole. Treatment-emergent AEs associated with palbociclib plus letrozole and dose modifications due to AEs were similar across preexisting condition subgroups.
This post hoc analysis of PALOMA-2 demonstrated a favorable effect of palbociclib on PFS and a safety profile consistent with previous observations, regardless of underlying preexisting condition. Pfizer Inc (NCT01740427).
在 PALOMA-2 试验中，帕博西尼联合来曲唑延长了无进展生存期（PFS），并且在雌激素受体阳性/人表皮生长因子受体 2 阴性晚期乳腺癌（ABC）患者中表现出可接受的安全性特征。这项 PALOMA-2 的事后分析评估了帕博西尼联合来曲唑在按 MedDRA 系统器官分类（SOC）预先存在疾病分组的患者中的疗效和安全性。
无 ABC 既往治疗史的绝经后患者按 2:1 随机分配接受帕博西尼（125mg/d，每 3 周用药 1 周停药）加来曲唑（2.5mg/d，持续）或安慰剂加来曲唑。患者按以下 MedDRA SOC 预先存在的疾病分组：胃肠道、肌肉骨骼、代谢和血管/心脏。中位 PFS 通过 Kaplan-Meier 方法估计，并且在每个预先存在的疾病亚组内比较治疗中出现的不良事件（AE）。
在基线时，276（41.4%）例患者有预先存在的胃肠道疾病，390（58.6%）例患者有肌肉骨骼疾病，259（38.9%）例患者有代谢疾病，382（57.4%）例患者有血管/心脏疾病。亚组之间和每个亚组内的各个治疗臂之间的基线特征相似。无论基线时预先存在的疾病如何，与安慰剂加来曲唑相比，帕博西尼加来曲唑均延长了 PFS。与帕博西尼加来曲唑相关的治疗中出现的 AEs 和因 AEs 进行剂量调整在预先存在的疾病亚组中相似。
这项 PALOMA-2 的事后分析表明，帕博西尼对 PFS 有有利影响，且安全性与先前观察一致，无论潜在的预先存在的疾病如何。辉瑞公司（NCT01740427）。
