University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, Department of Medicine (Hematology/Oncology), 1825 4th Street, 3rd Floor, Box 1710, San Francisco, CA, 94158, USA.
Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, 101 Daehak-ro, Jonro-gu, Seoul 03080, Republic of Korea.
Breast. 2022 Dec;66:324-331. doi: 10.1016/j.breast.2022.11.005. Epub 2022 Nov 15.
Previous analyses from the PALOMA-2 and PALOMA-3 studies showed that palbociclib (PAL) plus endocrine therapy (ET) prolongs time to first subsequent chemotherapy (TTC) versus placebo (PBO) plus ET in the overall population of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+/HER2-) advanced breast cancer (ABC). Here, we evaluated TTC in relevant patient subgroups.
These post hoc analyses evaluated TTC by subgroup using data from 2 randomized, phase 3 studies of women with HR+/HER2- ABC. In PALOMA-2, postmenopausal patients previously untreated for ABC were randomized 2:1 to receive PAL (125 mg/day, 3/1-week schedule) plus letrozole (LET; 2.5 mg/day; n = 444) or PBO plus LET (n = 222). In PALOMA-3, premenopausal or postmenopausal patients whose disease had progressed after prior ET were randomized 2:1 to receive PAL (125 mg/day, 3/1-week schedule) plus fulvestrant (FUL; 500 mg; n = 347) or PBO plus FUL (n = 174).
First subsequent chemotherapy was received by 35.5% and 56.2% in PALOMA-2 and PALOMA-3 after progression on palbociclib plus ET or placebo plus ET. Across all subgroups analyzed, the median progression-free survival (PFS) was longer in the PAL plus ET arm than the PBO plus ET arm. TTC was longer with PAL plus ET versus PBO plus ET across the same patient subgroups in both studies.
Across all subgroups, PAL plus ET versus PBO plus ET had longer median PFS and resulted in prolonged TTC in both the PALOMA-2 and PALOMA-3 studies. Pfizer Inc (NCT01740427, NCT01942135).
来自 PALOMA-2 和 PALOMA-3 研究的先前分析表明，帕博西尼（PAL）联合内分泌治疗（ET）可延长激素受体阳性/人表皮生长因子受体 2 阴性（HR+/HER2-）晚期乳腺癌（ABC）患者的总人群中无后续化疗的首次时间（TTC），而非安慰剂（PBO）联合 ET。在此，我们评估了相关患者亚组的 TTC。
这两项事后分析使用来自 2 项针对 HR+/HER2-ABC 女性的随机、3 期研究的数据，按亚组评估 TTC。在 PALOMA-2 中，未经 ABC 治疗的绝经后患者按 2:1 随机分配接受 PAL（125mg/天，每 3 周 1 次方案）联合来曲唑（LET；2.5mg/天；n=444）或 PBO 联合 LET（n=222）。在 PALOMA-3 中，疾病在先前 ET 后进展的绝经前或绝经后患者按 2:1 随机分配接受 PAL（125mg/天，每 3 周 1 次方案）联合氟维司群（FUL；500mg；n=347）或 PBO 联合 FUL（n=174）。
在 PALOMA-2 和 PALOMA-3 中，接受 PAL 联合 ET 或 PBO 联合 ET 治疗后进展的患者中，分别有 35.5%和 56.2%接受了后续化疗。在所有分析的亚组中，PAL 联合 ET 组的中位无进展生存期（PFS）长于 PBO 联合 ET 组。在这两项研究中，相同的患者亚组中，PAL 联合 ET 组的 TTC 长于 PBO 联合 ET 组。
在所有亚组中，PAL 联合 ET 组与 PBO 联合 ET 组的中位 PFS 较长，并且在 PALOMA-2 和 PALOMA-3 研究中均导致 TTC 延长。辉瑞公司（NCT01740427，NCT01942135）。
