Palbociclib, Trastuzumab, and Endocrine Therapy in Pretreated HER2-Positive and PAM50 Luminal Advanced Breast Cancer: Randomized Phase II, SOLTI-1303 PATRICIA Trial.

patients_and_methods

SOLTI-PATRICIA cohort C is a randomized, multicenter, prospective, open-label, phase II study.

SOLTI-PATRICIA队列C是一个随机、多中心、前瞻性、开放标签的II期研究。

Pretreated patients with HER2-positive, hormone receptor-positive, and PAM50 luminal A/B advanced breast cancer were randomized 1:1 to receive either i) the triplet regimen or ii) trastuzumab-based treatment of physician's choice (TPC).

接受过治疗的HER2阳性、激素受体阳性以及PAM50 luminal A/B型晚期乳腺癌患者按1:1的比例随机分配接受i) 三药联合方案或ii) 选择性曲妥珠单抗治疗（TPC）。

Patients allocated in the TPC arm were eligible for re-randomization upon disease progression, if the inclusion criteria were still met.

在TPC组中的患者在疾病进展后，如果仍符合纳入标准，则有资格进行重新随机分配。

The primary endpoint was investigator-assessed progression-free survival(PFS) per RECIST version 1.1.

主要终点是根据RECIST版本1.1评估的无进展生存期（PFS）。

Results

A total of 264 participants were prescreened from August 2019 to 2023, and 73 patients were randomly assigned (including seven re-randomizations).

从2019年8月到2023年，共有264名参与者进行了预筛选，其中73名患者被随机分配（包括七次重新随机分配）。

In the TPC arm, 48.5% were treated with trastuzumab plus chemotherapy, 39.4% with trastuzumab emtansine, and 12.1% with trastuzumab plus ET.

在TPC组中，48.5%接受了曲妥珠单抗加化疗治疗，39.4%接受了曲妥珠单抗emtansine治疗，12.1%接受了曲妥珠单抗加内分泌治疗。

The triplet was associated with a significantly better PFS compared with TPC [stratified hazard ratio= 0.52; 95% confidence interval(CI), 0.29-0.95; two-sided P = 0.03].

与TPC相比，三药联合方案与显著更佳的无进展生存期相关[分层风险比=0.52; 95%置信区间(CI), 0.29-0.95; 双侧P=0.03]。

PFS rates after 24 months were 24.0% with the triplet and 4.3% in the TPC arm.

24个月无进展生存（PFS）率在三药联合治疗组为24.0%，而在TPC治疗组为4.3%。

The overall response rate was 18.9% (95% CI, 8.6-35.7) and 7.1% (95% CI, 1.2-25.0), respectively.

总体缓解率分别为18.9%（95%置信区间，8.6-35.7）和7.1%（95%置信区间，1.2-25.0）。

In the triplet arm, grade ≥3 adverse events occurred in 61.5% of patients, with neutropenia being the most frequent (53.9%).

在三药联合治疗组中，61.5%的患者出现了3级或更高级别的不良事件，其中中性粒细胞减少症是最常见的不良事件（发生率为53.9%）。

No permanent discontinuations due to toxicity were observed.

未观察到因毒性导致的永久性停药。

Conclusions

Combining palbociclib, trastuzumab, and ET was safe and significantly improved PFS, compared with TPC, in previously treated patients with HER2-positive, PAM50 luminal A/B advanced breast cancer.

联合使用帕博西利、曲妥珠单抗和内分泌治疗（ET）对于既往接受过治疗的HER2阳性、PAM50 luminal A/B型晚期乳腺癌患者是安全的，并且与标准治疗方案（TPC）相比，显著改善了无进展生存期（PFS）。