A Phase II Randomized Study of Paclitaxel Alone or Combined with Pelareorep with or without Avelumab in Metastatic Hormone Receptor-Positive Breast Cancer: The BRACELET-01/PrE0113 Study.

We determined the objective response rate(ORR) with paclitaxel (Pac), Pac + Pel, or Pac + Pel + avelumab (Ave).

我们确定了紫杉醇 (Pac)、Pac + Pel 或 Pac + Pel + 阿维单抗 (Ave) 的客观缓解率 (ORR)。

patients_and_methods

Patients with hormone receptor-positive, HER2-negative metastatic breast cancer who had progressed on at least one line of endocrine therapy with a cyclin-dependent kinase 4/6 inhibitor and had not received chemotherapy for metastatic breast cancer were eligible.

接受过至少一线内分泌治疗且进展的激素受体阳性、HER2阴性转移性乳腺癌患者，且未接受过转移性乳腺癌化疗，符合入组条件。

Patients were randomized 1:1:1 to Pac, Pac/Pel, or Pac/Pel/Ave after a three-patient run-in confirmed safety of the triplet regimen.

患者按1:1:1的比例随机分配至Pac、Pac/Pel或Pac/Pel/Ave治疗组，此前三名患者的安全性测试已确认三药联合方案的安全性。

Response was assessed every 8 weeks until week 16 and then every 12 weeks using RECIST v1.1.

使用RECIST v1.1标准，每8周评估一次反应，直至第16周，之后每12周评估一次。

The primary endpoint was 16-week ORR.

主要终点是16周的客观缓解率(ORR)。

Statistical comparison across arms was not planned.

各组之间的统计比较并未计划。

Results

Forty-eight patients were enrolled, with 45 randomized.

共有48名患者被纳入研究，其中45名进行了随机分组。

The 16-week ORR was 20%, 31%, and 14% in the Pac, Pac/Pel, and Pac/Pel/Ave arms, respectively.

在Pac、Pac/Pel和Pac/Pel/Ave治疗组中，16周的客观缓解率分别为20%、31%和14%。

The median progression-free survivalwas 6.4, 12.1, and 5.8 months in the Pac, Pac/Pel, and Pac/Pel/Ave arms, respectively.

在Pac、Pac/Pel和Pac/Pel/Ave治疗组中，无进展生存期的中位数分别为6.4个月、12.1个月和5.8个月。

There were more adverse events, particularly infusion reactions, in the combination arms than the Pac arm.

在联合治疗组中，特别是输注反应的不良事件比Pac单药治疗组更多。

Expansion of peripheral T-cell clones was observed by cycle 4 in Pac/Pel but not the Pac or Pac/Pel/Ave arms.

在Pac/Pel组中，外周T细胞克隆的扩增在第4个周期被观察到，但在Pac或Pac/Pel/Ave组中并未观察到。

Conclusions

The addition of Pel to Pac was associated with increased toxicity, expanded peripheral T-cell clones, and numerically increased the ORR and progression-free survivalcompared with Pac; Pac/Pel/Ave further increased toxicity and blunted T-cell responses without obvious increase in efficacy.

将Pel添加到Pac中与增加的毒性、外周T细胞克隆扩增以及客观缓解率和无进展生存期的数值增加相关，与单独使用Pac相比；Pac/Pel/Ave进一步增加了毒性并减弱了T细胞反应，而没有明显的疗效增加。

Investigation of the Pac/Pel combination warrants consideration with careful attention to acute toxicity.

对Pac/Pel联合方案的调查值得考虑，但需仔细关注急性毒性。