Survival Analysis of the WSG TP-II Trial: Neoadjuvant Trastuzumab and Pertuzumab Plus Endocrine Therapy Versus Chemotherapy in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer.

Analysis of the primary end point revealed that the pCR rate in the paclitaxel + trastuzumab + pertuzumab arm was superior compared with that in the ET + trastuzumab + pertuzumab arm (56.4% v 23.7%).

主要终点分析显示，紫杉醇+曲妥珠单抗+帕妥珠单抗组的pCR率优于内分泌治疗+曲妥珠单抗+帕妥珠单抗组（56.4%对比23.7%）。

Methods

Here, we present the final 5-year survival analysis of this multicenter, randomized phase II, open-label trial, with 207 participants randomly assigned 1:1 to the two study arms.

在这里，我们展示了这项多中心、随机化二期、开放标签试验的最终5年生存分析结果，共有207名参与者按1:1的比例随机分配到两个研究组。

All patients received dual HER2 blockade in the adjuvant setting.

所有患者在辅助治疗阶段接受了双HER2阻断治疗。

Further standard chemotherapy was obligatory in all patients with non-pCR, but optional after pCR.

所有非完全缓解（non-pCR）患者必须接受进一步的标准化疗，但在完全缓解（pCR）后可选择是否接受化疗。

Results

After a 5-year follow-up, an overall survivalrate of 100% (95% CI, 100.0 to 100.0) in the ET arm versus 97.9% (95% CI, 95.0 to 100.0) in the paclitaxel arm was estimated.

经过5年的随访，估计实验治疗（ET）组的总生存率为100%（95% 置信区间，100.0至100.0），而紫杉醇组为97.9%（95% 置信区间，95.0至100.0）。

The corresponding 5-year event-free survival-ductal carcinoma in situ rates were 92.1% (95% CI, 86.6 to 97.9) versus 94.8% (95% CI, 90.5 to 99.3), and 5-year invasive disease-free survival rates were 97.7% (95% CI, 94.5 to 100.0) versus 79.8% (95% CI, 55.6 to 100.0).

相应的5年无事件生存率-导管原位癌分别为92.1%（95%置信区间，86.6至97.9）与94.8%（95%置信区间，90.5至99.3），5年侵袭性疾病无复发生存率分别为97.7%（95%置信区间，94.5至100.0）与79.8%（95%置信区间，55.6至100.0）。

Conclusions

Our results show excellent survival outcomes in patients with hormone receptor-positive/HER2-positive eBC who received either a de-escalated chemotherapy or ET in combination with trastuzumab and pertuzumab in the neoadjuvant setting.

我们的结果显示，在接受降阶梯化疗或内分泌治疗联合曲妥珠单抗和帕妥珠单抗的新辅助治疗的激素受体阳性/HER2阳性早期乳腺癌患者中，生存结果非常优秀。

WSG TP-II confirms the safety and efficacy of a de-escalated and well-tolerated neoadjuvant therapy approach with pCR-guided adjuvant therapy in hormone receptor-positive/HER2-positive eBC.

WSG TP-II研究确认了在激素受体阳性/HER2阳性早期乳腺癌中，以病理完全缓解(pCR)指导辅助治疗的降阶梯且耐受性良好的新辅助治疗方案的安全性和有效性。