Agostinetto Elisa, Ameye Lieveke, Martel Samuel, Aftimos Philippe, Pondé Noam, Maurer Christian, El-Abed Sarra, Wang Yingbo, Vicente Malou, Chumsri Saranya, Bliss Judith, Kroep Judith, Colleoni Marco, Petrelli Fausto, Del Mastro Lucia, Moreno-Aspitia Alvaro, Piccart Martine, Paesmans Marianne, de Azambuja Evandro, Lambertini Matteo
Academic Trials Promoting Team, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Humanitas University, Department of Biomedical Sciences, via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy.
NPJ Breast Cancer. 2022 Jul 20;8(1):87. doi: 10.1038/s41523-022-00452-8.
The prognostic performance of PREDICT in patients with HER2-positive early breast cancer (EBC) treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies is unclear. Therefore, we investigated its prognostic performance using data extracted from ALTTO, a phase III trial evaluating adjuvant lapatinib ± trastuzumab vs. trastuzumab alone in patients with HER2-positive EBC. Our analysis included 2794 patients. After a median follow-up of 6.0 years (IQR, 5.8-6.7), 182 deaths were observed. Overall, PREDICT underestimated 5-year OS by 6.7% (95% CI, 5.8-7.6): observed 5-year OS was 94.7% vs. predicted 88.0%. The underestimation was consistent across all subgroups, including those according to the type of anti HER2-therapy. The highest absolute differences were observed for patients with hormone receptor negative-disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively). AUC under the ROC curve was 73.7% (95% CI 69.7-77.8) in the overall population, ranging between 61.7% and 77.7% across the analyzed subgroups. In conclusion, our analysis showed that PREDICT highly underestimated OS in HER2-positive EBC. Hence, it should be used with caution to give prognostic estimation to HER2-positive EBC patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.
在现代采用有效化疗和抗HER2靶向治疗的HER2阳性早期乳腺癌（EBC）患者中，PREDICT的预后性能尚不清楚。因此，我们使用从ALTTO试验中提取的数据研究了其预后性能，ALTTO是一项III期试验，评估在HER2阳性EBC患者中辅助使用拉帕替尼±曲妥珠单抗与单独使用曲妥珠单抗的疗效。我们的分析纳入了2794例患者。中位随访6.0年（四分位间距，5.8 - 6.7年）后，观察到182例死亡。总体而言，PREDICT低估了5年总生存率6.7%（95%置信区间，5.8 - 7.6）：观察到的5年总生存率为94.7%，而预测值为88.0%。在所有亚组中，包括根据抗HER2治疗类型划分的亚组，这种低估都是一致的。在激素受体阴性疾病、淋巴结受累和肿瘤体积较大的患者中观察到的绝对差异最高（分别为13.0%、15.8%和15.3%）。总体人群中ROC曲线下的AUC为73.7%（95%置信区间69.7 - 77.8），在各分析亚组中范围为61.7%至77.7%。总之，我们的分析表明，PREDICT在HER2阳性EBC中严重低估了总生存率。因此，在对现代采用有效化疗和抗HER2靶向治疗的HER2阳性EBC患者进行预后评估时，应谨慎使用PREDICT。
