Predictors of Long-Term Disease Control and Survival for HER2-Positive Advanced Breast Cancer Patients Treated With Pertuzumab, Trastuzumab, and Docetaxel

Background: HER2-positive advanced breast cancer (ABC) is associated with significant heterogeneity in long-term disease control and survival. Prognostic models for HER2-positive ABC patients considering first-line pertuzumab, trastuzumab, and docetaxel have not been evaluated. Methods: A pre-treatment prognostic model for progression-free survival (PFS) and overall survival (OS) was developed for HER2-positive ABC patients initiating first-line pertuzumab, trastuzumab, and docetaxel using clinicopathological data from the randomized clinical trial CLEOPATRA (n = 408). Cox proportional hazard analysis with a backwards deletion process was used. Results: Metastatic sites count (<3 vs. ≥ 3) and lactate dehydrogenase (LDH) (≤ ULN vs. >ULN) were identified as common pre-treatment risk predictors for PFS and OS (P < 0.05). Based on these two factors, patients can be characterized as one of three prognostic groups (good = 0 factors; intermediate = 1 factor; poor = 2 factors). The prognostic groups were associated with significantly different PFS (P < 0.001), with 3-year PFS probabilities of 44% (36–55), 28% (22–36), and 17% (11–29) for the good, intermediate and poor prognostic groups, respectively. Similarly, there was significant differences in OS (P < 0.001), with 4-year OS probabilities of 75% (95% CI: 67–84), 60% (53–68) and 31% (21–45) for the good, intermediate and poor prognostic groups, respectively. Conclusions: Pre-treatment prognostic groups identified for HER2-positive ABC patients initiating first-line pertuzumab, trastuzumab, and docetaxel had significantly different long-term disease control and survival outcomes.