5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or...

Area of Science:

• Oncology
• Clinical Trials
• Breast Cancer Research

Background:

• The NeoSphere trial initially demonstrated improved pathological complete response with neoadjuvant pertuzumab, trastuzumab, and docetaxel versus trastuzumab and docetaxel in HER2-positive breast cancer.
• This report focuses on the 5-year progression-free survival (PFS), disease-free survival (DFS), and safety outcomes.

Purpose of the Study:

• To evaluate the 5-year progression-free survival (PFS) and disease-free survival (DFS) in patients with HER2-positive breast cancer treated with different neoadjuvant regimens.
• To assess the long-term safety and tolerability of these neoadjuvant treatments.

Main Methods:

• A multicenter, open-label, phase 2 randomized trial involving treatment-naive adults with locally advanced, inflammatory, or early-stage HER2-positive breast cancer.
• Patients received four neoadjuvant cycles of: trastuzumab + docetaxel (Group A), pertuzumab + trastuzumab + docetaxel (Group B), pertuzumab + trastuzumab (Group C), or pertuzumab + docetaxel (Group D).
• Post-surgery, all patients received FEC chemotherapy and trastuzumab for a total of 1 year of treatment. PFS and DFS were analyzed in the intention-to-treat and post-surgery populations, respectively.

Main Results:

• At 5 years, progression-free survival rates were 81% (Group A), 86% (Group B), 73% (Group C), and 73% (Group D).
• Disease-free survival rates were consistent: 81% (Group A), 84% (Group B), 80% (Group C), and 75% (Group D).
• Patients achieving a total pathological complete response (tpCR) had significantly longer PFS (85%) compared to those who did not (76%). Safety profiles were similar across groups, with neutropenia being the most common severe adverse event.

Conclusions:

• The 5-year PFS and DFS data support the benefit of neoadjuvant pertuzumab when added to trastuzumab and docetaxel in HER2-positive breast cancer.
• Achieving a total pathological complete response (tpCR) appears to be a reliable early indicator of favorable long-term outcomes in this patient population.