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Randomized Controlled Trial
. 2023 Apr 14;29(8):1468-1476.
doi: 10.1158/1078-0432.CCR-22-1092.

Pertuzumab, Trastuzumab, and an Aromatase Inhibitor for HER2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer: PERTAIN Final Analysis

Grazia Arpino  1 , Juan de la Haba Rodríguez  2   3   4 , Jean-Marc Ferrero  5 , Sabino De Placido  1 , C Kent Osborne  6 , Dirk Klingbiel  7 , Valentine Revelant  8 , Christine Wohlfarth  9 , Raf Poppe  9 , Mothaffar F Rimawi  6 ; PERTAIN Study Group
Affiliations
Randomized Controlled Trial

Pertuzumab, Trastuzumab, and an Aromatase Inhibitor for HER2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer: PERTAIN Final Analysis

Grazia Arpino et al. Clin Cancer Res. .

Abstract

Purpose: In PERTAIN's primary analysis (31 months' median follow-up), adding pertuzumab to trastuzumab and an aromatase inhibitor (AI) with/without chemotherapy significantly improved progression-free survival (PFS) in patients with previously untreated HER2-positive and hormone receptor-positive metastatic or locally advanced breast cancer (M/LABC). A potentially enhanced treatment effect was observed in patients with no induction chemotherapy. We present the final analysis (>6 years' median follow-up).

Patients and methods: Patients (N = 258) were randomized 1:1 to pertuzumab (loading/maintenance: 840/420 mg) plus trastuzumab (loading/maintenance: 8/6 mg/kg) every 3 weeks and an AI (1 mg anastrozole or 2.5 mg letrozole daily; Arm A), or trastuzumab and an AI (Arm B). Induction chemotherapy was at investigator discretion. Primary endpoint: PFS. Key secondary endpoints: overall survival (OS) and safety.

Results: Median PFS was 20.6 versus 15.8 months in Arms A and B, respectively (stratified HR, 0.67; P = 0.006). Median OS was 60.2 versus 57.2 months (stratified HR, 1.05; P = 0.78). Pertuzumab treatment effect was potentially enhanced in patients with no induction chemotherapy (26.6 vs. 12.5 months). Any-grade adverse events (AE) occurred in 122 patients per arm (96.1% vs. 98.4%); grade ≥ 3 AEs in 72 (56.7%) and 51 (41.1%); serious AEs in 46 (36.2%) and 28 (22.6%).

Conclusions: The PFS benefit of pertuzumab was maintained and OS was similar between arms at final analysis. Adding pertuzumab may enhance activity in patients who do not require first-line chemotherapy for M/LABC. No new safety concerns were reported. These data provide additional evidence of the role of first-line pertuzumab and trastuzumab in HER2-positive M/LABC.

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Figures

Figure 1. PFS in (A) the ITT population, (B) patients who were chosen to receive induction chemotherapy, (C) patients who were not chosen to receive induction chemotherapy, and (D) patients with estrogen receptor expression ≥ 10%.
Figure 1.
PFS in (A) the ITT population, (B) patients who were chosen to receive induction chemotherapy, (C) patients who were not chosen to receive induction chemotherapy, and (D) patients with estrogen receptor expression ≥ 10%.
Figure 2. OS in (A) the ITT population, (B) patients who were chosen to receive induction chemotherapy, (C) patients who were not chosen to receive induction chemotherapy, and (D) patients with estrogen receptor expression ≥ 10%.
Figure 2.
OS in (A) the ITT population, (B) patients who were chosen to receive induction chemotherapy, (C) patients who were not chosen to receive induction chemotherapy, and (D) patients with estrogen receptor expression ≥ 10%.
See this image and copyright information in PMC

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