Final results from PERUSE, a global study of pertuzumab (P), trastuzumab (H) and investigator’s chosen taxane as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC)

Background P + H + docetaxel (DOC) is the standard first-line therapy for HER2-positive LR/mBC, based on results from the phase 3 CLEOPATRA trial. The single-arm PERUSE study (NCT01572038) assessed the safety and efficacy of P + H with investigator-selected taxane in this setting. We present final safety and efficacy results.

Methods Patients (pts) with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy [ET]) received DOC, paclitaxel (PAC) or nab-PAC with H + P until disease progression or unacceptable toxicity. Primary endpoint was safety. Progression-free survival (PFS) and overall survival (OS) were secondary endpoints. Subgroup analyses according to taxane and hormone receptor (HR) status were prespecified.

Results 1436 pts were treated. At data cut-off (26 Aug 2019), median follow-up was 69 mo (range 0-87). The safety profile and efficacy results were consistent with CLEOPATRA. Grade ≥3 adverse events (AEs) occurred in 61% of pts (10% neutropenia, 8% diarrhoea) and were considered related to P in 20%, H in 17% and taxane in 36%. Median PFS was ~21 mo, irrespective of HR status. 295 pts (21%) received maintenance ET. 679 pts (47%) received post-study anticancer therapy (monoclonal antibodies in 34%: 25% H, 19% T-DM1, 7% P).

Conclusions Final results from PERUSE are consistent with CLEOPATRA, support first-line P + H + taxane therapy for HER2-positive LR/mBC and suggest PAC as a valid alternative to DOC as backbone chemotherapy.

Interessenkonflikt

Nothing to disclose Bondarenko Honoraria (self) Miles Roche, Eisai, Genomic Health Ciruelos Roche, Lilly, Novartis, Pfizer Schneeweiss Roche, Celgene, Pfizer, AstraZeneca, Novartis, MSD, Tesaro, Lilly Puglisi Roche Wardley Roche, Novartis, Pfizer, Eli Lilly, Daiichi-Sankyo, MSD, AstraZeneca, Athenex, Gerson Lehrman Group, Guidepoint Global, Coleman Expert Network, Helios, Health Care America Bachelot Roche, Novartis, AstraZeneca, Pfizer, Seattle Genetics Honoraria (institution) Wardley AstraZeneca, Lilly, Novartis, Roche Advisory/Consultancy Miles Roche, Eisai, Genomic Health Ciruelos Roche, Lilly, Novartis, Pfizer Schneeweiss Roche, AstraZeneca Puglisi Amgen, Roche, Novartis Peretz-Yablonski Pfizer, J&J, Lilly, Medison, Roche, AstraZeneca, MSD, Novartis Campone Advisory Board: AstraZeneca, Novartis, AbbVie, Sanofi, Pfizer, Sandoz, ACCORD, Lilly GT1 group; consultant: Pierre Fabre Oncology, Sanofi, Novartis, Servier, Sanofi Errihani Roche, MSD, Pfizer, Merck Paluch-Shimon Roche, Novartis, AstraZeneca, Pfizer, Eli Lilly Wardley Roche, Novartis, Pfizer, Lilly, Daiichi-Sankyo, MSD Oncology, NAPP Pharma, AstraZeneca, Athenex, Accord Research, Coleman Research, Gerson Lehrman Group, Guidepoint Global Speaker Bureau/Expert testimony Errihani Novartis, Amgen Paluch-Shimon Roche, Novartis, AstraZeneca, Pfizer, Eli Lilly Wardley Roche, Novartis, Pfizer, Lilly, AstraZeneca, Eisai Leadership role Wardley Medical Director of NIHR Manchester Clinical Research Facility at The Christie, Strategy Director for Association of Cancer Physicians, Committee Member UK Breast Cancer Group, Committee Member NHS England Chemotherapy Clinical Reference Group, ESMO Breast cancer faculty Research grant/Funding (self) Puglisi Roche, Eisai, AstraZeneca Wardley NIHR Research grant/Funding (institution) Schneeweiss Roche, Celgene, AbbVie, Molecular Partner Wardley Most Cancer Pharma including Novartis, Pfizer, Roche, Seattle Genetics, 1G1 Therapeutics, Accord Research, AstraZeneca, Athenext, Daiichi Sankyo, Lilly, MSD Oncology Merot Roche Bachelot Novartis, AstraZeneca, Pfizer Travel/Accommodation/Expenses Ciruelos Roche, Pfizer Schneeweiss Roche, Celgene, Pfizer Puglisi Roche, Celgene Peretz-Yablonski BMS, Medison Campone Pfizer, Novartis, Roche, AstraZeneca Nowecki Roche Wardley Roche, MSD, Daiichi Sankyo Bachelot Roche, Novartis, AstraZeneca, Pfizer Shareholder/Stockholder/Stock options Wardley Andrew Wardley Limited, Manchester Cancer Academy, Outreach Research & Innovation Group Limited du Toit Roche Klingbiel Roche Revelant Roche Full/Part-time employment Wardley Medical Director of NIHR Manchester Clinical Research Facility at The Christie du Toit Roche Klingbiel Roche Revelant Roche Officer/Board of Directors Wardley Andrew Wardley Limited, Manchester Cancer Academy, Outreached Research & Innovation Group Limited Spouse/Financial dependent Wardley Andrew Wardley Limited

Publication History

Article published online:
01 June 2021