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)
AuthorsMiles, D. W.
Ciruelos, E. M.
Wardley, Andrew M
Merot, J. L.
du Toit, Y.
AffiliationMedical Oncology, Mount Vernon Cancer Centre, Northwood, UK
MetadataShow full item record
AbstractBackground: P + H + docetaxel (DOC) is the standard first-line therapy for HER2- positive LR/mBC, based on results from the phase III CLEOPATRA trial. The single-arm PERUSE study (NCT01572038) assessed the safety and efficacy of P + H with investigator- selected taxane in this setting. Preliminary results by taxane have been reported [Bachelot, Ann Oncol 2019]; 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 (8/6 mg/kg q3w) + P (840/420 mg q3w) until disease progression or unacceptable toxicity. The 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 (median age 54 y, 69% visceral disease, 55% prior (neo)adjuvant chemotherapy, 36% de novo mBC). At data cut-off (26 Aug 2019), median follow-up was 69 mo (range 0e87). Pts received a median of 16 mo of study treatment (24 cycles of P and H, 6 taxane cycles). 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%. AEs led to discontinuation of P in 10% of pts, H in 9% and taxane in 20%. Median PFS was w21 mo, irrespective of HR status (table). 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).
CitationMiles DW, Ciruelos EM, Schneeweiss A, Puglisi F, Peretz-Yablonski T, Campone M, et al. 288P 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). Annals of Oncology. 2020;31:S356-S7.
JournalAnnals of Oncology
TypeMeetings and Proceedings