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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)
Miles, D. W. Ciruelos, E. M. Schneeweiss, A. Puglisi, F. Peretz-Yablonski, T. Campone, M. Bondarenko, I. Nowecki, Z. Errihani, H. Paluch-Shimon, S.
Miles, D. W.
Ciruelos, E. M.
Schneeweiss, A.
Puglisi, F.
Peretz-Yablonski, T.
Campone, M.
Bondarenko, I.
Nowecki, Z.
Errihani, H.
Paluch-Shimon, S.
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Abstract
Background: 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).
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Miles 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.