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• W3088976779 abstract "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. 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. 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 0–87). 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 ∼21 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).Table 288PSubgroupPFSOSEvents (%)Median (95% CI), moEvents (%)Median (95% CI), moAll (n=1436)872 (61)20.7 (18.9–23.1)658 (46)65.3 (60.9–70.9)HR+ (n=918)a550 (60)20.6 (18.5–23.8)411 (45)66.7 (62.4–77.3)HR– (n=512)a318 (62)20.7 (17.1–23.8)245 (48)60.2 (52.3–67.7)DOC (n=775)479 (62)19.4 (16.9–22.1)351 (45)66.5 (61.7–77.3)PAC (n=588)356 (61)23.2 (19.6–25.6)273 (46)64.0 (56.6–72.2)Nab-PAC (n=65)35 (54)19.2 (11.7–37.1)28 (43)70.9 (39.7–NE)aHR status unknown in 6 pts. NE=not evaluable. Open table in a new tab aHR status unknown in 6 pts. NE=not evaluable. Final results from PERUSE are consistent with CLEOPATRA, support first-line P + H + taxane therapy for HER2-positive LR/mBC and suggest that PAC is a valid alternative to DOC as backbone chemotherapy." @default.
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• W3088976779 date "2020-09-01" @default.
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• W3088976779 title "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)" @default.
• W3088976779 doi "https://doi.org/10.1016/j.annonc.2020.08.390" @default.
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