Evidence map›Paper›PMID 36716289›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

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

Grazia Arpino, Juan de la Haba Rodríguez, Jean-Marc Ferrero, Sabino De Placido, C Kent Osborne, Dirk Klingbiel, Valentine Revelant, Christine Wohlfarth, Raf Poppe, Mothaffar F Rimawi and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
9.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

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  19. Updates in Treatment of HER2-positive Metastatic Breast Cancer.Current treatment options in oncology · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 5 countries.

Grazia ArpinoDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.ORCID 0000-0002-4074-2530
Juan de la Haba RodríguezDepartment of Medicine, University of Córdoba, Córdoba, Spain.ORCID 0000-0001-5111-1702
Jean-Marc FerreroDepartment of Medical Oncology, Centre Antoine Lacassagne, Nice, France.ORCID 0000-0003-0069-3743
Sabino De PlacidoDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.ORCID 0000-0001-5077-6286
C Kent OsborneDan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas.ORCID 0000-0002-0044-618X
Dirk KlingbielProduct Development Data Sciences, F. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0002-9914-0243
Valentine RevelantProduct Development Safety Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0001-8924-5976
Christine WohlfarthGlobal Product Development Medical Affairs - Oncology, F. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0001-6735-4100
Raf PoppeGlobal Product Development Medical Affairs - Oncology, F. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID 0000-0001-9434-2674
Mothaffar F RimawiDan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas.ORCID 0000-0002-4284-5656
PERTAIN Study Group
Roche (Switzerland) · CHChildren's Cancer Center · USUniversity of Naples Federico II · ITCentre Antoine Lacassagne · FRInstituto Maimónides de Investigación Biomédica de Córdoba · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn 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

methodsPatients (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.

resultsMedian 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%).

conclusionsThe 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.

Indexed as

Breast NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsErb-b2 Receptor Tyrosine KinasesFemaleHumansTrastuzumabAntibodies, Monoclonal, HumanizedAromatase InhibitorsErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumab

Identifiers

PMID36716289
PMCPMC10102835
OpenAlexW4318586343

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.