Evidence map›Paper›PMID 28592618›Full record

Trial reportThe oncologist2017

Efficacy and Safety of Pertuzumab and Trastuzumab Administered in a Single Infusion Bag, Followed by Vinorelbine: VELVET Cohort 2 Final Results.

Michael Andersson, José M López-Vega, Thierry Petit, Claudio Zamagni, Valerie Easton, Julia Kamber, Eleonora Restuccia, Edith A Perez

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The oncologist, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03811418 (Phase III Study to Compare Trastuzumab-biosimilar), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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.

NCT03811418 phase3withdrawnnot on this mapstarted 2019, after this paper: background citation

Phase III Study to Compare Trastuzumab-biosimilar (Kanjinti®) Plus Pertuzumab Plus Vinorelbine With Trastuzumab-biosimilar (Kanjinti®) Plus Pertuzumab Plus Docetaxel as First-line Treatment for HER2-positive Advanced Breast Cancer

TypeinterventionalSponsoriOMEDICO AGRan2019 to 2019Enrolled0ConditionsAdvanced Breast Cancer, HER2-positive Breast CancerArmsTrastuzumab, Pertuzumab, Vinorelbine, Docetaxel
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

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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

8 authors at 6 institutions in 6 countries.

Michael AnderssonDepartment of Oncology, Rigshospitalet, Copenhagen, Denmark Michael.Andersson@regionh.dk.
José M López-VegaHospital Universitario Marqués de Valdecilla, Santander, Spain.
Thierry PetitDepartment of Medical Oncology, Paul Strauss Cancer Center and University of Strasbourg, Strasbourg, France.
Claudio ZamagniPoliclinico S. Orsola-Malpighi Hospital, Bologna, Italy.
Valerie EastonF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Julia KamberF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Eleonora RestucciaF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Edith A PerezMayo Clinic, Jacksonville, Florida, USA.
Roche (Switzerland) · CHMarqués de Valdecilla University Hospital · ESMayo Clinic in Florida · USPoliclinico S.Orsola-Malpighi · ITRigshospitalet · DKUniversité de Strasbourg · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVELVET Cohort 1 demonstrated the applicability of pertuzumab, trastuzumab, and vinorelbine as an alternative first-line treatment regimen for patients with HER2-positive locally advanced or metastatic breast cancer (MBC) who cannot receive docetaxel. Co-infusion of pertuzumab and trastuzumab may reduce clinic time and medical resource utilization. We report results from Cohort 2, in which pertuzumab and trastuzumab were co-infused, followed by vinorelbine. PATIENTS AND

methodsDuring cycle 1, patients with HER2-positive locally advanced or MBC received loading doses of pertuzumab (840 mg) and trastuzumab (8 mg/kg) on consecutive days, followed by vinorelbine (25 mg/m

resultsCohort 2 enrolled 107 patients. The ORR was 63.7% (95% confidence interval [CI] 53.0-73.6) in patients with measurable disease (91/107; 85.0%). Median PFS was 11.5 months (95% CI 10.3-15.8). The most common adverse events [AEs] were diarrhea (57.9%), neutropenia (57.0%), and nausea (41.1%). Grade ≥3 AEs occurred in 85 patients (79.4%) and serious AEs in 44 patients (41.1%). Eighteen patients (16.8%) had AEs suggestive of congestive heart failure.

conclusionThese results support the feasibility of pertuzumab and trastuzumab co-infusion from a safety perspective and support Cohort 1 conclusions that vinorelbine offers an alternative chemotherapy companion for pertuzumab and trastuzumab.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsFemaleHumansTrastuzumabTreatment OutcomeVinblastineVinorelbineAntibodies, Monoclonal, HumanizedpertuzumabTrastuzumabVinblastineVinorelbineHER2-positiveMetastatic breast cancerPertuzumabTrastuzumabVinorelbine

Identifiers

PMID28592618
PMCPMC5634765
OpenAlexW2623460738

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.