Evidence map›Paper›PMID 24960402›Full record

Trial reportBritish journal of cancer2014

A phase IIa dose-finding and safety study of first-line pertuzumab in combination with trastuzumab, capecitabine and cisplatin in patients with HER2-positive advanced gastric cancer.

Y-K Kang, S Y Rha, P Tassone, J Barriuso, R Yu, T Szado, A Garg, Y-J Bang

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 pooled it
6.4field-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

55 citing papers in PubMed, 1 synthesis or guideline pooled it, 94 citations in OpenAlex.

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  15. Targeting PI3K/AKT/mTOR and MAPK Signaling Pathways in Gastric Cancer.International journal of molecular sciences · 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

8 authors at 4 institutions in 3 countries.

Y-K KangAsan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro, 43-gil, Songpa-gu, Seoul 138-736, Korea.
S Y RhaYonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.
P TassoneMedical Oncology Unit, Magna Graecia University, Viale Europa, 88100 Catanzaro, Italy.
J BarriusoHospital Universitario La Paz, Paseo de la Castellana 261, 28046 Madrid, Spain.
R YuGenentech, 1 DNA Way, South San Francisco, CA 94080, USA.
T SzadoGenentech, 1 DNA Way, South San Francisco, CA 94080, USA.
A GargGenentech, 1 DNA Way, South San Francisco, CA 94080, USA.
Y-J BangSeoul National University College of Medicine, 01 Daehak-ro, Jongno-gu, Seoul 110-744, Korea.
Hospital Universitario La Paz · ESMagna Graecia University · ITSeoul National University · KRUniversity of Ulsan · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPertuzumab plus trastuzumab provides a more comprehensive blockade of HER2 signalling than trastuzumab alone. Therefore, we conducted a phase IIa study of the pharmacokinetics and safety of pertuzumab plus trastuzumab and chemotherapy in advanced gastric cancer (aGC).

methodsPatients received pertuzumab 840 mg for cycle 1 and 420 mg q3w for cycles 2-6 (Arm A) or pertuzumab 840 mg q3w for six cycles (Arm B). Trastuzumab, cisplatin and capecitabine were also given for six cycles, then trastuzumab q3w until disease progression or unmanageable toxicity. The co-primary endpoints were day 43 pertuzumab serum trough concentration (Cmin) and safety.

resultsThirty patients were randomised. Mean pertuzumab Cmin at day 43 was 40.0 μg ml(-1) (s.d.: 17.3) in Arm A and 62.7 μg ml(-1) (29.1) in Arm B. Mean day 43 Cmin in Arm A was ~37% lower than that seen in metastatic breast cancer. The safety profiles were similar between arms and treatment was well tolerated. Partial responses were achieved by 86% and 55% of patients in Arms A and B, respectively.

conclusionsOn the basis of the pharmacokinetic and safety data, the 840 mg q3w pertuzumab dose has been selected for a phase III study of pertuzumab, trastuzumab and chemotherapy in HER2-positive aGC.

Indexed as

AdenocarcinomaAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCisplatinDeoxycytidineDiarrheaErb-b2 Receptor Tyrosine KinasesFemaleFluorouracilHumansMaleMiddle AgedNeoplasm StagingStomach NeoplasmsAntibodies, Monoclonal, HumanizedCapecitabineCisplatinDeoxycytidineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFluorouracilpertuzumabTrastuzumab

Identifiers

PMID24960402
PMCPMC4134501
OpenAlexW2024326621

What OpenQuestion holds

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LicenceCC BY-NC-SA
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Registered trials

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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.