Evidence map›Paper›PMID 31183514›Full record

Trial reportCancer chemotherapy and pharmacology2019

Pharmacokinetic and exposure-response analysis of pertuzumab in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer.

Whitney P Kirschbrown, Bei Wang, Ihsan Nijem, Atsushi Ohtsu, Paulo M Hoff, Manish A Shah, Lin Shen, Yoon-Koo Kang, Maria Alsina, Sandhya Girish and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01774786 (A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 31% 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.

NCT01774786 phase3completednot on this map

A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2013 to 2019Enrolled780ConditionsGastric CancerArms5-Fluorouracil, Capecitabine, Cisplatin, Pertuzumab, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
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 7 institutions in 6 countries.

Whitney P KirschbrownClinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.
Bei WangClinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.
Ihsan NijemClinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.
Atsushi OhtsuDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Paulo M HoffInstituto do Câncer de São Paulo, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Manish A ShahMedical Oncology/Solid Tumor Program, Sandra and Edward Meyer Cancer Center, Weill Cornell Medical College, New York, NY, USA.
Lin ShenKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Maria AlsinaVall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.
Sandhya GirishClinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.
Amit GargClinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA. gargamit1@gmail.com.ORCID 0000-0002-4553-9216
Genesys (United States) · USCornell University · USNational Cancer Center Hospital East · JPPeking University · CNUlsan College · KRUniversidade de São Paulo · BRUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo characterize the pharmacokinetics (PK) of pertuzumab and trastuzumab in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer in the randomized, double-blind, phase III JACOB study (NCT01774786), and to evaluate the appropriateness of the pertuzumab regimen in these patients.

methodsPatients received 840 mg intravenous pertuzumab or placebo plus trastuzumab q3w and chemotherapy. Pertuzumab and trastuzumab were administered until disease progression or unacceptable toxicity. Chemotherapy was administered for up to six cycles or disease progression or unacceptable toxicity. Serum concentrations of pertuzumab and trastuzumab were measured. Pertuzumab PK was characterized across treatment cycles. The impact of anti-drug antibodies (ADAs) on pertuzumab PK and the impact of pertuzumab on trastuzumab PK were assessed. An exploratory exposure-efficacy analysis was also conducted.

resultsIn total, 374 patients in the pertuzumab arm had evaluable PK data. The mean observed pertuzumab steady-state serum trough (minimum) concentration (C

conclusionsPertuzumab exposure in JACOB was consistent with prior studies in advanced gastric cancer and breast cancer. The 840 mg q3w dose allowed the majority of patients in JACOB to achieve target pertuzumab concentrations and appears to be an appropriate dose selection.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesEsophageal NeoplasmsEsophagogastric JunctionFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisAntibodies, Monoclonal, HumanizedERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumabHER2-positiveMetastatic gastric cancerMetastatic gastroesophageal junctionPertuzumabPharmacokineticsTrastuzumab

Identifiers

PMID31183514
PMCPMC6682857
OpenAlexW2951180478

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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.