Evidence map›Paper›PMID 22817698›Full record

Trial reportBreast cancer research : BCR2012

Results of a phase II open-label, non-randomized trial of cisplatin chemotherapy in patients with BRCA1-positive metastatic breast cancer.

Tomasz Byrski, Rebecca Dent, Pawel Blecharz, Malgorzata Foszczynska-Kloda, Jacek Gronwald, Tomasz Huzarski, Cezary Cybulski, Elzbieta Marczyk, Robert Chrzan, Andrea Eisen and 2 more

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

Trial report in Breast cancer research : BCR, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01611727 (Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer), which is not on this map. Cited by 109 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 1 pooled it
8.3field-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.

NCT01611727 phase2completednot on this map

Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer

TypeinterventionalSponsorPomeranian Medical University SzczecinRan2007 to 2009Enrolled20ConditionsBRCA1 Mutation, Metastatic Breast CancerArmsCisplatin
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 1 synthesis or guideline pooled it, 208 citations in OpenAlex.

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  7. TBCRC009: A Multicenter Phase II Clinical Trial of Platinum Monotherapy With Biomarker Assessment in Metastatic Triple-Negative Breast Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
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49 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Tomasz Byrski
Rebecca Dent
Pawel Blecharz
Malgorzata Foszczynska-Kloda
Jacek Gronwald
Tomasz Huzarski
Cezary Cybulski
Elzbieta Marczyk
Robert Chrzan
Andrea Eisen
Jan Lubinski
Steven A Narod
International Hereditary Cancer Center · PLThe Maria Sklodowska-Curie National Research Institute of Oncology · PLUniversity of Toronto · CAJagiellonian University · PLSunnybrook Health Science Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe purpose of this investigation was to evaluate the efficacy of cisplatin chemotherapy in BRCA1 mutation carriers with metastatic breast cancer.

methodsIn a phase II, open-label study, 20 patients with metastatic breast cancer who carried a mutation in BRCA1 were treated with cisplatin 75 mg/m2 intravenously every 3 weeks as part of a 21-day cycle for 6 cycles. Restaging studies to assess response were performed after cycles 2 and 6, and every three months thereafter.

resultsBetween July 2007 and January 2009, 20 patients were enrolled. Baseline characteristics were as follows: 65% had prior adjuvant chemotherapy, 55% had prior chemotherapy for metastatic breast cancer; mean age was 48 years (ranges 32 to 70); 30% estrogen receptor (ER) or progesterone receptor (PR)+, 70% ER/PR/Human Epidermal Growth Factor Receptor 2 (HER2)- and 0% HER2+. Overall response rate was 80%; nine patients experienced a complete clinical response (45%) and seven experienced a partial response (35%). Overall survival was 80% at one year, 60% at two years and 25% at three years. Four of the 20 patients are alive four years after initiating treatment. The median time to progression was 12 months. The median survival from the start of cisplatinum treatment was 30 months. Cisplatin-related adverse events, including nausea (50%), anemia (5%) and neutropenia (35%) were mostly mild to moderate in severity.

conclusionsThis phase II study demonstrates that cisplatin chemotherapy has high activity in women with a BRCA1 mutation and metastatic breast cancer and is generally well tolerated.

trial registrationThis trial is registered retrospectively on the clinical trials website ClinicalTrials.gov. The identifier is NCT01611727.

Indexed as

Genes, BRCA1AdultAgedAntineoplastic AgentsBreast NeoplasmsCisplatinFemaleHeterozygoteHumansMiddle AgedMutationNeoplasm MetastasisReceptors, EstrogenReceptors, ProgesteroneTomography, X-Ray ComputedTreatment OutcomeAntineoplastic AgentsCisplatinReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID22817698
PMCPMC3680929
OpenAlexW2105567212

What OpenQuestion holds

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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.