Evidence map›Paper›PMID 31500588›Full record

Trial reportBMC cancer2019

Long-term responders to trastuzumab monotherapy in first-line HER-2+ advanced breast cancer: characteristics and survival data.

Sabine Schmid, Dirk Klingbiel, Stefan Aebi, Aron Goldhirsch, Christoph Mamot, Elisabetta Munzone, Franco Nolè, Christian Oehlschlegel, Olivia Pagani, Bernhard Pestalozzi and 6 more

Registry-linked trialAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00004935 (Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT00004935 phase3terminatednot on this map

Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.

TypeinterventionalSponsorSwiss Cancer InstituteRan1999 to 2022Enrolled175ConditionsBreast CancerArmsHerceptin™ (Her), Herceptin™ (Her) + chemo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. OncoTargets and therapy · 2020
    Article
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

16 authors.

Sabine SchmidBreast Center St. Gallen, Kantonsspital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland. sabine.schmid@kssg.ch.
Dirk KlingbielSwiss Group for Clinical Cancer Research (SAKK), Berne, Switzerland.
Stefan AebiCancer Center, Lucerne Cantonal Hospital, Lucerne and University of Bern, Bern, Switzerland.
Aron GoldhirschDepartment of Oncology, European Institute of Oncology (IEO), Milan, Italy.
Christoph MamotDepartment of Oncology and Haematology, Kantonsspital Aarau, Aarau, Switzerland.
Elisabetta MunzoneDivision of Medical Senology, European Institute of Oncology (IEO), Milan, Italy.
Franco NolèDepartment of Oncology, European Institute of Oncology (IEO), Milan, Italy.
Christian OehlschlegelFormerly Institute of Pathology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
Olivia PaganiBreast Unit and Institute of Oncology of Southern Switzerland, Ospedale Regionale Bellinzona e Valli and Geneva University Hospitals, Bellinzona, Switzerland.
Bernhard PestalozziDepartment of Oncology, University Hospital Zürich, Zürich, Switzerland.
Christoph RochlitzDepartment of Oncology, University Hospital Basel, Basel, Switzerland.
Beat ThürlimannBreast Center St. Gallen, Kantonsspital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.
Roger von MoosDepartment of Oncology, Kantonsspital Graubünden, Chur, Switzerland.
Patrik WederBreast Center St. Gallen, Kantonsspital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.
Khalil ZamanBreast Center CHUV, Department of Oncology, University Hospital CHUV, Lausanne, Switzerland.
Thomas RuhstallerBreast Center St. Gallen, Kantonsspital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.

Funding

Staatssekretariat für Bildung, Forschung und Innovation SAKK
6 · The paper itself

Abstract

backgroundThe impact of HER2-targeted therapy alone followed by the addition of chemotherapy at disease progression (PD) versus upfront combination was investigated by the SAKK 22/99 trial. The aim of this exploratory analysis of the SAKK 22/99 trial was to characterize the specific subset of patients deriving long-term benefit from trastuzumab monotherapy alone and to identify potential predictive factors of long-term response.

methodsThis is an unplanned post-hoc analysis of patients randomized to Arm A (trastuzumab monotherapy). Patients were divided in two groups: patients with durable clinical benefit from trastuzumab monotherapy and short-term responders without durable clinical benefit from trastuzumab monotherapy Univariate and multivariate analyses of clinical characteristics correlating with response duration was performed.

resultsEighty six patients were randomized in arm A, 24 patients (28%) were long-term responders and 62 (72%) were short-term responders with a 5y-overall survival (OS) of 54% (95% CI 31-72) and of 18% (95%CI 10-30), respectively. Absence of ER expression, absence of PgR expression and presence of visceral disease emerged as possible negative predictive factors for durable clinical benefit.

conclusionDurable clinical benefit can be achieved with trastuzumab monotherapy in a subgroup of HER2-positive patients with advanced disease and it is predictive for longer OS. Further investigations of predictive biomarkers are necessary to better characterize this subgroup of patients and develop further de-escalating strategies.

trial registrationNCT00004935 ; first posted 27.01.2003, retrospectively registered.

Indexed as

Erb-b2 Receptor Tyrosine KinasesAgedAntineoplastic Agents, ImmunologicalBreast NeoplasmsDisease-Free SurvivalFemaleHumansMiddle AgedPrognosisRetrospective StudiesTrastuzumabAntineoplastic Agents, ImmunologicalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumabHER-positive breast cancerLong-term respondersTrastuzumab monotherapy

Identifiers

PMID31500588
PMCPMC6734335

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.