Evidence map›Paper›PMID 35059593›Full record

ArticleEuropean journal of breast health2022

An Open-Label, Multinational, Multicenter, Phase IIIb Study with Subcutaneous Administration of Trastuzumab in Patients with HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction.

İrfan Cicin, Mohammed Oukkal, Hassen Mahfouf, Amel Mezlini, Blaha Larbaoui, Slim Ben Ahmed, Hassan Errihani, Khalid Alsaleh, Rhizlane Belbaraka, Perran Fulden Yumuk and 2 more

Open access · diamondAbstract read
In one paragraph

Article in European journal of breast health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 44% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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

12 authors at 12 institutions in 5 countries.

İrfan CicinDepartment of Medical Oncology, Trakya University Faculty of Medicine, Edirne, Turkey.ORCID https://orcid.org/0000-0002-7584-3868
Mohammed OukkalDepartment of Medical Oncology, Beni Messous University Hospital, Beni Messous, Algeria.ORCID https://orcid.org/0000-0002-4306-8377
Hassen MahfoufCentre Hospitalo-Univerisitaire de Rouiba, Service D'oncologie Médicale, Rouiba, Algeria.ORCID https://orcid.org/0000-0002-7805-5461
Amel MezliniService de Médecine Carcinologique, Institut Salah Azaïz, Tunis, Tunisia.ORCID https://orcid.org/0000-0001-5995-443X
Blaha LarbaouiService D'oncologie Médicale, EHS Oncologie Emir Abdelkader Oran, Oran, Algeria.ORCID https://orcid.org/0000-0001-9100-9059
Slim Ben AhmedDeparment of Oncology, Farhat Hached Hospital, Sousse, Tunisia.ORCID https://orcid.org/0000-0001-8925-7416
Hassan ErrihaniDepartment of Oncology, National Institute of Oncology, Mohammed V University, Rabat, Morocco.ORCID https://orcid.org/0000-0002-3389-0017
Khalid AlsalehCollege of Medicine, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.ORCID https://orcid.org/0000-0002-5801-5745
Rhizlane BelbarakaCadi Ayyad University, Faculty of Medicine, Medical Oncology Department, Marrakech, Morocco.ORCID https://orcid.org/0000-0002-3947-775X
Perran Fulden YumukDeparment of Medical Oncology, Marmara University School of Medicine, Marmara University Pendik Training and Research Hospital, İstanbul, Turkey.ORCID https://orcid.org/0000-0001-8650-299X
Burce GoktasRoche Müstahzarları Industry Inc., İstanbul, Turkey.ORCID https://orcid.org/0000-0002-8153-0753
Mustafa Özgüroğluİstanbul University-Cerrahpasa Cerrahpasa Medical Faculty, İstanbul, Turkey.ORCID https://orcid.org/0000-0002-8417-8628
Acıbadem University · TRCadi Ayyad University · MAEmir Abdelkader University of Islamic Sciences · DZHôpital Farhat Hached · TNInstitut Salah-Azaïz · TNIstanbul University-Cerrahpaşa · TRKing Saud University · SAMarmara University · TRMohammed V University · MARoche (Turkey) · TRTrakya University · TRUniversity of Algiers Benyoucef Benkhedda · DZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study was designed to investigate treatment satisfaction in patients and Health Care Professionals (HCP) and to evaluate the safety and tolerability of subcutaneous (SC) trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC). MATERIALS AND

methodsTwo-hundred and twenty-three patients with eBC were screened, of whom 173 patients met the eligibility criteria and received at least one dose of SC trastuzumab. The primary efficacy endpoint was to assess patient satisfaction via a questionnaire.

resultsThe majority of patients (n = 166, 97.6%) reported satisfaction with the SC route. Patients and HCPs stated that SC trastuzumab was easy to use (93.5% and 62.5%, respectively) compared to the intravenous (IV) route and all HCPs (n = 16) expressed satisfaction with the SC route. Progression, disease recurrence or death was reported in 24 patients (13.8%) by two years of follow up. Four-year disease-free survival (DFS) and overall survival (OS) rates were 84.2% (±3.1) and 90.5% (±4.7), respectively. A total of 1299 adverse events (AEs) were recorded over 4-years follow-up, nearly 97% of which were judged non-serious. The most common AEs were arthralgia (n = 54, 4.2%), flu-like symptoms (n = 41, 3.2%) and nausea (n = 39, 3.0%). Fifty-four cardiac events, including left ventricular dysfunction, left ventricular failure and cardiotoxicity, were reported. Ejection fraction (EF) decrease [median decrease 3.5% (0.12-19.0)] was reported in 5.4% of cases. SC trastuzumab treatment was interrupted due to decreased EF in two cases.

conclusionSC trastuzumab was widely acceptable to both patients and HCPs. The safety and tolerability of SC trastuzumab was consistent with the known safety profile of SC and IV administration.

Indexed as

breast cancerHER2patient satisfactionsubcutaneoustrastuzumab

Identifiers

PMID35059593
PMCPMC8734518
OpenAlexW4200618787

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.