Evidence map›Paper›PMID 34307126›Full record

ArticleFrontiers in oncology2021

Long-Term Cardiac Safety and Survival Outcomes of Neoadjuvant Pegylated Liposomal Doxorubicin in Elderly Patients or Prone to Cardiotoxicity and Triple Negative Breast Cancer. Final Results of the Multicentre Phase II CAPRICE Study.

Miguel J Gil-Gil, Meritxell Bellet, Milana Bergamino, Serafín Morales, Agustí Barnadas, Luís Manso, Cristina Saura, Adela Fernández-Ortega, Elena Garcia-Martinez, Noelia Martinez-Jañez and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00563953 (A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT00563953 phase2completednot on this map

A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin (Caelyx®) as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease or Age Over 65 Years.

TypeinterventionalSponsorSOLTI Breast Cancer Research GroupRan2007 to 2016Enrolled50ConditionsBreast CancerArmsLiposomal pegylated doxorubicine
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

16 authors at 9 institutions in 1 country.

Miguel J Gil-GilDepartment of Medical Oncology, Institut Català d'Oncologia, IDIBELL, L'Hospitalet, Spain.
Meritxell BelletDepartment of Medical Oncology, Hospital Vall d'Hebron, Barcelona, Spain.
Milana BergaminoDepartment of Medical Oncology, Institut Català d'Oncologia, IDIBELL, L'Hospitalet, Spain.
Serafín MoralesDepartment of Medical Oncology, Hospital Arnau de Vilanova, Lleida, Spain.
Agustí BarnadasDepartment of Medical Oncology, Hospital de Sant Pau, Barcelona, Spain.
Luís MansoDepartment of Medical Oncology, Hospital, 12 de Octubre, Madrid, Spain.
Cristina SauraDepartment of Medical Oncology, Hospital Vall d'Hebron, Barcelona, Spain.
Adela Fernández-OrtegaDepartment of Medical Oncology, Institut Català d'Oncologia, IDIBELL, L'Hospitalet, Spain.
Elena Garcia-MartinezDepartment of Medical Oncology Hospital, JM Morales Messeguer, Murcia, Spain.
Noelia Martinez-JañezDepartment of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain.
Mireia MeléDepartment of Medical Oncology, Hospital Sant Joan, Reus, Spain.
Patricia VillagrasaSOLTI Breast Cancer Research Group, Barcelona, Spain.
Pamela CelizSOLTI Breast Cancer Research Group, Barcelona, Spain.
X Perez MartinClinical Research Unit, Institut Català d'Oncologia, L'Hospitalet, Spain.
Eva CiruelosDepartment of Medical Oncology, Hospital, 12 de Octubre, Madrid, Spain.
Sonia PernasDepartment of Medical Oncology, Institut Català d'Oncologia, IDIBELL, L'Hospitalet, Spain.
Institut Català d'Oncologia · ESInstitut d'Investigació Biomédica de Bellvitge · ESResearch Institute Hospital 12 de Octubre · ESVall d'Hebron Hospital Universitari · ESHospital Arnau de Vilanova · ESHospital de Sant Pau · ESHospital General Universitario Morales Meseguer · ESHospital Universitario Ramón y Cajal · ESHospital Universitari Sant Joan de Reus · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe CAPRICE trial was designed to specifically evaluate neoadjuvant pegylated liposomal doxorubicin (PLD) in elderly patients or in those with other cardiovascular risk factors in whom conventional doxorubicin was contraindicated. The primary analysis of the study showed a pathological complete response (pCR) of 32% and no significant decreases in LVEF during chemotherapy. Here, we report important secondary study objectives: 5-year cardiac safety, disease-free survival (DFS), overall survival (OS) and breast cancer specific survival (BCSS).

methodsIn this multicentre, single-arm, phase II trial, elderly patients or those prone to cardiotoxicity and high risk stage II-IIIB breast cancer received PLD (35 mg/m

resultsBetween Oct 2007, and Jun 2010, 50 eligible patients were included. Median age was 73 (35-84) years, 84% were older than 65; 64% of patients suffered from hypertension, and 10% had prior cardiac disease. Most of tumors (88%) were triple negative. No significant decreases in LVEF were observed. The mean baseline LVEF was 66.6% (52-86) and after a median follow-up of 5 years, mean LVEF was 66 (54.5-73). For intention to treat population, 5-year DFS was 50% (95% CI 40.2-68.1) and 5-year OS was 56% (95%CI 41.2-68.4). There were 8 non-cancer related deaths, achieving a 5 years BCSS of 67.74% (CI 95%:54.31%- 81.18%).

conclusionAt 5-year follow-up, this PLD-based NAC regimen continued to be cardiac-safe and effective in a population of very high-risk breast cancer patients. This scheme should be considered as an option in elderly patients or in those with other risks of developing cardiotoxicity. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov reference NCT00563953.

Indexed as

cardiotoxicityelderlylong-term resultsneoadjuvant chemotherapypegylated liposomal doxorubicinphase II studysurvivaltriple negative breast cancer

Identifiers

PMID34307126
PMCPMC8300427
OpenAlexW3182895469

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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.