Evidence map›Paper›PMID 39095679›Full record

ArticleOncology and therapy2024

Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials.

Amit Rauthan, Ankita Jain, Manmohan Singh, Mehmet A N Sendur

Abstract readScoping Review
In one paragraph

Article in Oncology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

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, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. 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

4 authors.

Amit RauthanDepartment of Medical Oncology, Manipal Hospital, Bengaluru, India.
Ankita JainMedical Affairs Oncology and Field Medical Excellence, Regional Medical Affairs, Pfizer Healthcare India Private Limited, The Capital, 1802/1901, Plot No. C-70, G-Block, Bandra Kurla Complex, Bandra (E), Mumbai, 400 051, India. Ankita.Jain@pfizer.com.ORCID http://orcid.org/0009-0000-4416-2624
Manmohan SinghRegional Medical Affairs, Pfizer Corporation Hong Kong Limited, Hong Kong, Hong Kong.ORCID http://orcid.org/0000-0002-9175-8559
Mehmet A N SendurDepartment of Medical Oncology, Faculty of Medicine and Ankara Bilkent City Hospital, Ankara Yıldırım Beyazıt University, Ankara, Turkey.ORCID http://orcid.org/0000-0001-7021-6139

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLimited awareness exists regarding real-world data (RWD) for palbociclib in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced/metastatic breast cancer in populations from certain countries outside of Western regions.

methodsA systematic scoping review was conducted using PubMed and Embase to evaluate RWD for palbociclib from countries outside of Western regions that are underrepresented in clinical trials. Search criteria were aligned with our research question for relevant English-language publications, without restrictions on publication date, followed by Phase 1 (title and abstract) and Phase 2 (full-text) screening of retrieved citations as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data analyses of eligible studies were done separately for abstracts and full-text publications to enhance the precision and reliability of the results.

resultsDatabase search yielded 1485 non-duplicate records, 46 qualified for inclusion, of which 47.8% were published as full text. The analysis of outcomes, based exclusively on full-text publications that collectively included 2048 patients treated with palbociclib, revealed the median progression-free survival (PFS) of 20.2-36.7 months, overall survival (OS) of 39.9 months (reported in one publication) and objective response rate (ORR) of 45.3-80.0% with first-line treatment. In ≥ second line, the median PFS, OS and ORR ranged from 7.0 to 24.2 months, 11 to 19.6 months, and 13.9% to 47.9%, respectively. The safety profile of palbociclib was similar to that reported in pivotal clinical studies, and no new safety concerns were identified.

conclusionsA comprehensive volume of evidence demonstrates that palbociclib's effectiveness and safety profile in real-world settings align with those observed in clinical trials, offering valuable insights for clinical decision-making in countries outside of Western regions underrepresented in clinical trials.

Indexed as

Breast neoplasmsCDK4/6 inhibitorsNon-Western countriesPalbociclibReal-world dataReal-world evidence

Identifiers

PMID39095679
PMCPMC11333781

What OpenQuestion holds

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Registered trials

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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.