Evidence map›Paper›PMID 22166932›Full record

ReviewEuropean journal of clinical pharmacology2012

Off-label use of anti-cancer drugs between clinical practice and research: the Italian experience.

Rosa Lerose, Pellegrino Musto, Michele Aieta, Carla Papa, Alfredo Tartarone

Abstract readReview
PubMed Publisher
In one paragraph

Review in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

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

16 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Off-label prescriptions in intensive care unit: the Chinese experience.Therapeutics and clinical risk management · 2018
    Article
  11. Article
  12. Article
  13. Review
  14. Rapid learning for precision oncology.Nature reviews. Clinical oncology · 2014
    Review
  15. Contraindicated use of bevacizumab and toxicity in elderly patients with cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013
    Article
  16. 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

5 authors.

Rosa LeroseHospital Pharmacy, IRCCS Centro di Riferimento Oncologico di Basilicata, Via Padre Pio 1, 85028 Rionero in Vulture, PZ, Italy. rosalerose@libero.it
Pellegrino Musto
Michele Aieta
Carla Papa
Alfredo Tartarone

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOff-label use is the practice of prescribing a drug outside the terms of its official labeling. Worldwide, about 20% of the commonly prescribed medications are off-label, and the percentage increases in specific patient populations, such as children, pregnant women, and cancer patients. Off-label use is particularly widespread in oncology for many reasons, including the wide variety of cancer subtypes, the difficulties involved in performing clinical trials, the rapid diffusion of preliminary results, and delays in the approval of new drugs by regulatory organizations/agencies.

objectiveThe aim of this article is to describe the use of off-label drugs in oncology, with an emphasis on the role of the world's leading regulatory agencies and an assessment of current Italian legislation.

conclusionOff-label drug utilization is essential in oncology when based on evidence. However, off-label drugs must be prescribed in accordance with existing national laws and only when the potential benefit outweighs the potential toxic effects.

Indexed as

Off-Label UseAntineoplastic AgentsCompassionate Use TrialsDrug ApprovalDrug CostsDrugs, InvestigationalEuropean UnionEvidence-Based MedicineGovernment AgenciesHumansItalyLegislation, DrugNeoplasmsReimbursement MechanismsAntineoplastic AgentsDrugs, Investigational

Identifiers

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.