Evidence map›Paper›PMID 14586211›Full record

Trial reportInvestigational new drugs2003

Weekly regimen of irinotecan/docetaxel in previously treated non-small cell lung cancer patients and correlation with uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism.

Albert Font, José Miguel Sánchez, Miquel Tarón, Eva Martinez-Balibrea, José Javier Sánchez, José Luis Manzano, Mireia Margelí, Martin Richardet, Agustí Barnadas, Albert Abad and 1 more

Abstract readClinical TrialClinical Trial, Phase IIComparative Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
3.1field-weighted citation impact, top 8% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Second- and third-line treatments in non-small cell lung cancer.Current treatment options in oncology · 2006
    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

11 authors at 1 institution in 1 country.

Albert FontMedical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain.
José Miguel Sánchez
Miquel Tarón
Eva Martinez-Balibrea
José Javier Sánchez
José Luis Manzano
Mireia Margelí
Martin Richardet
Agustí Barnadas
Albert Abad
Rafael Rosell
Hospital Universitari Germans Trias i Pujol · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeInherited variations in drug metabolizing enzymes may influence drug efficacy. This phase II study assesses the impact of second-line weekly irinotecan (CPT-11)/docetaxel in non-small cell lung cancer (NSCLC) patients, and gauges the uridine diphosphate glucuronosyl transferase (UGT1A1) polymorphism influence in toxicity and antitumor activity. EXPERIMENTAL

designFifty-one patients with NSCLC treated with at least one prior chemotherapy regimen were enrolled. Patients received irinotecan 70 mg/m(2) followed by docetaxel 25 mg/m(2). Both drugs were given on days 1, 8, and 15 every 28 days. UGT1A1 polymorphism were analyzed in blood samples of 47 patients. The UGT1A1 polymorphism are classified according to the number of TA repeats in the promoter region of this gene.

resultsThree patients (6%) achieved a partial response and nineteen patients (37%) had stable disease. Median survival was 8 months (95% CI: 4.8-11.2) and 1-year survival 30%. Grade 3-4 hematologic toxicity was low (less than 10% of patients); 15% of patients had grade 3 asthenia and 25% of patients had grade 3/4 diarrhea. The frequency of UGT1A1 genotypes was as follows: 6/6 49%, 6/7 36%, and 7/7 15%. No differences in toxicity were observed according to UGT1A1 polymorphism. A nonsignificant improvement in time to progression (4 vs. 3 months) and median survival (11 vs. 8 months) was detected in patients with the variant alleles (6/7 and 7/7).

conclusionsThis weekly irinotecan/docetaxel regimen has shown an acceptable toxicity profile while encouraging median and 1-year survival in heavily pretreated NSCLC patients. The tendency to better prognosis in patients carrying the variant genotypes 6/7 and 7/7 of UGT1A1 gene requires further validation.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCarcinoma, Non-Small-Cell LungChi-Square DistributionConfidence IntervalsDocetaxelDrug Administration ScheduleFemaleGlucuronosyltransferaseHumansIrinotecanLung NeoplasmsMaleMiddle AgedCamptothecinDocetaxelGlucuronosyltransferaseIrinotecanTaxoidsUGT1A1 Enzyme

Identifiers

PMID14586211
OpenAlexW1501426350

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.