Evidence map›Paper›PMID 15083178›Full record

Trial reportBritish journal of cancer2004

A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer.

D C Doval, J S Sekhon, S K Gupta, J Fuloria, V K Shukla, S Gupta, B S Awasthy

Open access · hybridAbstract readClinical TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
10.5field-weighted citation impact, top 1% 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

47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 136 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. NCCN clinical practice guidelines in oncology: hepatobiliary cancers.Journal of the National Comprehensive Cancer Network : JNCCN · 2009
    Guideline
  4. Guidelines for chemotherapy of biliary tract and ampullary carcinomas.Journal of hepato-biliary-pancreatic surgery · 2008
    Guideline
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. Review
  15. Article
  16. Gallbladder cancer: Progress in the Indian subcontinent.World journal of clinical oncology · 2024
    Review
  17. Article
  18. Article
  19. Article
  20. 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

7 authors at 5 institutions in 2 countries.

D C DovalRajiv Gandhi Cancer Institute & Research Center, Delhi, India.
J S Sekhon
S K Gupta
J Fuloria
V K Shukla
S Gupta
B S Awasthy
Eli Lilly (India) · INBanaras Hindu University · INDayanand Medical College & Hospital · INOchsner Medical Center · USRajiv Gandhi Cancer Institute and Research Centre · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary objective of this study was to determine the response rates of the gemcitabine and cisplatin combination in unresectable gall bladder cancer patients. The secondary objectives were to evaluate the toxicity, time to progressive disease, and overall survival. Chemonaïve patients with histologically proven, unresectable bidimensionally measurable gall bladder cancer were enrolled into this study. All patients were required to have a Zubrod's performance status <or=2, no prior radiotherapy, and adequate major organ function. Patients received gemcitabine (1000 mg x m(-2) intravenously over 30-60 min) on days 1 and 8, and cisplatin (70 mg x m(-2) intravenously over 2 h) on day 1, every 21 days. Response assessment was done by a CT scan after every other cycle of chemotherapy. In all, 30 patients were eligible for efficacy and toxicity analysis. There were four (13.3%) complete responders, seven (23.3%) partial responders, and seven (23.3%) with stable disease, with four (13.2%) patients showing disease progression. The median time to progression was 18 weeks (95% confidence interval (CI) 14-24 weeks), and the median duration of response was 13.5 weeks (range 5.5-104 weeks). The median overall survival was 20 weeks (95% CI 14-31 weeks), with 1-year survival rate of 18.6%. WHO grade 3 or 4 anaemia was seen in seven (23.3%) and four (13.3%) patients, respectively. Five (16.6%) patients each experienced grade 3 or 4 neutropenia, and grade 3 or 4 thrombocytopenia was seen in three (10%) and two (6.6%) patients, respectively. The present study shows that gemcitabine/cisplatin combination is well tolerated and active in advanced unresectable gall bladder cancer.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinDeoxycytidineDisease ProgressionFemaleGallbladder NeoplasmsGemcitabineHumansMaleMiddle AgedNeoplasm StagingSurvival AnalysisTreatment OutcomeCisplatinDeoxycytidineGemcitabine

Identifiers

PMID15083178
PMCPMC2409709
OpenAlexW1990738112

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.