Evidence map›Paper›PMID 32007714›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2020

Long-term outcomes with intensive induction chemotherapy (carboplatin, bleomycin, vincristine and cisplatin/bleomycin, etoposide and cisplatin) and standard bleomycin, etoposide and cisplatin in poor prognosis germ cell tumours: A randomised phase II trial (ISRCTN53643604).

Fay H Cafferty, Jeff D White, Jonathan Shamash, Ivo Hennig, Sally P Stenning, Robert A Huddart, TE23 Trial Management Group and Collaborators

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2020. 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
0.4field-weighted citation impact, top 39% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Programmed cell death, redox imbalance, and cancer therapeutics.Apoptosis : an international journal on programmed cell death · 2021
    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

7 authors at 5 institutions in 1 country.

Fay H CaffertyMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK. Electronic address: f.cafferty@ucl.ac.uk.
Jeff D WhiteBeatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow, G12 0YN, UK.
Jonathan ShamashSt Bartholomew's Hospital, West Smithfield, London, EC1A 7BE, UK.
Ivo HennigNottingham University Hospitals NHS Trust, Hucknall Road, Nottingham, NG5 1PB, UK.
Sally P StenningMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Robert A HuddartThe Institute of Cancer Research and the Royal Marsden NHS Foundation Trust, Downs Road, Sutton, SM2 5PT, UK.
TE23 Trial Management Group and Collaborators
MRC Clinical Trials Unit at UCL · GBBeatson West of Scotland Cancer Centre · GBNottingham University Hospitals NHS Trust · GBRoyal Marsden NHS Foundation Trust · GBSt Bartholomew's Hospital · GB

Funding

Cancer Research UK C1198 / A4274Medical Research Council MC_U122861331Medical Research Council MC_UU_12023/28
6 · The paper itself

Abstract

backgroundUp to 50% of men with poor prognosis, non-seminoma germ cell tumours (GCTs) die with standard BEP (bleomycin, etoposide and cisplatin) chemotherapy. An intensive regimen, CBOP/BEP (carboplatin, bleomycin, vincristine and cisplatin/BEP), met response targets in a randomised, phase II trial (74% complete response or partial response marker negative, 90% confidence interval (CI) 61%-85%).

aimTo assess long-term outcomes and late toxicity associated with CBOP/BEP.

methodsPatients with poor prognosis extracranial GCT were randomised to 4xBEP or CBOP/BEP (2xCBOP, 2xBO, 3xBEP with 15,000iu of bleomycin). Low-dose, stabilising chemotherapy before entry was permitted. Response rates (primary outcome) were reported previously. Here, we report secondary outcomes: progression-free survival (PFS), overall survival (OS) and late toxicity. Prognostic factors and the impact of marker decline are assessed in exploratory analysis.

resultsEighty-nine patients (43 CBOP/BEP) were randomised. After median 63 months follow-up, 3-year PFS is 55.7% (95% CI: 39.7%, 69.0%) for CBOP/BEP and 38.7% (95% CI: 24.7%, 52.4%) for BEP (hazard ratio [HR]: 0.59 (0.33, 1.06), p = 0.079). Three-year OS is 65.0% (48.8%, 77.2%) and 58.5% (43.0%, 71.2%), respectively (HR: 0.79 (0.41, 1.52), p = 0.49). Twelve-month toxicity was affected by subsequent treatments, with no clear differences between arms. Stabilising chemotherapy was associated with poorer PFS (HR: 2.09 (1.14, 3.81), p = 0.017), whereas unfavourable marker decline, in 60 (70%) patients, was not.

conclusionAlthough not powered for PFS, results for CBOP/BEP are promising. Impact on OS was less clear (and will be affected by subsequent therapy). Further study in an international phase III trial is warranted.

trial registrationISRCTN 53643604.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBleomycinCarboplatinCisplatinEtoposideFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasms, Germ Cell and EmbryonalPrognosisSurvival RateVincristineBleomycinCarboplatinCisplatinEtoposideVincristineBleomycinGerm cell tumoursPoor prognosisRandomised trial

Identifiers

PMID32007714
PMCPMC7045084
OpenAlexW3003557236

What OpenQuestion holds

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LicenceCC BY
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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.