Evidence map›Paper›PMID 37075255›Full record

SynthesisJCO clinical cancer informatics2023

Benefit From Fractionated Dose-Dense Chemotherapy in Patients With Poor Prognostic Ovarian Cancer: ICON-8 Trial.

Olivier Colomban, Andrew Clamp, Adrian Cook, Iain A McNeish, Benoit You

Registry-linked trialOpen access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in JCO clinical cancer informatics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01654146 (An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
4.6field-weighted citation impact, top 5% 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.

NCT01654146 phase3unknown statusnot on this map

An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

TypeinterventionalSponsorMedical Research CouncilRan2011Enrolled1,485ConditionsOvarian CancerArmsCarboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
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  4. Observational
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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 at 4 institutions in 2 countries.

Olivier ColombanFaculté de Médecine Lyon-Sud, Université Lyon, Université Claude Bernard Lyon 1, EA3738 CICLY, Lyon, France.ORCID 0000-0003-1671-3470
Andrew ClampThe Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.
Adrian CookMRC Clinical Trials Unit at UCL, London, United Kingdom.
Iain A McNeishDepartment of Surgery and Cancer, Imperial College London, London, United Kingdom.ORCID 0000-0002-9387-7586
Benoit YouFaculté de Médecine Lyon-Sud, Université Lyon, Université Claude Bernard Lyon 1, EA3738 CICLY, Lyon, France.ORCID 0000-0002-3177-8857
Université Claude Bernard Lyon 1 · FRImperial College London · GBMRC Clinical Trials Unit at UCL · GBThe Christie NHS Foundation Trust · GB

Funding

Cancer Research UK 17092Cancer Research UK C1489/A12127Cancer Research UK CA1489/A17092Medical Research Council
6 · The paper itself

Abstract

purposeAn international meta-analysis identified a group of patients with advanced epithelial ovarian cancer (EOC) with a very poor survival because of two unfavorable features: (1) a poor chemosensitivity defined by an unfavorable modeled CA-125 ELIMination rate constant K (KELIM) score <1.0 with the online calculator CA-125-Biomarker Kinetics, and (2) an incomplete debulking surgery. We assumed that patients belonging to this poor prognostic group would benefit from a fractionated densified chemotherapy regimen.

methodsThe data set of ICON-8 phase III trial (ClinicalTrials.gov identifier: NCT01654146), where patients with EOC were treated with the standard three-weekly, or the weekly dose-dense, carboplatin-paclitaxel regimens and debulking primary surgery (immediate primary surgery [IPS] or delayed primary [or interval] surgery [DPS]), was investigated. The association between treatment arm efficacy, standardized KELIM (scored as favorable ≥1.0, or unfavorable <1.0), and surgery completeness was assessed by univariate/multivariate analyses in IPS and DPS cohorts.

resultsOf 1,566 enrolled patients, KELIM was calculated with the online model in 1,334 with ≥3 CA-125 available values (85%). As previously reported, both KELIM and surgery completeness were complementary prognostic covariates, and could be combined into three prognostic groups with large OS differences: (1) good if favorable KELIM and complete surgery; (2) intermediate if either unfavorable KELIM or incomplete surgery; and (3) poor if unfavorable KELIM and incomplete surgery. Weekly dose-dense chemotherapy was associated with PFS/OS improvement in the poor prognostic group in both the IPS cohort (PFS: hazard ratio [HR], 0.50; 95% CI, 0.31 to 0.79; OS: HR, 0.58; 95% CI, 0.35 to 0.95) and the DPS cohort (PFS: HR, 0.53; 95% CI, 0.37 to 0.76; OS: HR, 0.57; 95% CI, 0.39 to 0.82).

conclusionFractionated dose-dense chemotherapy might be beneficial for patients belonging to the poor prognostic group characterized by lower tumor chemosensitivity assessed with the online calculator CA-125-Biomarker Kinetics and incomplete debulking surgery. Further investigation in the future SALVOVAR trial is warranted.

Indexed as

Ovarian NeoplasmsCarboplatinCarcinoma, Ovarian EpithelialFemaleHumansPaclitaxelPrognosisCarboplatinPaclitaxel

Identifiers

PMID37075255
PMCPMC10281428
OpenAlexW4366447056

What OpenQuestion holds

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Registered trials

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.