Evidence map›Paper›PMID 28787430›Full record

Trial reportBritish journal of cancer2017

GEIS-21: a multicentric phase II study of intensive chemotherapy including gemcitabine and docetaxel for the treatment of Ewing sarcoma of children and adults: a report from the Spanish sarcoma group (GEIS).

J Mora, A Castañeda, S Perez-Jaume, A Lopez-Pousa, E Maradiegue, C Valverde, J Martin-Broto, X Garcia Del Muro, O Cruz, J Cruz and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006734 (Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.2field-weighted citation impact, top 19% 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.

NCT00006734 phase3completednot on this map

Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors

TypeinterventionalSponsorChildren's Oncology GroupRan2001 to 2023Enrolled587ConditionsSarcomaArmsfilgrastim, cyclophosphamide, doxorubicin hydrochloride, etoposide, ifosfamide
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 26 citations in OpenAlex.

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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

15 authors at 10 institutions in 1 country.

J MoraDepartment of Pediatric Oncology and Hematology, Hospital Sant Joan de Déu, Barcelona 08950, Spain.
A CastañedaDepartment of Pediatric Oncology and Hematology, Hospital Sant Joan de Déu, Barcelona 08950, Spain.
S Perez-JaumeDepartment of Pediatric Oncology and Hematology, Hospital Sant Joan de Déu, Barcelona 08950, Spain.
A Lopez-PousaDepartment of Medical Oncology, Hospital de Sant Pau, Barcelona 08025, Spain.
E MaradiegueDepartment of Pediatric Oncology and Hematology, Hospital Sant Joan de Déu, Barcelona 08950, Spain.
C ValverdeDepartment of Medical Oncology, Hospital Vall d'Hebron, Barcelona 08035, Spain.
J Martin-BrotoDepartment of Medical Oncology, Hospital de Son Espases, Palma de Mallorca 07210, Spain.
X Garcia Del MuroDepartment of Medical Oncology, Institut Català d'Oncologia, IDIBELL, Universitat de Barcelona, Barcelona 08907, Spain.
O CruzDepartment of Pediatric Oncology and Hematology, Hospital Sant Joan de Déu, Barcelona 08950, Spain.
J CruzDepartment of Medical Oncology, Hospital Universitario de Canarias, Tenerife 38001, Spain.
J Martinez-TruferoDepartment of Medical Oncology, Hospital Miguel Servet, Zaragoza 50009, Spain.
J MaurelDepartment of Medical Oncology, Hospital Clinic, Barcelona 08036, Spain.
M A VazDepartment of Medical Oncology, Hospital Ramón y Cajal, Madrid 28034, Spain.
E de AlavaDepartment of Pathology, Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital/CSIC/University of Sevilla-CIBERONC, Sevilla 41013, Spain.
C de TorresDepartment of Pediatric Oncology and Hematology, Hospital Sant Joan de Déu, Barcelona 08950, Spain.
Hospital Sant Joan de Déu Barcelona · ESHospital Clínic de Barcelona · ESHospital de Sant Pau · ESHospital Universitario de Canarias · ESHospital Universitario Miguel Servet · ESHospital Universitario Ramón y Cajal · ESHospital Universitario Son Espases · ESInstitut Català d'Oncologia · ESInstituto de Biomedicina de Sevilla · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFirst Spanish trial of Ewing sarcoma (ES) including adults and children with the aim to test the efficacy of Gemcitabine and Docetaxel (G/D) in newly diagnosed high-risk (HR) patients.

methodsThis was a prospective, multicentric, non-randomised, open study for patients ⩽40 years with newly diagnosed ES. HR patients (metastatic, axial-pelvic primaries or bone marrow micrometastasis) received 2 window cycles of G/D. Patients with an objective response (OR) to G/D received 12 monthly cycles of G/D after completion of mP6. The primary end point was the OR rate to the G/D window phase and the event-free survival (EFS) and overall survival (OS) for all patients. The study is registered at ClinicalTrials.gov (identifier: NCT00006734).

resultsForty-three patients were enroled, median age 17 years (range, 3-40). After a median follow-up of 43.4 months, the 5-year OS rate is 55.0% (95% CI, 41-74%) with an EFS of 50.0% (95% CI, 36-68%). The 5-year OS and EFS rates for standard risk (SR) patients was 76.0% (95% CI, 57-100%) and 71.0% (CI, 54-94%); for HR 36.0% (CI, 20-65%) and 29.0% (CI, 15-56%). Twelve of 17 (70.6%) high-risk (HR) patients showed an OR (7 PR and 5 SD) to G/D window therapy. The 5-year OS rate for patients ⩽18 years of age was 74.0% (CI, 56-97%) and 31.0% for >18 years (95% CI, 15-66%), P<0.001. Grade 4 adverse events during mP6 occurred in 28/39 of patients (72%) and did not correlate with age. Multivariate survival analyses with <18 vs ⩾18 and risk groups significant differences, P<0.00001. Using a Cox model for OS, both age and risk group were statistically significant (P=0.0011 and P=0.0065, respectively).

conclusionsAge at diagnosis is an independent prognostic factor superior to the presence of metastases with 18 years as the strongest cut-off. The mP6 regimen provided survival curves that plateau at 3 years and G/D produced significant responses in HR-ES that is worth further exploring.

Indexed as

AdolescentAdultAge FactorsAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsChildChild, PreschoolDeoxycytidineDisease-Free SurvivalDocetaxelGemcitabineHumansKaplan-Meier EstimateOdds RatioPrognosisProspective StudiesDeoxycytidineDocetaxelGemcitabineTaxoids

Identifiers

PMID28787430
PMCPMC5589997
OpenAlexW2743351613

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.