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Title: 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).
Authors: Mora, J
Castañeda, A
Perez-Jaume, S
Lopez-Pousa, A
Maradiegue, E
Valverde, C
Martin-Broto, J
Garcia Del Muro, X
Cruz, O
Cruz, J
Martinez-Trufero, J
Maurel, J
Vaz, M A
de Alava, E
de Torres, C
metadata.dc.subject.mesh: Adolescent
Age Factors
Antineoplastic Combined Chemotherapy Protocols
Bone Neoplasms
Child, Preschool
Disease-Free Survival
Kaplan-Meier Estimate
Odds Ratio
Prospective Studies
Sarcoma, Ewing
Survival Rate
Issue Date: 8-Aug-2017
Abstract: First 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. This 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 (identifier: NCT00006734). Forty-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%), P18 years (95% CI, 15-66%), P Age 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.
metadata.dc.identifier.doi: 10.1038/bjc.2017.252
Appears in Collections:Producción 2020

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