RT Journal Article
T1 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).
A1 Mora, J
A1 Castañeda, A
A1 Perez-Jaume, S
A1 Lopez-Pousa, A
A1 Maradiegue, E
A1 Valverde, C
A1 Martin-Broto, J
A1 Garcia Del Muro, X
A1 Cruz, O
A1 Cruz, J
A1 Martinez-Trufero, J
A1 Maurel, J
A1 Vaz, M A
A1 de Alava, E
A1 de Torres, C
K1 gemcitabine
K1 docetaxel
K1 Ewing sarcoma
K1 adolescent and young adult sarcomas
K1 minimal residual disease management
AB 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 ClinicalTrials.gov (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.
PB Nature Publishing Group
YR 2017
FD 2017-08-08
LK http://hdl.handle.net/10668/11488
UL http://hdl.handle.net/10668/11488
LA en
NO Mora J, Castañeda A, Perez-Jaume S, Lopez-Pousa A, Maradiegue E, Valverde C, et al. 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). Br J Cancer. 2017 Sep 5;117(6):767-774.
NO This work was supported by Fundación FERO (primera beca de Oncología traslacional esponsorizada por la Fundació Josep Botet); Instituto de Salud Carlos III, Ministerio de sanidad y consumo; Fondo de investigación sanitaria (TRA-130 2009 to JM); Asociación Pablo Ugarte; Ministry of Economy and Competitiveness of Spain-FEDER grants (PT13/0010/0047, PT13/0010/0056, RD12/0036/0017, PI14/01466 to JM). We gratefully acknowledge the editorial contribution of Callum Fletcher.
DS RISalud
RD Apr 8, 2025