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)

Autor: E Maradiegue, Antonio Lopez-Pousa, Josefina Cruz, Jaume Mora, Ofelia Cruz, Claudia Valverde, X. Garcia del Muro, Javier Martinez-Trufero, Juan Maurel, Javier Martin-Broto, Sara Perez-Jaume, C. de Torres, M.A. Vaz, E. de Álava, Alicia Castañeda
Rok vydání: 2017
Předmět:
0301 basic medicine
Oncology
Cancer Research
sarcoma
humanos
adolescente
Phases of clinical research
Docetaxel
Kaplan-Meier Estimate
Deoxycytidine
Gastroenterology
0302 clinical medicine
estudios prospectivos
Antineoplastic Combined Chemotherapy Protocols
Odds Ratio
docetaxel
Prospective Studies
supervivencia sin enfermedad
Child
Prospective cohort study
protocolos de quimioterapia antineoplásica combinada
Age Factors
gemcitabine
adulto
Prognosis
cociente de probabilidades relativas
Survival Rate
pronóstico
Child
Preschool
030220 oncology & carcinogenesis
Taxoids
taxoides
adolescent and young adult sarcomas
medicine.drug
Adult
estimación de Kaplan-Meier
medicine.medical_specialty
Adolescent
Bone Neoplasms
Sarcoma
Ewing
Disease-Free Survival
03 medical and health sciences
Internal medicine
medicine
Humans
tasa de supervivencia
minimal residual disease management
Survival rate
Survival analysis
neoplasias óseas
Proportional hazards model
business.industry
Odds ratio
Gemcitabine
desoxicitidina
Regimen
030104 developmental biology
Spain
Clinical Study
business
Ewing sarcoma
Zdroj: BRITISH JOURNAL OF CANCER
r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
Fundació Sant Joan de Déu
Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid
Consejería de Sanidad de la Comunidad de Madrid
British Journal of Cancer
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname
r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
ISSN: 1532-1827
0007-0920
0000-6734
DOI: 10.1038/bjc.2017.252
Popis: Background: 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. Methods: This was a prospective, multicentric, non-randomised, open study for patients p40 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). Results: 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 p18 years of age was 74.0% (CI, 56-97%) and 31.0% for 418 years (95% CI, 15-66%), Po0.001. Grade 4 adverse events during mP6 occurred in 28/39 of patients (72%) and did not correlate with age. Multivariate survival analyses with o18 vs X18 and risk groups significant differences, Po0.00001. Using a Cox model for OS, both age and risk group were statistically significant (P = 0.0011 and P = 0.0065, respectively). Conclusions: 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.
This work was supported by Fundacion FERO (primera beca de Oncologia traslacional esponsorizada por la Fundacio Josep Botet); Instituto de Salud Carlos III, Ministerio de sanidad y consumo; Fondo de investigacion sanitaria (TRA-130 2009 to JM); Asociacion 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.
Databáze: OpenAIRE
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