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)
Mora, J. (Hospital Sant Joan de Déu (Barcelona, Catalunya))
Castañeda, A. (Hospital Sant Joan de Déu (Barcelona, Catalunya))
Perez-Jaume, S. (Hospital Sant Joan de Déu (Barcelona, Catalunya))
López Pousa, Antonio (Institut d'Investigació Biomèdica Sant Pau)
Maradiegue, E. (Hospital Sant Joan de Déu (Barcelona, Catalunya))
Valverde, C. (Hospital Universitari Vall d'Hebron)
Martin-Broto, J. (Universidad de Sevilla)
Garcia Del Muro, X. (Hospital Universitari de Bellvitge)
Cruz, O. (Hospital Sant Joan de Déu (Barcelona, Catalunya))
Cruz, J. (Hospital Universitario de Canarias (La Laguna))
Martinez-Trufero, J. (Hospital Universitario Miguel Servet (Saragossa))
Maurel, J. (Hospital Clínic i Provincial de Barcelona)
Vaz, M.A. (Hospital Ramón y Cajal)
De Alava, E. (Universidad de Sevilla)
De Torres, C. (Hospital Sant Joan de Déu (Barcelona, Catalunya))
Universitat Autònoma de Barcelona

Date:	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 1/240 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 218 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 418 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). 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.
Grants:	Ministerio de Economía y Competitividad PT13/0010/0047 Ministerio de Economía y Competitividad PT13/0010/0056 Ministerio de Economía y Competitividad RD12/0036/0017 Ministerio de Economía y Competitividad PI14/01466 Ministerio de Economía y Competitividad
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra, i la creació d'obres derivades, sempre que no sigui amb finalitats comercials i que es distribueixin sota la mateixa llicència que regula l'obra original. Cal que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	British Journal of Cancer, Vol. 117 Núm. 6 (may 2017) , p. 767-774, ISSN 1532-1827

DOI: 10.1038/bjc.2017.252
PMID: 28787430

8 p, 509.4 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles