visitant ::
identificació
|
|||||||||||||||
Cerca | Lliura | Ajuda | Servei de Biblioteques | Sobre el DDD | Català English Español |
Pàgina inicial > Articles > Articles publicats > GEIS-21 : |
Data: | 2017 |
Resum: | 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. |
Ajuts: | 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 |
Drets: | 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. |
Llengua: | Anglès |
Document: | Article ; recerca ; Versió publicada |
Publicat a: | British Journal of Cancer, Vol. 117 Núm. 6 (may 2017) , p. 767-774, ISSN 1532-1827 |
8 p, 509.4 KB |