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)
Por:
Mora, J, Castaneda, A, Perez-Jaume, S, Lopez-Pousa, A, Maradiegue, E, Valverde, C, Martin-Broto, J, del Muro, XG, Cruz, O, Cruz, J, Martinez-Trufero, J, Maurel, J, Vaz, MA, de Alava, E, de Torres, C
Publicada:
5 sep 2017
Resumen:
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.
Filiaciones:
Mora, J:
Hosp St Joan de Deu, Dept Pediat Oncol & Hematol, Barcelona 08950, Spain
Castaneda, A:
Hosp St Joan de Deu, Dept Pediat Oncol & Hematol, Barcelona 08950, Spain
Perez-Jaume, S:
Hosp St Joan de Deu, Dept Pediat Oncol & Hematol, Barcelona 08950, Spain
Lopez-Pousa, A:
Hosp Santa Creu & Sant Pau, Dept Med Oncol, Barcelona 08025, Spain
Maradiegue, E:
Hosp St Joan de Deu, Dept Pediat Oncol & Hematol, Barcelona 08950, Spain
Valverde, C:
Hosp Valle De Hebron, Dept Med Oncol, Barcelona 08035, Spain
Martin-Broto, J:
Hosp Son Espases, Dept Med Oncol, Palma De Mallorca 07210, Spain
Univ Seville, CSIC, Dept Pathol, Virgen del Rocio Univ Hosp,Inst Biomed Sevilla IB, Seville 41013, Spain
del Muro, XG:
Univ Barcelona, IDIBELL, Dept Med Oncol, Inst Catala Oncol, Barcelona 08907, Spain
Cruz, O:
Hosp St Joan de Deu, Dept Pediat Oncol & Hematol, Barcelona 08950, Spain
Cruz, J:
Hosp Univ Canarias, Dept Med Oncol, Tenerife 38001, Spain
Martinez-Trufero, J:
Hosp Miguel Servet, Dept Med Oncol, Zaragoza 50009, Spain
Maurel, J:
Hosp Clin Barcelona, Dept Med Oncol, E-08036 Barcelona, Spain
Vaz, MA:
Hosp Ramon & Cajal, Dept Med Oncol, E-28034 Madrid, Spain
de Alava, E:
Univ Seville, CSIC, CIBERONC,Dept Pathol, Virgen del Rocio Univ Hosp,Inst Biomed Sevilla IB, Seville 41013, Spain
de Torres, C:
Hosp St Joan de Deu, Dept Pediat Oncol & Hematol, Barcelona 08950, Spain
Green Published, Hybrid Gold
|