2019 ASCO Annual Meeting!
Session: Central Nervous System Tumors
Type: Oral Abstract Session
Time: Monday June 3, 1:15 PM to 4:15 PM
Randomized phase IIb clinical trial of continuation or non-continuation with six cycles of temozolomide after the first six cycles of standard first-line treatment in patients with glioblastoma: A Spanish research group in neuro-oncology (GEINO) trial.
Central Nervous System Tumors
Central Nervous System Tumors
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 2001)
Author(s): Carmen Balana, Carlos Mesia Barroso, Sonia Del Barco Berron, Estela Pineda Losada, José Muñoz-Langa, Anna Estival, Ramon De las Peñas, Jose Fuster, Miguel J. Gil Gil, L Miguel Navarro, Miriam Alonso, Ana Herrero, María Ángeles Vaz Salgado, Sergi Peralta, Clara Olier, Pedro Pérez-Segura, Marta Covela Rúa, Cristina Carrato, Carolina Sanz, Juan Manuel Sepulveda-Sanchez; Institut Catala Oncologia Badalona, Hospital Germans Trias I Pujol, Badalona/Barcelona, Spain; Institut Català d'Oncologia Hospital Duran i Reynals, Barcelona, Spain; Institut Català d'Oncologia, Hospital Universitari Josep Trueta, Girona, Spain; Medical Oncology, Hospital Clinic de Barcelona, Barcelona, Spain; Hospital Universitario La Fé, València, Spain; Medical Oncology Department. Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Barcelona, Spain; Oncology Service. Hospital Provincial de Castellon, Castellon, Spain; Hospital Son Espases, Palma De Mallorca, Spain; Breast Cancer Unit & Medical Oncology Department, Institut Català d'Oncologia, IDIBELL, Barcelona, Spain; Department of Medical Oncology, Complejo Asistencial Universitario de Salamanca, Salamanca, Spain; Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen del Rocio/CSIC/Universidad de Sevilla, Seville, Spain; Hospital Miguel Servet, Zaragoza, Spain; Medical Oncology Department, Ramon y Cajal University Hospital, Madrid, Spain; Hospital Sant Joan de Reus, Reus/Tarragona, Spain; H Universitario Fundación Alcorcón, Alcorcón, Spain; Medical Oncology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain; Hospital Universitario Lucus Augusti, Lugo, Spain; Hospital Germans Trias i Pujol, Barcelona, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain
Background: The GEINO-14-01 trial (NCT02209948) investigated the role of extending temozolomide (TMZ) for 6 cycles after the standard 6 cycles to improve 6m-PFS, SLP and OS in newly diagnosed glioblastoma (GBM) patients (p). Methods: Between 08/2014 and 11/2018, 166 p were screened and 159 randomized to extend (80p) or not (79p) TMZ treatment for 6 cycles after proving stable disease in the MRI performed before inclusion. Centralized review of histology and determination of MGMT status, if not previously available, were performed before randomizing patients. Two criteria of stratification were used: MGMT status and presence/absence of residual disease on the basal MRI (defined as a residual enhancement larger than 1cm in one). The primary endpoint was differences in 6mPFS, secondary endpoints were differences in PFS, OS, toxicity, between arms and per stratification factors. Results: Median age was 60.3 (range 29-83), 97p (61%) were methylated, basal MRI showed residual disease in 57p (35.8%). After a median follow up of 14.0 months, with 121 p(76.1%) already progressed and 81p (50.9%) already dead, median PFS is presented. Median (m) PFS is 8.0 months (95%CI: 5.7-10.2). There is no difference in mPFS between arms (adjusted HR = 0.98, 95% CI: 0.82-1.18, P = 0.907). Methylated tumors had longer mPFS (HR=0.57, 95% CI: 0.39-0.83, P=0.004) irrespectively to the study treatment. Conclusions: There is not apparent benefit of continuing TMZ treatment for more than 6 cycles. Data will be actualized for the congress.Supported by a Grant of the ISCIII: PI13/01751. Clinical trial information: NCT02209948