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2019 ASCO Annual Meeting!


Session: Central Nervous System Tumors

Type: Oral Abstract Session

Time: Monday June 3, 1:15 PM to 4:15 PM

Location: S102

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.

Sub-category:
Central Nervous System Tumors

Category:
Central Nervous System Tumors

Meeting:
2019 ASCO Annual Meeting

Abstract No:
2001

Citation:
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

Abstract Disclosures

Abstract:

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

 
Other Abstracts in this Sub-Category:

 

1. Second interim and first molecular analysis of the EORTC randomized phase III intergroup CATNON trial on concurrent and adjuvant temozolomide in anaplastic glioma without 1p/19q codeletion.

Meeting: 2019 ASCO Annual Meeting Abstract No: 2000 First Author: Martin J. Van Den Bent
Category: Central Nervous System Tumors

 

2. Updated predictive analysis of the WHO-defined molecular subgroups of low-grade gliomas within the high-risk treatment arms of NRG Oncology/RTOG 9802.

Meeting: 2019 ASCO Annual Meeting Abstract No: 2002 First Author: Erica Hlavin Bell
Category: Central Nervous System Tumors

 

3. A phase I, open label, perioperative study of AG-120 and AG-881 in recurrent IDH1 mutant, low-grade glioma: Results from cohort 1.

Meeting: 2019 ASCO Annual Meeting Abstract No: 2003 First Author: Ingo K. Mellinghoff
Category: Central Nervous System Tumors

 

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