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Poster Discussion – CNS tumours

4589 - Extending temozolomide longer than six cycles in glioblastoma: results of the randomized GEINO-014 TRIAL.

Date

28 Sep 2019

Session

Poster Discussion – CNS tumours

Presenters

Maria Angeles Salgado

Citation

Annals of Oncology (2019) 30 (suppl_5): v143-v158. 10.1093/annonc/mdz243

Authors

M.A.V. Salgado1, J.M. Sepulveda Sanchez2, S. del barco3, E. Pineda4, J. Fuster5, M. Navarro Martin6, A. Herrero Ibañez7, M. Alonso8, J. Perez9, C. Mesia10, J. Munoz-Langa11, R. de las Penas Bataller12, S. Peralta13, C. Olier14, P. Pérez-Segura15, A. Estival16, C. Carrato17, C. Saez18, M.J. Gil19, C. Balana20

Author affiliations

  • 1 Medical Oncology, Ramon y Cajal University Hospital, 28029 - Madrid/ES
  • 2 Medical Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 3 Medical Oncology, ICO Girona, 17007 - Girona/ES
  • 4 Medical Oncology, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 5 Medical Oncology, Hospital Son Espases, Palma de Mallorca/ES
  • 6 Medical Oncology, IBSAL - Instituto de Investigación Biomédica de Salamanca, 37007 - Salamanca/ES
  • 7 Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 8 Oncology, Hospital Universitario Virgen del Rocío, Sevilla/ES
  • 9 Biostatistic, ICO hospitalet, Barcelona/ES
  • 10 Medical Oncology, ICO Hospitalet, Barcelona/ES
  • 11 Medical Oncology, Hospital Universitari i Politècnic La Fe, 46026 - Valencia/ES
  • 12 Medical Oncology, Hospital Provincial Castellon, 12002 - Castellón/ES
  • 13 Medical Oncology, Hospital Sant Joan de Reus, Tarragona/ES
  • 14 Medical Oncology, Hospital de Alcorcon, Madrid/ES
  • 15 Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 16 Medical Oncology, H German Trias i Pjol, Barcelona/ES
  • 17 Pathology, Hospital Universitari Germans Trias i Pujol, 08916 - Badalona/ES
  • 18 Pathology, German Trias i Pujol, Barcelona/ES
  • 19 Medical Oncology, Institut Català d'Oncologia Hospital Duran i Reynals, 08907 - Barcelona/ES
  • 20 Medical Oncology, Germans Trias i Pujol, Barcelona/ES

Resources

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Abstract 4589

Background

Standard treatment of glioblastoma (GBM) is focal radiation with concomitant and adjuvant temozolomide (TMZ) for 6 cycles. The GEINO-14-01 trial (NCT02209948) investigated the role of extending adjuvant TMZ to 12 cycles in a randomized multicenter study.

Methods

Between Aug/2014 and Nov/2018, 166 patients (p) were screened and 159 randomized to extend (80p) or not (79p) TMZ treatment to 12 cycles after proving lack of progression of the disease in the MRI performed before inclusion. The trial was stratified by MGMT status and presence or absence of residual disease (defined as a residual enhancement larger than 1cm on the MRI). The primary endpoint was differences in 6monthsPFS, secondary endpoints were differences in PFS, OS, toxicity, between arms and per stratification factors.

Results

Median age was 60.4 (range 29-83), all p had ECOG≤1 and 86.2% were without DXM treatment. MGMT status: Met: 97 (61%) UnMet:62 (39%). RD yes: 83 (52.2%) and no: 76 (47.8%). At the time of the abstract report 3 patients are still on treatment or control without a documented progression and 5 patients have not been yet 6m in the study: 31 patients (19.5) are still free of progression and 60 patients (37.7%) are still alive. Median (m) PFS has been reached: 7.9 months (95%CI: 6.1-9.8) as well as mOS: 20.9 (95%CI: 17.6-24.1). A methylated status was a factor of better PFS (HR = 0.29, 95% CI 0.46-0.95; p = 0.029) and better OS (HR = 0.43: 95% CI 0.28-0.66; p = 0.000) as well as the absence of residual disease (PFS: HR = 0.84: 95% CI = 0.71-1.01; p = 0.068; OS: HR = 0.77, 95%CI 0.63-0.96; p = 0.019). We didn’t find any difference in PFS (HR = 1.02, 95%CI 0.85-1.21; p = 0.82), or OS (HR = 0.90; 0.73-1.11; p = 0.34) on extending treatment with temozolomide longer than 6 cycles. Toxicity data and final results are expected for the congress.

Conclusions

There is no benefit of continuing TMZ treatment for more than 6 cycles in the adjuvant treatment of glioblastoma. Met status and absence of RD are factors of better SLP after adjuvant treatment. Supported by a Grant of the ISCIII: PI13/01751.

Clinical trial identification

NCT02209948.

Editorial acknowledgement

Legal entity responsible for the study

GEINO (Grupo Español de Investigación en Neurooncologia).

Funding

Supported by a Grant of the ISCIII.

Disclosure

M.A.V. Salgado: Advisory / Consultancy: Lilly; Research grant / Funding (institution): Pfizer; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: pharmamar; Advisory / Consultancy: eisai; Advisory / Consultancy: Celgene. All other authors have declared no conflicts of interest.

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