RT Journal Article T1 A phase II randomized, multicenter, open-label trial of continuing adjuvant temozolomide beyond 6 cycles in patients with glioblastoma (GEINO 14-01). A1 Balana, Carmen A1 Vaz, Maria Angeles A1 Manuel Sepúlveda, Juan A1 Mesia, Carlos A1 Del Barco, Sonia A1 Pineda, Estela A1 Muñoz-Langa, Jose A1 Estival, Anna A1 de Las Peñas, Ramón A1 Fuster, Jose A1 Gironés, Regina A1 Navarro, Luis Miguel A1 Gil-Gil, Miguel A1 Alonso, Miriam A1 Herrero, Ana A1 Peralta, Sergio A1 Olier, Clara A1 Perez-Segura, Pedro A1 Covela, Maria A1 Martinez-García, Maria A1 Berrocal, Alfonso A1 Gallego, Oscar A1 Luque, Raquel A1 Perez-Martín, Franciso Javier A1 Esteve, Anna A1 Munne, Nuria A1 Domenech, Marta A1 Villa, Salvador A1 Sanz, Carolina A1 Carrato, Cristina K1 MGMT methylation K1 extended adjuvant temozolomide K1 glioblastoma K1 prognosis AB Standard treatment for glioblastoma is radiation with concomitant and adjuvant temozolomide for 6 cycles, although the optimal number of cycles of adjuvant temozolomide has long been a subject of debate. We performed a phase II randomized trial investigating whether extending adjuvant temozolomide for more than 6 cycles improved outcome. Glioblastoma patients treated at 20 Spanish hospitals who had not progressed after 6 cycles of adjuvant temozolomide were centrally randomized to stop (control arm) or continue (experimental arm) temozolomide up to a total of 12 cycles at the same doses they were receiving in cycle 6. Patients were stratified by MGMT methylation and measurable disease. The primary endpoint was differences in 6-month progression-free survival (PFS). Secondary endpoints were PFS, overall survival (OS), and safety (Clinicaltrials.gov NCT02209948). From August 2014 to November 2018, 166 patients were screened, 7 of whom were ineligible. Seventy-nine patients were included in the stop arm and 80 in the experimental arm. All patients were included in the analyses of outcomes and of safety. There were no differences in 6-month PFS (control 55.7%; experimental 61.3%), PFS, or OS between arms. MGMT methylation and absence of measurable disease were independent factors of better outcome. Patients in the experimental arm had more lymphopenia (P  Continuing temozolomide after 6 adjuvant cycles is associated with greater toxicity but confers no additional benefit in 6-month PFS. 1. Extending adjuvant temozolomide to 12 cycles did not improve 6-month PFS.2. Extending adjuvant temozolomide did not improve PFS or OS in any patient subset.3. Extending adjuvant temozolomide was linked to increased toxicities. YR 2020 FD 2020 LK http://hdl.handle.net/10668/15425 UL http://hdl.handle.net/10668/15425 LA en DS RISalud RD Apr 5, 2025