A phase II randomized, multicenter, open-label trial of continuing adjuvant temozolomide beyond 6 cycles in patients with glioblastoma (GEINO 14-01)
Por:
Balana, C, Vaz, MA, Sepulveda, JM, Mesia, C, del Barco, S, Pineda, E, Munoz-Langa, J, Estival, A, de las Penas, R, Fuster, J, Girones, R, Navarro, LM, Gil-Gil, M, Alonso, M, Herrero, A, Peralta, S, Olier, C, Perez-Segura, P, Covela, M, Martinez-Garcia, M, Berrocal, A, Gallego, O, Luque, R, Perez-Martin, FJ, Esteve, A, Munne, N, Domenech, M, Villa, S, Sanz, C, Carrato, C
Publicada:
1 dic 2020
Resumen:
Background. 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.
Methods. 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).
Results. From August 2014 to November 2018, 166 patients were screened, 7 of whom were ineligible. Seventynine 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 < 0.001), thrombocytopenia (P < 0.001), and nausea and vomiting (P = 0.001).
Conclusions. Continuing temozolomide after 6 adjuvant cycles is associated with greater toxicity but confers no additional benefit in 6-month PFS.
Filiaciones:
Balana, C:
Inst Catala Oncol, Med Oncol Serv, Badalona, Spain
Inst Invest Ciencies Salut Germans Trias & Pujol, Appl Res Grp Oncol B ARGO, Badalona, Spain
Vaz, MA:
Hosp Ramon & Cajal, Med Oncol Serv, Madrid, Spain
Sepulveda, JM:
Hosp Univ 12 Octubre, Med Oncol Serv, Madrid, Spain
Mesia, C:
Inst Catala Oncol, Med Oncol Serv, Lhospitalet De Llobregat, Spain
Bellvitge Biomed Res Inst IDIBELL Hospitalet Llob, Lhospitalet De Llobregat, Spain
del Barco, S:
Inst Catala Oncol Girona, Med Oncol Serv, Girona, Spain
Pineda, E:
Hosp Clin Barcelona, Med Oncol Serv, Barcelona, Spain
Munoz-Langa, J:
Hosp Univ La Fe, Med Oncol Serv, Valencia, Spain
Estival, A:
Inst Catala Oncol, Med Oncol Serv, Badalona, Spain
Inst Invest Ciencies Salut Germans Trias & Pujol, Appl Res Grp Oncol B ARGO, Badalona, Spain
de las Penas, R:
Hosp Prov Castellon, Med Oncol Serv, Castellon de La Plana, Spain
Fuster, J:
Hosp Son Espases, Med Oncol Serv, Palma De Mallorca, Spain
Girones, R:
Hosp Univ La Fe, Med Oncol Serv, Valencia, Spain
Navarro, LM:
Hosp Salamanca, Med Oncol Serv, Salamanca, Spain
Gil-Gil, M:
Inst Catala Oncol, Med Oncol Serv, Lhospitalet De Llobregat, Spain
Bellvitge Biomed Res Inst IDIBELL Hospitalet Llob, Lhospitalet De Llobregat, Spain
Alonso, M:
Hosp Virgen del Rocio, Med Oncol Serv, Seville, Spain
Herrero, A:
Hosp Miguel Servet, Med Oncol Serv, Zaragoza, Spain
Peralta, S:
Hosp St Joan Reus, Med Oncol Serv, Reus, Spain
Olier, C:
Fdn Alcorcon, Med Oncol Serv, Madrid, Spain
Perez-Segura, P:
Hosp Univ Clin San Carlos, Med Oncol Serv, Madrid, Spain
Covela, M:
Hosp Lucus Agusti, Med Oncol Serv, Lugo, Spain
Martinez-Garcia, M:
Hosp del Mar, Med Oncol Serv, Barcelona, Spain
Berrocal, A:
Hosp Gen Univ Valencia, Med Oncol Serv, Valencia, Spain
Gallego, O:
Hosp Santa Creu & Sant Pau, Med Oncol Serv, Barcelona, Spain
Luque, R:
Hosp Univ Virgen de las Nieves, Med Oncol Serv, Granada, Spain
Perez-Martin, FJ:
Inst Catala Oncol, Med Oncol Serv, Lhospitalet De Llobregat, Spain
Bellvitge Biomed Res Inst IDIBELL Hospitalet Llob, Lhospitalet De Llobregat, Spain
Esteve, A:
Inst Invest Ciencies Salut Germans Trias & Pujol, Appl Res Grp Oncol B ARGO, Badalona, Spain
Munne, N:
Hosp Badalona Germans Trias & Pujol, Pathol Serv, Badalona, Spain
Domenech, M:
Inst Catala Oncol, Med Oncol Serv, Badalona, Spain
Villa, S:
Inst Catala Oncol, Radiat Therapy Oncol Serv, Badalona, Spain
Sanz, C:
Hosp Badalona Germans Trias & Pujol, Pathol Serv, Badalona, Spain
Carrato, C:
Hosp Badalona Germans Trias & Pujol, Pathol Serv, Badalona, Spain
Green Published, Bronze
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