Temozolomide in Patients with Glioblastoma at Second Relapse after First Line Nitrosourea-Procarbazine Failure: A Phase II Study
2002; Karger Publishers; Volume: 63; Issue: 1 Linguagem: Inglês
10.1159/000065718
ISSN1423-0232
AutoresAlba A. Brandes, Mario Ermani, Umberto Basso, Myriam Paris, Franco Lumachi, Franco Berti, Pietro Amistà, Marina Gardiman, P. Iuzzolino, S. Turazzi, S. Monfardini,
Tópico(s)Cancer Treatment and Pharmacology
Resumo<i>Objectives:</i> To investigate the efficacy of temozolomide (TMZ) in relationship to progression free survival at 6 months (PFS-6), median time to progression (TTP), response rate and toxicity, a phase II study was conducted in patients with recurrent glioblastoma multiforme (GBM) following surgery plus radiotherapy and a first-line regimen based on nitrosourea, procarbazine and vincristine. <i>Methods:</i> Forty-two patients with GBM were administered TMZ at the dose of 150 mg/m<sup>2</sup>/daily for 5 days every 4 weeks. <i>Results:</i> The PFS-6 and at 12 months (PFS-12) was 24% (95% Confidence Interval [CI] = 14–42%) and 8% (CI = 2–27%), respectively, with a median TTP of 11.7 weeks (CI = 9–22 weeks). The response was assessed in all 42 patients; we observed 2 complete responses (CR) (4.7%), 6 partial responses (PR) (14.3%), and 9 stable disease (SD) (21.4%), with CR+PR = 19% (CI = 7–31%). <i>Conclusion: </i>TMZ as a second line regimen is a valid option in patients with heavily pretreated GBM.
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