Temozolomide in patients with glioblastoma at second relapse after first line nitrosourea-procarbazine failure: a phase II study.
OBJECTIVE
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.


METHODS
Forty-two patients with GBM were administered TMZ at the dose of 150 mg/m(2)/daily for 5 days every 4 weeks.


RESULTS
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%).


CONCLUSIONS
TMZ as a second line regimen is a valid option in patients with heavily pretreated GBM.
Department of Medical Oncology, Azienda Ospedale-Università, Padova, Italy. aabrandes@unipd.it
Alba A
AA
Brandes
Mario
M
Ermani
Umberto
U
Basso
Myriam K
MK
Paris
Franco
F
Lumachi
Franco
F
Berti
Pietro
P
Amistà
Marina
M
Gardiman
Paolo
P
Iuzzolino
Sergio
S
Turazzi
Silvio
S
Monfardini
D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D009607:Nitrosourea Compounds / Q000008:administration & dosage; D011344:Procarbazine / Q000008:administration & dosage; D012008:Recurrence; D015996:Survival Rate; D000077204:Temozolomide; D016896:Treatment Outcome
D018906:Antineoplastic Agents, Alkylating; D009607:Nitrosourea Compounds; D011344:Procarbazine; D003606:Dacarbazine; D000077204:Temozolomide