Phase II study of temozolomide plus pegylated liposomal doxorubicin in the treatment of brain metastases from solid tumours.
OBJECTIVE
A combination regimen of temozolomide (TMZ) and pegylated liposomal doxorubicin has been evaluated in the treatment of brain metastases from solid tumours.


METHODS
Nineteen consecutive patients (pts) have been enrolled in a prospective phase II trial and treated with TMZ 200 mg/m2 (days 1-5) and pegylated liposomal doxorubicin 35 mg/m2 (day 1) every 28 days. The study was prospectively projected according to the Simon's two-stage optimal design.


RESULTS
Major toxicities have been grade III neutropenia and thrombocytopenia in one patient (pt) and grade III erythrodisesthesia in two pts. Three pts achieved a complete response (CR) and four a partial response (PR), for an overall response rate of 36.8% (95% CI: 19.1-59.2), which exceeded the target activity in the study design. A significant improvement in quality of life was demonstrated by FACT-G analysis. The median Progression Free Survival (PFS) was 5.5 (95% CI: 2.7-8.2) months while the median Overall Survival (OS) was 10.0 months (95% CI: 6.3-13.7).


CONCLUSIONS
The TMZ/pegylated liposomal doxorubicin regimen was well tolerated with an encouraging activity in brain metastases from solid tumours.
Caraglia
Michele
M
Oncology Department, S.Giovanni di Dio Hospital, ASL Napoli 3 Via Giovanni XXIII, 80028 Frattaminore, Naples, Italy. michele.caraglia@fondazionepascale.it
Addeo
Raffaele
R
Costanzo
Raffaele
R
Montella
Liliana
L
Faiola
Vincenzo
V
Marra
Monica
M
Abbruzzese
Alberto
A
Palmieri
Giovannella
G
Budillon
Alfredo
A
Grillone
Francesco
F
Venuta
Salvatore
S
Tagliaferri
Pierosandro
P
Del Prete
Salvatore
S
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D000077204:Temozolomide
D008081:Liposomes; D003606:Dacarbazine; D004317:Doxorubicin; D000077204:Temozolomide