A phase II study of concurrent temozolomide and cis-retinoic acid with radiation for adult patients with newly diagnosed supratentorial glioblastoma.
OBJECTIVE
This Phase II study was designed to determine the median survival time of adults with supratentorial glioblastoma treated with a combination of temozolomide (TMZ) and 13-cis-retinoic acid (cRA) given daily with conventional radiation therapy (XRT).


METHODS
This was a single arm, open-labeled, Phase II study. Patients were treated with XRT in conjunction with cRA and TMZ. Both drugs were administered starting on Day 1 of XRT, and chemotherapy cycles continued after the completion of XRT to a maximum of 1 year.


RESULTS
Sixty-one patients were enrolled in the study. Time to progression was known for 55 patients and 6 were censored. The estimated 6-month progression-free survival was 38% and the estimated 1-year progression-free survival was 15%. Median time to progression was estimated as 21 weeks. The estimated 1-year survival was 57%. The median survival was 57 weeks.


CONCLUSIONS
The combined therapy was relatively well tolerated, but there was no survival advantage compared with historical studies using XRT either with adjuvant nitrosourea chemotherapy, with TMZ alone, or with the combination of TMZ and thalidomide. Based on this study, cRA does not seem to add a significant synergistic effect to TMZ and XRT.
Butowski
Nicholas
N
Department of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Prados
Michael D
MD
Lamborn
Kathleen R
KR
Larson
David A
DA
Sneed
Patricia K
PK
Wara
William M
WM
Malec
Mary
M
Rabbitt
Jane
J
Page
Margaretta
M
Chang
Susan M
SM
D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D015173:Supratentorial Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D000077204:Temozolomide
D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D015474:Isotretinoin; D000077204:Temozolomide