Skip to main content
release_alert
Welcome to the new Scholars 3.0! Read about new features and let us know what you think.
cancel
Journal cover image

Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma.

Publication ,  Journal Article
Omuro, A; Chan, TA; Abrey, LE; Khasraw, M; Reiner, AS; Kaley, TJ; Deangelis, LM; Lassman, AB; Nolan, CP; Gavrilovic, IT; Hormigo, A; Heguy, A ...
Published in: Neuro Oncol
February 2013

BACKGROUND: In this phase II trial, we investigated the efficacy of a metronomic temozolomide schedule in the treatment of recurrent malignant gliomas (MGs). METHODS: Eligible patients received daily temozolomide (50 mg/m2) continuously until progression. The primary endpoint was progression-free survival rate at 6 months in the glioblastoma cohort (N = 37). In an exploratory analysis, 10 additional recurrent grade III MG patients were enrolled. Correlative studies included evaluation of 76 frequent mutations in glioblastoma (iPLEX assay, Sequenom) aiming at establishing the frequency of potentially "drugable" mutations in patients entering recurrent MG clinical trials. RESULTS: Among glioblastoma patients, median age was 56 y; median Karnofsky performance score (KPS) was 80; 62% of patients had been treated for ≥2 recurrences, including 49% of patients having failed bevacizumab. Treatment was well tolerated; clinical benefit (complete response + partial response + stable disease) was seen in 10 (36%) patients. Progression-free survival rate at 6 months was 19% and median overall survival was 7 months. Patients with previous bevacizumab exposure survived significantly less than bevacizumab-naive patients (median overall survival: 4.3 mo vs 13 mo; hazard ratio = 3.2; P = .001), but those patients had lower KPS (P = .04) and higher number of recurrences (P < .0001). Mutations were found in 13 of the 38 MGs tested, including mutations of EGFR (N = 10), IDH1 (N = 5), and ERBB2 (N = 1). CONCLUSIONS: In spite of a heavily pretreated population, including nearly half of patients having failed bevacizumab, the primary endpoint was met, suggesting that this regimen deserves further investigation. Results in bevacizumab-naive patients seemed particularly favorable, while results in bevacizumab-failing patients highlight the need to develop further treatment strategies for advanced MG. Clinical trials.gov identifier NCT00498927 (available at http://clinicaltrials.gov/ct2/show/NCT00498927).

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Neuro Oncol

DOI

EISSN

1523-5866

Publication Date

February 2013

Volume

15

Issue

2

Start / End Page

242 / 250

Location

England

Related Subject Headings

  • Temozolomide
  • Survival Rate
  • Prospective Studies
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Neoplasm Grading
  • Middle Aged
  • Maximum Tolerated Dose
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Omuro, A., Chan, T. A., Abrey, L. E., Khasraw, M., Reiner, A. S., Kaley, T. J., … Mellinghoff, I. (2013). Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma. Neuro Oncol, 15(2), 242–250. https://doi.org/10.1093/neuonc/nos295
Omuro, Antonio, Timothy A. Chan, Lauren E. Abrey, Mustafa Khasraw, Anne S. Reiner, Thomas J. Kaley, Lisa M. Deangelis, et al. “Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma.Neuro Oncol 15, no. 2 (February 2013): 242–50. https://doi.org/10.1093/neuonc/nos295.
Omuro A, Chan TA, Abrey LE, Khasraw M, Reiner AS, Kaley TJ, et al. Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma. Neuro Oncol. 2013 Feb;15(2):242–50.
Omuro, Antonio, et al. “Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma.Neuro Oncol, vol. 15, no. 2, Feb. 2013, pp. 242–50. Pubmed, doi:10.1093/neuonc/nos295.
Omuro A, Chan TA, Abrey LE, Khasraw M, Reiner AS, Kaley TJ, Deangelis LM, Lassman AB, Nolan CP, Gavrilovic IT, Hormigo A, Salvant C, Heguy A, Kaufman A, Huse JT, Panageas KS, Hottinger AF, Mellinghoff I. Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma. Neuro Oncol. 2013 Feb;15(2):242–250.
Journal cover image

Published In

Neuro Oncol

DOI

EISSN

1523-5866

Publication Date

February 2013

Volume

15

Issue

2

Start / End Page

242 / 250

Location

England

Related Subject Headings

  • Temozolomide
  • Survival Rate
  • Prospective Studies
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Neoplasm Grading
  • Middle Aged
  • Maximum Tolerated Dose
  • Male