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Journal of Clinical Oncology, Vol 17, Issue 9 (September), 1999: 2762
© 1999 American Society for Clinical Oncology

Multicenter Phase II Trial of Temozolomide in Patients With Anaplastic Astrocytoma or Anaplastic Oligoastrocytoma at First Relapse

W.K. Alfred Yung, Michael D. Prados, Ricardo Yaya-Tur, Steven S. Rosenfeld, Michael Brada, Henry S. Friedman, Robert Albright, Jeffrey Olson, Susan M. Chang, Alison M. O'Neill, Allan H. Friedman, Janet Bruner, Nancy Yue, Margaret Dugan, Sara Zaknoen, Victor A. Levin, for the Temodal Brain Tumor Group

From the University of Texas M.D. Anderson Cancer Center, Houston, TX; University of California, San Francisco, San Francisco, CA; University of Alabama, Birmingham, AL; Duke University, Durham, NC; University of Cincinnati, Cincinnati, OH; Emory Clinic, Atlanta, GA; Johns Hopkins University, Baltimore, MD; Schering-Plough Pharmaceuticals, Kenilworth, NJ; Hôpital de la Pitié-Salpetrière, Paris, France; and Royal Marsden Hospital, Surrey, United Kingdom.

Address reprint requests to W.K. Alfred Yung, MD, University of Texas M.D. Anderson Cancer Center, Department of Neuro-oncology, Box 100, 1515 Holcombe Blvd, Houston, TX 77030; emailyung@ manderson.org.

PURPOSE: To determine the antitumor efficacy and safety profile of temozolomide in patients with malignant astrocytoma at first relapse.

PATIENTS AND METHODS: This open-label, multicenter, phase II trial enrolled 162 patients (intent-to-treat [ITT] population). After central histologic review, 111 patients were confirmed to have had an anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma. Chemotherapy-naive patients were treated with temozolomide 200 mg/m2/d. Patients previously treated with chemotherapy received temozolomide 150 mg/m2/d; the dose could be increased to 200 mg/m2/d in the absence of grade 3/4 toxicity. Therapy was administered orally on the first 5 days of a 28-day cycle.

RESULTS: Progression-free survival (PFS) at 6 months, the primary protocol end point, was 46% (95% confidence interval, 38% to 54%). The median PFS was 5.4 months, and PFS at 12 months was 24%. The median overall survival was 13.6 months, and the 6- and 12-month survival rates were 75% and 56%, respectively. The objective response rate determined by independent central review of gadolinium-enhanced magnetic resonance imaging scans of the ITT population was 35% (8% complete response [CR], 27% partial response [PR]), with an additional 26% of patients with stable disease (SD). The median PFS for patients with SD was 4.4 months, with 33% progression-free at 6 months. Maintenance of progression-free status and objectively assessed response (CR/PR/SD) were both associated with health-related quality-of-life (HQL) benefits. Adverse events were mild to moderate, with hematologic side effects occurring in less than 10% of patients.

CONCLUSION: Temozolomide demonstrated good single-agent activity, an acceptable safety profile, and documented HQL benefits in patients with recurrent AA.


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W. J. Bodell, N. W. Gaikwad, D. Miller, and M. S. Berger
Formation of DNA Adducts and Induction of lacI Mutations in Big Blue Rat-2 Cells Treated with Temozolomide: Implications for the Treatment of Low-Grade Adult and Pediatric Brain Tumors
Cancer Epidemiol. Biomarkers Prev., June 1, 2003; 12(6): 545 - 551.
[Abstract] [Full Text] [PDF]

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 Neuro Oncol DukeHome page
M. van den Bent, O.-L. Chinot, and J. G. Cairncross
Recent developments in the molecular characterization and treatment of oligodendroglial tumors
Neuro-oncol, April 1, 2003; 5(2): 128 - 138.
[Abstract] [PDF]

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 Ann OncolHome page
M. J. van den Bent, O. Chinot, W. Boogerd, J. Bravo Marques, M. J. B. Taphoorn, J. M. Kros, C. C. D. van der Rijt, C. J. Vecht, N. De Beule, and B. Baron
Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972
Ann. Onc., April 1, 2003; 14(4): 599 - 602.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
E. Raymond, M. Fabbro, V. Boige, O. Rixe, M. Frenay, G. Vassal, S. Faivre, E. Sicard, C. Germa, J. M. Rodier, et al.
Multicentre phase II study and pharmacokinetic analysis of irinotecan in chemotherapy-naive patients with glioblastoma
Ann. Onc., April 1, 2003; 14(4): 603 - 614.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. A. Quinn, D. A. Reardon, A. H. Friedman, J. N. Rich, J. H. Sampson, J. M. Provenzale, R. E. McLendon, S. Gururangan, D. D. Bigner, J. E. Herndon II, et al.
Phase II Trial of Temozolomide in Patients With Progressive Low-Grade Glioma
J. Clin. Oncol., February 15, 2003; 21(4): 646 - 651.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. C. Buckner, D. Gesme Jr, J. R. O'Fallon, J. E. Hammack, S. Stafford, P. D. Brown, R. Hawkins, B. W. Scheithauer, B. J. Erickson, R. Levitt, et al.
Phase II Trial of Procarbazine, Lomustine, and Vincristine as Initial Therapy for Patients With Low-Grade Oligodendroglioma or Oligoastrocytoma: Efficacy and Associations With Chromosomal Abnormalities
J. Clin. Oncol., January 15, 2003; 21(2): 251 - 255.
[Abstract] [Full Text] [PDF]

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 JCOHome page
L. S. Lashford, P. Thiesse, A. Jouvet, T. Jaspan, D. Couanet, P. D. Griffiths, F. Doz, J. Ironside, K. Robson, R. Hobson, et al.
Temozolomide in Malignant Gliomas of Childhood: A United Kingdom Children's Cancer Study Group and French Society for Pediatric Oncology Intergroup Study
J. Clin. Oncol., December 15, 2002; 20(24): 4684 - 4691.
[Abstract] [Full Text] [PDF]

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 Neuro Oncol DukeHome page
M. R. Gilbert, H. S. Friedman, J. F. Kuttesch, M. D. Prados, J. J. Olson, G. H. Reaman, and S. L. Zaknoen
A phase II study of temozolomide in patients with newly diagnosed supratentorial malignant glioma before radiation therapy
Neuro-oncol, October 1, 2002; 4(4): 261 - 267.
[Abstract] [PDF]

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 JCOHome page
D. Antonadou, M. Paraskevaidis, G. Sarris, N. Coliarakis, I. Economou, P. Karageorgis, and N. Throuvalas
Phase II Randomized Trial of Temozolomide and Concurrent Radiotherapy in Patients With Brain Metastases
J. Clin. Oncol., September 1, 2002; 20(17): 3644 - 3650.
[Abstract] [Full Text] [PDF]

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 JCOHome page
K. Seiter, D. Liu, T. Loughran, A. Siddiqui, P. Baskind, and T. Ahmed
Phase I Study of Temozolomide in Relapsed/Refractory Acute Leukemia
J. Clin. Oncol., August 1, 2002; 20(15): 3249 - 3253.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
D. B. Bocangel, S. Finkelstein, S. C. Schold, K. K. Bhakat, S. Mitra, and D. M. Kokkinakis
Multifaceted Resistance of Gliomas to Temozolomide
Clin. Cancer Res., August 1, 2002; 8(8): 2725 - 2734.
[Abstract] [Full Text] [PDF]

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W.-J. Hwu, S. E. Krown, K. S. Panageas, J. H. Menell, P. B. Chapman, P. O. Livingston, L. J. Williams, C. J. Quinn, and A. N. Houghton
Temozolomide Plus Thalidomide in Patients With Advanced Melanoma: Results of a Dose-Finding Trial
J. Clin. Oncol., June 1, 2002; 20(11): 2610 - 2615.
[Abstract] [Full Text] [PDF]

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 BloodHome page
L. Tentori, C. Leonetti, M. Scarsella, G. d'Amati, I. Portarena, G. Zupi, E. Bonmassar, and G. Graziani
Combined treatment with temozolomide and poly(ADP-ribose) polymerase inhibitor enhances survival of mice bearing hematologic malignancy at the central nervous system site
Blood, March 15, 2002; 99(6): 2241 - 2244.
[Abstract] [Full Text] [PDF]

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R. Stupp, P.-Y. Dietrich, S. O. Kraljevic, A. Pica, I. Maillard, P. Maeder, R. Meuli, R. Janzer, G. Pizzolato, R. Miralbell, et al.
Promising Survival for Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concomitant Radiation Plus Temozolomide Followed by Adjuvant Temozolomide
J. Clin. Oncol., March 1, 2002; 20(5): 1375 - 1382.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
W. Wick, A. Wick, J. B. Schulz, J. Dichgans, H. P. Rodemann, and M. Weller
Prevention of Irradiation-induced Glioma Cell Invasion by Temozolomide Involves Caspase 3 Activity and Cleavage of Focal Adhesion Kinase
Cancer Res., March 1, 2002; 62(6): 1915 - 1919.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
C. R. Miller, C. R. Williams, D. J. Buchsbaum, and G. Y. Gillespie
Intratumoral 5-Fluorouracil Produced by Cytosine Deaminase/5-Fluorocytosine Gene Therapy Is Effective for Experimental Human Glioblastomas
Cancer Res., February 1, 2002; 62(3): 773 - 780.
[Abstract] [Full Text] [PDF]

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D. Bafaloukos, H. Gogas, V. Georgoulias, E. Briassoulis, G. Fountzilas, E. Samantas, Ch. Kalofonos, D. Skarlos, A. Karabelis, and P. Kosmidis
Temozolomide in Combination With Docetaxel in Patients With Advanced Melanoma: A Phase II Study of the Hellenic Cooperative Oncology Group
J. Clin. Oncol., January 15, 2002; 20(2): 420 - 425.
[Abstract] [Full Text] [PDF]

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 Neuro Oncol DukeHome page
R. B. Khan, J. J. Raizer, M. G. Malkin, K. A. Bazylewicz, and L. E. Abrey
A phase II study of extended low-dose temozolomide in recurrent malignant gliomas
Neuro-oncol, January 1, 2002; 4(1): 39 - 43.
[Abstract] [PDF]

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 Neuro Oncol DukeHome page
S. Gururangan, I. Cokgor, J. N. Rich, S. Edwards, M. L. Affronti, J. A. Quinn, J. E. Herndon II, J. M. Provenzale, R. E. McLendon, S. Tourt-Uhlig, et al.
Phase I study of GliadelTM wafers plus temozolomide in adults with recurrent supratentorial high-grade gliomas
Neuro-oncol, October 1, 2001; 3(4): 246 - 250.
[Abstract] [PDF]

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 NeurologyHome page
M.J. van den Bent, F. Keime-Guibert, A.A. Brandes, M.J.B. Taphoorn, J.M. Kros, F.A.L.M. Eskens, and A.F. Carpentier
Temozolomide chemotherapy in recurrent oligodendroglioma
Neurology, July 24, 2001; 57(2): 340 - 342.
[Abstract] [Full Text] [PDF]

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O.-L. Chinot, S. Honore, H. Dufour, M. Barrie, D. Figarella-Branger, X. Muracciole, D. Braguer, P.-M. Martin, and F. Grisoli
Safety and Efficacy of Temozolomide in Patients With Recurrent Anaplastic Oligodendrogliomas After Standard Radiotherapy and Chemotherapy
J. Clin. Oncol., May 1, 2001; 19(9): 2449 - 2455.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
D. M. Kokkinakis, R. M. Hoffman, E. P. Frenkel, J. B. Wick, Q. Han, M. Xu, Y. Tan, and S. C. Schold
Synergy between Methionine Stress and Chemotherapy in the Treatment of Brain Tumor Xenografts in Athymic Mice
Cancer Res., May 1, 2001; 61(10): 4017 - 4023.
[Abstract] [Full Text]

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 Clin. Cancer Res.Home page
Y. Ino, R. A. Betensky, M. C. Zlatescu, H. Sasaki, D. R. Macdonald, A. O. Stemmer-Rachamimov, D. A. Ramsay, J. G. Cairncross, and D. N. Louis
Molecular Subtypes of Anaplastic Oligodendroglioma: Implications for Patient Management at Diagnosis
Clin. Cancer Res., April 1, 2001; 7(4): 839 - 845.
[Abstract] [Full Text]

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 Neuro Oncol DukeHome page
N. D. Doolittle, C. P. Anderson, W. A. Bleyer, J. G. Cairncross, T. Cloughesy, S. L. Eck, P. Guastadisegni, W. A. Hall, L. L. Muldoon, S. J. Patel, et al.
Importance of dose intensity in neurooncology clinical trials: Summary Report of the Sixth Annual Meeting of the Blood-Brain Barrier Disruption Consortium
Neuro-oncol, January 1, 2001; 3(1): 46 - 54.
[Abstract] [PDF]

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 Neuro Oncol DukeHome page
D. Osoba, M. Brada, M. D. Prados, and W.K. A. Yung
Effect of disease burden on health-related quality of life in patients with malignant gliomas
Neuro-oncol, October 1, 2000; 2(4): 221 - 228.
[Abstract] [PDF]

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 Clin. Cancer Res.Home page
V. J. Patel, G. B. Elion, P. J. Houghton, S. Keir, A. E. Pegg, S. P. Johnson, M. E. Dolan, D. D. Bigner, and H. S. Friedman
Schedule-dependent Activity of Temozolomide plus CPT-11 against a Human Central Nervous System Tumor-derived Xenograft
Clin. Cancer Res., October 1, 2000; 6(10): 4154 - 4157.
[Abstract] [Full Text]

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 Clin. Cancer Res.Home page
H. S. Friedman, T. Kerby, and H. Calvert
Temozolomide and Treatment of Malignant Glioma
Clin. Cancer Res., July 1, 2000; 6(7): 2585 - 2597.
[Abstract] [Full Text]

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 NeurologyHome page
J. G. Cairncross
Understanding low-grade glioma: A decade of progress
Neurology, April 11, 2000; 54(7): 1402 - 1403.
[Full Text] [PDF]

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 The OncologistHome page
S. S. Agarwala and J. M. Kirkwood
Temozolomide, a Novel Alkylating Agent with Activity in the Central Nervous System, May Improve the Treatment of Advanced Metastatic Melanoma
Oncologist, April 1, 2000; 5(2): 144 - 151.
[Abstract] [Full Text]


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