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Phase II trial of temozolomide in patients with progressive low-grade glioma.

Publication ,  Journal Article
Quinn, JA; Reardon, DA; Friedman, AH; Rich, JN; Sampson, JH; Provenzale, JM; McLendon, RE; Gururangan, S; Bigner, DD; Herndon, JE; Finlay, J ...
Published in: J Clin Oncol
February 15, 2003

PURPOSE: Temozolomide (Temodar; Schering-Plough Corp, Kenilworth, NJ) is an imidazole tetrazinone that undergoes chemical conversion to the active methylating agent 5-(3-methyltriazen-1yl)imidazole-4-carboximide under physiologic conditions. Previous studies have confirmed activity of Temodar in the treatment of progressive and newly diagnosed malignant gliomas. We have extended these results, and now we report results of a phase II trial of Temodar for patients with progressive, low-grade glioma. PATIENTS AND METHODS: Temodar was administered orally once a day for five consecutive days (in a fasting state) at a starting dose of 200 mg/m(2)/d. Treatment cycles were repeated every 28 days following the first daily dose of Temodar. Response criteria used a combination of magnetic resonance imaging and physical examination to evaluate activity. RESULTS: Forty-six patients with low-grade glioma have been treated to date. The objective response rate was 61% (24% complete response and 37% partial response), with an additional 35% of patients having stable disease. Median progression-free survival (PFS) was 22 months (95% confidence interval [CI], 15 to infinity months) with a 6-month PFS of 98% (95% CI, 94% to 100%) and a 12-month PFS of 76% (95% CI, 63% to 92%). Toxicity observed during the study was limited to only six patients. Three patients experienced grade 3 neutropenia, with a duration greater than 3 weeks in one patient, and two patients experienced grade 3 thrombocytopenia. One patient experienced > or = grade 4 toxicity, with intracerebral hemorrhage, neutropenia, thrombocytopenia, sepsis, and death. CONCLUSION: Initial results indicate that Temodar may be active in the treatment of low-grade glioma, and thus, further evaluation of this agent in the treatment of these tumors is warranted.

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Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

February 15, 2003

Volume

21

Issue

4

Start / End Page

646 / 651

Location

United States

Related Subject Headings

  • Temozolomide
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Glioma
  • Female
  • Disease-Free Survival
  • Dacarbazine
  • Combined Modality Therapy
 

Citation

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Quinn, J. A., Reardon, D. A., Friedman, A. H., Rich, J. N., Sampson, J. H., Provenzale, J. M., … Friedman, H. S. (2003). Phase II trial of temozolomide in patients with progressive low-grade glioma. J Clin Oncol, 21(4), 646–651. https://doi.org/10.1200/JCO.2003.01.009
Quinn, Jennifer A., David A. Reardon, Allan H. Friedman, Jeremy N. Rich, John H. Sampson, James M. Provenzale, Roger E. McLendon, et al. “Phase II trial of temozolomide in patients with progressive low-grade glioma.J Clin Oncol 21, no. 4 (February 15, 2003): 646–51. https://doi.org/10.1200/JCO.2003.01.009.
Quinn JA, Reardon DA, Friedman AH, Rich JN, Sampson JH, Provenzale JM, et al. Phase II trial of temozolomide in patients with progressive low-grade glioma. J Clin Oncol. 2003 Feb 15;21(4):646–51.
Quinn, Jennifer A., et al. “Phase II trial of temozolomide in patients with progressive low-grade glioma.J Clin Oncol, vol. 21, no. 4, Feb. 2003, pp. 646–51. Pubmed, doi:10.1200/JCO.2003.01.009.
Quinn JA, Reardon DA, Friedman AH, Rich JN, Sampson JH, Provenzale JM, McLendon RE, Gururangan S, Bigner DD, Herndon JE, Avgeropoulos N, Finlay J, Tourt-Uhlig S, Affronti ML, Evans B, Stafford-Fox V, Zaknoen S, Friedman HS. Phase II trial of temozolomide in patients with progressive low-grade glioma. J Clin Oncol. 2003 Feb 15;21(4):646–651.

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

February 15, 2003

Volume

21

Issue

4

Start / End Page

646 / 651

Location

United States

Related Subject Headings

  • Temozolomide
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Glioma
  • Female
  • Disease-Free Survival
  • Dacarbazine
  • Combined Modality Therapy