A phase II study of temozolemide vs. procarbazine in patients with glioblastoma multiforme at first relapse

W. K.A. Yung, R. E. Albright, J. Olson, R. Fredericks, K. Fink, M. D. Prados, M. Brada, A. Spence, Raymond Hohl, W. Shapiro, Michael Glantz, H. Greenberg, R. G. Selker, N. A. Vick, R. Rampling, H. Friedman, P. Phillips, J. Bruner, N. Yue, D. OsobaS. Zaknoen, V. A. Levin

Research output: Contribution to journalArticle

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Abstract

A randomized, multicentre, open-label, phase II study compared temozolomide (TMZ), an oral second-generation alkylating agent, and procarbazine (PCB) in 225 patients with glioblastoma multiforme at first relapse. Primary objectives were to determine progression-free survival (PFS) at 6 months and safety for TMZ and PCB in adult patients who failed conventional treatment. Secondary objectives were to assess overall survival and health-related quality of life (HRQL). TMZ was given orally at 200 mg/m2/day or 160 mg/m2/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m2/day or 125 mg/m2/day (prior chemotherapy) for 28 days, repeated every 56 days. HRQL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 [+3]) and the Brain Cancer Module 20 (BCM20). The 6-month PFS rate for patients who received TMZ was 21%, which met the protocol objective. The 6-month PFS rate for those who received PCB was 8% (P = 0.008, for the comparison). Overall PFS significantly improved with TMZ, with a median PFS of 12.4 weeks in the TMZ group and 8.32 weeks in the PCB group (P = 0.0063). The 8-month overall survival rate for TMZ patients was 60% vs. 44% for PCB patients (P = 0.019). Freedom from disease progression was associated with maintenance of HRQL, regardless of treatment received. TMZ had an acceptable safety profile; most adverse events were mild or moderate in severity. (C) 2000 Cancer Research Campaign.

Original languageEnglish (US)
Pages (from-to)588-593
Number of pages6
JournalBritish Journal of Cancer
Volume83
Issue number5
StatePublished - Aug 31 2000

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temozolomide
Procarbazine
Glioblastoma
Recurrence
Disease-Free Survival
Quality of Life
Survival Rate
Safety
Drug Therapy
Alkylating Agents
Brain Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Yung, W. K. A., Albright, R. E., Olson, J., Fredericks, R., Fink, K., Prados, M. D., ... Levin, V. A. (2000). A phase II study of temozolemide vs. procarbazine in patients with glioblastoma multiforme at first relapse. British Journal of Cancer, 83(5), 588-593.
Yung, W. K.A. ; Albright, R. E. ; Olson, J. ; Fredericks, R. ; Fink, K. ; Prados, M. D. ; Brada, M. ; Spence, A. ; Hohl, Raymond ; Shapiro, W. ; Glantz, Michael ; Greenberg, H. ; Selker, R. G. ; Vick, N. A. ; Rampling, R. ; Friedman, H. ; Phillips, P. ; Bruner, J. ; Yue, N. ; Osoba, D. ; Zaknoen, S. ; Levin, V. A. / A phase II study of temozolemide vs. procarbazine in patients with glioblastoma multiforme at first relapse. In: British Journal of Cancer. 2000 ; Vol. 83, No. 5. pp. 588-593.
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abstract = "A randomized, multicentre, open-label, phase II study compared temozolomide (TMZ), an oral second-generation alkylating agent, and procarbazine (PCB) in 225 patients with glioblastoma multiforme at first relapse. Primary objectives were to determine progression-free survival (PFS) at 6 months and safety for TMZ and PCB in adult patients who failed conventional treatment. Secondary objectives were to assess overall survival and health-related quality of life (HRQL). TMZ was given orally at 200 mg/m2/day or 160 mg/m2/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m2/day or 125 mg/m2/day (prior chemotherapy) for 28 days, repeated every 56 days. HRQL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 [+3]) and the Brain Cancer Module 20 (BCM20). The 6-month PFS rate for patients who received TMZ was 21{\%}, which met the protocol objective. The 6-month PFS rate for those who received PCB was 8{\%} (P = 0.008, for the comparison). Overall PFS significantly improved with TMZ, with a median PFS of 12.4 weeks in the TMZ group and 8.32 weeks in the PCB group (P = 0.0063). The 8-month overall survival rate for TMZ patients was 60{\%} vs. 44{\%} for PCB patients (P = 0.019). Freedom from disease progression was associated with maintenance of HRQL, regardless of treatment received. TMZ had an acceptable safety profile; most adverse events were mild or moderate in severity. (C) 2000 Cancer Research Campaign.",
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Yung, WKA, Albright, RE, Olson, J, Fredericks, R, Fink, K, Prados, MD, Brada, M, Spence, A, Hohl, R, Shapiro, W, Glantz, M, Greenberg, H, Selker, RG, Vick, NA, Rampling, R, Friedman, H, Phillips, P, Bruner, J, Yue, N, Osoba, D, Zaknoen, S & Levin, VA 2000, 'A phase II study of temozolemide vs. procarbazine in patients with glioblastoma multiforme at first relapse', British Journal of Cancer, vol. 83, no. 5, pp. 588-593.

A phase II study of temozolemide vs. procarbazine in patients with glioblastoma multiforme at first relapse. / Yung, W. K.A.; Albright, R. E.; Olson, J.; Fredericks, R.; Fink, K.; Prados, M. D.; Brada, M.; Spence, A.; Hohl, Raymond; Shapiro, W.; Glantz, Michael; Greenberg, H.; Selker, R. G.; Vick, N. A.; Rampling, R.; Friedman, H.; Phillips, P.; Bruner, J.; Yue, N.; Osoba, D.; Zaknoen, S.; Levin, V. A.

In: British Journal of Cancer, Vol. 83, No. 5, 31.08.2000, p. 588-593.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase II study of temozolemide vs. procarbazine in patients with glioblastoma multiforme at first relapse

AU - Yung, W. K.A.

AU - Albright, R. E.

AU - Olson, J.

AU - Fredericks, R.

AU - Fink, K.

AU - Prados, M. D.

AU - Brada, M.

AU - Spence, A.

AU - Hohl, Raymond

AU - Shapiro, W.

AU - Glantz, Michael

AU - Greenberg, H.

AU - Selker, R. G.

AU - Vick, N. A.

AU - Rampling, R.

AU - Friedman, H.

AU - Phillips, P.

AU - Bruner, J.

AU - Yue, N.

AU - Osoba, D.

AU - Zaknoen, S.

AU - Levin, V. A.

PY - 2000/8/31

Y1 - 2000/8/31

N2 - A randomized, multicentre, open-label, phase II study compared temozolomide (TMZ), an oral second-generation alkylating agent, and procarbazine (PCB) in 225 patients with glioblastoma multiforme at first relapse. Primary objectives were to determine progression-free survival (PFS) at 6 months and safety for TMZ and PCB in adult patients who failed conventional treatment. Secondary objectives were to assess overall survival and health-related quality of life (HRQL). TMZ was given orally at 200 mg/m2/day or 160 mg/m2/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m2/day or 125 mg/m2/day (prior chemotherapy) for 28 days, repeated every 56 days. HRQL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 [+3]) and the Brain Cancer Module 20 (BCM20). The 6-month PFS rate for patients who received TMZ was 21%, which met the protocol objective. The 6-month PFS rate for those who received PCB was 8% (P = 0.008, for the comparison). Overall PFS significantly improved with TMZ, with a median PFS of 12.4 weeks in the TMZ group and 8.32 weeks in the PCB group (P = 0.0063). The 8-month overall survival rate for TMZ patients was 60% vs. 44% for PCB patients (P = 0.019). Freedom from disease progression was associated with maintenance of HRQL, regardless of treatment received. TMZ had an acceptable safety profile; most adverse events were mild or moderate in severity. (C) 2000 Cancer Research Campaign.

AB - A randomized, multicentre, open-label, phase II study compared temozolomide (TMZ), an oral second-generation alkylating agent, and procarbazine (PCB) in 225 patients with glioblastoma multiforme at first relapse. Primary objectives were to determine progression-free survival (PFS) at 6 months and safety for TMZ and PCB in adult patients who failed conventional treatment. Secondary objectives were to assess overall survival and health-related quality of life (HRQL). TMZ was given orally at 200 mg/m2/day or 160 mg/m2/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m2/day or 125 mg/m2/day (prior chemotherapy) for 28 days, repeated every 56 days. HRQL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 [+3]) and the Brain Cancer Module 20 (BCM20). The 6-month PFS rate for patients who received TMZ was 21%, which met the protocol objective. The 6-month PFS rate for those who received PCB was 8% (P = 0.008, for the comparison). Overall PFS significantly improved with TMZ, with a median PFS of 12.4 weeks in the TMZ group and 8.32 weeks in the PCB group (P = 0.0063). The 8-month overall survival rate for TMZ patients was 60% vs. 44% for PCB patients (P = 0.019). Freedom from disease progression was associated with maintenance of HRQL, regardless of treatment received. TMZ had an acceptable safety profile; most adverse events were mild or moderate in severity. (C) 2000 Cancer Research Campaign.

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Yung WKA, Albright RE, Olson J, Fredericks R, Fink K, Prados MD et al. A phase II study of temozolemide vs. procarbazine in patients with glioblastoma multiforme at first relapse. British Journal of Cancer. 2000 Aug 31;83(5):588-593.