A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse
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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/m(2)/day or 150 mg/m(2)/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m(2)/day or 125 mg/m(2)/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 6-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.
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The average historical PFS6 based on the above studies is 15.3 ± 3.8%.
“The average historical PFS6 based on the above studies is 15.3 ± 3.8%”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [25]
The average historical TTP is 9.5 ± 1.6 weeks.
“and the average historical TTP is 9.5 ± 1.6 weeks.”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [25]
The average historical OS is 29.3 ± 6 weeks.
“OS averaged 29.3 ± 6 weeks (see SI Table 2).”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [25]
Efficacy analysis was performed for 10 recurrent GBM patients by comparing TTP, PFS6, and OS in recurrent GBM patients treated with the NovoTTF-100A device with the TTP, PFS6, and OS of recurrent GBM patients in a literature based historical control group.
“Efficacy analysis was performed for 10 recurrent GBM patients by comparing TTP, PFS6, and OS in recurrent GBM patients treated with the NovoTTF-100A device with the TTP, PFS6, and OS of recurrent GBM patients in a literature based historical control group (10, 25–28).”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [25]
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- Authors
- Yung, W. K. A., Albright, R. E., Olson, J., Fredericks, R., Fink, K., Prados, M. D., Brada, M., Spence, A., Hohl, R. J., Shapiro, W., Glantz, M., 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.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Emory University (US)
- University of Mississippi Medical Center (US)
- The University of Texas Southwestern Medical Center (US)
- University of California, San Francisco (US)
- Royal Marsden NHS Foundation Trust (GB)
- University of Washington (US)
- University of Iowa Hospitals and Clinics (US)
- Barrow Neurological Institute (US)
- Memorial Hospital of Rhode Island (US)
- University of Michigan (US)
- Western Pennsylvania Hospital (US)
- Evanston Hospital (US)
- Beatson West of Scotland Cancer Centre (GB)
- Duke University (US)
- BC Cancer Agency (CA)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Venue
- British Journal of Cancer
- Published
- 2000-09
- Volume
- 83
- Issue
- 5
- Pages
- 588-593
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC2363506
- OpenAlex
- W1977392502
- Cited by
- 929
- References
- 27
- Citations by year
- 2026: 7 · 2025: 9 · 2024: 8 · 2023: 23 · 2022: 19 · 2021: 21 · 2020: 21 · 2019: 20 · 2018: 27 · 2017: 23 · 2016: 31 · 2015: 32 · 2014: 33 · 2013: 38 · 2012: 50
- FWCI
- 21.15
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-sa
- Locations
- British Journal of Cancer (publishedVersion, cc-by-nc-sa)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- temozolomide, procarbazine, glioblastoma, first relapse, progression-free survival, overall survival, health-related quality of life, alkylating agents, oral chemotherapy, treatment safety
- MeSH terms
- Temozolomide, Adult, Aged, Antineoplastic Agents, Brain Neoplasms, Dacarbazine, Female, Glioblastoma, Humans, Male, Middle Aged, Procarbazine, Prognosis, Quality of Life, Recurrence, Time Factors, Gliosarcoma, Disease-Free Survival, Antineoplastic Agents, Alkylating
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