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

By W. Yung, R. Albright, J. Olson, R. Fredericks, K. Fink, M. Prados, M. Brada, A. Spence, R. Hohl, W. Shapiro and 12 more. British Journal of Cancer, 2000

961 citations recorded by the source corpus.

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 150 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 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. © 2000 Cancer Research Campaign

Subfields: Genetics, Pulmonary and Respiratory Medicine, Surgery

View Paper: https://www.semanticscholar.org/paper/d7624d82d5c5c95ddf27c193408ef88e067c9871

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In Genetics

1. Jeremy N. Rich
2. Michael Weller
3. Guido Reifenberger
4. William C. Hahn
5. R. DePinho

Citations in the corpus

• Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. (2007, methodology): “This study was conducted to improve the prognosis for recurrent GBM, for which response to therapy has generally been less than 20% and 6-month PFS less than 30%.(19-22) Although temozolomide in combination with radiation therapy followed by 6 months of temozolomide has become the standard of care f”
• EANO guideline for the diagnosis and treatment of anaplastic gliomas and glioblastoma. (2014, background): “In the elderly, this is now the preferred regimen for patients with tumors lacking MGMT promoter methylation.(23,31) Neither accelerated hyper- nor hypofractionated regimens nor brachytherapy nor radiosurgery or a stereotactic RT boost have been shown to be superior to standard fractionation in term”
• Phase II trial of gefitinib in recurrent glioblastoma. (2004, background): “Statistical Considerations Because previous studies for patients with recurrent glioblastoma have shown a 6-month PFS rate of approximately 21% [25], this single-stage study of 53 assessable patients was designed to differentiate between a 6-month PFS rate of 15% and 30% with type I and II error rat”
• Malignant astrocytic glioma: genetics, biology, and paths to treatment. (2007, background): “In comparison, TMZ given at first recurrence in GBM yields a PFS6 of 21% (Yung et al. 2000).”
• Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. (2009, background): “Despite therapy, 6-month progression-free survival (PFS) for relapsed or progressive glioblastoma is 9% to 21%, objective response (OR) rate is less than 10%, and median overall survival (OS) is 30 weeks or less.(2-8) Thus, recurrent glioblastoma remains a largely unmet medical need, which highlight”