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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 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 SIMILAR CONTENT BEING VIEWED BY OTHERS A RANDOMISED PHASE 2B STUDY COMPARING THE EFFICACY AND SAFETY OF BELOTECAN VS. TOPOTECAN AS

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CARCINOMA: A MULTICENTER RANDOMIZED PHASE 3 TRIAL Article 02 August 2021 ARTICLE PDF CHANGE HISTORY * _ 16 NOVEMBER 2011 This paper was modified 12 months after initial publication to switch

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http://www.qmetric.com/products/manuals/SF-36-Summary.php3 [1999, March 1] Download references AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Department of Neuro-Oncology, UTMD Anderson

Cancer Center, Box 100, 1515 Holcombe Boulevard, Houston, 77030, Texas, USA W K A Yung, J Bruner & V A Levin * Barret Cancer Center, 234 Goodman Street, Cincinnati, 45267, Ohio, USA R E

Albright * Department of Neurosurgery, Emory University, 1327 Clifton Road, Atlanta, 30322, Georgia, USA J Olson * University of Mississippi Medical Center, 2500 North State Street, Jackson,

39216, Mississippi, USA R Fredericks * Department of Neurology, University of Texas, Southwestern Medical School, 5323 Harry Hines Boulevard, Dallas, 75235, Texas, USA K Fink * Department

of Neurosurgery, University of California San Francisco, 533 Parnassus Street, Room U107, San Francisco, 94143, California, USA M D Prados * The Royal Marsden NHS Trust and the Institute of

Cancer Research, Royal Marsden Hospital, Downs Road, Sutton, SM2 5PT, Surrey, United Kingdom M Brada * Department of Neurology, University of Washington, Box 356465, 1959 N.E. Pacific

Street, Seattle, 98195, Washington, USA A Spence * University of Iowa, Hospitals and Clinics, 200 Hawkins Drive, Iowa City, 52242, Iowa, USA R J Hohl * Division of Neurology, Barrow

Neurological Institute, 350 West Thomas Road, Phoenix, 85013, Arizona, USA W Shapiro * Memorial Hospital of Rhode Island, PO Box 665, 710 Robinson Road, Hinsdale, 01235, Massachusetts, USA M

Glantz * Department of Neurology, University of Michigan Medical Center, Box 0316, 1500 East Medical Center Drive, 1914 Taubman Center, Ann Arbor, 48109, Michigan, USA H Greenberg * West

Penn Hospital, Center for Neuro-Oncology, 4800 Friendship Avenue – Suite 1614, Pittsburgh, 15224, Pennsylvania, USA R G Selker * Division of Neurology, Evanston Hospital, 2650 Ridge Avenue,

Evanston, 60201, Illinois, USA N A Vick * Beatson Oncology Centre, Western Infirmary, Glasgow, G11 6NT, United Kingdom R Rampling * Department of Pediatric Hematology-Oncology, Duke

University Medical Center, Duke North – Room 5418, Erwin Road, Durham, 27710, North Carolina, USA H Friedman * Department of Neuroscience, University of Pennsylvania Medical Center, Abramson

516, 3400 Civic Center Boulevard, Philadelphia, 19104, Pennsylvania, USA P Phillips * MRI Reading Center at St. Joseph, 8216 Carrbridge Circle, Baltimore, 21204, Maryland, USA N Yue *

British Columbia Cancer Agency, 1515 Larch Street, Vancouver, V6K 3N6, British Columbia, Canada D Osoba * Schering-Plough Research Institute, 2000 Galloping Hill Road, Kenilworth, 07033, New

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permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Yung, W., Albright, R., Olson, J. _et al._ A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at

first relapse. _Br J Cancer_ 83, 588–593 (2000). https://doi.org/10.1054/bjoc.2000.1316 Download citation * Received: 13 August 1999 * Revised: 23 April 2000 * Accepted: 01 May 2000 *

Published: 08 August 2000 * Issue Date: 01 September 2000 * DOI: https://doi.org/10.1054/bjoc.2000.1316 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this

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KEYWORDS * malignant glioma * temozolomide * procarbazine * glioblastoma multiforme