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      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. © 2000 Cancer Research Campaign

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          Author and article information

          Br J Cancer
          British Journal of Cancer
          Nature Publishing Group
          16 August 2000
          September 2000
          : 83
          : 5
          : 588-593
          [1 ]Department of Neuro-Oncology, UTMD Anderson Cancer Center, Box 100, 1515 Holcombe Boulevard, Houston, Texas, 77030
          [2 ]Barret Cancer Center, 234 Goodman Street, Cincinnati, Ohio, 45267
          [3 ]Department of Neurosurgery, Emory University, 1327 Clifton Road, Atlanta, Georgia, 30322
          [4 ]University of Mississippi Medical Center, 2500 North State Street, Jackson, Mississippi, 39216
          [5 ]Department of Neurology, University of Texas, Southwestern Medical School, 5323 Harry Hines Boulevard, Dallas, Texas, 75235
          [6 ]Department of Neurosurgery, University of California San Francisco, 533 Parnassus Street, Room U107, San Francisco, CaliCityfornia, 94143
          [7 ]The Royal Marsden NHS Trust and the Institute of Cancer Research, Royal Marsden Hospital, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom
          [8 ]Department of Neurology, University of Washington, Box 356465, 1959 N.E. Pacific Street, Seattle, Washington, 98195
          [9 ]University of Iowa, Hospitals and Clinics, 200 Hawkins Drive, Iowa City, Iowa, 52242
          [10 ]Division of Neurology, Barrow Neurological Institute, 350 West Thomas Road, Phoenix, Arizona, 85013
          [11 ]Memorial Hospital of Rhode Island, 710 Robinson Road, PO Box 665, Hinsdale, Massachusetts, 01235
          [12 ]Department of Neurology, University of Michigan Medical Center, 1500 East Medical Center Drive, 1914 Taubman Center, Box 0316, Ann Arbor, Michigan, 48109
          [13 ]West Penn Hospital, Center for Neuro-Oncology, 4800 Friendship Avenue – Suite 1614, Pittsburgh, Pennsylvania, 15224
          [14 ]Division of Neurology, Evanston Hospital, 2650 Ridge Avenue, Evanston, Illinois, 60201
          [15 ]Beatson Oncology Centre, Western Infirmary, Glasgow, G11 6NT, United Kingdom
          [16 ]Department of Pediatric Hematology-Oncology, Duke University Medical Center, Duke North – Room 5418, Erwin Road, Durham, North Carolina, 27710
          [17 ]Department of Neuroscience, University of Pennsylvania Medical Center, Abramson 516, 3400 Civic Center Boulevard, Philadelphia, Pennsylvania, 19104
          [18 ]MRI Reading Center at St. Joseph, 8216 Carrbridge Circle, Baltimore, Maryland, 21204
          [19 ]British Columbia Cancer Agency, 1515 Larch Street, Vancouver, British Columbia, V6K 3N6, Canada
          [20 ]Schering-Plough Research Institute, 2000 Galloping Hill Road, Kenilworth, New Jersey, 07033, USA
          Copyright 2000, Cancer Research Campaign
          Regular Article

          Oncology & Radiotherapy

          malignant glioma, glioblastoma multiforme, temozolomide, procarbazine


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