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Cited by 372Glioma Diagnosis and TreatmentCancer survivorship and careOvarian cancer diagnosis and treatment

The DOI matches its Crossref record; 33 of the 35 references it cites were found in a registry or an index.

Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse

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Brada, M., Hoang-Xuan, K., Rampling, R., Dietrich, P.-Y., Dirix, L.Y., Macdonald, D., Heimans, J.J., Zonnenberg, B.A., Bravo-Marques, J.M., Henriksson, R., Stupp, R., Yue, N., Bruner, J., Dugan, M., Rao, S., Zaknoen, S.·2001·Annals of Oncology
DOI 10.1023/a:1008382516636
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Abstract

Background Recurrent glioblastoma multiforme (GBM) is resistant to most therapeutic endeavors, with low response rates and survival rarely exceeding six months. There are no clearly established chemotherapeutic regimens and the aim of treatment is palliation with improvement in the quality of life.Patients and methods We report an open-label, uncontrolled, multicenter phase II trial of temozolomide in 138 patients (intent-to-treat [ITT] population) with glioblastoma multiforme at first relapse and a Karnofsky performance status (KPS) > or = 70. One hundred twenty-eight patients were histologically confirmed with GBM or gliosarcoma (GS) by independent central review. Chemotherapy-naïve patients were treated with temozolomide 200 mg/m2/day orally for the first five days of a 28-day cycle. Patients previously treated with nitrosourea-containing adjuvant chemotherapy received 150 mg/m2/day for the first five days of a 28-day cycle. In the absence of grade 3 or 4 toxicity, patients on the 150 mg/m2 dose schedule were eligible for a 200 mg/m2 dose on the next cycle.Results The primary endpoint was six-month progression-free survival assessed with strict radiological and clinical criteria. Secondary endpoints included radiological response and Health-related Quality of Life (HQL). Progression-free survival at six months was 18% (95% confidence interval (CI): 11%-26%) for the eligible-histology population. Median progression-free survival and median overall survival were 2.1 months and 5.4 months, respectively. The six-month survival rate was 46%. The objective response rate (complete response and partial response) determined by independent central review of gadolinium-enhanced magnetic resonance imaging (MRI) scans was 8% for both the ITT and eligible-histology populations, with an additional 43% and 45% of patients, respectively, having stable disease (SD). Objectively assessed response and maintenance of a progression-free status were both associated with HQL benefits (characterized by improvements over baseline in HQL domains). Temozolomide had an acceptable safety profile, with only 9% of therapy cycles requiring a dose reduction due to thrombocytopenia. There was no evidence of cumulative hematologic toxicity.Conclusions Temozolomide demonstrated modest clinical efficacy, with an acceptable safety profile and measurable improvement in quality of life in patients with recurrent GBM. The use of this drug should be explored further in an adjuvant setting and in combination with other agents.

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2 of the 35 references couldn’t be matched to a known paper.

Research works printed but not linked: 2

  1. Rodier, 1996, Fotemustine (F) and cisplatin (P) association in patients with recurrent malignant glioma, Proc ASCO, 15, A292
  2. Brada, 1999, Phase I dose-escalation and pharmacokinetic study of temozolomide (SCH 52365) for refractory or relapsing malignancies, Br J Cancer, 81, 1022, 10.1038/sj.bjc.6690802 · DOI

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Metadata

Authors
Brada, M., Hoang-Xuan, K., Rampling, R., Dietrich, P.-Y., Dirix, L. Y., Macdonald, D., Heimans, J. J., Zonnenberg, B. A., Bravo-Marques, J. M., Henriksson, R., Stupp, R., Yue, N., Bruner, J., Dugan, M., Rao, S., & Zaknoen, S.
Affiliations
  • Royal Marsden Hospital (GB)
  • Beatson West of Scotland Cancer Centre (GB)
  • University Hospital of Geneva (CH)
  • KU Leuven (BE)
  • University Medical Center Utrecht (NL)
  • Instituto Português de Oncologia Francisco Gentil (PT)
  • University Hospital of Umeå (SE)
  • Johns Hopkins University (US)
  • The University of Texas MD Anderson Cancer Center (US)
ORCID
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2001-02
Volume
12
Issue
2
Pages
259-266
ISSN
0923-7534 (ISSN-L)
DOI
10.1023/a:1008382516636
OpenAlex
W2125643269
Cited by
372
References
35
Citations by year
2026: 3 · 2025: 4 · 2024: 3 · 2023: 7 · 2022: 3 · 2021: 7 · 2020: 9 · 2019: 4 · 2018: 10 · 2017: 12 · 2016: 15 · 2015: 14 · 2014: 12 · 2013: 11 · 2012: 17
FWCI
10.86
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • reroDoc Digital Library (submittedVersion)
  • IRIS (submittedVersion)
  • SERVAL (Université de Lausanne) (submittedVersion)
Funders
University of California, San Francisco
Topics
  • Health Sciences › Medicine › Oncology › Glioma Diagnosis and Treatment
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
  • Health Sciences › Medicine › Oncology › Ovarian cancer diagnosis and treatment
Keywords
temozolomide, recurrent glioblastoma, first relapse, gliosarcoma, progression-free survival, objective response rate, health-related quality of life, thrombocytopenia, chemotherapy toxicity, dose escalation, palliative care, overall survival, Karnofsky performance status
MeSH terms
Temozolomide, Adult, Aged, Brain Neoplasms, Dacarbazine, Female, Glioblastoma, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Quality of Life, Disease-Free Survival, Antineoplastic Agents, Alkylating

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