Trial reportCancer chemotherapy and pharmacology2010
Evaluation of the exposure equivalence of oral versus intravenous temozolomide.
Trial report in Cancer chemotherapy and pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 55 citations in OpenAlex.
- A Randomized, Open-Label, Two-Way Crossover, Single-Dose Bioequivalence Study of Temozolomide 200 mg/mDrugs in R&D · 2017Trial
- Diphenyl Diselenide and Temozolomide: Downregulation of Inflammatory, Redox, and Tumor-Associated Pathways in Glioblastoma.Biological trace element research · 2026Article
- Low-dose temozolomide selectively increases glioblastoma's vascular permeability, tumor microenvironment penetration and the killing potential of systemic actinium-225 α-particle dendrimer-radioconjugates improving treatment efficacy.European journal of nuclear medicine and molecular imaging · 2025Article
- A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules.Pharmaceutics · 2023Article
- Triolein emulsion enhances temozolomide brain delivery: an experimental study in rats.Drug delivery · 2021Article
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- Glioblastoma Treatments: An Account of Recent Industrial Developments.Frontiers in pharmacology · 2018Review
- In Vitro Radiosensitizing Effects of Temozolomide on U87MG Cell Lines of Human Glioblastoma Multiforme.Iranian journal of medical sciences · 2017Article
- Retrospective analysis of safety and feasibility of a 3 days on/11 days off temozolomide dosing regimen in recurrent adult malignant gliomas.CNS oncology · 2014Article
- What is the role of chemotherapy in the treatment of melanoma?Current treatment options in oncology · 2014Review
- Oral anticancer drugs: mechanisms of low bioavailability and strategies for improvement.Clinical pharmacokinetics · 2013Review
- Success at last: a molecular factor that informs treatment.Current oncology reports · 2013Article
- Intravenous administration of temozolomide as a useful alternative over oral treatment with temozolomide capsules in patients with gliomas.Journal of neuro-oncology · 2012Article
- Phase I dose-escalation study of procaspase-activating compound-1 in combination with temozolomide in patients with recurrent high-grade astrocytomas.Neuro-oncology advancesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOral temozolomide is approved in many countries for malignant glioma and for melanoma in some countries outside the USA. This study evaluated the exposure equivalence and safety of temozolomide by intravenous infusion and oral administration.
methodsSubjects with primary central nervous system malignancies (excluding central nervous system lymphoma) received 200 mg/m(2) of oral temozolomide on days 1, 2 and 5. On days 3 and 4, subjects received 150 mg/m(2) temozolomide either as a 90-min intravenous infusion on one day or by oral administration on an alternate day.
resultsRatio of log-transformed means (intravenous:oral) of area under the concentration-time curve and maximum concentration of drug after dosing for temozolomide and 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC) met exposure equivalence criteria (90% confidence interval = 0.8-1.25). Treatment-emergent adverse events were consistent with those reported previously in subjects with recurrent glioma treated with oral temozolomide, except for mostly mild and transient injection site reactions with intravenous administration.
conclusionsThis study demonstrated an exposure equivalence of a 90-min intravenous infusion of temozolomide and an equivalent oral dose.
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