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Jen, J.; Cutler, David L.; Pai, Sudhakar M.; Batra, Vishal; Affrime, Melton B.; Zambas, Demetris; Heft, Samuel; Hajian, Gerald

doi:10.1023/a:1026403805756

Cited by 54 publications

(10 citation statements)

References 10 publications

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“…This is consistent with previous studies evaluating the PK profile of oral temozolomide, which demonstrated that temozolomide exhibits linear pharmacokinetics over the therapeutic dose range [2, 4, 16–19] and that the PK profile of temozolomide is independent of the route of administration (i.e., intravenous, oral or hepatic intra-arterial infusion) [2]. Other studies have demonstrated that total body clearance of temozolomide is linear [8, 16] and independent of dose [16]. Moreover, the PK characteristics of temozolomide have been shown to be independent of dosing schedules [17].…”

Section: Discussionsupporting

confidence: 90%

“…The key parameter that required optimization was the rate of intravenous infusion so as to better match gastrointestinal absorption kinetics and achieve similar C max values to that achieved via oral administration. Subsequently, Monte Carlo simulations to evaluate virtual crossover exposure equivalence trials using a population PK model derived from a previous population study of oral temozolomide [8] were conducted and suggested that a 90-min intravenous infusion could achieve exposure equivalence with respect to C max (unpublished data). The goal of this pivotal, randomized crossover study was to examine the exposure equivalence and safety profile of a 90-min intravenous infusion of temozolomide compared with an equivalent oral dose.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the exposure equivalence of oral versus intravenous temozolomide

Diez

Statkevich²,

Zhu³

et al. 2009

Cancer Chemother Pharmacol

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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/m2 of oral temozolomide on days 1, 2 and 5. On days 3 and 4, subjects received 150 mg/m2 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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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Evaluation of the exposure equivalence of oral versus intravenous temozolomide

Diez

Statkevich²,

Zhu³

et al. 2009

Cancer Chemother Pharmacol

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“…Finally, intestinal absorption of TEM-CAP might be diminished in patients who have undergone intestinal surgery including small bowel resection, extended mesenteric lymphadenectomy or even pancreatico-duodenectomy. Although the bioavailability of TEM is considered to be > 95%, and its variability is mainly influenced by body surface area, individual variations in pharmacokinetic variables cannot be excluded [41, 42]. The “raw” median OS was similar between the 2 groups (47.05 months with 5FU-DTIC vs. 60.53 months with TEM-CAP, p = 0.24).…”

Section: Discussionmentioning

confidence: 99%

Comparison of Temozolomide-Capecitabine to 5-Fluorouracile-Dacarbazine in 247 Patients with Advanced Digestive Neuroendocrine Tumors Using Propensity Score Analyses

et al. 2019

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Introduction: Although chemotherapy combining 5-fluorouracil (5FU)-dacarbazine (DTIC) or temozolomide (TEM)-capecitabine (CAP) is extensively used in patients with neuroendocrine tumors (NET), they were never compared. We compared their tolerance and efficacy in advanced NET. Methods: We evaluated the records of consecutive patients with pancreatic or small-intestine advanced NET who received 5FU-DTIC or TEM-CAP between July 2004 and December 2017 in 5 French centers. Tolerance, tumor response and progression-free survival (PFS) were compared. Factors associated with PFS were analyzed using Cox multivariate regression model. To reduce the confounding bias of the nonrandomized design, PFS was compared using propensity score analyses. Results: Ninety-four (5FU-DTIC) patients and 153 (TEM-CAP) patients were included. Pancreatic NET represented 82.3% of cases and 17.1, 61.8 and 10.9% of patients had G1, G2 or G3 NET respectively. Progression at baseline was reported in 92.7% of patients with available data. Grades 3–4 adverse events occurred in 24.7 and 8.5% of TEM-CAP and 5FU-DTIC patients respectively (p = 0.002). The overall response rate was 38.3 and 39.2% respectively (p = 0.596). Median PFS on raw analysis was similar to 5FU-DTIC and TEM-CAP (13.9 vs. 18.3 months, respectively p = 0.86). TEM-CAP was associated with an increased risk of progression on the raw multivariate analysis (hazard ratio [HR] 1.90, 95% CI [1.32–2.73], p = 0.001) and when adjusted on propensity score (HR 1.65, 95% CI [1.18–2.31], p = 0.004). Conclusion: PFS may be longer with 5FU-DTIC than TEM-CAP in patients with advanced NET. Although patients often prefer oral chemotherapy, 5FU-DTIC is a relevant alternative. A randomized comparison is needed to confirm these results.

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“…i Brandes, Grossman, & Ahmad (2006); Eli Lilly (2013); Ohana, Brahim, & Ibrahim (2016); Rombola et al (2015). j Janus et al (2013); Jen et al (2000); Merck (2008). k Herrington, Figueroa, Kirstein, Zamboni, & Stewart (2001); Novartis (2015); O'Reilly et al (1996).…”

Section: Pemetrexedmentioning

confidence: 99%

Systemic Treatments for Lung Cancer Patients Receiving Hemodialysis

Leung

Hughes

Cambareri

et al. 2018

JADPRO

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Chemotherapy, and now targeted therapies and immunotherapies, are widely used for the management of patients with all stages of lung cancer. Some challenges present when patients are receiving concomitant hemodialysis for various comorbid conditions. However, this should not immediately rule out a patient for treatment. Many drugs may be safely given to patients who are receiving hemodialysis with the proper dosing schedule and careful monitoring. This article will outline the current literature surrounding the use of these drugs in patients undergoing active hemodialysis while being treated for lung cancer.

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Abstract: The current dose regimen is administered according to BSA which is the most important factor influencing temozolomide clearance. No further dose adjustment is required.

Cited by 54 publications

References 10 publications

Evaluation of the exposure equivalence of oral versus intravenous temozolomide

Evaluation of the exposure equivalence of oral versus intravenous temozolomide

Comparison of Temozolomide-Capecitabine to 5-Fluorouracile-Dacarbazine in 247 Patients with Advanced Digestive Neuroendocrine Tumors Using Propensity Score Analyses

Systemic Treatments for Lung Cancer Patients Receiving Hemodialysis

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