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  • 1
    Online Resource
    Online Resource
    Pharmacokinetics of Temozolomide in a Patient With Glioblastoma Undergoing Hemodialysis: A Short Communication
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Therapeutic Drug Monitoring ( 2023-8-15)
    Details
    In: Therapeutic Drug Monitoring, Ovid Technologies (Wolters Kluwer Health), ( 2023-8-15)
    Abstract: Temozolomide (TMZ) is an alkylating agent used to treat glioblastoma. However, the pharmacokinetics of TMZ to establish a treatment strategy for patients undergoing hemodialysis (HD) remain unclear. In this case report, we evaluated the pharmacokinetics and HD removal rate of TMZ in a patient with glioblastoma undergoing HD to determine optimal dosing of TMZ. Methods: A 78-year-old man with glioblastoma who underwent HD 3 times a week was treated with TMZ concomitant with radiotherapy. One dose of TMZ was prescribed at 75 mg/m 2 on the day before HD and another dose of 37.5 mg/m 2 on the day before non-HD. Peak and trough concentrations (1 hour and 12 hours after dosing, respectively) were evaluated before HD and on non-HD days. HD removal rate of TMZ was calculated based on the predialyzer and postdialyzer plasma concentrations. Furthermore, the TMZ plasma concentrations were measured using liquid chromatography–tandem mass spectrometry. Results: The mean plasma peak and trough concentrations ± SD after 75 mg/m 2 TMZ were 2917 ± 914 and 108 ± 17.6 ng/mL, respectively. Those after 37.5 mg/m 2 TMZ dosage were 1305 ± 650 and 53.8 ± 11.8 ng/mL, respectively. The mean HD TMZ removal rate was 84.9 ± 1.9%. Conclusions: TMZ was tolerable in patients undergoing HD. Based on the data from a single individual pharmacokinetic perspective, the pharmacokinetics of TMZ in this patient undergoing HD were comparable with those observed in patients with normal renal function. In addition, it may be reasonable to administer TMZ after HD because of the high HD removal rate.
    Type of Medium: Online Resource
    ISSN: 0163-4356
    URL: Article
    DOI: 10.1097/FTD.0000000000001125
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
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  • 2
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    Associated characteristics and treatment outcomes of medication-related osteonecrosis of the jaw in patients receiving denosumab or zoledronic acid for bone metastases
    Springer Science and Business Media LLC ; 2021
    In:  Supportive Care in Cancer Vol. 29, No. 8 ( 2021-08), p. 4763-4772
    Details
    In: Supportive Care in Cancer, Springer Science and Business Media LLC, Vol. 29, No. 8 ( 2021-08), p. 4763-4772
    Abstract: This study aimed to evaluate the association between clinical characteristics and development of medication-related osteonecrosis of the jaw (MRONJ) in patients who underwent dental examinations before the initiation of treatment with denosumab or zoledronic acid, which are bone-modifying agents (BMAs), for bone metastases. Additionally, the clinical outcomes of patients who developed MRONJ were evaluated along with the time to resolution of MRONJ. Methods The medical charts of patients with cancer who received denosumab or zoledronic acid for bone metastases between January 2012 and September 2016 were retrospectively reviewed. Patients were excluded if they did not undergo a dental examination at baseline. Results Among the 374 included patients, 34 (9.1%) developed MRONJ. The incidence of MRONJ was significantly higher in the denosumab group than in the zoledronic acid (27/215 [12.6%] vs 7/159 [4.4%] , P = 0.006) group. Multivariate Cox proportional hazards regression analysis revealed that denosumab treatment, older age, and tooth extraction before and after starting BMA treatments were significantly associated with developing MRONJ. The time to resolution of MRONJ was significantly shorter for patients who received denosumab (median 26.8 months) than for those who received zoledronic acid (median not reached; P = 0.024). Conclusion The results of this study suggest that treatment with denosumab, age 〉  65 years, and tooth extraction before and after starting BMA treatments are significantly associated with developing MRONJ in patients undergoing treatment for bone metastases. However, MRONJ caused by denosumab resolves faster than that caused by zoledronic acid.
    Type of Medium: Online Resource
    ISSN: 0941-4355 , 1433-7339
    URL: Article
    DOI: 10.1007/s00520-021-06018-x
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 1463166-0
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  • 3
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    Risk evaluation of denosumab and zoledronic acid for medication-related osteonecrosis of the jaw in patients with bone metastases: a propensity score–matched analysis
    Springer Science and Business Media LLC ; 2022
    In:  Supportive Care in Cancer Vol. 30, No. 3 ( 2022-03), p. 2341-2348
    Details
    In: Supportive Care in Cancer, Springer Science and Business Media LLC, Vol. 30, No. 3 ( 2022-03), p. 2341-2348
    Abstract: This study evaluated the risk of medication-related osteonecrosis of the jaw (MRONJ) in patients with cancer who received denosumab or zoledronic acid (ZA) for treating bone metastasis. Methods The medical records of patients were retrospectively reviewed. Patients who did not undergo a dental examination at baseline were excluded. The primary endpoint was a comparison of the risk of developing MRONJ between the denosumab and ZA groups. Propensity score matching was used to control for baseline differences between patient characteristics and compare outcomes for both groups. Results Among the 799 patients enrolled, 58 (7.3%) developed MRONJ. The incidence of MRONJ was significantly higher in the denosumab group than in the ZA group (9.6% [39/406] vs. 4.8% [19/393] , p  = 0.009). Multivariate Cox proportional hazards regression analysis revealed that denosumab treatment (hazard ratio [HR], 2.89; 95% confidence interval [CI] , 1.65–5.25; p   〈  0.001) and tooth extraction after starting ZA or denosumab (HR, 4.26; 95% CI, 2.38–7.44; p   〈  0.001) were significant risk factors for MRONJ. Propensity score–matched analysis confirmed that the risk of developing MRONJ was significantly higher in the denosumab group than in the ZA group (HR, 2.34; 95% CI, 1.17–5.01; p  = 0.016). Conclusion The results of this study suggest that denosumab poses a significant risk for developing MRONJ in patients treated for bone metastasis, and thus these patients require close monitoring.
    Type of Medium: Online Resource
    ISSN: 0941-4355 , 1433-7339
    URL: Article
    DOI: 10.1007/s00520-021-06634-7
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 1463166-0
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  • 4
    Online Resource
    Online Resource
    Switching from zoledronic acid to denosumab increases the risk for developing medication-related osteonecrosis of the jaw in patients with bone metastases
    Springer Science and Business Media LLC ; 2021
    In:  Cancer Chemotherapy and Pharmacology Vol. 87, No. 6 ( 2021-06), p. 871-877
    Details
    In: Cancer Chemotherapy and Pharmacology, Springer Science and Business Media LLC, Vol. 87, No. 6 ( 2021-06), p. 871-877
    Abstract: Switch from zoledronic acid (ZA) to denosumab may increase the risk of medication-related osteonecrosis of the jaw (MRONJ) owing to the additive effect of denosumab on the jawbone and residual ZA activities. We evaluated the risk of developing MRONJ in patients who received ZA, denosumab, or ZA-to-denosumab for the treatment of bone metastases. Methods The medical charts of patients with cancer who received denosumab or ZA for bone metastases were retrospectively reviewed. Patients who did not undergo a dental examination at baseline were excluded. Primary endpoint was the evaluation of the risk of developing MRONJ in the ZA-to-denosumab group. Secondary endpoints were probability of MRONJ and the relationship between risk factors and the time to the development of MRONJ. Results Among the 795 patients included in this study, 65 (8.2%) developed MRONJ. The incidence of MRONJ was significantly higher in the ZA-to-denosumab group than in the ZA group [7/43 (16.3%) vs. 19/350 (5.4%), p  = 0.007]. Multivariate Cox proportional hazards regression analysis revealed that denosumab treatment [hazard ratio (HR), 2.41; 95% confidence interval (CI), 1.37–4.39; p  = 0.002], ZA-to-denosumab treatment (HR, 4.36; 95% CI, 1.63–10.54, p  = 0.005), tooth extraction after starting ZA or denosumab (HR, 4.86; 95% CI, 2.75–8.36; p   〈  0.001), and concomitant use of antiangiogenic agents (HR, 1.78; 95% CI, 1.06–2.96; p  = 0.030) were significant risk factors for MRONJ. Conclusion Our results suggest that switching from ZA to denosumab significantly increases the risk for developing MRONJ in patients with bone metastases.
    Type of Medium: Online Resource
    ISSN: 0344-5704 , 1432-0843
    URL: Article
    DOI: 10.1007/s00280-021-04262-w
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 1458488-8
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  • 5
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    Evaluation of the usefulness of protocol‐based pharmacist‐facilitated laboratory monitoring to ensure the safety of immune checkpoint inhibitors in patients with lung cancer
    Hindawi Limited ; 2020
    In:  Journal of Clinical Pharmacy and Therapeutics Vol. 45, No. 6 ( 2020-12), p. 1288-1294
    Details
    In: Journal of Clinical Pharmacy and Therapeutics, Hindawi Limited, Vol. 45, No. 6 ( 2020-12), p. 1288-1294
    Type of Medium: Online Resource
    ISSN: 0269-4727 , 1365-2710
    URL: Issue
    URL: Article
    DOI: 10.1111/jcpt.v45.6
    DOI: 10.1111/jcpt.13207
    Language: English
    Publisher: Hindawi Limited
    Publication Date: 2020
    detail.hit.zdb_id: 2006678-8
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  • 6
    Online Resource
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    Table1.docx
    Frontiers Media SA ; 2022
    In:  Frontiers in Pharmacology Vol. 13 ( 2022-5-19)
    Details
    In: Frontiers in Pharmacology, Frontiers Media SA, Vol. 13 ( 2022-5-19)
    Abstract: Background: Enzalutamide is useful for the treatment of castration-resistant prostate cancer (CRPC). Despite its usefulness, adverse events (AEs) sometimes force patients to discontinue treatment. To maximize patient care, we developed an ambulatory care pharmacy practice that allows collaboration between a pharmacist and urologist to manage patients with CRPC receiving enzalutamide. In this study, we investigated the efficacy of this collaborative management. Methods: A retrospective chart review of 103 patients with CRPC receiving enzalutamide in our hospital between May 2014 and December 2020 was performed. Our collaborative management was implemented in October 2016. Before being examined by urologists, patients visited the oncology pharmacy consultation room for a face-to-face consultation, wherein the oncology pharmacists assessed factors such as adherence to enzalutamide, any AEs and their grades, and provided their suggestions to the urologists. The time to enzalutamide discontinuation and prostate-specific antigen progression were compared between patients who started enzalutamide before ( n = 41) and after ( n = 62) the implementation of the collaborative management. A multivariate Cox regression analysis was performed to analyze the factors associated with enzalutamide discontinuation. Results: After implementing collaborative management, the pharmacists had 881 patient consultations. Among the 476 suggestions from pharmacists, 345 were accepted by urologists. The most frequent suggestion was supportive care in enzalutamide treatment (224 suggestions). Multivariate analysis showed that collaborative management [hazard ratio (HR) 0.53, 95% confidence interval (CI) 0.31–0.89, p = 0.017] and higher prostate-specific antigen (PSA; HR 2.41, 95% CI 1.36–4.28, p = 0.003) were significantly associated with enzalutamide discontinuation. The median time to discontinuation (18.9 vs. 7.6 months, p = 0.012), time to discontinuation due to AEs (not reached in both groups, p = 0.001), and time to PSA progression (13.3 vs. 5.8 months, p = 0.002) were all significantly longer in the after group. Conclusions: We implemented a pharmacist-urologist collaborative management program for outpatients with CRPC receiving enzalutamide. The results revealed that collaborative management was useful for prolonging the time to enzalutamide discontinuation.
    Type of Medium: Online Resource
    ISSN: 1663-9812
    URL: Article
    URL: Article
    DOI: 10.3389/fphar.2022.901099
    DOI: 10.3389/fphar.2022.901099.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
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  • 7
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    Safety evaluation of enzalutamide dose-escalation strategy in patients with castration-resistant prostate cancer
    Elsevier BV ; 2021
    In:  Urologic Oncology: Seminars and Original Investigations Vol. 39, No. 4 ( 2021-04), p. 233.e15-233.e20
    Details
    In: Urologic Oncology: Seminars and Original Investigations, Elsevier BV, Vol. 39, No. 4 ( 2021-04), p. 233.e15-233.e20
    Type of Medium: Online Resource
    ISSN: 1078-1439
    URL: Article
    DOI: 10.1016/j.urolonc.2020.09.013
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
    detail.hit.zdb_id: 2011021-2
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  • 8
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    Safety and blood levels of daratumumab after switching from intravenous to subcutaneous administration in patients with multiple myeloma
    Springer Science and Business Media LLC ; 2023
    In:  Investigational New Drugs Vol. 41, No. 5 ( 2023-10), p. 761-767
    Details
    In: Investigational New Drugs, Springer Science and Business Media LLC, Vol. 41, No. 5 ( 2023-10), p. 761-767
    Abstract: The intravenous administration (IV) of daratumumab sometimes causes an infusion reaction and needs a long infusion time. Recently, a subcutaneous formulation (SC) of daratumumab, which has fewer infusion reactions and shorter administration time, was approved. However, because SC has a fixed dose, overdosing is a concern for patients with low body weights. In this study, we investigated the safety and blood levels of daratumumab after switching from IV to SC in patients with multiple myeloma (MM). Patients who switched from IV to SC of daratumumab between June 2021 and May 2022 at Kobe City Medical Center General Hospital were included in the study. Blood daratumumab levels were measured using liquid chromatography-tandem mass spectrometry. Safety after switching from IV to SC was evaluated for six months and graded according to the Common Terminology Criteria for Adverse Events, version 5.0. The median body weight of ten patients included in the analysis was 57.4 kg (range: 45.0–74.4). Blood daratumumab levels were significantly increased after switching to SC (p = 0.002); median through concentration at the last IV dose was 403.6 μg/mL (range: 96.3–776.3) and that at the third SC dose was 557.1 μg/mL (range: 288.3–997.2). Grade 1–2 injection site reactions were observed in six patients (60.0%) after switching to SC. A new grade 3 adverse event was observed in only one patient (neutropenia). The blood levels of daratumumab were significantly increased after switching from IV to SC in patients with MM; however, the dosage was tolerable.
    Type of Medium: Online Resource
    ISSN: 0167-6997 , 1573-0646
    URL: Article
    DOI: 10.1007/s10637-023-01392-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2009846-7
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  • 9
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    Population Pharmacokinetics of Nivolumab in Japanese Patients with Nonsmall Cell Lung Cancer
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Therapeutic Drug Monitoring Vol. 45, No. 1 ( 2023-02), p. 110-116
    Details
    In: Therapeutic Drug Monitoring, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 1 ( 2023-02), p. 110-116
    Abstract: Nivolumab is an antiprogrammed death-1 (PD-1) antibody used for immuno-oncological therapy of various cancers, including nonsmall cell lung cancer (NSCLC). This study aimed to characterize the real-world population pharmacokinetics (PK) of nivolumab in patients with NSCLC. Methods: PK samples were collected by opportunistic sampling of Japanese patients with NSCLC treated with nivolumab monotherapy. Population PK analysis was performed using a two-compartment model in Nonlinear Mixed Effect Model. Patient-specific factors such as body weight, age, sex, serum albumin, estimated glomerular filtration rate, performance status, programmed cell death receptor ligand 1 expression in tumors, and treatment periods were evaluated as potential covariates for clearance. Results: A total of 223 serum samples collected from 34 patients were available for analysis. The median (min–max) age and weight were 69 years (38–83 years) and 62.7 kg (36.8–80.5 kg), respectively. The mean (95% confidence interval) clearance estimate was 0.0064 L/h (0.0058–0.0070 L/h). The inclusion of the ALB level, estimated glomerular filtration rate, and treatment period significantly improved the model fit. Conclusions: A real-world nivolumab population PK model was developed using an opportunistic sampling strategy in Japanese patients with NSCLC. Further studies are warranted to characterize the exposure–response relationship and determine the optimal dosing regimens for these patients.
    Type of Medium: Online Resource
    ISSN: 0163-4356
    URL: Article
    DOI: 10.1097/FTD.0000000000000996
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2048919-5
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  • 10
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    Risk factors of proteinuria and potentially protective effect of renin–angiotensin system inhibitors in patients with renal cell carcinoma receiving axitinib
    Springer Science and Business Media LLC ; 2022
    In:  Cancer Chemotherapy and Pharmacology Vol. 89, No. 6 ( 2022-06), p. 833-838
    Details
    In: Cancer Chemotherapy and Pharmacology, Springer Science and Business Media LLC, Vol. 89, No. 6 ( 2022-06), p. 833-838
    Abstract: Patients receiving vascular endothelial growth factor–tyrosine kinase inhibitors are at a risk of developing proteinuria. Renin–angiotensin system (RAS) inhibitors exert renoprotective effects and might reduce proteinuria risk in these patients. We investigated the risk factors for and protective effect of RAS inhibitors against proteinuria in patients with renal cell carcinoma (RCC) receiving axitinib. Methods We retrospectively reviewed the medical records of patients with RCC receiving axitinib at Kobe City Medical Center General Hospital between September 2012 and October 2020. Patients with proteinuria ≥ 2+ at baseline were excluded. The patients were categorized into RAS inhibitor user, non-RAS inhibitor user, and non-user groups. The severity of proteinuria was graded based on the Common Terminology Criteria for Adverse Events, version 5.0. A multivariate Cox proportional hazards model was employed to identify the risk factors for developing grade ≥ 2 proteinuria. Results Among 42 patients, 28 received antihypertensive drugs at baseline. Among these, 17 and 11 patients were in the RAS inhibitor and non-RAS inhibitor user groups, respectively. Twenty-three patients (54.8%) developed grade ≥ 2 proteinuria. The multivariate analysis revealed that the non-RAS inhibitor user group ( P  = 0.001) and patients with pre-existing grade 1 proteinuria ( P  = 0.022) were significantly associated with the development of grade ≥ 2 proteinuria, whereas the RAS inhibitor user group was not significantly associated with it. Conclusion In patients with RCC receiving axitinib, pre-existing proteinuria and non-RAS inhibitor use were significantly associated with grade ≥ 2 proteinuria development. Our preliminary data should be confirmed by further studies.
    Type of Medium: Online Resource
    ISSN: 0344-5704 , 1432-0843
    URL: Article
    DOI: 10.1007/s00280-022-04408-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 1458488-8
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