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Letter to the editor regarding the paper by Loquai C et al. 'Use of complementary and alternative medicine: A multicenter cross-sectional study in 1089 melanoma patients'

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... Furthermore, about 40% of cancer patients treated with conventional therapies may also use complementary medicine (CM), defined as health care approaches that are not typically part of conventional medical care, such as herbs and vitamins, naturopathy, homeopathy… [12,13]. Although some CM may be beneficial, it is possible that others may induce herb-drug interactions or vitamin-drug interactions that could impact efficacy or safety profile of cancer treatments [14,15]. ...
... Since the risk of toxicity is higher in TKI-treated patients, we developed in our center a follow up of these patients by plasma drug monitoring and systematic phone calls. Plasma drug monitoring, could be also helpful to detect new pharmacokinetic drug-drug interactions or herb-drug interactions, as we previously described [15,[44][45][46]. Therefore, we recommend a systematic multidisciplinary risk assessment including a medication review by a pharmacist to prevent DDI in sarcoma patients. ...
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Background The risk of drug–drug interactions (DDI) has become a major issue in cancer patients. However, data in sarcoma patients are scarce. We aimed to evaluate the frequency and the factors associated with DDI with antitumor treatments, and to evaluate the impact of a pharmacist evaluation before anticancer treatment.Patients and methodsWe performed a retrospective review of consecutive sarcoma patients starting chemotherapy (CT) or Tyrosine kinase inhibitor (TKI). A pharmacist performed medication reconciliation and established an early toxicity risk assessment. Potential DDI with antitumor drugs were identified using Micromedex electronic software.ResultsOne hundred and twenty-two soft-tissue and 80 bone sarcoma patients (103 males, median age 50 years,) were included before CT (86%) or TKI (14%). The median number of medications was 3; 34 patients (22% of patients with medication reconciliation) reported complementary medicine use. 37 potential DDI classified as major, were identified (12% of the 243 pre-therapeutic assessments). In multivariate analysis, TKI (p < 0.0001), proton pump inhibitor (p = 0.026) and antidepressant (p < 0.001) were identified as risk factors of DDI (p < 0.02). Only marital status (p = 0.003) was associated with complementary medicine use. A pharmacist performed 157 medication reconciliations and made 71 interventions among 59 patients (37%). In multivariate analysis, factors associated with pharmacist intervention were: complementary medicines (p = 0.004), drugs number (p = 0.005) and treatment with TKI (p = 0.0002)Conclusions Clinical interventions on DDI are more frequently required among sarcoma patients treated with TKI than CT. Multidisciplinary risk assessment including a medication reconciliation by a pharmacist could be crucial to prevent DDI with TKI.
... Furthermore, about 40% of cancer patients treated with conventional therapies may also use complementary medicine (CM), de ned as health care approaches that are not typically part of conventional medical care, such as herbs and vitamins, naturopathy, homeopathy… (12,13). Although some CM may be bene cial, it is possible that others may induce herb -drug interactions or vitamin-drug interactions that could impact e cacy or safety pro le of cancer treatments (14,15). ...
... Since the risk of toxicity is higher in TKI-treated -patients, we developed in our center a follow up of these patients by plasma drug monitoring and systematic phone calls. Plasma drug monitoring, could be also helpful to detect new pharmacokinetic drug drug interactions or herb-drug interactions, as we previously described (15,(40)(41)(42) . ...
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Background: The risk of drug drug interactions (DDI) has become a major issue in cancer patient care. However, data in sarcoma patients are scarce. We aimed to evaluate the frequency of DDI with antitumor treatments, identify the risk factors for DDI and evaluate the impact of a pharmacist evaluation before anticancer treatment. Patients and Methods: We performed a retrospective review of consecutive sarcoma patients starting chemotherapy (CT) or Tyrosine kinase inhibitor (TKI). A pharmacist performed medication reconciliation and established an early toxicity risk assessment. Potential DDI with antitumor drugs were identified using Micromedex electronic software. Results: One hundred twenty-two soft-tissue and 80 bone sarcoma patients (103 males, median age 50 years,) were included before chemotherapy (86%) or tyrosine kinase inhibitor (14%). The median number of medications was 3; 34 patients (22% of patients with medication reconciliation) reported complementary medicine use. 37 potential DDI classified as major, were identified (12% of the 243 pre-therapeutic assessments). In multivariate analysis, TKI (p<0.0001), proton pump inhibitor (p=0.026) and antidepressant (p<0.001) were identified as risk factors of DDI (p<0.02). Marital status (p=0.003) was the single factor associated with complementary medicine use. A pharmacist performed 157 medication reconciliation and made 71 interventions among 59 patients (37%). In multivariate analysis, factors associated with pharmacist intervention were: complementary medicines (p= 0.004), drugs number (p=0.005) and treatment with TKI (p=0.0002) Conclusions: Clinical interventions on DDI are more frequently required among sarcoma patients treated with TKI than CT. Multidisciplinary risk assessment including a medication reconciliation by a pharmacist could be crucial to prevent DDI with TKI.
... Drug-drug interactions are a major concern in the management of cancer patients [22] since they often receive multiple drugs to maximize the therapeutic effect, counter the adverse events of chemotherapy, or treat comorbidities. Additionally, they can concomitantly consume herbs, food and dietary supplements that can interact significantly on the PK of anticancer drugs [23]. PDI may result in severe adverse events related to plasma overexposure or decreased efficacy in the case of subtherapeutic concentration. ...
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Factors associated with olaparib toxicity remain unknown in ovarian cancer patients. The large inter-individual variability in olaparib pharmacokinetics could contribute to the onset of early significant adverse events (SAE). We aimed to retrospectively analyze the pharmacokinetic/pharmacodynamic relationship for toxicity in ovarian cancer patients from “real life” data. The clinical endpoint was the onset of SAE (grade III/IV toxicity or dose reduction/discontinuation). Plasma olaparib concentration was assayed using liquid chromatography at any time over the dosing interval. Trough concentrations (CminPred) were estimated using a population pharmacokinetic model. The association between toxicity and clinical characteristics or CminPred was assessed by logistic regression and non-parametric statistical tests. Twenty-seven patients were included, among whom 13 (48%) experienced SAE during the first six months of treatment. Olaparib CminPred was the only covariate significantly associated with increased risk of SAE onset (odds ratio = 1.31, 95%CI = [1.10; 1.57], for each additional 1000 ng/mL). The ROC curve identified a threshold of CminPred = 2500 ng/mL for prediction of SAE onset (sensitivity/specificity 0.62 and 1.00, respectively). This study highlights a significant association between olaparib plasma exposure and SAE onset and identified the threshold of 2500 ng/mL trough concentration as potentially useful to guide dose adjustment in ovarian cancer patients.
Article
Purpose Erlotinib is an oral first-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor approved for non–small cell lung cancers (NSCLC) with EGFR-activating mutations. Older patients experience more toxicities compared with younger patients at the standard recommended dose of 150 mg once daily. The aims of this study were to describe the pharmacokinetic profile of erlotinib in unselected patients with NSCLC, to quantify and explain its variability, to challenge the standard recommended dose in older patients, and to propose clinical recommendations for the therapeutic management of patients taking erlotinib. Methods : A population pharmacokinetic model was developed using erlotinib plasma concentrations collected from patients with NSCLC participating in a routine therapeutic drug monitoring program (with the nonlinear mixed effect modeling program NONMEM). Relevant demographic characteristics, clinical factors, and co-medications were tested as potential covariates. An independent dataset was used for model validation. Simulations based on the final model allowed comparison of expected erlotinib concentrations under standard and alternative dosing regimens for smokers and for several age groups. Findings A total of 481 erlotinib plasma concentrations from 91 patients with NSCLC were used for model building and 239 plasma drug concentrations from 107 patients for model validation. A one-compartment model with first-order absorption and elimination provided the best fit. Average erlotinib CL/F with interindividual variability (%CV) was 3.8 L/h (41.5%), and V/F was 166 L (53.8%). The absorption rate constant was 1.48 h⁻¹. The external validation showed a negligible bias of −4% (95% CI, −7 to −1) in the individual predictions, with a precision of 23%. Current smoking and use of proton pump inhibitors were associated with higher CL/F, whereas age was associated with lower CL/F. Simulations suggest that a lower dose in older patients would decrease the risk of overexposure. Implications This large cohort study confirms the substantial interindividual variability in erlotinib plasma exposure and the impact of smoking and proton pump inhibitor intake. This large variability in erlotinib pharmacokinetics indicates that the standard recommended dose of 150 mg once daily is likely not appropriate to reach the expected concentrations in each patient. Concentration monitoring should be performed to individually adjust the erlotinib dosing regimen. The observed decrease in erlotinib CL/F with age suggests that a lower starting daily dose of 100 mg with concentration-guided dose adjustment would prevent overexposure and potential toxicity in older frail patients with co-morbidities.
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