Combined Use of Calcium-channel Blockers With Ombitasvir/Paritaprevir/Ritonavir Exacerbates Peripheral Edema in Elderly Japanese Patients.

BACKGROUND/AIM: The antiviral agent ritonavir is a substrate for cytochrome P450 3A4 (CYP3A4); therefore, concomitant use of CYP3A4-metabolising drugs might cause adverse reactions to this drug. We investigated the plasma level of calcium channel blockers (CCBs) as CYP3A4 substrates and peripheral edema as a potential adverse drug reaction possibly caused by the anti-hepatitis C virus (HCV) regimen of ombitasvir/paritaprevir/ritonavir (OPR) and CCBs. PATIENTS AND METHODS: We enrolled Japanese patients prescribed OPR for HCV infection. Peripheral edema was graded according to the Common Terminology Criteria for Adverse Events ver. 4. Plasma samples were collected on days 0, 7, 14, 28, and 42 after antiviral treatment, at the trough level. RESULTS: Out of 52 patients, 64% experienced grade 1 or grade 2 peripheral edema, but not grade 3. Concomitant use of CCBs significantly increased the emergence of grade 2 edema (62%), compared with patients treated solely with OPR (48%). The use of OPR significantly increased the plasma concentration of amlodipine. CONCLUSION: Peripheral edema in patients treated with OPR and CCBs, although tolerable, should be closely monitored.

Efficacy and Safety of Enzalutamide in a Real-World Cohort of Japanese Patients With Castration-resistant Prostate Cancer.

BACKGROUND/AIM: It has been reported that some adverse events (AEs) of enzalutamide (ENZ) occur more frequently in Japanese patients with castration-resistant prostate cancer (CRPC) due to higher steady-state trough plasma concentrations of ENZ (CSS, ENZ) and its active metabolite (NDE), (CSS, NDE). Thus, we investigated the efficacy, safety, and pharmacokinetics of ENZ in Japanese patients with CRPC. PATIENTS AND METHODS: Fourteen patients were administered ENZ at a standard dose (160 mg/day) or reduced doses (80 or 120 mg/day). Prostate-specific antigen (PSA), AEs, CSS, ENZ, and CSS, NDE were examined. RESULTS: A maximum PSA decrement of ≥50% from baseline was achieved in 92% of patients. AEs were few (>20%) and mild. No differences in CSS, ENZ and CSS, NDE between other ethnic groups in previous literature and our subjects was observed. CONCLUSION: ENZ shows adequate efficacy and safety in Japanese patients with CRPC, even if administered at reduced doses in real-world conditions.

[Predictors of Nivolumab-Induced Skin Reactions].

Skin reactions to nivolumab are typical immune-related adverse events. We investigated the relation between patient background and test values before nivolumab administration and skin reactions. From February 2016 to February 2017, we evaluated the clinical outcomes of 21 patients who were administered nivolumab. Patients were divided into 2 groups: 3 cases of skin reactions to nivolumab(skin reaction group)and 18 cases without skin reactions to nivolumab(non-skin reaction group). In the skin reaction group, the numbers of eosinophils and basophils before nivolumab administration were significantly higher than those in the non-skin reaction group(p=0.0015 and p=0.0075, respectively). It was suggested that the numbers of eosinophils or basophils before nivolumab administration might be associated with the appearance of skin reactions.

Impact of pharmacist counseling on reducing instances of adverse events that can affect the quality of life of chemotherapy outpatients with breast Cancer.

BACKGROUND: In recent years, cancer chemotherapy is being conducted at outpatient clinics, wherein pharmacists are involved with patient guidance and management of adverse events as experts in medication therapy. Therefore, we clarified the influence of interventions by pharmacists during counseling of patients with cancer on patients' quality of life. METHODS: To determine this influence, we conducted a survey to assess the quality of life of 39 patients with breast cancer who underwent their initial course of outpatient cancer chemotherapy at Gifu Municipal Hospital. A quality of life survey was conducted before the 1st, 2nd, and 3rd courses of treatment and was based on a method obtained from a survey paper entitled, "Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs." RESULTS: Twenty patients were assigned to the intervention group, which received pharmacist counseling, and nineteen patients were assigned to the non-intervention group, which received no pharmacist counseling. Both groups were compared immediately before the 1st course and 2nd course. Regarding the subscale of social relationships, a significant difference was observed for malaise (p = 0.043), with the non-intervention group experiencing them to a greater degree than the intervention group. Regarding the change between immediately before the 1st course and the 3rd course, a significant difference was observed in the subscale of social relationships for nausea (p = 0.017), with the non-intervention group experiencing it to a greater degree than the intervention group. CONCLUSIONS: The results suggest that receiving pharmacists' guidance on adverse events and individually adjusted prescriptions tailored to address the occurrence of adverse events improved the treatment environment and enhanced the quality of life in the intervention group. These findings are beneficial in maintaining patients' quality of life during cancer treatment. TRIAL REGISTRATION: No. UMIN000027171, Registration date: Apr 27, 2017. Retrospectively registered.

The impact of side effects from outpatient chemotherapy on presenteeism in breast cancer patients: a prospective analysis.

In the field of occupational health services, productivity loss can be expressed by absenteeism (i.e., employees being absent from work and taking leave due to health problems) and presenteeism (i.e., a reduction in the ability to perform one's tasks at work). Similar to absenteeism, it is important to assess presenteeism because it can severely reduce productivity. Despite numerous reports about the impact of disease and medical treatments on presenteeism, there is a lack of data regarding the influence of medication side effects. In this study, a prospective analysis was conducted via questionnaire survey to clarify the influence of the side effects of anticancer drugs on presenteeism in workers receiving outpatient chemotherapy for breast cancer. Between December 2012 and November 2013, the influence of side effects on the quality of life, absenteeism, and presenteeism was investigated via a questionnaire conducted before and after 1 course of chemotherapy in 19 currently employed breast cancer patients receiving outpatient chemotherapy for the first time at Gifu Municipal Hospital, Japan. The rate of absenteeism was 24.7 %, resulting in financial losses of 2002 yen/day (national statistical data) and 881 yen/day (our questionnaire data). The rate of presenteeism was 33.7 %, resulting in financial losses of 1354 yen/day (national statistical data) and 1263 yen/day (our questionnaire data). Furthermore, a significant positive correlation was observed between absenteeism and presenteeism (r = 0.687, p = 0.001), suggesting that the productivity losses associated with presenteeism due to the side effects of anticancer drugs in breast cancer patients are large and similar to that associated with absenteeism in these patients. Our results may be useful for improving the occupational health of workers receiving chemotherapy for cancer.