Simple Summary: Docetaxel has been approved as an anti-cancer agent in 1995. High rates of hypersensitivity reactions (HSR) and fluid retention were observed when this agent was first introduced.... Show moreSimple Summary: Docetaxel has been approved as an anti-cancer agent in 1995. High rates of hypersensitivity reactions (HSR) and fluid retention were observed when this agent was first introduced. The use of high dose systemic corticosteroids around docetaxel infusion appeared to decrease the incidence of HSR and fluid retention and has been applied in daily practice ever since. However, there is little evidence that supports this high dose of dexamethasone. Furthermore, the application of high-dosed corticosteroids can lead to undesirable adverse effects. In this phase 1 study, we aim to evaluate the impact of reducing the dose of dexamethasone as an adjunct to docetaxel on the incidence of HSR and fluid retention in patients with prostate or breast cancer. Background: There is little evidence that supports the registered high dose of dexamethasone used around docetaxel. However, this high dose is associated with considerable side effects. This study evaluates the feasibility of reducing the prophylactic oral dosage of dexamethasone around docetaxel infusion. Patients and methods: Eligible patients had a histologically confirmed diagnosis of prostate or breast cancer and had received at least three cycles of docetaxel as monotherapy or combination therapy. Prophylactic dexamethasone around docetaxel infusion was administered in a de-escalating order per cohort of patients. Primary endpoint was the occurrence of grade III/IV fluid retention and hypersensitivity reactions (HSRs). Results: Of the 46 enrolled patients, 39 were evaluable (prostate cancer (n = 25), breast cancer (n = 14). In patients with prostate cancer, the dosage of dexamethasone was reduced to a single dose of 4 mg; in patients with breast cancer, the dosage was reduced to a 3-day schedule of 4 mg-8 mg-4 mg once daily, after which no further reduction has been tested. None of the 39 patients developed grade III/IV fluid retention or HSR. One patient (2.6%) had a grade 1 HSR, and there were six patients (15.4%) with grade I or II edema. There were no differences in quality of life (QoL) between cohorts. Conclusions: It seems that the prophylactic dose of dexamethasone around docetaxel infusion can be safely reduced with respect to the occurrence of grade III/IV HSRs or the fluid retention syndrome. Show less
Matsuda, A.; Inoue, K.; Momiyama, M.; Kobayashi, K.; Kubota, K.; Ohkubo, T.; ... ; Yamaoka, K. 2019
The 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-10) questionnaire was used as an indirect measure of the patients' perception of the strength of their therapeutic connection... Show moreThe 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-10) questionnaire was used as an indirect measure of the patients' perception of the strength of their therapeutic connection with their physician. The English version of the PEPPI-10 could serve as a valuable research tool for analyzing the relationship between patient and physician. The incidence of breast cancer is amongst the highest in Japan, and Patient Reported Outcome is often used as an outcome measure for breast cancer. It is particularly important to establish a strong patient-physician interaction for patients with breast cancer, since these patients require long-term treatment. We designed the present study to assess the reliability and validity of the Japanese version of the PEPPI-10 in female Japanese breast cancer outpatients. A cross-sectional study was performed at the Saitama Cancer Center, Japan. From August 2014 to August 2015, the Japanese versions of the PEPPI-10 that measure patient-perceived self-efficacy and the Brief Illness Perception Questionnaire (BIPQ) that measure illness perception were used for 92 breast cancer patients who received outpatient chemotherapy (mean age: 52.9 years, Cancer Stage I or Stage II : 82.6%, receiving adjuvant chemotherapy: 69.6%). We found that the Japanese version of the PEPPI-10 scale had a high coefficient of internal consistency (Cronbach's a coefficient, 0.83) for reliability, and concurrent validity analysis indicated that the utility of PEPPI-10 was moderately correlated with that of the BIPQ. In conclusion, the Japanese version of the PEPPI-10 is a useful tool that can empower breast cancer outpatients during the course of their treatment. Show less
Fischer, M.J.; Krol-Warmerdam, E.M.M.; Ranke, G.M.C.; Vermeulen, H.M.; Heijden, J. van der; Nortier, J.W.R.; Kaptein, A.A. 2015
