Radioligand therapy (RLT) has emerged as a novel therapeutic approach for various cancers. Among RLT agents, 177Lu-DOTATATE specifically targets somatostatin receptors, which are highly expressed on neuroendocrine tumor (NET) cells, and exerts antitumor effects through β-emission. The efficacy of 177Lu-DOTATATE was demonstrated in a phase III clinical trial, which led to regulatory approvals in various countries and transformed the treatment landscape for NETs. Consequently, the clinical relevance of RLT as a new therapeutic modality is increasingly recognized. Pharmacists play a critical role in the safe and effective implementation of this therapy. Their responsibilities include radiopharmaceutical preparation, regimen-based administration management, drug-related information provision, and adverse effects monitoring. Nuclear medicine-certified pharmacists collaborate with multidisciplinary teams to ensure the safety and efficacy of treatment. This review outlines the pharmacological characteristics and clinical development of 177Lu-DOTATATE, as well as its current challenges and future perspectives, with a focus on the involvement of pharmacists in clinical practice.
Diarrhea is the most common adverse event associated with abemaciclib, a CDK4/6 inhibitor for HR+/HER2 breast cancer. Data on risk factors in Japanese patients are limited; thus, this study aimed to identify them. We retrospectively analyzed data from 75 Japanese patients who received abemaciclib between May 2019 and June 2025. Risk factors for Grade ≥ 2 diarrhea within 56 days of initiation were identified using multivariate logistic regression and Cox proportional hazards models. Sensitivity analysis was also performed to evaluate the impact of short observation periods. Grade ≥ 2 diarrhea occurred in 18 patients (24.0%). In the multivariate logistic regression, a history of three or more prior chemotherapy regimens (Adjusted Odds Ratio [aOR]; 13.70, 95% Confidence Interval [CI]; 1.710 – 109.000, P = 0.014) and a starting dose of 300 mg (aOR; 18.80, 95%CI; 1.780 – 199.000, P = 0.015) were identified as independent risk factors. Cox regression analysis also confirmed these two factors as independent predictors of early onset. Although the initial analysis suggested a protective effect of concomitant probiotics, this association lost significance in a sensitivity analysis excluding patients with short observation periods. These findings indicate that risk assessment should prioritize detailed treatment history and dose to enable individualized management strategies.
Febrile neutropenia (FN) is a critical adverse event in cancer chemotherapy and affects clinical outcomes, such as reduction of the relative dose intensity. In this study, we retrospectively investigated the factors involved in FN occurrence using three periods of blood test results from patients. We enrolled 114 patients receiving anthracycline-based chemotherapy as perioperative breast cancer treatment. We collected the data on the blood test results containing neutrophile-lymphocyte ratio (NLR) at the start of the initial chemotherapy (baseline), 7 days after the initial chemotherapy (day 7), and at the start of the next chemotherapy, and also calculated the rate of change between each blood test value. Patients were divided into two groups according to whether they had or had not experienced fever during the chemotherapy course, and the data were compared between the groups. A total of 35 patients experienced at least one episode of fever. The fever group showed a significantly greater NLR reduction rate from baseline to day 7 (fever group: 87.6% vs. non-fever group: 67.3%, P = 0.013) and a markedly rebound from day 7 to the next chemotherapy (1326.8% vs. 611.1%, P = 0.008). From receiver operating characteristic analysis, the cutoff values for the change ratio of NLR were 83.0% as decrease on day 7 and 995.0% as increase on the next chemotherapy (AUC = 0.645 – 0.657). It would be thought that following up on the changes in NLR during chemotherapy, as well as neutrophil counts, is important for predicting FN occurrence.
A formulary is the standard use policy of congeneric drugs that is prepared considering medical appropriateness and economic efficiency; therefore, the economic effects of various drugs are reported. Opioid injections are frequently used in palliative care, and the prices of various opioid injection types vary. Therefore, we considered whether the development of a use selection criterion for opioid injections resulted in economic benefit. This study included patients who were newly administered morphine, oxycodone, fentanyl, and hydromorphone in the palliative care ward of Kagoshima Medical Association Hospital from January to December 2024. The opioid injection dose, internal or topical opioid use before the start of injections, renal function, and the presence or absence of respiratory symptoms were surveyed retrospectively. Subsequently, considering economic efficiency, we developed a selection criterion for opioid injections and confirmed whether the administered drugs were in accordance with the recommended drugs in the selection criterion. If there was disagreement, the price difference was calculated assuming that the selection criterion–recommended drug was administered. The overall agreement rate of the actual administered drug with the selection criterion–recommended drug was 56.0%. Hydromorphone injection, which was higher-priced than other opioids, exhibited the lowest agreement rate of 38.2%. The calculated change from the administered drug to the selection criterion–recommended drug revealed a cost reduction of 79,505 yen per year. Our results suggest that developing a formulary for opioid injection can reduce drug costs.
Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) therapy is the standard treatment for diffuse large B-cell lymphoma. However, optimal dosing in older patients remains unclear. At Hiroshima Citizens Hospital, an approach to define the maximum dose of cytotoxic anticancer drugs for patients ≥70 years commencing R-CHOP therapy was introduced in July 2020, based on age, Charlson Comorbidity Index, serum albumin (ACA Index), and the International Prognostic Index. The efficacy of this method was evaluated in this study. Patients were classified into pre- or post-implementation groups. The initial dose (actual dose relative to the standard dose), average relative dose intensity (ARDI) across all treatment cycles, 2-year progression-free survival (PFS) rate, and incidence of Grade 4 neutrophil count decreased (severe neutrophil count decreased) in the first cycle were compared between the groups. There were 27 patients in the pre-implementation group and 34 in the post-implementation group. The initial cytotoxic anticancer drug dose was significantly lower in the post-implementation group. However, there were no significant differences between the groups for ARDI (pre, 76% vs. post, 72%) or 2-year PFS rate (pre, 73% vs. post, 68%). In addition, 17 patients from each group were selected using propensity score matching. The incidence of severe neutrophil count decrease in the first cycle was significantly lower in the post-implementation group than in the pre-implementation group (pre, 71% vs. post, 29%, P = 0.038). These results indicate that defining the maximum dose based on patient and prognostic factors may reduce the severity of decreased neutrophil count while maintaining ARDI and therapeutic outcomes.
This exploratory retrospective study aimed to investigate factors associated with treatment outcomes in 37 adult patients with methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. We assessed the association of clinical factors, including vancomycin (VCM) exposure area under the curve divided by minimum inhibitory concentration (AUC/MIC) estimated by Bayesian analysis from initial therapeutic drug monitoring and baseline host factors (e.g., serum albumin and Charlson Comorbidity Index [CCI]), with treatment outcomes. Owing to the limited sample size, the statistical power was insufficient to identify independent predictors through multivariate analysis. Baseline serum albumin showed a notable, albeit non-significant, trend toward an association with treatment failure. However, this finding should be interpreted with caution owing to potential confounding by factors, such as high CCI scores and malignancy. In conclusion, this study could not identify independent predictors for MRSA bacteremia, suggesting that a complex interplay of multiple factors influences treatment outcomes. Larger, prospective studies are required to construct a comprehensive predictive model.