Journal of Oncology Pharmacy Practice最新文献

To review pharmacology, pharmacokinetics, therapeutic use, product safety/description and perspectives on use of lutetium Lu 177 vipivotide tetraxetan in patients with metastatic castration-resistant prostate cancer (mCRPC). Data sources: A literature search was conducted using PubMed/Dynamed (October 2013-May 2025), limited to English language, humans, clinical trials, case reports, and guidelines. Data summary: Lutetium Lu 177 vipivotide tetraxetan is comprised of the beta-emitting radioisotope lutetium Lu-177 linked to a peptide, vipivotide tetraxetan, which binds to cells expressing prostate-specific membrane antigen (PSMA), resulting in cell death from the radiation. Kidney excretion may result in increased renal toxicity in patients with reduced renal function. Based on 2 phase III clinical trials, lutetium Lu 177 vipivotide tetraxetan 7.4 GBq administered intravenously every 6 weeks for up to 6 doses is effective in patients with mCRPC and PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor and docetaxel therapy or an androgen receptor pathway inhibitor alone, by significantly improving radiographic progression-free survival. It is generally well tolerated, with asthenia/fatigue, dry mouth, mild nausea and low-grade anemia most commonly occurring. Severe adverse drug reactions are uncommon. It should only be administered by trained personnel in a designated clinical setting with existing radiation safety protocols. Patients must limit close contact, use precautions with using the bathroom and other daily activities in days following treatment. Patient education is necessary to ensure safe daily practices. Several ongoing trials are evaluating lutetium Lu 177 vipivotide tetraxetan in combination with other anticancer agents for treatment of mCRPC, using different dosing strategies, or in other settings (metastatic castration-sensitive prostate cancer and early-stage prostate cancer). Conclusion: Lutetium Lu 177 vipivotide tetraxetan is an effective and well tolerated treatment for patients with mCRPC, PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor ± docetaxel. Ongoing studies evaluating its use in earlier disease stages and with different dosing strategies, will better define the role of this therapy in the treatment of prostate cancer.

IntroductionInfectious complications are a leading cause of morbidity and mortality in pediatric leukemia, particularly during intensive chemotherapy. Febrile neutropenia (FN), bacteremia, and fungemia are common and potentially life-threatening. This study evaluated the effectiveness of antimicrobial prophylaxis in preventing infectious complications in pediatric patients with leukemia.MethodsA retrospective, matched chart review was conducted involving 182 pediatric patients (aged 1-18 years) diagnosed with leukemia. Patients were stratified based on receipt of antimicrobial prophylaxis, Levofloxacin, Caspofungin, Fluconazole, or a combination (n = 40), versus no prophylaxis (n = 64). Primary outcomes included the number of FN episodes, bacteremia, and fungemia.ResultsPatients who received antimicrobial prophylaxis experienced significantly fewer FN episodes and bacteremia events compared to those who did not receive prophylaxis. No cases of increased antimicrobial resistance were observed in the prophylaxis group. Rates of fungemia were low in both groups.ConclusionsAntimicrobial prophylaxis during high-risk phases of chemotherapy is associated with reduced FN and bacteremia in pediatric leukemia patients. These findings support its implementation as a preventative strategy in HR patients to reduce infectious complications without increasing antimicrobial resistance.

IntroductionPatient safety is a fundamental objective in healthcare practice, aiming to prevent errors and avoid their impact on patients. A significant proportion of these errors occur at the household level, where monitoring is particularly challenging.MethodsAccording to the principles of safety culture, Reason's model of error suggests that human errors can be mitigated through the design of more robust systems that reduce the likelihood of their occurrence. Cytotoxic drugs, such as lomustine, are classified as high-risk medications due to their potential to cause severe harm to patients.ResultsFollowing an incident in which a patient ingested a higher-than-prescribed dose of lomustine, a root cause analysis (RCA) was conducted. This analysis identified critical points in the process that contributed to the error, enabling the design of a comprehensive medication circuit. This circuit was developed collaboratively by the Oncology and Pharmacy departments and addressed key stages such as prescription, validation, custody, and dispensing.ConclusionThe implementation of a structured lomustine circuit successfully eliminated medication errors associated with its use. Since its introduction, no further incidents have been reported, indicating improved safety and reliability in the medication-use process.

Objective: Non-small cell lung cancer (NSCLC) is a common and deadly cancer, and predicting survival can be useful for guiding treatment. This study aimed to investigate the impact of metabolic status-specifically resting energy expenditure (REE)-and clinicopathological characteristics on survival outcomes in patients with metastatic NSCLC receiving nivolumab as second-line therapy following platinum-based chemotherapy. Methods: This prospective, non-interventional, observational, single-center study included 148 adult patients with metastatic NSCLC receiving nivolumab as second-line treatment. Demographic data, cancer diagnosis-related characteristics, laboratory parameters, measured REE (mREE), and predicted REE (pREE) were recorded just before nivolumab treatment was initiated. Results: The mean ages of non-hypermetabolic and hypermetabolic patients were 63 ± 8 and 64 ± 9, respectively. Weight, height, BMI, and pREE were significantly higher in the non-hypermetabolic group. In the hypermetabolic group, the incidence of brain metastasis and the mREE were significantly higher. The median progression-free survival (PFS) and overall survival (OS) were 5.3 and 15.8 months, respectively. Multivariate analysis identified several predictors of survival. Poor ECOG performance status (PS) (p < 0.001), liver metastases (p = 0.018), and mREE/pREE ratio > 120% (p = 0.005) were significantly associated with shorter PFS. Similarly, poor ECOG PS (p = 0.037), liver metastases (p = 0.041), and mREE/pREE ratio > 120% (p = 0.009) were also linked to reduced OS. Conclusions: In patients with NSCLC treated with nivolumab, poor ECOG PS, the presence of liver metastases, and an mREE/pREE ratio > 120% were associated with poorer survival outcomes. Further prospective multicenter studies are required to validate these findings.

Within clinical practice, information sources such as clinical guidelines ensure practitioners apply evidence-based information, supporting both effectiveness and safety of the prescribed medicines. Paediatric cancer - a leading cause of death in children - is a complex condition, thus is an area where clinical guidelines are important to give guidance on, e.g., recommended doses, drug dispensing, and toxicity monitoring measures. However, exploring clinical guidelines/information sources and their content regarding medicine-pertaining aspects is rarely done despite the fact they directly inform patient care. This comment summarises the main findings of a document analysis study aimed to describe available documents and their content for Scotland-based paediatric prescribers in oncology wards and provides insights into the documents' comprehensiveness and consistency. The analysis covered three clinical indications which are either highly prevalent or troublesome in practice: emesis, tumour lysis syndrome (TLS), and Pneumocystis Pneumonia (PCP) prophylaxis.

Background: In acute lymphoblastic leukemia (ALL), pegaspargase is included in the backbone of numerous chemotherapy regimens. Treatment-related toxicities can be substantial, often resulting in treatment delays, dose reductions, or early discontinuation. This study aimed to evaluate whether differences in efficacy, safety, and economic outcomes exist between standard dosing and modified approaches involving dose-reduced and delayed administration of pegaspargase.MethodsThis retrospective, single-center study evaluated hospitalized adult patients who received pegaspargase as part of CALGB 10403 induction course I. Patients were stratified into two groups: 1) full pegaspargase dose 2500 units/m² and standard administration on day 4 (Early PEG group), or 2) dose reduced pegaspargase 1000 units/m² and delayed administration on day 15 (Delayed PEG group).ResultsEight patients (27%) were treated with a reduced dose of pegaspargase on day 15 of induction (Delayed PEG). Median age of the study population was 27 years, and median BMI was 29.6 kg/m². The majority of patients were male (60%), Hispanic (53%), and had a diagnosis of Philadelphia chromosome negative B-ALL (70%). Incidence of grade 3 or higher toxicities was not significantly different between groups. MRD status at the end of induction was similar between groups [Early PEG 12 (55%) vs Delayed PEG 4 (50%), p = 0.51]. Economic outcomes within 30 days were also similar.ConclusionOur study demonstrates comparable incidence of high-grade toxicities and MRD negative status, suggesting that concomitant dose reduction and delay of pegaspargase administration during CALGB 10403 induction does not significantly impact effectiveness, safety, or economic outcomes.

ObjectiveAnaplastic lymphoma kinase (ALK) rearrangements are one of the key therapeutic targets in non-small cell lung cancer (NSCLC). Ensartinib, a second-generation ALK tyrosine kinase inhibitor (TKI), was recently approved by the FDA for the treatment of ALK-positive NSCLC. This systematic review aims to evaluate the efficacy and safety of ensartinib in adult patients with ALK-positive NSCLC.Data sourcesIn this systematic review, we identified five studies including a total of 621 participants, by searching PubMed, Scopus, and Embase from January 2010 to May 2025. We included clinical trials on adult NSCLC patients receiving ensartinib monotherapy or combination therapy, assessing treatment response and safety, and excluded observational studies, brief reports, protocols, and conference abstracts. Study quality was assessed using the MINORS and RoB 2 tools. Results were synthesized qualitatively, providing a comprehensive overview of efficacy and safety outcomes.Data summaryOur comprehensive synthesis of the included studies revealed favorable outcomes. The phase I clinical trials suggested a recommended phase II dose (RP2D) of 225 mg. Ensartinib demonstrated favourable efficacy across dose-escalation, phase II and phase III trials. In treating naïve patients, ORRs ranged from 80-81%, with median PFS reaching up to 26.2 months. In pre-treated cases, efficacy was also notable, including intracranial response up to 70%. Phase III trial confirmed superior PFS with ensartinib compared to crizotinib. Common AEs include rash, transaminase elevations, and gastrointestinal symptoms, which were mostly manageable and grade 1-2 in severity.ConclusionEnsartinib is a highly effective and tolerable option for ALK-positive NSCLC. However, limitations include the open-label nature of most included studies and the descriptive synthesis, precluding formal meta-analysis and assessment of certainty of evidence. Further studies are needed to assess long-term outcomes and to optimize its use in a molecularly diverse patient population. This review received no specific funding. The protocol was not registered.

ObjectiveImplementation of a Standard Doses (SD) workflow is a big challenge for pharmacists, in order to optimize the organization of chemotherapy preparation and support in day hospital activity. The objective is to map and determine the feasibility of a SD routine and to identify eligible molecules with and corresponding SD.MethodsA Preliminary Risk Analysis (PRA) of the process from prescription to preparation was carried out, with a failure mode and effects critical analysis (FMECA) method. A survey on standard dose concept was distributed to all prescribers. The rules to define eligible dosage of each drugs was an annual production of more than 250 preparations and for each eligible molecule, at least a 70% coverage rate for a maximum of 7 SD. These doses have been rounded up to a maximum of +/- 10% for cytotoxics and antibody-drug conjugates, and +/- 15% for monoclonal antibodies.ResultsAfter medical approval, sixteen molecules were eligible and thirteen are used routinely to date. The PRA highlighted 52 risks over 16 stages of the process. A risk retains a significant criticality after application of control actions: the risk of musculoskeletal disorders (MSD) during preparation.ConclusionThis work enabled us to study the feasibility of setting up a SD workflow in our hospital to optimize the provision of chemotherapy to the patient. Due to persistent MSD risk and limited storage capacity, we decided to prescribe exclusively in SD, pending the automation of our preparation unit in 2025.

IntroductionHand-foot syndrome (HFS) is a common dose-limiting toxicity of capecitabine that impairs quality of life and can lead to treatment modification or discontinuation. Predictive markers for HFS remain unclear. This study aimed to identify clinical and biochemical factors associated with the development and severity of HFS in patients receiving capecitabine.MethodsWe conducted a retrospective cohort study of patients with breast, colorectal, or gastric cancer who received capecitabine between December 2017 and December 2019. Patients were eligible if they received at least one treatment cycle and had follow-up data for 12 weeks. HFS incidence and severity were assessed using CTCAE version 4.0. Associations between clinical factors and HFS were evaluated using univariate analysis and time-dependent Cox proportional hazards models.ResultsAmong 146 patients, 55 (37.7%) developed HFS: Grade 1 (n = 28), Grade 2 (n = 21), and Grade 3 (n = 6). No patients discontinued treatment due to HFS. In the prespecified model, cumulative capecitabine dose was not significantly associated with HFS. However, in exploratory analysis, increased alanine aminotransferase (ALT) levels were associated with both the development (HR: 1.02; 95% CI: 1.00-1.04; p = 0.02) and severity (HR: 1.03; 95% CI: 1.01-1.05; p = 0.01) of HFS.ConclusionsIncreased ALT may serve as a potential biomarker for predicting HFS risk in capecitabine-treated patients. This finding could aid in early identification and management of at-risk patients, improving treatment outcomes.