Journal of Oncology Pharmacy Practice最新文献

IntroductionImmune checkpoint inhibitors have improved outcomes for solid tumors but are associated with immune-related adverse events (irAEs). Literature suggests that patients with an absolute lymphocyte count (ALC) ≥ 2000 cells/mm3 prior to treatment with PD-1 inhibitors have an increased risk for irAEs, but the relationship between ALC and irAEs has not been examined with PD-L1 inhibitors. This study evaluates the correlation between ALC and PD-L1 inhibitor related irAEs.MethodsThis retrospective cohort study at an academic health system used electronic health record data from adult patients with solid tumors receiving their first dose of a PD-L1 inhibitor between January 1, 2022, to December 31, 2023. Patients were excluded if they did not have a baseline ALC within 30 days of initial treatment, had a prior irAE(s), had a hematologic malignancy, received any other immunotherapy prior to or during the study period, or were treated with corticosteroids within 1 month prior to treatment.ResultsAmong 210 patients, 186 had a baseline ALC < 2000 cells/mm3 and 24 had a baseline ALC ≥ 2000 cells/mm3. 20 grade 2 + irAE events occurred, 19 in patients with an ALC < 2000 cells/mm3 and only 1 in patients with a baseline ALC ≥ 2000 cells/mm3. There was no correlation between a baseline ALC ≥ 2000 cells/mm3 and incidence of grade 2 + irAE (OR 0.503; 95% CI: 0.064, 3.98; P = 0.515).ConclusionIn this cohort study of patients treated with PD-L1 immune checkpoint inhibitors, baseline ALC ≥ 2000 cells/mm3 did not predict PD-L1 inhibitor related irAEs.

ObjectiveTo summarize the current status, mechanisms, challenges, and future directions of immunotherapy in advanced rectal cancer.Data SourcesPublished clinical trials, translational studies, and mechanistic reports on immunotherapeutic strategies for colorectal and rectal cancer.Data SummaryImmune checkpoint inhibitors (ICIs), particularly PD-1/PD-L1 and CTLA-4 blockade, show promise in MSI-H rectal cancer, while combination therapies are under investigation for microsatellite stable (MSS) tumors. Tumor vaccines and T-cell-based approaches, such as CAR-T and TCR-engineered therapies, are emerging strategies. Major barriers include immune evasion, microenvironment heterogeneity, and resistance mechanisms in MSS disease.ConclusionsImmunotherapy is transforming the treatment landscape of advanced rectal cancer, yet challenges persist. Continued mechanistic exploration and rational combination strategies are essential to improve response rates and expand benefit to MSS patients.

IntroductionThe benefit of clinical trials for lung cancer treatment extends beyond scientific advancement, offering significant cost savings for healthcare systems. This study aims to quantify the economic benefits obtained from the enrollment of lung cancer patients in clinical trials by analyzing the cost savings achieved through reduced medication expenses and medical tests.MethodsA retrospective and longitudinal analysis was performed to evaluate the economic benefits obtained from sponsor-provided medications and medical tests by analyzing data from lung cancer clinical trials conducted at a tertiary hospital in Spain from 2017-2021. Patient demographics, lung cancer histology, mutation status, cancer stage, treatment regimens, and the types and costs of imaging tests were collected from electronic medical records and the pkEnsayos^® software. Cost savings were estimated based on the expenses that would have been incurred under standard-of-care treatment.ResultsA total of 117 patients were enrolled in 35 trials, generating an economic benefit of €2,207,726 over five years. Most of these benefits (94.6%) were associated with NSCLC trials. Trial-medications accounted for €2,079,278 in savings, with phase III studies contributing 76.1% of this amount. A total of 642 imaging tests resulted in an economic benefit of €128,448. The difference in economic benefit between medications and imaging tests was statistically significant.ConclusionThis study showed that lung cancer clinical trials were associated with substantial economic benefits reducing medication expenses and sponsor-financing imaging medical tests. By participating in such trials, healthcare institutions can potentially alleviate the economic burden associated with lung cancer treatment and improve patient access to innovative therapies.

BackgroundAnticancer drugs excreted in urine can disperse during urination, contaminating toilets and causing secondary exposure. Activated carbon sheets adsorb urinary drugs and limit surface diffusion, but whether adsorbed drugs subsequently vaporize is unknown. We evaluated vaporization of cyclophosphamide (CPA) applied to activated carbon sheets.MethodsCPA (10 mg/2 mL) was placed on 100-cm² activated carbon sheets or control sheets without activated carbon and incubated for 24 h in a 4-L chamber at 37 °C. Vaporization was assessed by Ames test (reverse-mutated Salmonella colony counts). CPA in chamber gas and wipe samples from the inner surfaces of the chamber was quantified by HPLC-MS/MS. Sheets were tested immediately after CPA application, after drying, and after rewetting (immediately and at 3 and 7 days after contamination).ResultsCompared with no-CPA exposure, colony counts increased significantly after exposure to CPA-dropped control sheets (p < 0.001), whereas no increase occurred with CPA-coated activated carbon sheets. Gas analysis detected no CPA above the quantification limit when applied to activated carbon sheets; a small amount (49 ng) appeared in one control sample. Wipe samples contained far less CPA on activated carbon than on control sheets (79-93% reduction), and these differences persisted through day 7.ConclusionsAcross bioassay and instrumental analyses, activated carbon sheets retained adsorbed CPA without measurable vaporization for at least 7 days. Activated carbon sheets may offer a practical measure to reduce urine-derived antineoplastic contamination and inhalational exposure from vaporization in toilet environments.

ObjectiveTo evaluate adherence and persistence to palbociclib treatment in patients with advanced HR+/HER2- breast cancer in real-world clinical practice.MethodsThis observational, retrospective study was conducted using electronic medical records from two regional hospitals. Patients with locally advanced or metastatic HR+/HER2- breast cancer who initiated palbociclib treatment between January 2017 and December 2024 were included. Adherence was assessed using the medication possession ratio (MPR), and persistence was evaluated through the Kaplan-Meier method.ResultsEighty-two patients were included, with a median age of 69 years. Treatment adherence was 92.7% (MPR ≥80%). Median treatment persistence was 40.9 months (IQR: 3.3), with rates of 83.2% at 6 months, 72.2% at 12 months, and 57.9% at 24 months. A total of 47.6% of patients discontinued treatment, mainly due to disease progression (37.8%) or toxicity (9.8%). The most frequent adverse events were neutropenia (72.0%) and anemia (63.3%).ConclusionsPalbociclib demonstrated high adherence and persistence in real-world clinical practice, with a discontinuation rate comparable to that of previous clinical trials.

BackgroundTriple-negative breast cancer (TNBC) is a subtype of breast cancer with high recurrence rates and poor prognosis. Capecitabine and pembrolizumab are emerging therapies aimed at improving survival outcomes in early-stage TNBC. This meta-analysis compares the efficacy of capecitabine and pembrolizumab in improving disease-free survival (DFS) and overall survival (OS) in early-stage TNBC.MethodsA systematic literature search identified four major randomized controlled trials (RCTs): CREATE-X, GEICAM, KEYNOTE-522, and SYSUCC-001. These studies investigated the efficacy of capecitabine and pembrolizumab in combination with chemotherapy in early-stage TNBC patients. Data on DFS and OS were pooled using a random-effects model, and heterogeneity was assessed using the I² statistic.ResultsThe pooled analysis included 3133 participants across four trials. For OS, pembrolizumab demonstrated a significant benefit with a hazard ratio (HR) of 0.66 (95% CI: 0.64-0.79), indicating a 34% reduction in the risk of death. Capecitabine showed mixed results across studies, with a pooled HR of 0.75 (95% CI: 0.55-1.03). The pooled HR across these studies, calculated using a random-effects model, was found to be 0.69 (95% CI: 0.64 to 0.79). For DFS, pembrolizumab provided a consistent benefit (HR: 0.63, 95% CI: 0.43-0.93), while capecitabine resulted in a significant reduction in recurrence risk (HR: 0.67, 95% CI: 0.52-0.88).ConclusionThis meta-analysis demonstrates that pembrolizumab significantly improves survival outcomes in early-stage TNBC. Capecitabine also provides benefit, especially in DFS, but its impact on OS concerns residual disease. Further studies should explore optimal treatment regimens and combinations, as well as long-term survival data.

IntroductionCancer patients often experience complications from their disease and treatment, frequently requiring intensive care units (ICU) admissions. Despite significant clinical and economic impacts, data are limited. This study evaluated medication utilization and associated costs in adult cancer patients admitted to the ICU.MethodsThis retrospective study included adult cancer patients treated in the ICU between August and November-2023, excluding post-surgical observation cases. Patients' demographics, ICU medications, and related-costs were recorded. Medication data were obtained from the hospital pharmacy-database, and direct costs were calculated. Descriptive statistics were done to report the results, with subgroup analysis based on cancer treatment status.ResultsA total of 233 admissions were analyzed; 64.0% were males, 79.1% had solid tumors, and 58.6% were not on active cancer treatment. Sepsis and respiratory conditions were the most common admission reasons. Antibiotics and proton pump inhibitors were the most utilized medications. The mean medication cost per admission was $2363.7, with a median (IQR) of $1001.8 (423.9-1886.8). Human albumin had the highest median (IQR) cost at $1243.6 (932.7-1865.4), followed by antifungals at $316.4 (158.2-1048.8) and antibiotics at $166.5 (85.4-340.4). Median (IQR) ICU medication costs were $980.1 (364.2-1661.6) for patients on active treatment and $1116.2 (460.5-2127.0) for those not.ConclusionsIn a cohort of cancer cases admitted to the ICU, multiple medications were utilized and contributed substantially to overall treatment costs. While antibiotics and proton pump inhibitors were the most commonly used medications, human albumin and antifungals accounted for the greatest share of costs.

BackgroundCancer remains the second leading cause of death worldwide, with nearly 10 million annual deaths. Chemotherapy, though essential, is highly complex and prone to dosing errors, interactions, and adverse effects. To improve safety and standardization, a Chemotherapy Order Template (COT) was developed based on NCCN guidelines.ObjectiveTo design, validate, and assess the reliability of a structured Chemotherapy Order Template that supports safe, accurate, and consistent chemotherapy prescribing in oncology settings.MethodsThe validation process included developing the template using NCCN (2025) guidelines, constructing a 22-item Likert-scale tool, obtaining multidisciplinary expert review, and conducting statistical testing using Pearson's correlation and Cronbach's alpha. A total of 54 experts participated.ResultsThe expert panel comprised 46.30% physicians, 33.33% academicians, and 9.26% clinical pharmacists. The validation tool demonstrated excellent internal consistency with an overall Cronbach's alpha of 0.99. All 22 items showed significant positive correlations (p < 0.01), confirming strong construct validity. Expert feedback led to key enhancements in the COT.ConclusionThe validated COT is a reliable and clinically relevant tool that improves safety, accuracy, and adherence to oncology guidelines in chemotherapy prescribing. Its structured design, based on expert consensus, promotes standardization, reduces medication errors, and supports coordinated, high-quality cancer care.

PurposeThe aim of this study was to develop and validate a HPLC stability indicating assay for evaluating the calcium levofolinate long-term stability at standardized rounded doses in polyolefin (POF) infusion bags and in polypropylene syringes.MethodsDiluted calcium levofolinate infusion solutions were aseptically prepared by further dilution of calcium levofolinate stock solution with dextrose 5% in POF infusion bags (268 mL) at banded doses of 160 mg, 300 mg, and 400 mg or in polypropylene syringes (10 mL) at 25 mg banded dose. The POF bags and the syringes were stored under refrigeration (5°C ± 3°C) in the dark. Microbiological, physical and chemical stabilities were evaluated.ResultsThe long-term stability of calcium levofolinate at banded doses 160 mg, 300 mg, 400 mg in POF infusion bags was confirmed for respectively 15 weeks, 18 weeks and 19 weeks. For syringes, for a 25 mg banded dose, this long-term stability was confirmed for 20 weeks. Microbiological tests performed were negative.ConclusionsA simple, accurate and stability-indicating HPLC method was developed to determine calcium levofolinate concentrations in dose-banding conditions associated with color variation investigation. This study supports a centralized production of calcium levofolinate in accordance with the studied conditions.

ObjectiveAbraxane^® intravenous infusion (albumin-bound paclitaxel nanoparticles; Abraxane^® or paclitaxel nanoparticles) is a lyophilized cake formulation containing paclitaxel and human serum albumin in nanoparticulate form. Before use, it must be uniformly dispersed in saline. However, this reconstitution process often leads to foaming, necessitating careful handling and prolonging preparation time. This study aimed to investigate shaking conditions for rapid, uniform paclitaxel nanoparticle dispersion while minimizing foam formation. Additionally, we evaluated whether shaking affects nanoparticle size.MethodsAfter adding 20 mL of saline to a vial containing 100 mg of lyophilized cake, the vial was placed either vertically or horizontally on a shaker. Two shaking types were examined: linear reciprocal and orbital shaking. We varied shaking intensity and recorded the dispersion time and foam formation. Particle size was analyzed under the following three conditions: (1) control, (2) minimal dispersion time without foaming, and (3) the condition causing the most severe foaming.ResultsWhen the vial was placed horizontally and subjected to orbital shaking at 100 rpm, uniform dispersion was achieved within 6.25 min without foaming. This was approximately one-third the time required under control conditions. Further, when particle size was measured under different shaking intensities in the horizontal setup, no significant change in nanoparticle size was observed regardless of shaking strength or time after preparation.ConclusionIn the reconstitution of Abraxane^®, the optimal shaking condition identified in this study was demonstrated to not only preserve nanoparticle integrity but also reduce the time and effort required for healthcare professionals.