Journal of Oncology Pharmacy Practice最新文献

IntroductionMelanoma, though relatively rare, is the most aggressive form of skin cancer due to its high metastatic potential and mortality rate. Immunotherapy, such as pembrolizumab, has improved outcomes for patients. However, access to these therapies remains limited in low- and middle-income countries, including Brazil, where real-world evidence is scarce and population genetics may influence treatment response and adverse drug reactions (ADRs).ObjectiveThis study aimed to analyze the effectiveness and safety of first-line treatment for advanced melanoma with pembrolizumab, with a focus on the kinetics of ADRs.MethodsThis retrospective study included patients from the Brazilian Public Health System, with a follow-up period of 1 year (CAAE: 95157018.9.0000.5274).ResultsThe study analyzed 40 patients (57.5% male, median age 65.5 years). The most frequent primary site of melanoma was the lower limbs (47.5%), and the main histological types were acral (30%) and nodular melanoma (30%). ADRs were identified in 87.5% of the patients, with pruritus (40%) and vitiligo (37.5%) being the most common. Cutaneous reactions were observed in the early cycles and persisted until the end of treatment. The cohort exhibited a different ADR profile and fewer severe events (10.5%) compared to clinical trials. The median progression-free survival was 7.7 months, and the overall survival rate was 60%.ConclusionPembrolizumab was effective and safe as a first-line treatment for advanced melanoma patients in a real-world Brazilian public health setting. Additionally, we characterized the kinetics of ADRs, offering practical insights for healthcare teams in managing these events throughout the treatment course.

Backgroundmhealth interventions are increasingly adopted to improve cancer care in low- and middle-income countries. Despite their potential, evidence on cost-effectiveness in oncology remains limited in India. This study evaluates the cost-utility of the OncoCare mobile application for oncology patients.MethodsA trial-based cost-utility analysis was conducted alongside a six-month randomized controlled trial (n = 342; App: 168, Control: 174). Costs were estimated from the provider's perspective using a micro-costing approach, including development costs and prorated annual maintenance costs. Health outcomes were measured using the EORTC QLQ-C30 and mapped to EQ-5D-5L utilities via an ordinal-logit algorithm, applying the Indian EQ-5D-5L tariff. QALYs were calculated using the area-under-the-curve method. Incremental cost-effectiveness ratios were estimated, with uncertainty explored through bootstrap replications, cost-effectiveness planes, and cost-effectiveness acceptability curves. Sensitivity analyses assessed alternative cost assumptions.ResultsThe per-patient incremental cost of OncoCare was ₹597 (₹642 including maintenance). Mean six-month QALYs were 0.249 in the App group compared to 0.239 in the control group. The adjusted incremental QALY gain was 0.0107 (95% CI: 0.0042-0.0174). The base-case ICER was ₹55,600 per QALY, well below both the opportunity-cost threshold for India (approximately ₹2.1 lakh/QALY) and the WHO's GDP-per-capita heuristic. The probability of cost-effectiveness exceeded 82% at ₹100,000/QALY and 95% at ₹150,000/QALY. Headroom analysis confirmed the cost-effectiveness, even with per-patient costs three- to five-fold higher.ConclusionOncoCare is a cost-effective digital intervention in Indian oncology, achieving measurable QALY gains at low incremental cost. These findings support its integration into cancer care pathways and national digital health strategies.

IntroductionThere is limited guidance available to indicate next steps when a child vomits after taking an oral medication. Vomiting is a frequent problem in pediatric oncology.MethodsThe primary objective was to describe factors influencing healthcare practitioners' decisions to re-dose oral medications, including chemotherapy, after vomiting in pediatric oncology patients. The primary outcome was the proportion of respondents who list a factor influencing their decision as "very important". Secondary objectives were to describe protocols and practice. An online survey was distributed via email networks to approximately 3600 nurses and 1470 pharmacists at pediatric oncology and Stem Cell Transplant centers in North America. Survey responses were analyzed using descriptive statistics and content and thematic analyses for the open-ended questions.ResultsOf the 110 responses received, 87 were included. Response rate could not be calculated, which has implications for non-response bias. Participants reported patients vomiting after oral medication occurred either weekly (41%) or monthly (33%). Seventy-four participants indicated they followed a general rule for re-dosing oral chemotherapy medications after vomiting, with 62% indicating they would re-dose if vomiting occurred within 30 min of the dose. The most important factors impacting the decision to re-dose were time after dose ingestion (77%), type of medication (67%) and whether the medication is an investigational drug (54%). Twenty-four participants reported that their institute had a guideline to assist with making the decision to re-dose a medication after vomiting.ConclusionsThe problem of vomiting after the administration of an oral medication is prevalent; however, there are few guidelines available.

IntroductionHigh-dose systemic methotrexate (HD-MTX) in doses ≥ 3 g/m² is the cornerstone of treatment for central nervous system (CNS) lymphomas and prophylaxis for patients with high-risk of CNS relapse. Its administration requires extensive supportive care until serum clearance is achieved. Risk factors for delayed methotrexate (MTX) clearance and renal injury are well-characterized and include baseline renal function, age, and hypoalbuminemia. Data assessing characteristics associated with slow terminal clearance are lacking.MethodsWe performed a single-center, retrospective cohort study between 1/2015 to 10/2023 to evaluate characteristics associated with the rate of MTX clearance in the 72 h after serum MTX levels decline to below 0.2 µmol/L in adult patients with lymphoma who received MTX at doses ≥ 3 g/m². MTX administration was evaluated at the cycle level with slow terminal clearance (STC) defined as > 72 h to clear from < 0.2 µmol/L to < 0.05 µmol/L.ResultsOverall, 135 patients were included with a total of 462 cycles, median of 3 cycles, and 76 (56.3%) experienced at least one cycle of STC. Of 462 cycles, 138 (29.9%) were STC. Multivariable analysis, based on variables significant by univariable analysis, identified that age ≥ 80 years, BMI > 30 kg/m², first MTX level > 10.0 µmol/L, and acute kidney injury (AKI) after MTX administration were significantly associated with STC.ConclusionUtilizing clinically and statistically significant variables from our analyses, we advocate for the development and validation of a model to inform supportive care management once MTX levels decline below 0.2 µmol/L.

Introduction: Immune checkpoint inhibitors (ICIs) can trigger cutaneous immune-related adverse events (irAEs), including rare follicular eruptions such as lichen planopilaris (LPP).

Case report: We report a 75-year-old woman with stable, biopsy-proven LPP who developed disease reactivation after ten cycles of pembrolizumab for stage IIC melanoma.

Management & outcome: Despite ongoing treatment with hydroxychloroquine and topical clobetasol, disease activity progressed. Oral doxycycline was added. After ten months of adjunctive therapy and completion of pembrolizumab, the disease stabilized, though areas of scarring alopecia persisted. The patient remains under multidisciplinary follow-up.

Discussion: LPP is an underrecognized follicular irAE. The timing, clinical course, and histopathologic findings suggest pembrolizumab-induced exacerbation. Causality was assessed using the Naranjo Algorithm, with a score of 6, indicating a probable adverse drug reaction. This case reinforces the importance of early recognition and tailored dermatologic care in patients receiving ICI therapy.

IntroductionChemotherapy remains a cornerstone of cancer treatment, but a narrow therapeutic index and toxic effects on normal tissues frequently constrain its clinical utility. Pharmacovigilance of these drugs is limited due to significant underreporting, which poses a substantial risk to patient safety. We aimed to assess the frequency, types, severity, and management of ADRs in chemotherapy patients.MethodsA 12-month cross-sectional study was conducted in a tertiary-care hospital, including 327 chemotherapy patients. The data was collected in a suspected ADR reporting form by the Central Drugs Standard Control Organisation (CDSCO) and reported to the ADR Monitoring Centre and Vigiflow at the National Coordinating Centre (NCC). The suspected drugs were evaluated for causality using the Modified Naranjo scale, and ADR severity was assessed with the Hartwig et al. severity scale.ResultsOut of 327 patients, 230 developed ADR (70%). A total of 372 ADRs were reported, which indicated 1.6 events per patient. ADRs primarily occurred in the 40-60-year age group (57.0%), with a predominance among females (64.8%). Common ADRs included thrombocytopenia (11.2%), neutropenia (9.9%), and diarrhoea (7.7%). Ovarian (17.3%) and breast cancer patients (15.6%) had the highest ADR incidence. Platinum-based agents and antimetabolites were the common culprit drugs. Causality assessment showed 36.1% of ADRs as 'possible' and 61.7% as 'probable.' The severity of ADRs was categorised as 'mild' (49.13%), 'moderate' (46.08%), and 'severe' (4.79%).ConclusionThe study emphasises the critical need for vigilant surveillance to minimise the impact of these complications on treatment outcomes. Future studies could stratify data by cancer stage.

IntroductionWhile the co-administration of oral protein kinase inhibitors (PKIs) and gastric acid suppressants (GASs) is widespread, the impact of GASs on the pharmacokinetics and survival outcomes of PKIs has remained systematically uninvestigated. The present study aimed to address this knowledge gap and to verify whether PKI plasma concentrations can predict these interactions.MethodsMEDLINE and CENTRAL databases were searched until April 4, 2025. We included studies of PKIs where their plasma concentrations and the survival outcomes of participants taking PKIs with GASs. All studies eligible for this analysis were assessed using the appropriate risk-of-bias tool. For the meta-analysis, we estimated the ratio of the mean plasma concentrations and the hazard ratios of survival outcomes.ResultsThis meta-analysis included 17,339 participants from 38 studies, including 11 PKIs. Our results revealed that the co-administration of PKIs with GASs led to a concurrent decrease in plasma concentrations and a shorter OS in 8 out of 11 PKIs, as well as a shorter PFS in 10 PKIs.ConclusionsWe found that changes in the plasma concentrations of PKIs administered with GASs could predict the changes in survival outcomes in cancer patients. One major limitation of this meta-analysis was that 68% of the eligible studies had a retrospective design.

IntroductionReuse of antineoplastic and supportive drugs can reduce costs by cutting down the amount of chemotherapy drug waste generated. Therefore, this study aims to analyze the disposal and reuse of preparations which contain these two pharmaceutical classes.MethodsThis is a prospective study conducted with pediatric and adult patients who did not undergo one or more chemotherapy session between July and November of 2024. The chemotherapy preparations were classified as reused or discarded and quantified. The reasons for drug disposal and patient's sociodemographic data were also analyzed.ResultsOne hundred and forty patients composed the studied population, all of them responsible for 188 missed chemotherapy sessions. The study's population is predominately adult, male, residing at Rio de Janeiro city and with less than 12 years of education. Almost half of the population (47.9%) had one or more comorbidity. The most prevalent tumors were those of the digestive system (40.1%). The drug disposal rate was 2.11%. The chemotherapy suspension rate was higher (66.3%) than non-attendance (32.6%). The patient's worsening clinical condition was the main reason (45.2%) that led to chemotherapy suspension, while miscommunication (37.1%) was the main reason attributed to non-attendance. Oxaliplatin was the most discarded drug whereas vincristine was the most reused drug.ConclusionsRate of chemotherapeutic drug disposal is higher than their reuse. Although session suspension and non-attendance are caused by different reasons, both can be reduced by implementation of an effective communication routine between patient and provider in the days prior to the scheduled session.

IntroductionMulticriteria Decision Analysis (MCDA) comprises a set of methods that support decision making in Health Technology Assessment (HTA). MCDA studies that support the incorporation of new treatments for non-metastatic HER2-positive breast cancer are still rare.ObjectiveTo elaborate a MCDA comparing 8 treatments alternatives for women with non-metastatic, HER2+, hormone receptor positive (HR+), postmenopausal breast cancer, who did not achieve a pathological complete response (PCR) after neoadjuvant chemotherapy with taxane plus anti-HER2 therapy.MethodsAn MCDA approach specifically built for application in oncology was used. The study was developed at the Cancer Institute of the State of São Paulo (ICESP) according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommendations.ResultsIt was possible to obtain a ranking of the 8 alternatives: the first, second and third position were respectively: neoadjuvant treatment without anthracycline and anti-HER2 therapy with only trastuzumab followed by adjuvant trastuzumab (global value 0.739); neoadjuvant treatment with anthracycline and anti-HER2 trastuzumab alone followed by adjuvant trastuzumab (global value 0.717) and neoadjuvant treament with anthracycline plus trastuzumab alone or double anti-HER2 blockade with trastuzumab and pertuzumab, followed by adjuvant T-DM1 (global value 0.697). The criteria that received the greatest weight from stakeholders were in descending order: disease-free survival, cost, severity of the disease, adverse reactions and overall survival.ConclusionMCDA made it possible to compare treatment alternatives for non-metastatic, HER2+, HR + breast cancer, with the most innovative technology T-DM1 appearing fourth.

Introduction5-Fluorouracil (5-FU) is a chemotherapeutic agent used in various malignancies. 5-FU-induced leukoencephalopathy is a rare but reversible neurotoxic effect occurring within days of administration. Symptoms include confusion, agitation, and cognitive disturbances, with severe cases potentially causing coma. Diagnosis is supported by magnetic resonance imaging (MRI) showing characteristic brain changes. Treatment involves discontinuing 5-FU and initiating supportive care. Most patients recover within one week, but relapse may occur with repeated exposure, making early recognition critical.Case reportA 42-year-old male with recurrent Stage IV gastric adenocarcinoma and chronic kidney disease developed progressive 5-FU-related leukoencephalopathy after repeated exposure. MRI findings and symptoms of confusion, disorientation, and memory deficits were consistent with 5-FU leukoencephalopathy. Initial work-up was inconclusive, therefore, treatment was continued. Neurologic symptoms worsened after further cycles, leading to chemotherapy discontinuation and surgical resection. Disease recurrence led to reinitiation of modified 5-FU therapy, triggering acute neurotoxicity confirmed by MRI.Management and outcomeThe patient was managed by discontinuing 5-FU, beginning high-dose intravenous thiamine and methylprednisolone, and providing supportive care. Neurologic symptoms including confusion, facial diplegia, and unsteady gait gradually resolved. By Day 9, he returned to baseline mental status without deficits.DiscussionEarly recognition and intervention in 5-FU-induced leukoencephalopathy is crucial, especially in patients with renal dysfunction or repeated exposures. Dihydropyrimidine dehydrogenase (DPD) deficiency has not been directly implicated in this condition. Metabolic disruption and thiamine depletion contribute to pathogenesis. Prompt 5-FU discontinuation and initiation of supportive care can hasten recovery. Clinical vigilance is imperative in patients with known risk factors.