Journal of Oncology Pharmacy Practice最新文献

Background: Immune checkpoint inhibitors (ICIs) are associated with potentially severe immune-related adverse events (irAEs). Emerging clinical practice reports have suggested higher incidence of irAEs in real-world settings than initially observed in phase III clinical trials. Objectives were to determine the incidence of irAEs associated with ICIs in a clinical population, the Veterans Health Administration, characterize their time to onset, and explore potential risk factors.

Methods: This retrospective observational study included patients from eight Midwest VA medical centers who initiated an ICI between January 1, 2014, and June 30, 2022. Courses of incident prednisone therapy lasting at least seven days at a dose ≥ 20 mg/day were used to identify irAEs, within two years following ICI initiation. A multivariate Cox proportional hazards regression model was used to explore potential irAE risk factors.

Results: Of 1314 patients, the incidence of irAEs was 19.8%, with most (86.5%) occurring within one year of ICI initiation. Monthly incidence rates peaked three months following ICI initiation at 3.0% and decreased thereafter. Female gender (hazard ratio [HR] = 2.01, 95% confidence interval [CI]: 1.01-4.00) and combination therapy with ipilimumab and nivolumab (HR = 2.46, 95% CI: 1.44-4.21) were significantly associated with irAE incidence.

Conclusions: These findings are consistent with recent studies in clinical populations that demonstrate higher irAE incidence rates than originally reported in clinical trials. Our findings may enhance prompt recognition and treatment of irAEs for VA patients.

There is a need to develop more effective salvage therapies for patients with relapsed melanoma of the skin. Research has shown that chemotherapy-induced cancer cell death may increase immunogenic antigen exposure, or upregulation of co-inhibitory ligands such as PD-L1, thereby augmenting immune checkpoint inhibitor (ICI) efficacy. In addition, chemotherapy preconditioning may lead to depletion of Tregs, known to suppress immune anti-melanoma responses. As a result, regimens including both chemotherapy and ICI constructs are currently successfully employed in the 1^st line therapy of many solid tumors. We report a series of three patients with metastatic melanoma, refractory to ICI treatment, who responded to salvage therapy with temozolomide (TMZ) in combination with PD-1 inhibitors, with or without CTLA-4 inhibitors. The responses were durable, each lasting more than 12 months. In two patients, complete responses are ongoing at 13 and 15 months, respectively. Randomized clinical trials with TMZ plus ICIs for patients with relapsed or refractory malignant melanoma seem warranted.

Introduction: Pomalidomide is used for treating multiple myeloma in patients who have relapsed after prior treatment with lenalidomide and a proteasome inhibitor. Common side effects include mild cytopenias, and deep vein thrombosis. While papulo-erythematous rash has been described, hair effects are rare with this class of agents.

Case report: We describe a 56-year-old man who was diagnosed with multiple myeloma type IgD lambda six years prior. He responded very well to initial treatment with bortezomib-lenalidomide-dexamethasone. After two years, he had a recurrence that was treated with daratumumab-pomalidomide-dexamethasone, and he entered a stringent complete response (CR) within six months. Daratumumab was discontinued after twelve months, and he subsequently remained on maintenance therapy with pomalidomide. Three months into the maintenance regimen, he noticed a change in hair texture to curly, which continued to progress. Causality assessment linked this change to pomalidomide use via the Naranjo nomogram questionnaire, by scoring 5.

Management and outcome: Pomalidomide maintenance therapy was continued without any dose alterations given the excellent clinical outcome. A year later, multiple myeloma remains in stringent complete response. The patient remains with a curly hair phenotype, having fully embraced his new physical appearance.

Discussion/conclusion: We report herein a unique hair texture alteration linked with pomalidomide use, not previously documented in literature. The observed hair texture change, from straight to curly, requires further investigation. Future studies may offer more insights into the mechanisms underlying this rare, yet intriguing side effect.

Introduction: The general-purpose rating scales used by clinical pharmacists to rate their activities have not been extensively studied in specialist care units. This study aims to describe drug-related problems (DRPs) and pharmacist interventions (PIs) in a French hematopoietic cell therapy (HCT) unit and to evaluate the PIs' likely clinical, economic, and organizational impacts.

Methods: We retrospectively assessed all DRPs reported and all PIs issued between December 2018 and December 2021. The Act-IP scale was used to rate DRPs and PIs, and the ClEO scale was used to rate each PI's clinical, economic and organizational impacts. Fisher's exact test was used to assess the relationships between PIs and DRPs and between the three dimensions of the ClEO scale.

Results: The DRPs were most frequently related to drug-drug interactions (16.5%), physicochemical incompatibilities (15.5%), and drug monitoring problems (14.9%). 62.8% of the PIs had at least a moderate clinical impact. PIs that recommended drug monitoring were most frequent (26.8%), and most of these (75%) were likely to have prevented incidents that would have required patient monitoring or treatment.

Conclusions: The results of this study showed that after a slight adaptation, the Act-IP scale can be used to map clinical pharmacy activity in an HCT unit. More than 60% of the DRPs/PIs were likely to have had a positive impact on the patient's clinical outcome. All the PIs were rated with a positive organizational impact and PIs likely to lead to cost savings were balanced by those likely to increase costs.

Introduction: Several meta-analyses (MAs) of the efficacy and safety of daratumumab in refractory/relapsed multiple myeloma (RRMM) exist. They include different types of populations, Daratumumab regimens, and outcomes. Moreover, there is a wide variation in methodological quality and risk of bias.

Objective: This study aimed to conduct a systematic review of MAs to summarize the literature on the efficacy and safety profile of daratumumab use in RRMM, and also provide an assessment of the quality and risk of bias of the MAs if sufficient data is available.

Methods: The literature databases Pubmed, Embase, Web of Science, and Cochrane were searched since inception. The quality of methodology was assessed by the AMSTAR-2 tool, and the risk of bias was assessed by the ROBIS tool.

Results: Eight MAs were included in the SR. Most studies reported ORR and CR improvement by adding daratumumab to the chemotherapy regimen. Five MAs reported improvement in PFS in daratumumab-based regimens compared to non- daratumumab-based regimens. Only two MAs reported molecular response, favoring daratumumab. Dara was associated with adverse drug events (ADEs), including pneumonia and diarrhea. Conflicting evidence regarding hematological ADEs association with daratumumab exists. The overall quality of the studies is poor, but the MAs had a low risk of bias overall.

Conclusion: Despite including low-quality MAs, this SR provides a summary that simplifies clinicians' access to efficacy and safety outcomes of daratumumab in RRMM patients. Future studies are required to reduce the uncertainty and produce higher-quality Mas, particularly regarding daratumumab's safety.

Introduction: This report describes a rare occurrence of corneal epithelial keratopathy associated with ribociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor widely used in breast cancer treatment.

Case report: An 83-year-old female with a recent breast cancer diagnosis presented with blurred vision during the third cycle of ribociclib treatment. Ocular examination revealed corneal epitheliopathy and fluorescein staining findings. Detailed assessments and comparisons were made with existing literature, identifying a few reported cases of vortex keratopathy linked to ribociclib. To the best of our knowledge, this is the first reported case of epitheliopathy.

Management and outcome: Since it decreased visual acuity, ribociclib treatment was discontinued in consultation with oncology. There was no regression in epithelopathy findings and visual acuity did not improve during follow-up visits.

Discussion: This report underscores the uncommon association between ribociclib and corneal epithelial keratopathy, emphasizing the need for comprehensive monitoring and collaboration between oncologists and ophthalmologists.

Background: Higher prevalence of inappropriate medication use among cancer patients increases risk of drug-related problems(DRP) like drug-drug interactions, ADR, and non-adherence. Potentially inappropriate medication (PIM) and Potential Prescription Omission (PPO) were identified using Screening Tool of Older Person's Prescriptions (STOPP) and Screening Tool to Alert Doctors to the Right Treatment (START) criteria. Objectives: The study objective was to optimize prescriptions for the elderly by analyzing the impact of medication review. Methods: An observational study in which PIM and/or PPO were identified and the prescriptions were optimized by a physician. Results: Out of 150 patients, a total of 35 drugs were stopped and 12 drugs were started. Medication omissions were identified in 12 patients (8%). There were no DRPs associated with medication adjustments. Conclusion: Based on a pharmacist-led comprehensive medication review of the elderly, the STOPP and START criteria allow the optimization of prescriptions.

Introduction: Venetoclax is a potent oral oncology drug (OOD) frequently used to treat hematologic cancers due to its convenience and high efficacy. However, some patients cannot tolerate solid oral formulations, requiring a reformulated version of venetoclax for effective administration. Currently, there is limited information in the literature regarding the extemporaneous compounding of venetoclax.

Methods: We present our institution's medication use process (MUP) for preparing compounded suspensions of venetoclax for patients with dysphagia who cannot tolerate solid oral formulations. This report has two main aims: to review our MUP from design to implementation, illustrated with real patient cases, and to present it as a strategy for administering venetoclax-based therapies to patients with dysphagia or feeding tubes. From February 2020 to January 2024, 17 patients received venetoclax through the standard MUP, with four developing tumor lysis syndrome (TLS). This study describes their clinical courses and evaluates their responses to the compounded suspensions, considering the uncertain effects of venetoclax prepared through this method.

Results: The four patients received venetoclax suspensions during hospitalization due to swallowing difficulties or nutritional support needs. We prepared extemporaneous venetoclax suspensions to ensure continuous therapy, thus avoiding treatment interruptions. TLS was managed using rasburicase and prophylactic allopurinol.

Conclusions: The clinical outcomes indicate that the current MUP provides a practical approach to administering venetoclax for dysphagic patients. However, additional research is needed to determine if there are pharmacokinetic differences in the bioavailability of venetoclax between oral and enterally delivered formulations. Further studies will help inform best practices for patient care.

Introduction: Leukemia, a complex hematological malignancy, requires a multidisciplinary treatment approach, with clinical pharmacists playing a crucial role. However, their involvement in clinical practice is not well-documented in the literature. This study aimed to examine the characteristics of clinical pharmacy interventions (CPIs) reported by clinical pharmacists.

Method: This retrospective study involved extraction of CPIs entered into a pharmacy documentation database "Quantifi^®" between January 2019 and June 2023. These CPIs included direct clinical pharmacist interventions (DCPIs), detected medication errors (MEs) and adverse drug reactions (ADRs).

Results: A total of 6286 CPIs were extracted, of which DCPIs, MEs and ADRs accounted for 5701 (90.7%), 357 (5.7%) and 228 (3.6%) reports, respectively. The most prevalent DCPIs were drug therapy discontinuation (n = 1080, 18.9%). Antimicrobials were the most common medications associated with DCPIs (n = 1991, 34.9%). Physicians accepted 99.4% of DCPIs and 64.1% (n = 3656) of direct interventions were considered significant. Among detected MEs, antimicrobials were the most reported medications (n = 158, 44.3%), with pharmacy internal errors being the most prevalent cause of the events (n = 172, 48.2%). Among the reported ADRs, hematological reactions were the most common (n = 81, 35.5%), and antineoplastic agents were the most frequently associated medications with ADRs (n = 164, 71.9%).

Conclusion: This study highlights the crucial role of clinical pharmacists in managing leukemia patients, emphasizing their key interventions and ability to identify MEs and ADRs. Further research is needed to explore the clinical outcomes and financial impact of their involvement.

Background: The Arab world consists of 22 countries, representing 5.5% of the world's population. Morphine consumption accounts for less than 1% of the world's consumption. This is the first study to identify barriers to opioid use in the Arab world.

Aim: This study aimed to investigate the barriers to opioid use in pain management in the Arab world.

Method: Online survey was developed to investigate barriers to governance, prescribing, distributing, dispensing and administering, as well as educational barriers in the Arab world. The questionnaire was sent via email and a mobile app to one expert physician in pain management and one licensed pharmacist from each Arab country.

Results: With the exception of Tunisia, Djibouti and Comoros, 34(77%) participants from 19 Arab countries answered the survey. Most countries lack local opioid production, necessitate special licenses for physicians, and restrict opioid prescribing to medical specialists. Special prescription forms are mandated, and pharmacists lack the authority to correct prescription errors or accept refill or verbal orders on opioids. Storage requirements for empty ampoules and prescriptions are enforced. Nurses are not allowed to carry opioids during home visits, and only first degree relatives can collect opioids for patients. Furthermore, the integration of palliative care and pain management curricula into pharmacies and medical schools is lacking.

Conclusion: There is a wide range of regulatory and other barriers to opioid use in the Arab world. There is a substantial need for regulatory review and reform, as well as for educational initiatives, in most Arab countries.