Immune checkpoint inhibitors (ICIs)—anti-programmed death-1 (PD-1) and their ligands (PD-L1 and PD-L2) have become widely used in the treatment of several malignancies. Many immune-related adverse ...events (irAEs) have been linked to these agents. Nonetheless, tuberculosis (TB) reactivation during their use is increasingly recognized and reported. Herein, we present a 58-year-old lady with advanced non-small cell lung cancer (NSCLC) ALK-negative, EGFR wild, and PD-L1 immune histochemistry (IHC) strongly positive in 95% of tumor cells, on ongoing treatment with Pembrolizumab as a first-line monotherapy. Our patient presented with 1-week history of productive cough and high-grade fever. Further workup yielded the diagnosis of pulmonary tuberculosis after her Pembrolizumab sixth cycle with positive AFB smear and TB PCR from BAL (rifampin resistance not detected), with negative HIV status. Hence, immunotherapy was held, and patient was commenced on anti-TB regimen. History revealed contact with active TB patient over the past decade, without previous documentation of latent TB or previous TB infection. Her sputum AFB smear remained persistently positive 4 weeks through anti-TB regimen course. Later, the patient was discharged after her sputum was cleared from AFB (two negative sets). In light of pembrolizumab mechanism of action as an immune checkpoint inhibitor, we suspected its implication on reactivating latent TB which was observed in our patient demonstrating features of pulmonary tuberculosis. She was not re-challenged with Pembrolizumab following TB diagnosis.
Objective
To identify the incidence of hypercalcemia and hypocalcemia in zoledronic acid and denosumab groups. Secondary objective was to determine the correlation between calcium supplement and ...calcium level control.
Methods
An observational retrospective cohort study was conducted by reviewing patient electronic records, laboratory results, and medication charts from 1 August 2015 to 31 July 2016. Adult cancer patients who were diagnosed with bone metastasis secondary to a solid tumor or multiple myeloma and who received either zoledronic acid or denosumab were included. Other indications for bone targeting agents were excluded. Data of bone targeting agents administration encounters were collected, evaluated, and analyzed.
Results
A total of 1141 encounters (for 271 patients) were included. The incidence of hypocalcemia was higher in denosumab compared to zoledronic acid group (5.5% vs. 3.1%, OR = 0.55, 95% CI 0.3–1.0; P = 0.05). Hypercalcemia incidence was also higher in denosumab group (8.5% vs. 3.1%, OR = 2.9, 95% CI 1.68–5.03; P < 0.0001). Breast cancer was the most common malignancy associated with hypocalcemia (27.3%) followed by ovarian cancer (25%) and multiple myeloma (22.7%). The risk of developing hypocalcemia was reduced by 16% in patients receiving calcium supplementation (RR = 0.84, 95% CI 0.55–1.20; P = 0.39).
Conclusion
Denosumab use was associated with higher rates of both hypercalcemia and hypocalcemia compared to zoledronic acid. Adequate supplementation with calcium substantially reduced the risk of hypocalcemia. Our results highlight the importance of taking preventative measures upon bone targeting agents initiation and during treatment including regular monitoring of calcium levels and providing supplements accordingly.
In line with global trends, cancer incidence and mortality may have decreased for specific types of cancer in Qatar. However, the cancer-related burden on patients, healthcare systems, and the ...economy is expected to expand; thus, cancer remains a significant public healthcare issue in Qatar. Qatar's free access to cancer care represents a considerable economic burden. Ensuring the best utilization of financial resources in the healthcare sector is important to provide unified and fair access to cancer care for all patients. Experts from the Qatar Oncology Health Economics Expert Panel (Q-OHEP) aimed to establish a consistent and robust base for evaluating oncology/hematology medications; involve patients' insights to accelerate access to cutting-edge medications; increase the value of cancer care; and reach a consensus for using cost-effective strategies and efficient methodologies in cancer treatment.
The Q-OHEP convened on 30 November 2021 for a 3-hour meeting to discuss cancer management, therapeutics, and health economics in Qatar, focusing on four domains: (1) regulatory, (2) procurement, (3) treatment, and (4) patients. Discussions, guided by a moderator, focused on a list of suggested open-ended questions.
Some of the salient recommendations included the development of a formal, fast-track, preliminary approval pathway for drugs needed by patients with severe disease or in critical condition; and encouraging and promoting the conduct of local clinical trials and real-world observational studies using existing registry data. The Q-OHEP also recommended implementing a forecast system using treatment center data based on the supply/demand of formulary oncology drugs to detect treatment patterns, estimate needs, expedite procurement, and prevent shortages/delays. Furthermore, the panel discussed the needs to define value concerning cancer treatment in Qatar, implement value-based models for reimbursement decision-making such as health technology assessment and multiple-criteria decision analysis, and promote patient education and involvement/feedback in developing and implementing cancer management guidelines.
Herein, we summarize the first Q-OHEP consensus recommendations, which aim to provide a solid basis for evaluating, registering, and approving new cancer medications to accelerate patient access to novel cancer treatments in Qatar; promote/facilitate the adoption and collection of patient-reported outcomes; and implement value-based cancer care in Qatar.
Celotno besedilo
Dostopno za:
CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
There has been less volume of literature focusing on the Immune-related Hematological Adverse Drug Events (Hem-irAEs) of Immune Checkpoint Inhibitors (ICPis) in cancer patients. Furthermore, there ...has been no consensus about the management of hematological toxicity from immunotherapy in the recently published practice guidelines by the European Society for Medical Oncology (ESMO). We conducted a systematic review of case reports/series to describe the diagnosis and management of potentially rare and unrecognized Hem-irAEs. We searched Medline, OVID, Web of Science for eligible articles. Data were extracted on patient characteristics, Hem-irAEs, and management strategies. We performed quality assessment using the Pierson-5 evaluation scheme and causality assessment using the Naranjo scale. Our search retrieved 49 articles that described 118 cases. The majority of patients had melanoma (57.6%) and lung cancer (26.3%). The most common Hem-irAEs reported with ICPis (such as nivolumab, ipilimumab, and pembrolizumab) were thrombocytopenia, hemolytic and aplastic anemias. Less reported adverse events included agranulocytosis and neutropenia. Steroids were commonly used to treat these adverse events with frequent success. Other used strategies included intravenous immunoglobulins (IVIG), rituximab, and transfusion of blood components. The findings of this review provide more insights into the diagnosis and management of the rarely reported Hem-irAEs of ICPis.
Palbociclib and ribociclib are indicated in the first-line treatment of hormonal receptor-positive HER-2 negative (HR+/HER2- negative) advanced breast cancer. Although randomized-controlled trials ...(RCTs) proved their clinical efficacy, there are no observational studies yet to validate the clinical findings in the real-world. Therefore, this study aimed to evaluate and compare the clinical effectiveness and safety profiles of palbociclib and ribociclib in Qatar.
A retrospective observational study was conducted on HR+/HER-2-negative stage-IV breast cancer patients receiving palbociclib or ribociclib in the state of Qatar. Clinical data were collected from the National Center for Cancer Care and Research (NCCCR) in Qatar using Cerner
. Primary outcomes were progression-free-survival (PFS) and overall-survival (OS) generated by Kaplan-Meier curves. Moreover, safety profiles of both two treatments were evaluated.
The data from 108 patients were included in the final analysis. There was no statistically significant difference in PFS between the palbociclib and ribociclib groups; PFS was 17.85 versus 13.55 months, respectively(p> 0.05). Similarly, there was no statistically significant difference in OS between the two medications, 29.82 versus 31.72 months, respectively(p>0.05). Adverse events were similar between the two groups. Neutropenia was the most common side effect in the study population accounting for 59.3% of the patients.
Therefore, both treatments have similar efficacy and safety profiles. Further research on a larger-scale population and longer follow-up period is recommeneded.
Background
Clinical pharmacy services started in 2009 at the National Center for Cancer Care and Research, Qatar. Clinical pharmacy services was established to provide comprehensive prescription of ...drug management and support, and consulting services to build clinically efficient and cost-effective pharmacy program.
Aim
To determine perceptions and expectations of healthcare providers toward the clinical pharmacy services at the National Center for Cancer Care and Research.
Methods
A cross-sectional survey of healthcare providers was conducted from January to May 2018. A self-administered electronic/paper survey containing four domains assessing healthcare providers’ perceptions and expectations towards clinical pharmacy services, perceived barriers to clinical pharmacist role and suggested area for improvement was sent to 375 healthcare providers including physicians, operational pharmacists, nurses and dietitians.
Results
The response rate was 112/375. Most of the healthcare providers (74%) perceived the increasing interest in clinical pharmacy services. Also, they expected (1) providing consultations regarding appropriate medication choices (82%); (2) providing information about medication availability and shortages (82%); (3) assisting in the prescribing of cost-effective drugs by providing pharmacogenomics information routinely (75%) and (4) Participating actively in research activities (74%). Overall, healthcare providers have a high level of trust in the clinical pharmacists’ abilities (P < 0.01). Nurses were less appreciative (P < 0.002) of the positive role of clinical pharmacists in direct patient care as compared to both physicians and pharmacists (64.2%, 90% and 95.7%, respectively).
Conclusion
This study revealed a positive attitude towards the role of clinical pharmacists by healthcare providers at National Center for Cancer Care and Research. However, there is an area of improvement by empowering with privilege and staffing, elevating the awareness and expansion in the ambulatory care settings.
Objective
To investigate the post‐COVID‐19 long‐term complications or long COVID of various organ systems in patients after 3 months of the infection, specifically before the Omicron variant, with ...comparative literature analysis.
Methods
A systemic literature search and meta‐analysis were conducted using multiple electronic databases (PubMed, Scopus, Cochrane library) with predefined search terms to identify eligible articles. Eligible studies reported long‐term complications of COVID‐19 infection before the Omicron variant infection. Case reports, case series, observational studies with cross‐sectional or prospective research design, case–control studies, and experimental studies that reported post‐COVID‐19 complications were included. The complications reported after 3 months after the recovery from COVID‐19 infection were included in the study.
Results
The total number of studies available for analysis was 34. The effect size (ES) for neurological complications was 29% with 95% confidence interval (CI): 19%–39%. ES for psychiatric complications was 24% with 95% CI: 7%–41%. ES was 9% for cardiac outcomes, with a 95% CI of 1%–18%. ES was 22%, 95% CI: 5%–39% for the gastrointestinal outcome. ES for musculoskeletal symptoms was 18% with 95% CI: 9%–28%. ES for pulmonary complications was 28% with 95% CI: 18%–37%. ES for dermatological complications was 25%, with a 95% CI of 23%–26%. ES for endocrine outcomes was 8%, with a 95% CI of 8%–9%. ES size for renal outcomes was 3% with a 95% CI of 1%–7%. At the same time, other miscellaneous uncategorized outcomes had ES of 39% with 95% CI of 21%–57%. Apart from analyzing COVID‐19 systemic complications outcomes, the ES for hospitalization and intensive care unit admissions were found to be 4%, 95% CI: 0%–7%, and 11% with 95% CI: 8%–14%.
Conclusion
By acquiring the data and statistically analyzing the post‐COVID‐19 complications during the prevalence of most virulent strains, this study has generated a different way of understanding COVID‐19 and its complications for better community health.
A 45-year-old female developed neurological symptoms and elevated diastolic blood pressure while on bevacizumab (Avastin) and gemcitabine for recurrent carboplatin-resistant high-grade serous ovarian ...cancer. A brain MRI diagnosed our patient with posterior reversible encephalopathy syndrome. We are discussing her presenting symptoms in this paper as well as the management and the outcome. We emphasize the importance of keeping this rare but very serious complication in all patients receiving bevacizumab.
Introduction Multiple Myeloma (MM) is a chronic and incurable hematologic malignancy affecting the plasma cells, and is more prevalent among the elderly. Interprofessional patient care showed ...superiority over physician-only care in multiple settings, including MM. (Sweiss K et al.2019)In Qatar, real-world data analysis of MM patients treated in the ambulatory setting at the National Center for Cancer Care and Research (NCCCR) showed that clinical pharmacists (CPs) had an evident role in therapy optimization and ensuring adherence to treatment protocol schedule and supportive medications.(Elazzazy S et al.,2023) We aimed to provide a more structured and accessible link to MM patients considering the complexity of their treatment protocols and supportive care through the establishment of a clinical pharmacist-led clinic (CPLC). The most common challenges to optimum care of MM patients in the NCCCR before CPLC were identified and categorized (Figure 1) and then used to design the collaborative model for the MM CPLC (Figure 2). Methods The collaborative MM CPLC was initiated at NCCCR in February 2022. A collaborative practice agreement was established for this clinic, to allow clinical pharmacists -managing MM patients- to issue refills for supportive medications, and order any necessary laboratory tests. To investigate the quality of care provided by the clinic, data was retrospectively collected and analyzed for all MM patients managed in the clinic between February 2022 and February 2023. All patients who were newly diagnosed with MM were eligible for referral by the attending physician. Dedicated advanced hematology CPs provided consultation twice weekly for referred patients without additional fees. The provided services (in-person or virtual) included thorough medication profile review (prescribed antineoplastic and refills of supportive medications), and ordering follow-up laboratory tests. Services also included assessment and optimization of medication adherence, including immunomodulators and supportive medications (i.e., Venous Thromboembolism (VTE) prophylaxis, antimicrobial prophylaxis, bone modifying agents and vaccinations), providing comprehensive patient education, and communicating the recommended adjustments with physicians. Results During the 12-month period, there was a total of 22 patients referred to the clinic. The average age for patients was 51 years (range 36-72). Patient characteristics are summarized in Table 1. The total number of documented encounters with the pharmacists was 73 visits, corresponding to a median of 4 visits per patient (range 1-11). The total amount of time spent with each patient over the course of their referral was 15 minutes. A total of 343 CPs interventions (average of 5 interventions per visit) were performed with an acceptance rate of 100%. The most common intervention was medication reconciliation (n=124), followed by monitoring for medication outcomes (n=72, safety and efficacy), addition of required medication (n=40), patient education (n=27), issuing refills (n=24), drug interactions review and management (n=19), suggesting referrals to relevant subspecialities (n=16), identification of adverse drug reactions (n=7), and required dose adjustments (n=12). Twenty-two medication refills for supportive medications and eight pre-chemotherapy laboratory investigations were issued and ordered by CPs, respectively. All newly diagnosed patients were started on the appropriate bisphosphonate therapy without the previously observed delay, with the median from diagnosis to initiation being 14 days range from 1 to 117 days. All clinic patients were maintained on the appropriate VTE prophylaxis (aspirin n=14, rivaroxaban n=7, warfarin n=1). All patients were adherent to antiviral and Pneumocystis jirovecii Pneumonia prophylaxis. Conclusion CPLC for MM patients treated in the ambulatory setting provided a robust and timely link to patients in alignment with the published literature. The newly implemented collaborative prescribing model in MM clinic encouraged the expansion of pharmacy services in other ambulatory clinics. Our collaborative model could be potentially applied to different cancer settings to optimize a safe and effective patient care. Further analysis is planned to compare the adherence to international MM care guidelines pre- and post-launch of our CPLC.
Abstract
Introduction: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are indicated in the first-line treatment of hormonal receptor positive and HER-2 negative (HR+/HER2- negative) metastatic ...breast cancer (MBC). Although phase III randomized controlled trials (RCTs) proved their clinical efficacy, they can increase healthcare expenditure. To date, there are no observational studies to validate the clinical findings of the existed RCTs. In addition, only a few pharmacoeconomic evaluations were published regarding the two common CDK4/6 inhibiting agents, palbociclib and ribociclib to evaluate their financial burden. Objectives: To evaluate the clinical efficacy of palbociclib and ribociclib in the local settings in Qatar. Moreover, to conduct a thorough pharmacoeconomic analysis for the two medications and compare them in terms of their cost-effectiveness and cost-utility. Methodology: A retrospective observational study on HR+/HER-2 negative stage IV breast cancer patients receiving palbociclib or ribociclib in Qatar was conducted, followed by a comparative pharmacoeconomic analysis. The primary outcomes were progression-free survival (PFS) and overall-survival (OS). Safety profiles of both medications were also evaluated. Clinical data of all MBC in Qatar were collected from the National Center for Cancer Care and Research (NCCCR) from January 2017 to December 2019 using Cerner ® system. To evaluate the long-term costs-effectiveness, a 10-year within-cycle corrected Markov’s model was developed. The Markov’s model consisted of three main health states: progression-free (PFS), progressed disease (PD), and death. Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were generated and compared to a three gross-domestic-product (3 GDP) per capita. Model costs were obtained from the department of accounting and finance in the NCCCR, transition probabilities were calculated from individual patient data obtained in the clinical phase, and utilities were summarized from the published literature. Deterministic and probabilistic sensitivity analyses were carried out. Modeling was conducted via TreeAge Pro ® software. Results: There was no statistically significant difference between palbociclib and ribociclib in PFS; median PFS time was 17.85 versus 13.55 months respectively; p> 0.05. Similarly, there was no statistically significant difference in OS (29.82 versus 31.72 months; p>0.05). For the pharmacoeconomic analysis, ribociclib dominated palbociclib in yielding an ICER of - 83,090.88 QAR per life-year gained, and ICUR of -31,868.06 QAR per quality-adjusted life-year gained. The results remained robust in all cases of the deterministic sensitivity analyses suggesting ribociclib is more cost-effective than palbociclib. Taking all combined uncertainties into account, the overall confidence in the base-case conclusion was around 60%. Conclusions: Both treatment strategies have similar efficacy and safety profiles. Nonetheless, ribociclib is a more cost-effective option than palbociclib based on the base-case results and based on the addressed uncertainties related to the model inputs.
Citation Format: Nour Hisham Al-Ziftawi, Shereen Elazzazy, Mohammed Fasihul Alam, Asrul Akmal Shafie, Anas Hamad, Salha Bujassoum, Mohamed Izham Ibrahim. Clinical and pharmacoeconomic analyses of CDK4/6 inhibitors use in stage IV breast cancer females in the state of Qatar: A comparative retrospective observational study with cost effectiveness and cost utility analyses abstract. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-16-03.
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