Search

Background Cancer-related fatigue (CRF) is a debilitating condition which commonly affects cancer survivors. The management of CRF remains a challenge due to the lack of effective pharmacological interventions. Traditional Chinese medicine (TCM) could be a potential therapeutic option for CRF. The modified Xiang Bei Yang Rong Tang (XBYRT) is a TCM herbal decoction, formulated to improve fatigue symptoms in cancer survivors. This clinical trial aims to evaluate the efficacy and safety of XBYRT in improving CRF and quality of life (QOL) of cancer survivors. Methods This is a single centre, randomized, double-blind, placebo-controlled, parallel trial. Eighty cancer survivors will be recruited and randomized to receive the XBYRT or placebo decoction, in a ratio of 1:1. Participants will consume the XBYRT/placebo decoction daily for 8 weeks and undergo assessments at baseline and 4, 8 and 10 weeks after baseline. The participants will be assessed for patient-reported outcomes (PRO), blood biomarkers and adverse events at each time point. The primary outcome is the overall health and QOL status, at 8 weeks follow-up. The secondary outcomes are the effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO. The incidence of adverse events and the effects of the XBYRT decoction on blood biomarkers associated with CRF will also be evaluated. Discussion Efficacy and safety outcomes from this trial will provide important clinical data to guide future large-scale randomized controlled trials, and the evaluation of the objective blood biomarkers can help to delineate the biological mechanisms of CRF. Trial registration number ClinicalTrials.govNCT04104113. Registered on 26 September 2019

Cancer-related cognitive impairment (CRCI) is commonly experienced by individuals with non- central nervous system cancers throughout the disease and treatment trajectory. CRCI can have a substantial impact on the functional ability and quality of life of patients and their families. To mitigate the impact, oncology providers must know how to identify, assess, and educate patients and caregivers. The objective of this review is to provide oncology clinicians with an overview of CRCI in the context of adults with non-central nervous system cancers, with a particular focus on current approaches in its identification, assessment, and management.

Background The aim of this study was to evaluate the psychometric properties of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group—Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy. Methods Patients were assessed with the FACT/GOG-Ntx subscale, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Scale 20 (EORTC QLQ-CIPN20), National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE), and light touch test using 10 g monofilament for up to ten assessment points from baseline (prior to initiation of first chemotherapy), after the end of each cycle (up to 6 cycles, 3 weeks per cycle), and at 6, 9, and 12 months after starting chemotherapy. Psychometric analyses included internal consistency reliability, convergent validity, factorial validity, sensitivity to change and responsiveness (minimal clinically important difference, MCID). Results Cronbach’s alpha coefficients of the FACT/GOG-Ntx subscale were 0.82–0.89 across assessment points. The subscale strongly correlated with the EORTC QLQ-CIPN20 (r = 0.79–0.93) but low-to-moderately correlated with the NCI-CTCAE sensory (rs = 0.23–0.45) and motor items (rs = 0.15–0.50) as well as the monofilament test (rs = 0.23–0.47). The hypothesized 4-factor structure of the FACT/GOG-Ntx subscale was not confirmed at assessment points (χ2/df = 2.26–8.50; all P r = 0.17–0.37). The MCIDs were between 1.38 and 3.68. Conclusion The FACT/GOG-Ntx subscale has satisfactory reliability, validity, sensitivity to change and responsiveness to evaluate CIPN in cancer patients. Future research is needed to explore the factorial structure of the FACT/GOG-Ntx subscale as the published four-factor structure was not supported in this study.

This editorial draws on the authors’ experiences and the results of a survey of cancer professionals to contextualize the major disruptions taking place globally in survivorship care as a result of the COVID-19 pandemic. Cancer survivors’ follow-up care has been severely affected due to increased risk of infection associated with hospital attendance, limited workforce availability and other resource constraints, implementation of new protocols to screen patients impacting workflow, and concerns of patients and health care providers about risk of infection [1]. Evidence-based recommendations on how to manage cancer survivors in a pandemic are lacking and much of the general guidance (such as CDC guidelines) [2] suggests that clinic visits for cancer survivors, including routine surveillance visits to detect cancer recurrence, should be postponed [3]. Such a situation is problematic especially if the pandemic is long lasting, leaving important survivorship issues and concerns unaddressed. In the absence of appropriate guidelines, cancer survivors are at increased risk of inappropriate or inconsistent follow-up care that could have far-reaching and even life-threatening results.

Background The International Society of Oncology Pharmacy Practitioners (ISOPP) Biosimilar Task Force was charged to develop educational resources to address the learning needs related to biosimilars use of oncology pharmacy practitioners. To facilitate the process, the task force conducted a survey in order to identify unmet education needs as well as barriers for obtaining biosimilar education among oncology pharmacy practitioners. Methods A cross sectional survey was conducted between 10 December 2018 and 18 February 2019. Members of International Society of Oncology Pharmacy Practitioners and national oncology pharmacy groups were invited to complete the survey. The survey contained 22 items and consisted of four sections. Descriptive statistics were utilized to analyze the survey results. Results A total of 363 International Society of Oncology Pharmacy Practitioners members were surveyed, with 75 members providing a response (response rate = 21%). In addition, 11 non-International Society of Oncology Pharmacy Practitioners members also participated in the survey, bringing the total to 86 respondents. The top three areas in which respondents reported learning needs included evaluating comparative efficacy of a biosimilar to an originator’s product (74.4%), managing the switchover to a biosimilar from the original product (74.4%), and understanding medication safety issues in relation to biosimilars use (73.3%). The most common challenges faced in obtaining education on biosimilars included limited financial support for education on biosimilar products (38.4%), heavy workload (31.4%), and inadequate educational resources (27.9%). Conclusion This survey has identified numerous biosimilar learning needs as well as challenges faced in obtaining biosimilars education among oncology pharmacy practitioners. Educational activities should be created to address these learning needs, and innovative strategies should be considered to overcome practitioner’s barriers in obtaining biosimilars education.

The International Society of Oncology Pharmacy Practitioners organized a workshop to create learning opportunities on biosimilars in pharmacy practice on 10 October 2019. The topics that were covered included (i) the development and testing of biosimilars, (ii) the challenges of bringing biosimilars to market, and (iii) real-world data on patient safety and perceptions during biosimilar implementation. The development of biosimilars can take up to eight years and the extensiveness of the process depends on several factors, such as the complexity of the production process and regulatory requirements. Compared to generic products of small-molecule drugs, there is a higher barrier to market entry for biosimilars, explaining the small number of biosimilars in the market. Appraisal of biosimilars for inclusion in hospital formularies is also different from the review process of originator biologics, where the former is usually institution-led and has fewer restrictions on use. When several biosimilar products are available, factors that should be considered besides cost are licensed indications, supply chain confidence, clinical data, and product attributes. Real-world data have shown that biosimilars are well-tolerated and have safety data that are comparable to that of the originator product. Oncology pharmacists from the United Kingdom, Kenya, and Canada also presented their respective experiences with biosimilar use. Different countries at varying stages of biosimilar implementation faced distinct challenges. Nevertheless, resources to assist biosimilar implementation can potentially be shared between different regions. International Society of Oncology Pharmacy Practitioners is well-positioned to foster professional cooperation at an international level to drive biosimilar implementation.

Background The International Society of Oncology Pharmacy Practitioners (ISOPP) Biosimilars Task Force was charged to develop educational activities and resources to assist members when implementing biosimilar medicines into their local practice. To facilitate the process, the task force conducted a survey in order to understand biosimilar implementation practice by ISOPP members across the world and the challenges that oncology pharmacists face when adopting biosimilars into their clinical practice. Methods A cross-sectional survey was conducted between 20 April 2019 and 27 May 2019. Members of ISOPP and a number of national oncology pharmacy groups were invited to complete the survey. The survey contained 29 items and consisted of three sections: respondents’ demographics, respondents’ institutional practice relating to biosimilar implementation and post implementation practice at the respondents’ institutions. Descriptive statistics were utilized to analyze the survey results. Results A total of 265 ISOPP members were surveyed, with 50 members providing a response (response rate = 19%). In addition, 40 nonmembers participated in the survey, bringing the total to 90 respondents. The most common factors that influence the decision to implement use of a biosimilar as reported by respondents are medication costs/pricing (92%), available clinical data (73%), and product availability (63%). Respondents also commented on the barriers to biosimilar implementation at their institutions, which included a reluctance of prescribers to use biosimilars (due to the lack of familiarity or perceived inferiority), a reluctance to switch established patients from an originator to a biosimilar and the preferences of insurance companies or funding bodies. Conclusion The results of this survey reinforce the need for greater education and training for health care professionals in the use of biosimilars, the importance of sharing good practice, and a need for standardization.

A decline in cognitive function following cancer treatment is one of the most commonly reported post-treatment symptoms among patients with cancer and those in remission, and include memory, processing speed, and executive function. A clear understanding of cognitive impairment as a result of cancer and its therapy can be obtained by delineating structural and functional changes using brain imaging studies and neurocognitive assessments. There is also a need to determine the underlying mechanisms and pathways that impact the brain and affect cognitive functioning in cancer survivors. Exosomes are small cell-derived vesicles formed by the inward budding of multivesicular bodies, and are released into the extracellular environment via an exocytic pathway. Growing evidence suggests that exosomes contribute to various physiological and pathological conditions, including neurological processes such as synaptic plasticity, neuronal stress response, cell-to-cell communication, and neurogenesis. In this review, we summarize the relationship between exosomes and cancer-related cognitive impairment. Unraveling exosomes’ actions and effects on the microenvironment of the brain, which impacts cognitive functioning, is critical for the development of exosome-based therapeutics for cancer-related cognitive impairment. Published version

Brain-derived neurotrophic factor (BDNF) and the BDNF Val66Met polymorphism (rs6265) have been implicated in neurodegenerative conditions. This study aimed to investigate the associations of plasma BDNF and rs6265 with cancer-related cognitive impairment (CRCI) at the end of chemotherapy, and with persistent and delayed CRCI up to 24 months post chemotherapy, among survivors of early-stage breast cancer. A multicenter, longitudinal study involving 174 breast cancer patients was conducted. CRCI was assessed using the FACT-Cog (V3) questionnaire and the CANTAB software. Plasma BDNF levels were quantified using an enzyme-linked immunosorbent assay at serial time points and genotyping was achieved using Sanger sequencing. The associations of BDNF and rs6265 with CRCI were analyzed using logistic regressions. A smaller magnitude of reduction in plasma BDNF between baseline and the end of chemotherapy was correlated with protection from overall subjective CRCI (OR 0.88; 95% CI 0.79–0.99). Furthermore, patients with higher plasma BDNF levels at the end of chemotherapy had lower odds of developing persistent overall subjective CRCI (OR 0.74; 95% CI 0.57–0.97) and persistent CRCI in the functional interference domain (OR 0.62; 95% CI 0.39–0.98). BDNF Met allele carriers were protected against subjective CRCI at the end of chemotherapy in the multitasking and memory domains, and against persistent subjective CRCI in the mental acuity and multitasking domains. BDNF plasma level or rs6265 genotype information may facilitate the identification of patients at higher risk of long-term CRCI during survivorship and enable the implementation of early intervention strategies that increase BDNF levels.

Background and purposeConducting peer assessment has been associated with positive learning outcomes in higher education. The primary objective was to evaluate pharmacy students' perceptions of using peer assessment as a pedagogical strategy in learning patient presentation skills. Secondary objectives were to determine helpful factors for providing and/or receiving peer assessment and to compare students' perceptions of peer assessment relative to receiving feedback from teaching assistants (TAs).Educational activity and settingPatient presentation skills were taught to third-year pharmacy students in three sessions (session 1: didactic lecture, session 2: faculty-led patient presentation workshops followed by peer assessment, session 3: one-on-one patient presentations to TAs). An anonymous survey instrument consisting of five-point Likert scale, yes/no, and open-ended questions was administered.FindingsA total of 187 students (98%) completed the survey. Peer assessment was perceived as a useful way to obtain feedback on patient presentations (87%). It facilitated higher level thinking and a self-reflection of students' own patient presentations. Most students felt that they received constructive feedback from peers (82%) that helped them improve their patient presentation skills (72%). However, students were more trusting of TAs' skills in assessing patient presentations (76% versus 93%, p

PurposeA breast cancer diagnosis has a substantial economic impact. Study aims were to evaluate for inter-individual differences in cancer's level of interference with employment and identify phenotypic and symptom characteristics associated with higher levels of interference.MethodsPatients (n= 387) were enrolled prior to breast cancer surgery and followed for 12months. Interference with employment was measured using a 0 (no problem) to 10 (severe problem) numeric rating scale. Hierarchical linear modeling (HLM) was used to evaluate for inter-individual differences in trajectories of employment interference and characteristics associated with employment interference at enrollment and over 12months.ResultsPatients' mean age was 55.0 (±11.7) years and the majority underwent breast conservation surgery (80.6%). Mean employment interference score was 3.2 (±3.7). Unconditional model for employment interference demonstrated a decreasing linear trend (-.076/month). Younger age, lower income, higher pain intensity, and having an axillary lymph node dissection were associated with higher pre-surgical interference scores. Having a sentinel lymph node biopsy was associated with ongoing employment interference scores. Higher sleep disturbance scores were associated with both initial and ongoing employment interference scores. Receipt of chemotherapy, use of complementary or alternative therapies, and re-excision or mastectomy following surgery were significant time varying covariates.ConclusionThis study is the first to use HLM to describe inter-individual differences in the trajectories of cancer's interference with employment and associated factors prior to and for 12months following breast cancer surgery. Patients with the identified risk factors warrant ongoing assessments of employment interference and appropriate referrals.

Purpose: With an increasing focus on developing survivorship services tailored for adolescent and young adult (AYA) cancer survivors, incorporation of viewpoints from both survivors and health care professionals (HCPs) is important. This study aims to explore the perceptions of current and prospective survivorship services from both groups in Singapore to propose service design and delivery strategies. Methods: Focus group discussions with 23 AYA cancer survivors between the ages of 16 and 39 years at diagnosis and 18 HCPs were conducted in National Cancer Centre Singapore (NCCS) and Singapore Cancer Society (SCS). All focus group discussions were transcribed verbatim. Deductive thematic analysis was performed according to the components of a design thinking model: empathizing with AYA survivors, defining care gaps, proposing services, and implementation strategies. Results: AYA survivors preferred age-specific services that are aligned with their personal goals. Current survivorship care failed to address the needs of survivors' dependents (caregivers and children) and to consider the utility of each service temporally. Prospective services should clarify disease disclosure obligation in job search and introduce a care navigator. Key implementation strategies included (1) training HCPs on communication techniques with AYA, (2) selecting engagement platforms that complement survivors' information-seeking behavior, (3) improving outreach to survivors through appropriate branding and publicity, and (4) consolidating services from multiple providers. Conclusions: The design of survivorship care services for AYA survivors should be systematic in its conceptualization process and employ implementation strategies. The coordination of the wide spectrum of services warrants a concerted effort by cancer centers, community partners, and the government.

Cancer-related fatigue (CRF) is characterized by a lack of energy, and mitochondrial dysfunction is postulated to contribute to its etiology. This prospective cohort study assesses the self-reported fatigue levels of early-stage breast cancer patients using the validated Multi-Dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) and blood samples drawn at three time points: before treatment, approximately 6 weeks, and 12 weeks after the initiation of chemotherapy. The aim of this study is to evaluate mitochondrial measures with CRF, over the course of chemotherapy using mitochondrial DNA (mtDNA content) and displacement loop (D-loop) region sequence variations at nucleotide positions 303, 489 and 514. The relative mtDNA copy number was determined via real-time quantitative polymerase chain reaction and compared between study time points and D-loop sequence variants. The association of mtDNA content with MFSI-SF total and sub-domain scores was analyzed in a sample of 155 patients (mean age ± SD: 51.7 ± 8.8 years). The median mtDNA content decreased over 12 weeks after the initiation of chemotherapy (p 0.001). Baseline mtDNA content was lower for nucleotide position 303 in sequence variations than for the reference sequence (67.2 copies vs 79.1 copies, p = 0.03). Physical fatigue negatively correlated with mtDNA content in both unadjusted (β = -0.0075, p = 0.048) and adjusted models (β = -0.0062, p = 0.042), accounting for age, anxiety, insomnia, haemoglobin levels and body mass index. Our findings add to the literature indicating that mitochondrial function serves as an important target for mitigating CRF.

Background The selective occurrence of hepatotoxicity observed with use of pazopanib may be attributed to its high level of plasma protein binding and low hepatic extraction ratio. The primary objective was to investigate changes in free drug concentration amongst patients with varying albumin concentrations. Methods A HPLC-MS/MS method using C18 column (4.6 × 150 mm, 5 μm) with ESI source in positive mode had been developed and validated for the quantitative determination of free pazaopanib concentration in human plasma. Prior to sample preparation, patient samples were subjected to 6-hour equilibrium dialysis with molecular weight cut-off set at 8000 Da. Results The calibration curves were linear over the range of 5–1000 ng/mL, with a lower limit of quantification of 5 ng/mL. The intra-day and inter-day precisions and accuracies were all within ± 15 %, at 3 different quality controls. Higher median fraction unbound of pazopanib were observed in patients (n = 17) with lower than normal albumin concentrations. Conclusion With the developed assay, monitoring of plasma free concentrations may be evaluated as an indicator of pazopanib exposure in patients., Pazopanib; Plasma free drug concentration; Fraction unbound; Liquid chromatography-tandem mass spectrometry; Equilibrium dialysis; Pharmacology; Clinical toxicology; Oncology; Evidence-based medicine; Clinical research.

Adverse drug reactions (ADRs) contribute to hospitalization but data on its economic burden is scant. Pre-emptive pharmacogenetic (PGx) testing can potentially reduce ADRs and its associated costs. The objectives of this study were to quantify the economic burden of ADRs and to estimate the breakeven cost of pre-emptive PGx testing in Singapore. We collected itemized costs for 1000 random non-elective hospitalizations of adults admitted to a tertiary-care general hospital in Singapore. The presence of ADRs at admission and their clinical characteristics were reported previously. The economic burden of ADRs was assessed from two perspectives: (1) Total cost and (2) incremental costs. The breakeven cost of PGx testing was estimated by dividing avoidable hospitalization costs for ADRs due to selected drugs by the number of patients taking those drugs. The total cost of 81 admissions caused by ADRs was US$570,404. Costs were significantly higher for bleeding/elevated international normalized ratio (US$9906 vs. US$2251, p = 6.58 × 10-3) compared to other ADRs, and for drugs acting on the blood coagulation system (US$9884 vs. US$2229, p = 4.41 × 10-3) compared to other drug classes. There were higher incremental laboratory costs due to ADRs causing or being present at admission. The estimated breakeven cost of a pre-emptive PGx test for patients taking warfarin, clopidogrel, chemotherapeutic and neuropsychiatric drugs was US$114 per patient. These results suggest that future studies designed to directly measure the clinical and cost impact of a pre-emptive genotyping program will help inform clinical practice and health policy decisions.

OBJECTIVE To identify those experiencing significant self-reported cognitive decline over 2 time points during chemotherapy, examine the risk factors for cognitive decline, and examine differences between those with and without significant decline in functional limitations. METHODS This secondary analysis used data from 163 cancer patients, collected from a Korean University hospital. Significant decline was determined by 15% or more reduction from baseline in the Functional Assessment of Cancer Therapy-Cognitive Function. Multivariate logistic regression was performed to estimate risk factors. Repeated-measures ANOVA and t tests tested differences in groups with and without cognitive decline in cognitive impairment and functional limitation. RESULTS About 31% (n = 51) experienced significant cognitive decline. Groups with and without decline significantly differed in cognitive-impairment changes over time (F = 238.49, P

OBJECTIVES Currently, there are no studies that have established the self-perceived cognitive trajectories experienced by breast cancer patients (BCPs) post-chemotherapy. Therefore, we characterized the long-term trajectory of self-perceived cognitive function among Asian early-stage BCPs using the minimal clinically important difference of a subjective measure of cognitive function. METHODS Early-stage BCPs who received chemotherapy were recruited and assessed at 4 time points: Before chemotherapy initiation (T1), 6 weeks post-chemotherapy initiation (T2), 12 weeks post-chemotherapy initiation (T3), and 15-months post-chemotherapy initiation (T4). All assessments were performed approximately within 2 weeks post-chemotherapy. Subjective and objective cognitive function were assessed using Functional Assessment of Cancer Therapy-Cognitive (version 3) and Headminder™. RESULTS A total of 166 BCPs were recruited, of whom 131 completed assessment at all time points. Using the minimal clinically important difference of Functional Assessment of Cancer Therapy-Cognitive, 5 distinct cognitive trajectories were established. Of the 131 patients, 70 (53.4%) did not report any clinically significant cognitive impairment. Twenty-one (16.0%) patients reported acute cognitive changes during chemotherapy (T2 and/or T3) but not at T4. Forty patients (30.5%) reported clinically significant cognitive impairment at T4, of whom 18 did not report any cognitive impairment at earlier time points. Fifteen (11.5%) patients reported persistent cognitive impairment throughout all time points, while 7 (5.3%) patients reported intermittent cognitive impairment at T2 and T4 but not at T3. CONCLUSION This is the first study to establish the existence of heterogeneous cognitive trajectories based on clinically significant thresholds of self-perceived cognitive impairment. The findings have important implications on the window for screening and management of post-chemotherapy cognitive impairment.

Background Currently, several fatigue measurement instruments are available to evaluate and measure cancer-related fatigue. Amongst them, Multidimensional Fatigue Syndrome Inventory-Short Form (MFSI-SF) is a self-reported instrument and a multidimensional scale that aims to capture the global, somatic, affective, cognitive and behavioural symptoms of fatigue. This study examines the psychometric properties and measurement equivalence of the English and Chinese versions of MFSI-SF in breast cancer and lymphoma patients in Singapore. Methods Patients were recruited from National Cancer Centre Singapore. Validity, reliability and responsiveness of MFSI-SF were evaluated in this study. Convergent validity was evaluated by correlating total and subscales of MFSI-SF to known related constructs in EORTC QLQ-C30. Known group validity was assessed based on patients’ cancer stage, pain, insomnia and depression symptoms. Reliability was evaluated by Cronbach’s α. Responsiveness analyses were performed with patients who have undergone at least one cycle of chemotherapy. Multiple regression was used to compare the total and subscale scores of MSFI-SF between the two language versions. Results Data from 246 (160 English and 86 Chinese version) breast cancer and lymphoma patients were included in the study. Moderate to high correlations were observed between correlated MFSI-SF subscales and EORTC QLQ-C30 domains (|r| = 0.524 to 0.774) except for a poor correlation (r = 0.394) observed between MFSI-SF vigour subscale and EORTC QLQ-C30 role functioning subscale. Total MFSI-SF scores could differentiate between patients with higher depression, pain and insomnia status. Internal consistency of MFSI-SF was also high (α = 0.749 to 0.944). Moderate correlation was observed between change in total MFSI-SF score and change in fatigue symptom scale score and global QoL score on EORTC QLQ-C30 (|r| = 0.478 and 0.404 respectively). Poor correlations were observed between change in scores of hypothesised subscales (|r| = 0.202 to 0.361) except for a moderate correlation between change in MFSI-SF emotional fatigue score and change in EORTC QLQ-C30 emotional functioning domain score. Measurement equivalence was established for all subscales and total MFSI-SF score except for the emotional and vigour subscales. Conclusions This study supports the use of MFSI-SF as a reasonably valid scale with good internal consistency for measuring fatigue levels in the Singapore cancer population. Electronic supplementary material The online version of this article (10.1186/s12955-018-0846-6) contains supplementary material, which is available to authorized users.

Cancer-related cognitive impairment (CRCI) is a significant problem for patients receiving chemotherapy. While a growing amount of pre-clinical and clinical evidence suggests that inflammatory mechanisms underlie CRCI, no clinical studies have evaluated for associations between CRCI and changes in gene expression. Therefore, the purpose of this study was to evaluate for differentially expressed genes and perturbed inflammatory pathways across two independent samples of patients with cancer who did and did not report CRCI. The Attentional Function Index (AFI) was the self-report measure used to assess CRCI. AFI scores of5 and of7.5 indicate low versus high levels of cognitive function, respectively. Of the 185 patients in Sample 1, 49.2% had an AFI score of5 and 50.8% had an AFI score of7.5. Of the 158 patients in Sample 2, 50.6% had an AFI score of5 and 49.4% had an AFI score of7.5. Data from 182 patients in Sample 1 were analyzed using RNA-seq. Data from 158 patients in Sample 2 were analyzed using microarray. Twelve KEGG signaling pathways were significantly perturbed between the AFI groups, five of which were signaling pathways related to inflammatory mechanisms (e.g., cytokine-cytokine receptor interaction, tumor necrosis factor signaling). This study is the first to describe perturbations in inflammatory pathways associated with CRCI. Findings highlight the role of cytokines both in terms of cytokine-specific pathways, as well as pathways involved in cytokine production and cytokine activation. These findings have the potential to identify new targets for therapeutics and lead to the development of interventions to improve cognition in patients with cancer.

203 Background: Cancer patients and survivors encounter a myriad of complex medical decisions starting from their diagnosis of cancer. However, current decision aids (DAs) largely focused on acute treatment and fertility decisions, and not on health service-related decisions such as adoption of supportive care services and programs targeting risk factor modification. This systematic review aims to identify and describe DAs supporting health service-related decisions after the completion of primary treatment until the end of life. Secondary objectives included assessing the effectiveness of these DAs and outlining implementation barriers. Methods: Electronic databases (PubMed and EMBASE) were searched comprehensively for relevant publications in English from inception through April 2020. Additional manual searches were performed on Google Scholar and from reference lists. We included studies that described the purpose and usage of DAs related to health services among cancer survivors 6 months post-diagnosis, after the typical acute treatment phase. Depending on the study design, included studies were assessed for quality using the Cochrane Collaboration’s tool and Critical Appraisal Skills Programme qualitative checklist. Results: Of 896 records screened, 11 studies describing seven DAs met the inclusion criteria. Non-interventional studies were generally of good quality, whereas most (4/6) interventional trials had a high risk of detection bias from failure to blind outcome assessors. DAs described were purposed for the creation of advanced directives, substance use behavior, preference for post-treatment follow-up care schedule, and health insurance were identified. All DAs adopted a multimedia format. DAs were generally acceptable and were associated with higher knowledge and satisfaction among users. No significant effects were observed for decision-making related outcomes, including decisional conflict and self-efficacy. Implementation barriers included time constraints, poor health statuses, limited perceived DA’s usefulness, and inadequate navigational support. Conclusions: The seven DAs identified addressed a diverse range of survivorship issues. Building on preliminary results reporting favorable acceptability, satisfaction, and knowledge, future work should explore the development and utility of DAs as facilitators to quality cancer survivorship care delivery, expanding into areas such as health promotion and choice of survivorship follow-up care models.

37 Background: Accessible Cancer Care to Enable Support for Cancer Survivors (ACCESS) is a multidisciplinary survivorship care model launched at the National Cancer Centre Singapore (NCCS) in 2019. ACCESS employs routine distress and problem screening to triage cancer patients with varying care needs and complexities for tailored care. Here, we described the study design to evaluate ACCESS, and reported the baseline characteristics of our study cohort to characterize the profile of prospective target recipients of the new care model. Methods: A cluster randomized controlled trial was initiated to assess the effectiveness of ACCESS on quality of life and symptom burden, with each cluster unit defined at the oncologist level. Clusters were randomized in a 1:1 ratio to receive ACCESS or usual care. Eligible patients were ≥21 years, newly diagnosed with breast or gynecological cancer, and receiving follow-up care in NCCS. Patients were followed up for one year and patient-reported outcomes were collected every three months using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Rotterdam Symptom Checklist. Results: By May 2021, 91 patients and 89 patients in the usual care and ACCESS arm were recruited, respectively. Both groups (usual care vs. ACCESS) had comparable mean age (56.2±10.9 vs. 56.2±10.7, P = 0.998) and racial composition (P = 0.760). Employment status was similar in both arms (48.4% vs. 56.2% employed, P = 0.293) and most patients were covered by health insurance (89.8% vs. 88.1%, P = 0.920). At baseline, patients in both arms had comparable mean quality of life scores (65.1±19.8 vs. 66.9±17.6, P = 0.51) and reported high physical, role, emotional, cognitive, and social functioning levels (all mean scores > 70). No statistically significant differences in physical symptom and psychological distress levels were observed. Prevalent symptoms reported included fatigue (82.4% vs. 71.9%), pain (68.1% vs. 55.1%), and insomnia (57.1% vs. 55.1%). Almost half of the cohort reported financial difficulties (45.1% vs. 46.1%). Conclusions: Comparable baseline characteristics suggested the absence of systematic differences in care needs and demand among patients cared by different oncologists. Despite high functioning statuses at baseline, participants reported impaired quality of life with active physical and financial problems. These results support our hypothesis that routine screening would be valuable to identify such problems promptly for management via standardized care pathways. Results from this ongoing trial will determine the effectiveness of ACCESS on quality of life and functional recovery through treatment and survivorship. Clinical trial information: NCT04014309.

138 Background: Childhood cancer survivors (CCS) are often impacted by cancer-related cognitive impairment (CRCI), requiring long-term follow-up care. It is unknown whether survivors reporting CRCI are at higher likelihood to suffer from adverse lifestyle behaviors such as smoking and vaping. Using the Project Forward cohort, we analyzed the prevalence of CRCI and its association with substance abuse. Methods: The Project Forward study surveyed adolescent and young adult CCS between 2015 to 2018 to evaluate the quality of cancer follow-up care. Associations between self-reported CRCI and adverse lifestyle behaviors were examined in multivariable logistic regressions, adjusting for covariates: cancer type, treatment intensity, race/ethnicity, gender, and age at diagnosis. Stratified analysis by recency of latest cancer follow-up care was performed to examine its impact on the risk of substance abuse among CRCI patients. Results: The cohort comprised 1,106 CCS, with median ages of 25.5 years (IQR: 22, 29) at survey completion and 13 years (IQR: 7, 16) at diagnosis, with over half (n = 570, 51.5%) were being Hispanic. A total of 144 (13%) patients self-reported CRCI, with the highest prevalence observed among brain cancer (25.4%) and leukemia (13.3%) survivors. Cancer-related follow-ups were more frequently observed among survivors reporting CRCI, comparing to non-CRCI survivors (66.7% vs 56.9%, p = 0.030). After adjusting for confounders, survivors reporting CRCI were at higher odds to vape with e-cigarettes than those without CRCI (OR = 2.24, 95% CI = 1.24–4.09, p = 0.008). Among those who did not engage any recent cancer follow-up care (n = 455), CRCI was associated with 2.9 times the odds of vaping with e-cigarettes (OR = 2.9, 95% CI = 1.07–7.88, p = 0.037). No association was observed between CRCI and the use of cigarettes, alcohol, or marijuana. Conclusions: Vaping is more prevalent among CCS reporting CRCI, especially those who are less likely to attend follow-up care. Our data suggests the importance of encouraging long-term follow-ups to monitor adverse lifestyle behaviors in CCS experiencing cognitive symptoms and provide timely interventions.

Recently updated American Society of Clinical Oncology (ASCO) guidelines for Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Survivors of Adult Cancers make a single recommendation to alter treatment by delaying, decreasing, or discontinuing dosing in patients who develop CIPN during neurotoxic chemotherapy treatment. Dosing guidelines have inconsistent recommendations for when (i.e., what CIPN severity) and how (i.e., delay, decrease, or discontinue) to alter neurotoxic chemotherapy treatment in patients with CIPN. Clinical decision making requires an understanding the benefits and risks of treatment alteration, in addition to consideration of other disease and patient factors. This review summarizes four areas of literature and culminates in a patient-centric decision framework to guide clinicians in helping patients to make treatment alteration decisions. First, we describe the current practice of altering treatment due to CIPN, including treatment alteration recommendations and published rates. Second, we summarize the potential benefits of treatment alteration including the reduction in CIPN severity and persistence. Third, we evaluate the potential risk of treatment alteration in compromising treatment efficacy by reviewing prospective trials comparing dosing regimens and retrospective analyses of the effect of relative dose intensity on efficacy. Fourth, we summarize disease and patient factors that should be considered when making a treatment alteration decision for a patient. We then propose a patient-centric decision framework that clinicians can use to assess an individual patient's current and anticipated future CIPN severity and compare that to their maximum tolerable severity to determine whether they should continue, delay, decrease, or discontinue neurotoxic chemotherapy.

With the long-term goal of optimising the delivery of breast cancer survivorship care in Singapore, we conducted a qualitative study to gather in-depth descriptions from community practitioners (general practitioners and community pharmacists) about their perceptions of community-based cancer survivorship care in Singapore. Sixteen participants (11 general practitioners and five community pharmacists) participated in four structured focus group discussions between August and November 2016. The focus group discussions were analysed using deductive content analysis. The majority of community practitioners do not encounter breast cancer survivors in their clinical practices. Perceived barriers to community-based survivorship care include patients' lack of confidence in primary care, financial constraints and lack of empanelment. Most community practitioners concur that the success of community-based survivorship care largely depends on the co-operation and participation of survivors. Survivorship management via standardised care pathways is not fully advocated by practitioners. Survivorship care plans are identified as useful, but they should also incorporate a non-cancer-related medical history and medication list. Community practitioners in Singapore are eager to participate in the delivery of cancer survivorship care. Future studies should develop a community-based care model that involves community practitioners and evaluate the cost-effectiveness of such a care model. The current model of cancer survivorship in Singapore is not sustainable. Differences in healthcare ecosystems, cultures and resources available in an Asian context should be taken into consideration before designing a community-based cancer survivorship program in Singapore.

Purpose Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. Methods This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. Findings A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17–12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). Implications The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute.

Objective The primary objective of this study is to prospectively evaluate the role of procalcitonin (PCT) in distinguishing infectious fever from noninfectious fever (NIF) among febrile lymphoma patients. The secondary objective is to evaluate the usefulness of PCT in distinguishing among bloodstream infections (BSI), local infections and unidentified infections (LIUI), and NIF. Methods Patients with lymphoma and fever were prospectively recruited between August 2014 and November 2015. PCT was measured within 24 hours of fever onset (PCT1) and 24-72 hours thereafter (PCT2). The higher PCT value between PCT1 and PCT2 was also documented (PCTmax ). PCT levels (PCT1, PCT2, and PCTmax ) were compared for BSI, LIUI, and NIF. In addition, the difference between PCT1 and PCT2 was evaluated in patients with complete data on both PCT1 and PCT2. Results Of 108 eligible patients, 12 were diagnosed with BSI, 83 with LIUI, and 13 with NIF. PCTmax was statistically different between the infectious fever (BSI and LIUI combined) and NIF groups (median PCTmax : 0.44 ng/ml vs 0.19 ng/ml; p=0.026). PCT1 was not statistically different for patients with BSI, LIUI, and NIF (p=0.217). However, PCT2 and PCTmax were significantly higher in patients with BSI compared to those with NIF (p=0.026 and 0.002, respectively). Meanwhile, patients with BSI have significantly higher PCTmax values than those with LIUI (p=0.034). Among 90 cases with complete data on both PCT1 and PCT2, PCT2 was significantly higher than PCT1 in patients with BSI (median PCT: 0.98 ng/ml vs 0.47 ng/ml; p=0.045) and patients with LIUI (median PCT: 0.43 ng/ml vs 0.24 ng/ml; p=0.004), while not significant in patients with NIF (p=0.374). Conclusion Two separate PCT measurements can differentiate between infectious fever and NIF and predict for BSI in lymphoma patients with fever.

Background As cancer mortality rates improve in Singapore, there is an increasing need to improve the transition to posttreatment survivorship care. This study aimed to evaluate the effectiveness of a psychoeducation group (PEG) intervention program compared with usual care to reduce distress for physical symptom and psychological aspects in Asian breast cancer survivors who have completed adjuvant chemotherapy. Methods This was a randomized, controlled trial comprising 72 Asian early stage breast cancer survivors who were randomized into the PEG (n = 34) or the control (n = 38) arm. The participants in the PEG arm underwent a weekly multidisciplinary PEG program delivered in a group format over 3 weeks coupled with cultural adaptation. Both arms were assessed at baseline and 2 months after intervention using the Rotterdam Symptom Checklist, Beck Anxiety Inventory, and EORTC QLQ-C30. A satisfaction questionnaire was also conducted among those survivors who have participated in the PEG program. Effective sizes were calculated using Cohen d. Results The mean age ± SD of all participants was 53.0 ± 8.9 years, with the majority being Chinese (84.7%) and Malay (6.9%), and clinical characteristics were well balanced in both arms. Compared to the control arm, the PEG arm showed a significantly greater reduction in physical symptom distress (d = 0.76, P = .01) and fatigue (d = 0.49, P = .04). The 82.4% of the participants in the intervention group responded to the satisfaction questionnaire, and the majority (92.9%) agreed that the overall duration of the PEG intervention program was appropriate. Conclusions A culturally adapted PEG program was effective in reducing physical symptom distress in Asian breast cancer survivors. (ClinicalTrials.gov: NCT02600299)

Author(s): Tan, Chia Jie; Mah, Jaclyn Jia Jun; Goh, Wei Lin; Poon, Eileen; Harunal Rashid, Mohamad Farid; Chan, Alexandre | Abstract: ObjectiveCancer-related cognitive impairment (CRCI) among adolescent and young adult (AYA) cancer patients with noncentral nervous system (CNS) cancers has not been well studied. In this study, we aimed to describe CRCI-associated trends and characteristics among AYA cancer patients.MethodsIn a longitudinal cohort of AYA cancer patients without CNS disease, CRCI was evaluated over 1 year using the Functional Assessment of Cancer Therapy-Cognitive Function Instrument, a self-reported cognitive outcome measure. CRCI prevalence was quantified using the previously established minimal clinically important difference. CRCI-associated longitudinal trends and factors were evaluated with mixed-effects model analysis.ResultsNinety-one patients (mean age = 28.4 ± 6.7 years) were included. Approximately one-third (34.1%) experienced CRCI at least once during the study follow-up. Female gender (P = .02), Indian ethnicity (P l .01), current smokers (P l .01), anxiety/depressive symptoms (P l .01) and fatigue (P l .01) were found to be associated with poorer cognitive function among AYAs.ConclusionsAlthough AYA cancer patients were relatively young and without CNS disease involvement, a significant proportion of them experienced clinically important decline in cognitive function. With improved understanding of this subject, effective strategies can be formulated to promote awareness of CRCI and mitigate its negative effects among AYA cancer patients.

Cancer-related cognitive impairment (CRCI) adversely affects cancer patients. We had previously demonstrated that the BDNF Val66Met genetic polymorphism is associated with lower odds of subjective CRCI in the multitasking and verbal ability domains among breast cancer patients receiving chemotherapy. To further assess our previous findings, we evaluated the association of BDNF Val66Met polymorphism with subjective and objective CRCI in a temporally separate cohort of patients and pooled findings from both the original (n = 145) and current (n = 193) cohorts in a meta-analysis. Subjective CRCI was assessed using FACT-Cog. Objective CRCI was evaluated using computerized neuropsychological tests. Genotyping was carried out using Sanger sequencing. The association of BDNF Val66Met genotypes and CRCI was examined with logistic regression. A fixed-effect meta-analysis was conducted using the inverse variance method. In the meta-analysis (n = 338), significantly lower odds of CRCI were associated with Met allele carriers based on the global FACT-Cog score (OR = 0.52, 95% CI 0.29–0.94). Furthermore, Met allele carriers were at lower odds of developing impairment in the domains of memory (OR = 0.34, 95% CI: 0.17–0.70), multitasking (OR = 0.33, 95% CI: 0.18–0.59), and verbal ability (OR = 0.46, 95% CI: 0.24–0.88). Consistent with the previous study, lower odds of subjective CRCI among patients with the BDNF Met allele was observed after adjusting for potential confounders in the multitasking (OR = 0.30, 95% CI: 0.14–0.67) domain. In conclusion, carriers of the BDNF Met allele were protected against global subjective CRCI, particularly in the domains of memory, multitasking, and verbal ability. Our findings further contribute to the understanding of CRCI pathophysiology. Electronic supplementary material The online version of this article (10.1007/s12035-018-1410-4) contains supplementary material, which is available to authorized users.

Background: Chronic kidney disease (CKD) patients requiring intravenous vancomycin bear considerable risks of adverse outcomes both from the infection and vancomycin therapy itself, necessitating especially precise dosing to avoid sub- and supratherapeutic vancomycin exposure. Methods: In this retrospective study, we performed a population pharmacokinetic analysis to construct a vancomycin dose prediction model for CKD patients who do not require renal replacement therapy. The model was externally validated on an independent cohort of patients to assess its prediction accuracy. The pharmacokinetic parameter estimates and the equations were productized into a Web application (VancApp) subsequently implemented in routine care. The association between VancApp-based dosing and time-to-target concentration attainment, 30-day mortality, and nephrotoxicity were assessed postimplementation. Results: The model constructed from an initial cohort (n = 80) revealed a population clearance and volume of distribution of 1.30 L/h and 1.23 L/kg, respectively. External model validation (n = 112) demonstrated a mean absolute prediction error of 1.25 mg/L. Following 4 months of clinical implementation of VancApp as an optional alternative to usual care [VancApp (n = 22) vs. usual care (n = 21)], patients who had received VancApp-based dosing took a shorter time to reach target concentrations (median: 66 vs. 102 h, p = 0.187) and had fewer 30-day mortalities (14% vs. 24%, p = 0.457) compared to usual care. While statistical significance was not achieved, the clinical significance of these findings appear promising. Conclusion: Clinical implementation of a population pharmacokinetic model for vancomycin in CKD can potentially improve dosing precision in CKD and could serve as a practical means to improve vital clinical outcomes.

Objectives This study was designed to evaluate the impact of a pharmacist-led anticoagulation service on international normalised ratio (INR) control and other outcomes among patients receiving warfarin therapy at a tertiary hospital in Zhuhai, China. Methods In this randomised controlled trial, adult patients who were newly initiated on warfarin with intended treatment duration of at least 3 months were recruited. Participants were randomly allocated to receive the pharmacist-led education and follow-up service (PEFS) or usual care (UC). Anticoagulation control was calculated as the proportions of time within the target INR range (TTR) and time within the expanded target range (TER). Key findings A total of 152 participants (77 in the PEFS group and 75 in the UC group) were included. Within 180 days after hospital discharge, the PEFS group spent more TER than the UC group (54.4% versus 42.0%; P = 0.024), whereas the difference in TTR did not reach statistical significance (35.9% versus 29.5%; P = 0.203). No major bleeding events were observed, and the cumulative incidences of major thromboembolic events (6.5% versus 9.3%) and mortality (1.3% versus 1.3%) were similar between the two groups (P> 0.05). At 30 days postdischarge, the PEFS group had better warfarin knowledge by answering 57.5% of questions correctly, compared with the UC group (43.0%) (P = 0.003). Conclusions The PEFS markedly enhanced anticoagulation control and warfarin knowledge but there was room for improvement. The expansion of pharmacists’ clinical role and the development of more effective education and follow-up strategies are warranted to optimise anticoagulation management services in China.

BackgroundThere are inconsistencies in the literature regarding the prevalence and assessment of chemotherapy-induced peripheral neuropathy (CIPN). This study explored CIPN natural history and its characteristics in patients receiving taxane- and platinum-based chemotherapy.Patients and methodsMulti-country multisite prospective longitudinal observational study. Patients were assessed before commencing and three weekly during chemotherapy for up to six cycles, and at 6,9, and 12 months using clinician-based scales (NCI-CTCAE; WHO-CIPN criterion), objective assessments (cotton wool test;10 g monofilament); patient-reported outcome measures (FACT/GOG-Ntx; EORTC-CIPN20), and Nerve Conduction Studies.ResultsIn total, 343 patients were recruited in the cohort, providing 2399 observations. There was wide variation in CIPN prevalence rates using different assessments (14.2-53.4%). Prevalence of sensory neuropathy (and associated symptom profile) was also different in each type of chemotherapy, with paclitaxel (up to 63%) and oxaliplatin (up to 71.4%) showing the highest CIPN rates in most assessments and a more complex symptom profile. Peak prevalence was around the 6-month assessment (up to 71.4%). Motor neurotoxicity was common, particularly in the docetaxel subgroup (up to 22.1%; detected by NCI-CTCAE). There were relatively moderately-to-low correlations between scales (rs= 0.15,p&nbsp

Introduction This study aimed to assess the perception of electronic peer review of subjective, objective, assessment, plan (SOAP) notes performed by pharmacy students during their first pharmacotherapeutic course experience. Methods In this single-center, cross-sectional study, a questionnaire was administered to students who had undergone an electronic peer review process of a SOAP note. Four areas were assessed: baseline knowledge, development of therapeutic plans, attitudes and perceptions on peer assessment in enhancing SOAP note writing skills, and perceptions of factors that were/would have been helpful toward providing and/or receiving peer assessment. Results One hundred students completed and returned the survey (response rate 61.3%). Most students (93%) reported no prior exposure to writing SOAP notes prior to their participation. SOAP note writing was a valuable component of the module, with most students (97%) recognizing that SOAP note writing skills are important for their future practice as pharmacists. Students also acknowledged that activities in the module improved their abilities to develop (93%) and communicate (80%) patient-specific therapeutic plans in the form of SOAP notes. Conclusions Students were comfortable receiving an assessment of a SOAP note from a classmate, and most students indicated that their classmates could provide an honest assessment of their SOAP notes. The electronic peer review process allowed students to receive feedback on their work, and this learning strategy could be further extended to the education of other functional skills that are essential in pharmacy practice.

This is the first study to determine the minimal clinically important difference (MCID) of the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (EORTC QLQ-CIPN20), a validated instrument designed to elicit cancer patients’ experience of symptoms and functional limitations related to chemotherapy-induced peripheral neuropathy. Cancer patients receiving neurotoxic chemotherapy completed EORTC QLQ-CIPN20 and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity [FACT/GOG-NTX] at baseline, second cycle of chemotherapy (T2, n = 287), and 12 months after chemotherapy (T3, n = 191). Anchor-based approach used the validated FACT/GOG-NTX neurotoxicity (Ntx) subscale to identify optimal MCID cutoff for deterioration. Distribution-based approach used one-third standard deviation (SD), half SD, and one standard error of measurement of the total EORTC QLQ-CIPN20 score. There was a moderate correlation between the change scores of the Ntx subscale and sensory and motor subscales of QLQ-CIPN20 (T2: r = − 0.722, p

e24086 Background: Chemotherapy induced nausea and vomiting (CINV) following carboplatin containing chemotherapy regimen remains a considerable problem for cancer patients (pts) despite standard antiemetic prophylaxis. This study was undertaken to prospectively evaluate the incidence of CINV in pts undergoing carboplatin-based chemotherapy receiving guidelines consistent CINV prophylaxis (GCCP). All sites did not prescribe NK1-RA as it is not included in all institutional guidelines. Methods: The study enrolled 207 pts undergoing carboplatin-based chemotherapy, the final analysis evaluated cycle 1 - 6 with a total of 183 evaluable pts from 6 countries. Pt diaries were used to collect data from day 1-10 beginning with cycle 1. Nausea was reported by the pts using a visual analog scale (VAS) with the end-point being no nausea. Vomiting episodes were recorded in the pts’ diaries. Demographic, occurrence and severity of emesis, numbers of emetic episodes and time to the onset of emesis, were summarized using descriptive statistics. Results: There were 129 females and 54 males. The overall incidence of acute and delayed nausea for was 17% and 25% respectively. The incidence of nausea of entire population was significantly higher than vomiting (58% vs. 14%; Chi2 22.271 p

Employing the same framework as in previous guideline updates, antineoplastic agents were classified into four emetic risk categories. The classification of the emetogenic level of new antineoplastic agents, especially for the oral drugs, represents an increasing challenge. Accurate reporting of emetogenicity of new antineoplastic agents in the absence of preventive antiemetic treatment is rarely available.A systematic search was conducted for drugs approved after 2009 until June 2015 using EMBASE and PubMed. The search term was "drug name." The restrictions were language (English records only), date (2009 to 2015), and level of evidence ("clinical trial").From January 2009 to June 2015, 42 new antineoplastic agents were identified and a systematic search was conducted to identify relevant studies to help define emetic risk levels. The reported incidence of vomiting varied across studies for many agents, but there was adequate evidence to allow 41 of the 42 new antineoplastic agents to be classified according to emetogenic risk. No highly emetogenic agents were identified. Seven moderately emetogenic agents, 26 low emetogenic, agents and eight minimal emetogenic agents were identified and classified accordingly. The MASCC/ESMO update committee also recommended reclassification of the combination of an anthracycline and cyclophosphamide (AC) as highly emetogenic.Despite several limitations, we have attempted to provide a reasonable approximation of the emetic risk associated with new antineoplastic agents through a comprehensive search of the available literature. Hopefully by the next update, more precise information on emetic risk will have been collected during new agent development process.

An attenuated dosing (AD) sunitinib regimen of 37.5 mg daily has been suggested to reduce the toxicity reported with the standard dosing regimen to metastatic renal cell carcinoma (mRCC) patients. The aim of this study was to characterize the population pharmacokinetic (PK) properties of sunitinib and SU12662, the active metabolite, in patients receiving the AD regimen and to ascertain significant covariates influencing PK parameters.Thirty-one mRCC patients receiving AD sunitinib regimen were included. Plasma samples were collected on day 29 of each treatment cycle after the start of the therapy. Nonlinear mixed-effects modeling was applied to estimate the population PK properties of sunitinib and SU12662 as well as the effect of covariates on PK parameters. Monte Carlo simulation was also performed to predict the total trough level (TTL) of sunitinib and SU12662.Sunitinib population means for CL/F and V d /F central were 13.8 L/h and 1720 L, respectively. SU12662 population means for CL/F and V d /F were 42.1 L/h and 1410 L, respectively. Body surface area (BSA) and ABCB1 polymorphism significantly influenced the CL/F variability of sunitinib: CL/F parent = 13.8 × exp((BSA - 1.75) × 2.08 + (ABCB1 genotype - 0.67) × 0.61), ABCB1-0: wild genotype, 1: mutant genotype. The effect size of ABCB1 mutant genotype and BSA greater than 1.75 m(2) in relation to sunitinib clearance was 31.14 % (p = 0.006) and 22.11 % (p = 0.011), respectively, relative to the reference group.Adjusting doses of sunitinib according to BSA and ABCB1 polymorphism in Asian mRCC patients may be recommended for sufficient attainment of a target TTL of sunitinib and its metabolite.

Background Computerized provider order entry (CPOE) has been developed and implemented within cancer center hospitals nationwide in Japan. To ensure that high-quality services are routinely provided by oncology pharmacists, this study was designed to evaluate the interventions through reviewing the orders that are generated by CPOE. Methods The objective of this retrospective chart review was to evaluate how pharmacists contributed to safe cancer treatment using paper-based pharmacy records. Data were collected from a total of 35,062 chemotherapy regimens for 18,515 outpatients between January and December 2013. Results Of these 35,062 chemotherapy regimens, the rate of pharmacists’ interventions was 1.1% ( n = 408). Among them, 53.1% (217/408) of the chemotherapy prescriptions were modified due to pharmacist interventions. The reasons for interventions included “changes in the chemotherapy regimen were unclear” in 49.5%, “physicians’ prescription errors” (22.0%), “pharmacist suggestions to improve chemotherapy” (15.1%), and “finding differences between physicians’ chemotherapy records and their chemotherapy prescriptions” (13.2%). The top three reasons for the 217 prescription modifications due to pharmacist interventions were “finding prescription errors” (34.5%), “reasons for change in the chemotherapy regimen were unclear” (32.7%), and “finding differences between physicians’ chemotherapy records and their chemotherapy prescriptions” (28.5%). Conclusion The computer could not evaluate chemotherapy protocols or adjust doses of anticancer medicines according to patients’ conditions. Therefore, oncology pharmacists should continue to ensure safe and appropriate administration of cancer chemotherapy.

With the increased focus and anticipated growth in specialty training and certification within the profession of pharmacy, it is important for the profession to step back and evaluate the manner in which its adopted education and certification systems interface. As a result of specialty practice development, significant growth is occurring in both postgraduate year two (PGY2) pharmacy residency programs and individuals seeking certification by the Board of Pharmacy Specialties. As the profession continues to evolve its specialty training and credentialing systems, it is important to consider the inherent relationship between these systems. This paper considers the current landscape of specialty training and certification, including issues related to the quality of PGY2 training, consistent application of standards across and within PGY2 programs, credentialing of preceptors and program directors, and alignment of training with specialty certification examination content domains. We outline recommendations across three areas: (1) creating consistency between specialty training and certification, (2) aligning qualifications of PGY2 residency program directors and preceptors with the designated specialty area, and (3) assessing program quality in the context of the expectations of specialists established by the profession. The goal of this paper is to stimulate professional dialogue on these issues. Establishing both formal and informal connections between specialty training and certification can serve as the foundation for a rational approach to professional development and the credentialing that will be recognized by stakeholders outside the pharmacy profession. Establishing these connections will also support and advance the profession's mission of meeting the medication needs of patients.

Objective To assess the perceptions of pharmacy students and pharmacists in Asia on the education of SOAP notes and their use as a communication tool. Methods This was a multicenter, cross-sectional study in which a questionnaire was administered to the final-year pharmacy students and the practicing pharmacists. Usefulness and importance of SOAP notes were measured via a 5-point Likert scale which ranged from strongly disagree to strongly agree. Results A total of 198 students and 119 practicing pharmacists were included. Both pharmacists and pharmacy students found SOAP notes to be useful (p=0.012) and important (p=0.023). Comparing to pharmacy students, practicing pharmacists were two times more agreeable to incorporate SOAP notes into the pharmacy curriculum ( p = 0.004). Pharmacists agreed that the use of SOAP notes improves communication between pharmacy colleagues (63.9%), and between pharmacists and physicians (62.2%); however, fewer participants agreed that SOAP would improve communication between pharmacists and nurses (31.9%), or between pharmacists and allied health professionals (34.5%). Conclusion In Asia, pharmacy students and practicing pharmacists agreed that SOAP note writing is an essential skill that should be taught in the pharmacy curriculum and practiced in the clinical settings.

34 Background: Accessible Cancer Care to Enable Support for Cancer Survivors (ACCESS) is a multidisciplinary survivorship care model launched at the National Cancer Centre Singapore, the largest ambulatory cancer centre serving 70% of adult cancer patients in the public sector. ACCESS employs routine distress screening to triage patients with varying care needs and complexities. This study aims to examine the feasibility, delivery, and acceptance of ACCESS in providing appropriate service referrals to cancer patients in clinical settings. Methods: As part of an ongoing evaluation, we evaluated ACCESS for a 6-month implementation period between September 2019 and February 2020. Feasibility was assessed by proportions of (1) eligible breast and gynecological cancer patients who completed the locally adapted Distress Thermometer (DT) screening tool, (2) highly distressed patients, and (3) highly distressed patients requiring multidisciplinary meetings (MDM). Delivery was characterized by the mode and number of supportive care team (SCT) reviews required. Acceptance rates of SCT reviews by distressed patients and the uptake rate of service referrals recommended by the SCT were tabulated. Results: ACCESS screened 1074/1471 (73.0%) of all eligible patients within the 6-month period and identified 239/1074 (22.3%) as highly distressed for follow-up with the SCT. Eventually, 84.5% agreed to SCT review, with approximately one-fourth (26.7%) requiring MDM reviews. The majority (62.4%) of all distressed patients were identified at their first DT completion, whereas 19.8% and 7.4% were identified at their second and third completions respectively. The most common modes of follow-up were phone reviews (49.9%) and face-to-face in clinic waiting areas (48.6%). The SCT recommended 80 referrals to distressed patients for the following services: psychosocial (27.2%), cancer rehabilitation (5.9%), and home hospice (5.0%). The acceptance rates of the referrals for psychosocial, rehabilitation, and hospice services were 43.6%, 75.0%, and 80.0% respectively. Conclusions: ACCESS is a feasible model for triaging Asian cancer patients based on distress levels, and identifying complex patients requiring care personalization through MDM. The poorer acceptance rate of psychosocial services highlights patients’ preference for interventions targeting physical than psychosocial issues. Future studies should explore whether the uptake of psychosocial services is higher in the post-COVID era.

The aim of the current study is to identify distinct cytokine profiles in relation to self-perceived cognitive trajectories. In our study cohort (n = 128), early-stage breast cancer patients were categorized into no impairment reported, acute, delayed, persistent and intermittent cognitive decline respectively. Pro-inflammatory cytokines were elevated compared to baseline; with TNF-α implicated in the acute cognitive trajectory while IL-6 and IL-8 were involved in the persistent cognitive trajectory. Our findings help to further our understanding of cytokine profiles implicated in cancer-related cognitive impairment (CRCI) and support the use of cytokine levels as biomarkers of cognitive decline over time.

Context: Financial toxicity (FT) is used to describe the financial distress/hardship associated with cancer and its treatment. Objectives: The aim of this review was to explore the relationship between FT and symptom burden. Method: A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched MEDLINE, EMBASE, and CINAHL (from January 2000 to January 2018) and accepted quantitative, mixed-methods and qualitative studies. Data were extracted and appraised by two reviewers. Owing to significant heterogeneity in the included studies, a narrative synthesis was performed. Results: Nine studies involving 11,544 cancer survivors were included. Of these nine studies, eight were of high quality. The relationships between FT and psychological symptoms and physical symptoms were examined in eight and three studies, respectively. Six studies reported a positive relationship between FT and depression. Three studies found a positive association between FT and anxiety. Limited evidence was found for an association between FT and stress, fear of recurrence, spiritual suffering, pain, and overall symptom burden. Conclusions: A relatively clear association exists between FT and psychological symptoms. Clinicians should regularly screen for, assess, and manage emotional distress that may be attributed to FT. Although the causal pathway is not known, future intervention studies aimed at minimizing or preventing FT should evaluate psychological symptoms as secondary outcomes. Little is known about the relationships between FT and physical symptoms. Future research should overcome methodological limitations by incorporating longitudinal data collection, use of mixed-methods approaches, and homogeneity of samples.

Despite being a relatively young nation, Singapore has established itself as a leading multifaceted medical hub, both regionally and globally. Although Singapore continues to pursue excellence in oncology care, cancer supportive care and survivorship care remain in the infancy stage. In an effort to advance this important aspect of oncology care in Singapore, the first cancer supportive and survivorship care forum was held in December 2016, involving 74 oncology practitioners. The primary goals of this forum were to raise awareness of the importance of cancer supportive and survivorship care and to provide a platform for oncology practitioners of diverse backgrounds to converge and address the challenges associated with the delivery of cancer supportive and survivorship care in Singapore. Key challenges identified during this forum included, but were not limited to, care fragmentation in an oncologist-centric model of care, poor integration of allied health and rehabilitation services, passive engagement of community partners, lack of specialized skill sets and knowledge in supportive and survivorship care, and patient-related barriers such as poor health literacy. The survivorship care model commonly used in Singapore places an imbalanced emphasis on surveillance for cancer recurrence and second primary cancers, with little attention given to the supportive and survivorship needs of the survivors. In summary, these challenges set the stage for the development and use of a more survivor-centric model, one that focuses not only on cancer surveillance, but also on the broad and unique physical and psychosocial needs of survivors of cancer in Singapore.

Objectives: 1) To develop both English and Chinese versions of the descriptions of health states describing different stages of breast cancer and different adverse effects related to tamoxifen and aromatase inhibitors for breast cancer and 2) to elicit individuals’ preferences for these health states from a group of oncology nurses. Methods: Twenty hypothetical health states and their descriptions were developed on the basis of literature review and oncology expert panel reviews. Health state utilities were obtained from 20 oncology nurses by using the visual analogue scale and standard gamble methods. After recalibration, the adjusted utility scores were on a scale of 0 (dead) and 1 (perfect health). Results: The health states developed represented different disease stages and the presence and type of treatment side effects in breast cancer. For each health state, various general healthrelated quality-of-life domains, such as pain/discomfort and ability to work, were included in the descriptions, along with a state-specific description. The mean utility score of respondents’ “current health” was greater than 0.9, while mean adjusted visual analogue scale– derived utility scores ranged from 0.256 to 0.860 and median adjusted standard gamble– derived utility scores ranged from 0.284 to 0.673. Among the side effects evaluated in the “no recurrence” health state, ischemic cerebrovascular events, pulmonary embolism, and spine fracture had the greatest utility detriment. Conclusions: The study results indicate the value that individuals place on the avoidance of disease progression and the side effects of hormonal therapies in breast cancer. The health state descriptions developed can be used in future research to obtain society’s utilities for use in a cost-utility analysis.

BackgroundAprepitant (a neurokinin 1 receptor antagonist), in combination with a serotonin receptor antagonist (5-HT3 RA) and dexamethasone, has demonstrated superior efficacy on end points related to chemotherapy-induced nausea and vomiting (CINV) compared with standard care (combination 5-HT3 RA and dexamethasone).ObjectiveTo determine the cost-effectiveness of an aprepitant-containing regimen compared with current clinical practice for the prevention of CINV in patients receiving highly emetogenic chemotherapy (HEC) in Singapore.MethodsA decision-analytic model was constructed to assess the costs and outcomes associated with an aprepitant-containing regimen compared with standard care in the prevention of CINV following HEC. Three scenarios were modeled on the basis of results of four double-blind randomized clinical trials of aprepitant. CINV event probabilities were calculated on the basis of the occurrence of nausea and vomiting and the need for rescue medication in the 5 days following a single cycle of HEC. The analysis was conducted from the Singapore health care system perspective.ResultsAprepitant reduced emesis and nausea, resulting in small but clinically important improvements when measured in quality-adjusted life-years. The aprepitant-containing regimen was associated with higher acquisition costs but lower costs relating to patient management, hospitalization, and use of rescue medication. Across the scenarios, the incremental cost per emetic event avoided ranged from cost saving to Singapore $63 (US $51). The incremental cost-effectiveness ratio ranged from cost saving to Singapore $49,800 per quality-adjusted life-year gained (US $40,600). The analysis was relatively insensitive to changes in the inputs.ConclusionsAprepitant is a clinically important and cost-effective therapy for the prevention of CINV in patients treated with HEC in Singapore.