Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial.

BACKGROUND: Single-agent nivolumab showed durable responses, manageable safety, and promising survival in patients with advanced hepatocellular carcinoma in the phase 1-2 CheckMate 040 study. We aimed to investigate nivolumab monotherapy compared with sorafenib monotherapy in the first-line setting for patients with advanced hepatocellular carcinoma. METHODS: In this randomised, open-label, phase 3 trial done at medical centres across 22 countries and territories in Asia, Australasia, Europe, and North America, patients at least 18 years old with histologically confirmed advanced hepatocellular carcinoma not eligible for, or whose disease had progressed after, surgery or locoregional treatment; with no previous systemic therapy for hepatocellular carcinoma, with Child-Pugh class A and Eastern Cooperative Oncology Group performance status score of 0 or 1, and regardless of viral hepatitis status were randomly assigned (1:1) via an interactive voice response system to receive nivolumab (240 mg intravenously every 2 weeks) or sorafenib (400 mg orally twice daily) until disease progression or unacceptable toxicity. The primary endpoint was overall survival assessed in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study drug. This completed trial is registered with ClinicalTrials.gov, NCT02576509. FINDINGS: Between Jan 11, 2016, and May 24, 2017, 743 patients were randomly assigned to treatment (nivolumab, n=371; sorafenib, n=372). At the primary analysis, the median follow-up for overall survival was 15·2 months (IQR 5·7-28·0) for the nivolumab group and 13·4 months (5·7-25·9) in the sorafenib group. Median overall survival was 16·4 months (95% CI 13·9-18·4) with nivolumab and 14·7 months (11·9-17·2) with sorafenib (hazard ratio 0·85 [95% CI 0·72-1·02]; p=0·075; minimum follow-up 22·8 months); the protocol-defined significance level of p=0·0419 was not reached. The most common grade 3 or worse treatment-related adverse events were palmar-plantar erythrodysaesthesia (1 [<1%] of 367 patients in the nivolumab group vs 52 [14%] of patients in the sorafenib group), aspartate aminotransferase increase (22 [6%] vs 13 [4%]), and hypertension (0 vs 26 [7%]). Serious treatment-related adverse events were reported in 43 (12%) patients receiving nivolumab and 39 (11%) patients receiving sorafenib. Four deaths in the nivolumab group and one death in the sorafenib group were assessed as treatment related. INTERPRETATION: First-line nivolumab treatment did not significantly improve overall survival compared with sorafenib, but clinical activity and a favourable safety profile were observed in patients with advanced hepatocellular carcinoma. Thus, nivolumab might be considered a therapeutic option for patients in whom tyrosine kinase inhibitors and antiangiogenic drugs are contraindicated or have substantial risks. FUNDING: Bristol Myers Squibb in collaboration with Ono Pharmaceutical.

CheckMate 040 cohort 5: A phase I/II study of nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis.

BACKGROUND & AIMS: Patients with advanced hepatocellular carcinoma (aHCC) and Child-Pugh B liver function are often excluded from clinical trials. In previous studies, overall survival for these patients treated with sorafenib was ∼3-5 months; thus, new treatments are needed. Nivolumab, alone or in combination with ipilimumab, is conditionally approved in the United States to treat patients with aHCC who previously received sorafenib. We describe nivolumab monotherapy outcomes in patients with Child-Pugh B status. METHODS: This phase I/II, open-label, non-comparative, multicentre trial (27 centres) included patients with Child-Pugh B (B7-B8) aHCC. Patients received intravenous nivolumab 240 mg every 2 weeks until unacceptable toxicity or disease progression. Primary endpoints were objective response rate (ORR) by investigator assessment (using Response Evaluation Criteria in Solid Tumors v1.1) and duration of response. Safety was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. RESULTS: Twenty-five sorafenib-naive and 24 sorafenib-treated patients began treatment between November 2016 and October 2017 (median follow-up, 16.3 months). Investigator-assessed ORR was 12% (95% CI 5-25%) with 6 patients responding; disease control rate was 55% (95% CI 40-69%). Median time to response was 2.7 months (interquartile range, 1.4-4.2), and median duration of response was 9.9 months (95% CI 9.7-9.9). Treatment-related adverse events (TRAEs) were reported in 25 patients (51%) and led to discontinuation in 2 patients (4%). The most frequent grade 3/4 TRAEs were hypertransaminasemia (n = 2), amylase increase (n = 2), and aspartate aminotransferase increase (n = 2). The safety of nivolumab was comparable to that in patients with Child-Pugh A aHCC. CONCLUSIONS: Nivolumab showed clinical activity and favourable safety with manageable toxicities, suggesting it could be suitable for patients with Child-Pugh B aHCC. LAY SUMMARY: In patients with advanced hepatocellular carcinoma, almost all systemic therapies require very good liver function, i.e. Child-Pugh A status. The evidence from this study suggests that nivolumab shows clinical activity and an acceptable safety profile in patients with hepatocellular carcinoma with Child-Pugh B status who have mild to moderate impairment of liver function or liver decompensation that might rule out other therapies. Further studies are warranted to assess the safety and efficacy of nivolumab in this patient population. CLINICAL TRIAL NUMBER: NCT01658878.

Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial.

IMPORTANCE: Most patients with hepatocellular carcinoma (HCC) are diagnosed with advanced disease not eligible for potentially curative therapies; therefore, new treatment options are needed. Combining nivolumab with ipilimumab may improve clinical outcomes compared with nivolumab monotherapy. OBJECTIVE: To assess efficacy and safety of nivolumab plus ipilimumab in patients with advanced HCC who were previously treated with sorafenib. DESIGN, SETTING, AND PARTICIPANTS: CheckMate 040 is a multicenter, open-label, multicohort, phase 1/2 study. In the nivolumab plus ipilimumab cohort, patients were randomized between January 4 and September 26, 2016. Treatment group information was blinded after randomization. Median follow-up was 30.7 months. Data cutoff for this analysis was January 2019. Patients were recruited at 31 centers in 10 countries/territories in Asia, Europe, and North America. Eligible patients had advanced HCC (with/without hepatitis B or C) previously treated with sorafenib. A total of 148 patients were randomized (50 to arm A and 49 each to arms B and C). INTERVENTIONS: Patients were randomized 1:1:1 to either nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, administered every 3 weeks (4 doses), followed by nivolumab 240 mg every 2 weeks (arm A); nivolumab 3 mg/kg plus ipilimumab 1 mg/kg, administered every 3 weeks (4 doses), followed by nivolumab 240 mg every 2 weeks (arm B); or nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (arm C). MAIN OUTCOMES AND MEASURES: Coprimary end points were safety, tolerability, and objective response rate. Duration of response was also measured (investigator assessed with the Response Evaluation Criteria in Solid Tumors v1.1). RESULTS: Of 148 total participants, 120 were male (81%). Median (IQR) age was 60 (52.5-66.5). At data cutoff (January 2019), the median follow-up was 30.7 months (IQR, 29.9-34.7). Investigator-assessed objective response rate was 32% (95% CI, 20%-47%) in arm A, 27% (95% CI, 15%-41%) in arm B, and 29% (95% CI, 17%-43%) in arm C. Median (range) duration of response was not reached (8.3-33.7+) in arm A and was 15.2 months (4.2-29.9+) in arm B and 21.7 months (2.8-32.7+) in arm C. Any-grade treatment-related adverse events were reported in 46 of 49 patients (94%) in arm A, 35 of 49 patients (71%) in arm B, and 38 of 48 patients (79%) in arm C; there was 1 treatment-related death (arm A; grade 5 pneumonitis). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, nivolumab plus ipilimumab had manageable safety, promising objective response rate, and durable responses. The arm A regimen (4 doses nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks then nivolumab 240 mg every 2 weeks) received accelerated approval in the US based on the results of this study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01658878.

A Population-Based Approach to Mapping Vulnerability to Diabetes.

Of the 382 million people worldwide with diabetes, and if current trends continue, nearly half a billion people worldwide will have diabetes by 2035. Two-thirds of current diabetics are living in urban centers and the urban concentration of individuals with diabetes is on the rise. The problem is that in the absence of widespread clinical testing, there is no reliable way to predict which segments of the population are the most vulnerable to the onset of diabetes. Knowing who the most vulnerable are, and where they live, can guide the efficient allocation of prevention resources. Toward this end, we introduce the concept of composite vulnerability, which includes both group and individual-level attributes, and we provide a demonstration of its application to a large urban setting. The components of composite vulnerability are estimated using a novel, population-based, procedure that relies on sample survey data and nonparametric statistical techniques. First, cluster analysis identified three multivariate profiles of adult residents with type 2 diabetes, based on 35 socioeconomic indicators. Second, the undiagnosed population was screened for vulnerability based on their resemblance or fit to these multivariate profiles. Geographic neighborhoods with high concentrations of "vulnerables" could then be identified. In parallel, recursive partitioning found the best predictors of type 2 diabetes in this urban population, combined them with indicators of disadvantage, and applied them to residents in the selected neighborhoods to establish relative levels of composite vulnerability. Neighborhoods with high concentrations of residents manifesting composite vulnerability can be easily identified for targeting community-based prevention measures.

Primary care physicians' utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study.

OBJECTIVE: To assess primary care physicians' (PCPs) knowledge of type 2 diabetes screening guidelines (American Diabetes Association (ADA) and 2008 US Preventive Services Task Force (USPSTF)), the alignment between their self-reported adherence and actual practice, and how often PCPs recommended diabetes prevention and self-management education programs (DPP/DSME). RESEARCH DESIGN AND METHODS: An online survey of PCPs to understand knowledge and adherence toward use of USPSTF/ADA guidelines and recommendation of DPP/DSME. Patient data from electronic medical records (EMRs) for each PCP were used to identify rates of screening in eligible patients as per guidelines and the two sources were compared to assess concordance. RESULTS: Of 305 surveyed physicians, 38% reported use of both guidelines (33% use ADA only, 25% USPSTF only). Approximately one-third of physicians who reported use of USPSTF/ADA guidelines had non-concordant EMR data. Similarly, while most PCPs reported they are 'very likely' to screen patients with risk factors listed in guidelines, for each criterion at least one-fourth (24%) of PCPs survey responses were non-concordant with EMRs. PCPs reported they provide referral to DPP and DSME on average to 45% and 67% of their newly diagnosed patients with pre-diabetes and diabetes, respectively. CONCLUSION: Findings show disconnect between PCPs' perceptions of adherence to screening guidelines and actual practice, and highlight limited referrals to DPP/DSME programs. More research is needed to understand barriers to guideline consistent screening and uptake of DPP/DSME, particularly in light of recent policy changes such as the linking USPSTF criteria to reimbursement and expected Medicare DPP reimbursement in 2018.

A Systematic Review of Insulin Adherence Measures in Patients with Diabetes.

BACKGROUND: Diabetes care is associated with a considerable burden to the health care system in the United States, and measuring the quality of health care is an important development goal of the Department of Health and Human Services and the Centers for Medicare & Medicaid Services. Diabetes is a priority disease within the National Quality Strategy and should therefore remain a focus in the measurement of health care quality. Despite the importance of measuring quality in diabetes care management, no quality measure is currently associated with adherence to insulin treatment, and measuring adherence to insulin is known to be complicated. OBJECTIVES: To (a) identify methods to measure insulin adherence in patients with diabetes and (b) evaluate whether identified methods could be considered for testing as a quality measure. METHODS: Systematic searches were conducted in the online electronic databases Embase, MEDLINE, and the Cochrane Library, supplemented with additional manual searches to identify publications on insulin adherence from the year 2000 onward. Identified citations were screened for relevance against predefined eligibility criteria, and methods to measure adherence to insulin were extracted from relevant studies into data extraction tables. Methods were critiqued on the feasibility for consideration as a quality measure. RESULTS: Seventy-eight publications met the inclusion criteria and were reviewed. Included studies reported various indirect methods to measure adherence to insulin, using prescription claims or self-report questionnaires. Commonly reported methods included the (adjusted) medication possession ratio, proportion of days covered, persistence, daily average consumption, and the Morisky Medication Adherence Scale. All types of identified methods were associated with measuring challenges varying from accuracy of estimated adherence, complexity of data collection, absence of validated threshold for good adherence, and reliability of adherence outcomes. CONCLUSIONS: Without additional research, none of the identified methods are appropriate for use as a quality measure for insulin adherence. We suggest patient involvement in future research and additional quality measure development. DISCLOSURES: Novo Nordisk paid DRG Abacus to complete the systematic review and manuscript and was involved in the study design, interpretation of data, and decision to publish the findings of the systematic review. Kroes and Webb report personal fees from Novo Nordisk during the conduct of the study and personal fees from DRG Abacus, outside of the submitted work. Webb is employed by DRG Abacus, and Kroes was employed by DRG Abacus at the time of this study. Wisniewski is an employee of Novo Nordisk, which funded the systematic review reported in this article, and also owns stocks in Novo Nordisk. Stolpe has nothing to disclose. Study concept and design were contributed by Kroes, Webb, and Wisniewski, with assistance from Stolpe. Webb took the lead in data collection, along with Kroes, and data interpretation was performed by all the authors. The manuscript was written by Kroes, Webb, and Wisniewski, with assistance from Stolpe, and revised by Kroes, Stolpe, Wisniewski, and Webb.

The nurse's role in managing chemotherapy-induced nausea and vomiting: an international survey.

BACKGROUND: Nurses play a substantial role in the prevention and management of chemotherapy-induced nausea and vomiting (CINV). OBJECTIVES: This study set out to describe nurses' roles in the prevention and management of CINV and to identify any gaps that exist across countries. METHODS: A self-reported survey was completed by 458 registered nurses who administered chemotherapy to cancer patients in Australia, China, Hong Kong, and 9 Latin American countries. RESULTS: More than one-third of participants regarded their own knowledge of CINV as fair to poor. Most participants (>65%) agreed that chemotherapy-induced nausea and chemotherapy-induced vomiting should be considered separately (79%), but only 35% were confident in their ability to manage chemotherapy-induced nausea (53%) or chemotherapy-induced vomiting (59%). Only one-fifth reported frequent use of a standardized CINV assessment tool and only a quarter used international clinical guidelines to manage CINV. CONCLUSIONS: Participants perceived their own knowledge of CINV management to be insufficient. They recognized the need to develop and use a standardized CINV assessment tool and the importance of adopting international guidelines to inform the management of CINV. IMPLICATIONS FOR PRACTICE: Findings indicate that international guidelines should be made available to nurses in clinically relevant and easily accessible formats, that a review of chemotherapy assessment tools should be undertaken to identify reliable and valid measures amenable to use in a clinical settings, and that a CINV risk screening tool should be developed as a prompt for nurses to enable timely identification of and intervention for patients at high risk of CINV.

Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis.

BACKGROUND: Treatment of growth hormone disorders typically involves daily injections of human growth hormone (GH) over many years, incurring substantial costs. We assessed the extent of undesired GH loss due to leakage in the course of pen preparation prior to injection, and differences between the prescribed dose, based on patient weight, and the actual delivered dose based on pen dosing increments in five GH administration devices. METHODS: Norditropin® prefilled FlexPro®, NordiFlex®, NordiLet®, and durable NordiPen®/SimpleXx® 5 mg pens (Novo Nordisk A/S, Bagsværd, Denmark) and durable Omnitrope® Pen-5 devices (Sandoz, Holzkirchen, Germany) were tested (n = 40 for each device type). Product wastage was measured in accordance with validated protocols in an ISO (International Organization for Standardization) 11608-1 and Good Manufacturing Practice compliant laboratory. The average mass of wasted GH from each device type was measured in simulations of dripping with the needle attached prior to injection and while setting a dose. Statistical significance (P < 0.05) was confirmed by Student's t-test, and a model was constructed to estimate mean annual GH wastage per patient in cohorts of pediatric patients with GH disorders. RESULTS: Mean GH mass wasted with the needle on prior to injection was 0.0 µg with Norditropin pens, relative to 98 µg with Omnitrope Pen-5. During dose dialing, 0.0-2.3 µg of GH was lost with Norditropin pens versus 0.8 µg with Omnitrope Pen-5. All Norditropin and Omnitrope device comparisons were statistically significant. Modeling GH wastage in a US cohort showed 5.5 mg of annual GH wastage per patient with FlexPro versus 43.6 mg with Omnitrope, corresponding to 7-8 additional pens per patient annually. CONCLUSION: Overall, Norditropin pens resulted in significantly less wastage than the Omnitrope Pen-5. The study suggests that GH devices of the same nominal volume exhibit differences that may affect the frequency of GH prescription refills required to remain adherent to therapy.

Administration burden associated with recombinant human growth hormone treatment: perspectives of patients and caregivers.

Patients treated with recombinant human growth hormone (rhGH) for growth hormone disorders follow a challenging treatment schedule. This study assessed patient and caregiver experiences with rhGH therapy treatment regimens. Patients 13 years or older with growth hormone deficiency and caregivers completed Web-based surveys. A total of 61 patients and 239 caregivers participated. Storage of rhGH was considered burdensome by more than a third. More than 51% considered storage "somewhat more" to "much more of a burden" relative to the burden while not traveling. "Away from home or traveling" was the most frequently endorsed reason for missing a dose. rhGH treatment while traveling is challenging because of rhGH storage burden.

Human growth hormone treatment: synthesis of literature on product delivery systems and administration practices.

PURPOSE: To synthesize current literature on recombinant human growth hormone (rhGH) use and to identify areas of research that have received little to no attention in light of administration practice and patient perception/behavior. DESIGN AND METHODS: Relevant articles for a systematic review were identified through PubMed. RESULTS: A total of 43 articles were identified: 9 (15.9%) studies on product administration practices and 34 (84.1%) on patient behavior patterns. Patients primarily preferred simple, convenient, and easy-to-use delivery devices. However, literature addressing the effect of convenient product administration practices on treatment outcomes using real-world patient/caregiver data is lacking. PRACTICE IMPLICATIONS: Better understanding of real-world product administration practices will help nurses identify areas of improvement in patient education and training.

Retrospective evaluation of caspofungin therapy in invasive aspergillosis (RECAM-IA).

To evaluate caspofungin in high-risk invasive aspergillosis (IA) patient, a retrospective review of patient characteristics, antifungal therapies and clinical outcomes on hospitalised patients at sites in Russia, Canada, Germany, and Thailand was performed. Fifty-five patients were included, six with proven and 49 with probable aspergillosis; 76.4% had haematological diseases, 80% were on immunosuppressive drugs, 32.7% were neutropenic at caspofungin initiation. Median duration of prior antifungal therapy was 9 days (range 1-232). Reasons for initiating caspofungin included: disease refractory to first-line antifungal (49.1%) and toxicities with prior antifungals (18.2%). Median caspofungin therapy duration was 14 days (range 2-62), with a median of 13 days (range 1-62) as monotherapy. Favourable responses were observed in 45.5% of the patients, complete responses in 40% and partial responses in 5.5%; 74.5% survived 7 days after completion of caspofungin therapy with 69.1% having been successfully discharged from the hospital. Few patients (14.6%) on caspofungin switched because of suspected resistance, lack of response or adverse events. There were no increases in hospital stay as a result of adverse events or drug-drug interactions related to caspofungin; 7.3% of patients had a mean value of 13 (± 14.11) days of increased stay attributable to treatment failure. Caspofungin was well-tolerated. It exhibited effectiveness and high survival in treating severe IA patients.

Resource utilization and costs associated with chemotherapy-induced nausea and vomiting (CINV) following highly or moderately emetogenic chemotherapy administered in the US outpatient hospital setting.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV), common adverse events of chemotherapy, may be associated with considerable healthcare resource utilization. This study was conducted to describe CINV-associated healthcare visits and costs following a first cycle of highly or moderately emetogenic chemotherapy (HEC or MEC). METHODS: This retrospective cohort study used the Premier Perspective™ Database to identify adult patients who received their first HEC or MEC and at least one antiemetic agent from 2003 to 2007 at US hospital-based outpatient facilities. Hospital visits with a CINV-related ICD-9 diagnosis were included from the chemotherapy administration date to 30 days later or 1 day before the second chemotherapy, whichever was first. CINV costs were hospital-reported costs. RESULTS: Of 19,139 patients (HEC, 16%; MEC, 84%), mean (SD) age was 59 (14) years; 59% were female; 66% were white. CINV prophylaxis included 5-HT3 antagonists (85%), dexamethasone (76%), and NK-1 antagonists (2%). Overall, 13.8% of patients had a CINV-associated visit (HEC, 18%; MEC, 13%): 0.2% for acute CINV (day of chemotherapy, excluding chemotherapy administration visit) and 13.7% for delayed CINV. CINV-associated visits included inpatient (IP, 64%), outpatient (OP, 26%), and emergency room (ER, 10%) visits. Mean (SD) costs of CINV visits were $5,299 ($6,639); for IP, $7,448 ($7,271); OP, $1,494 ($2,172); and ER, $918 ($1,071). Mean per-patient CINV-associated costs across all patients were $731 ($3,069). Sensitivity analysis excluding visits where CINV was a secondary diagnosis code resulted in a CINV incidence of 4.4%, a mean CINV visit cost of $4,043, and a mean per-patient CINV-associated cost across all patients of $176. CONCLUSIONS: CINV visits in the first HEC or MEC cycle were common and costly, especially inpatient hospitalizations in the delayed phase. Strategies to reduce CINV in the delayed phase could reduce healthcare utilization and costs.

Treatment and outcomes in patients with asthma and allergic rhinitis in the United kingdom.

BACKGROUND: Since allergic rhinitis in asthma patients is associated with worse asthma control, the treatment of the comorbid condition may improve outcomes. METHODS: A 1-year retrospective study using the UK Mediplus database (2001-2004) included asthmatic patients aged 15-55 with allergic rhinitis. Patients starting therapy based on the Global Initiative for Asthma guidelines, defined as an increase in inhaled corticosteroids (high-dose inhaled corticosteroids, hdICS), or the addition of montelukast (ICS+MON) or long-acting beta-agonists (ICS+LABA) to ICS, were studied. Univariable and multiple logistic regressions evaluated asthma-related outcomes. RESULTS: Among 2,596 asthma and allergic rhinitis patients, 83.2% initiated ICS+LABA, 12.1% hdICS and 4.7% ICS+MON. The mean age was 34 years and 60% were female. ICS+MON patients had more moderate-severe asthma (p = 0.04). Approximately 84% of the ICS+LABA patients experienced an asthma control failure compared to 50% in the other groups (p < 0.0001). The proportions of patients requiring treatment change were 73.8, 22 and 27.3% in the ICS+LABA, hdICS and ICS+MON groups, respectively (p = 0.001). Asthma-related resource use was similar among all groups. The ICS+MON group received fewer mean prescriptions for oral corticosteroids (p = 0.024) than the other groups (p = 0.026). CONCLUSIONS: In asthma and allergic rhinitis, treatment with ICS+MON or hdICS was associated with lower rates of asthma control failure and fewer treatment changes than the ICS+LABA group. MON users also required fewer oral corticosteroids.

Incidence of chemotherapy-induced nausea and vomiting in Mexico: healthcare provider predictions versus observed.

OBJECTIVE: An understanding of the incidence of chemotherapy-induced nausea and vomiting (CINV) may assist healthcare providers (HCP) when making treatment decisions. We investigated the incidence of CINV after highly or moderately emetogenic chemotherapy (HEC or MEC), in comparison with predictions of CINV by HCP. RESEARCH DESIGN AND METHODS: This prospective study was conducted at nine oncology centers in Mexico. Eligible patients were >/=18 years old and scheduled to receive a single, initial cycle of chemotherapy. Patients recorded nausea severity, episodes of emesis, and rescue medication use for the first 5 days after chemotherapy. HCP predicted the general incidence of acute (day 1) and delayed (days 2-5) CINV. RESULTS: A total of 82 patients were enrolled, with complete data available for 73. Mean age was 50 years; 67 (92%) were women; and 57 (78%) received HEC, while 16 (22%) received MEC. HCP predictions were comparable to the incidence of acute CINV after HEC and MEC and of delayed CINV after MEC. However, HCP predictions underestimated delayed CINV after HEC. 75.4% of patients (95% CI: 62.2-85.9) reported delayed nausea and HCP predicted 41.7% (95% CI: 30.2-55.0); 63.2% of patients (95% CI: 49.3-75.6) reported delayed emesis and HCP predicted 31.8% (95% CI: 21.0-44.5). Limitations of the study include the small sample size, possible selection bias and lack of a standardized antiemetic regimen. CONCLUSIONS: Healthcare providers underestimated the incidence of delayed CINV after HEC. There is a need for a better understanding of the incidence of delayed nausea and emesis, which remain common side-effects of chemotherapy.