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Background: The objective of this study was to conduct an indirect treatment comparison between cabazitaxel, abiraterone and enzalutamide to determine the clinical efficacy and safety of cabazitaxel relative to comparators in the treatment of patients with metastatic castrate-resistant prostate cancer who progress on docetaxel-based therapies., Methods: A systematic literature review was conducted to inform the network meta-analysis of cabazitaxel, abiraterone and enzalutamide. Due to a lack of head-to-head trials, studies with a comparator arm of best supportive care were included in the analysis. Overall survival, progression-free survival, and adverse events were compared within both Bayesian and Frequentist frameworks. The ratios for survival outcomes were estimated using hazard ratios (HR), and the ratios for adverse events between groups were estimated using odds ratios (ORs); uncertainty was reported as 95% confidence (Frequentist) and credible (Baysesian) Intervals., Results: Three of thirteen trials identified for abstraction were relevant for analyses. Median overall survival was not statistically significantly different for abiraterone (HR = 1.04; 95% CI = 0.83-1.28) or enzalutamide (HR = 0.88; 95% CI = 0.69-1.11) when compared to cabazitaxel in the Bayesian analysis. Anaemia (OR = 3.71; 95% CI = 1.01-10.44), diarrhoea (OR = 16.60; 95% CI = 1.41-75.31) and haematuria (OR = 3.88; 95% CI = 1.03-10.09) were more likely to occur in the cabazitaxel group than the abiraterone group, while pyrexia risk was higher in cabazitaxel compared to enzalutamide (OR = 36.23; 95% CI = 1.14-206.40). Frequentist analyses produced similar results., Conclusions: The scarcity of clinical studies and lack of a common comparator limited analyses. The adverse event results must be interpreted with caution as many were based on small numbers. The results from this analysis indicate comparable survival outcomes and adverse event profiles. As these pivotal studies may not reflect the contemporary treatment landscape and patient profiles, additional research, including head-to-head clinical trials and real world observational studies, should be conducted to further elucidate the beneficial effects of these therapies.

Background: Romiplostim, a thrombopoietin receptor agonist (TPOra), is a second-line medical treatment option for adults with chronic immune thrombocytopenia (ITP). Clinical trials have shown that romiplostim increases platelet counts, while reducing the risk of bleeding and, in turn, the need for costly rescue medications., Aims: The objective of this study was to assess the cost effectiveness of romiplostim in the treatment of adult ITP in Ireland, in comparison with eltrombopag and the medical standard of care (SoC)., Methods: A lifetime treatment-sequence cost-utility Markov model with embedded decision tree was developed from an Irish healthcare perspective to compare romiplostim with eltrombopag and SoC. The model was driven by platelet response (platelet count ≥50 × 10(9)/L), which determined effectiveness and progression along the treatment pathway, need for rescue therapy (e.g. intravenous immunoglobulin [IVIg] and steroids) and risk of bleeding. Probability of response, mean treatment duration, average time to initial response and utilities were derived from clinical trials and other published evidence. Treatment sequences and healthcare utilization practice were validated by Irish clinical experts. Costs were assessed in for 2011 and included drug acquisition costs and costs associated with monitoring patients and management of bleeding, as available from published Irish reimbursement lists and other relevant sources. Deterministic and probabilistic sensitivity analyses were conducted., Results: Romiplostim treatment resulted in an average of 20.2 fewer administrations of rescue medication (IVIg or intravenous steroids) over a patient lifetime than eltrombopag, and 29.3 fewer rescue medication administrations than SoC. Romiplostim was dominant, with cost savings of 13,258 and 22,673 and gains of 0.76 and 1.17 quality-adjusted life-years (QALYs), compared with eltrombopag and SoC, respectively. Romiplostim remained cost effective throughout a variety of potential scenarios, including short-term TPOra treatment duration (1 year). One-way sensitivity analysis showed that the model was most sensitive to variation in the cost of IVIg and use of romiplostim and IVIg. Probabilistic sensitivity analysis showed that romiplostim was likely to be cost effective in over 90 % of cases compared with eltrombopag, and 96 % compared with SoC at a willingness-to-pay threshold of 30,000 per QALY., Conclusions: Use of romiplostim in the ITP treatment pathway, compared with eltrombopag or SoC, is likely to be cost effective in Ireland. Romiplostim improves clinical outcomes by increasing platelet counts, reducing bleeding events and the use of IVIg and steroids, resulting in both cost savings and additional QALYs when compared with current treatment practices.

Objectives: Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by platelet destruction, sub-optimal platelet production, and mild-to-severe bleeding. Nplate® (romiplostim), a thrombopoietin receptor agonist, and intravenous immunoglobulin (IVIg), an expensive and occasionally scarce blood product, are used in the treatment of ITP. The objective of this study was to compare the total cost of treating patients with romiplostim vs IVIg in Québec, Canada., Methods: A net cost impact model was developed to calculate the annual cost of romiplostim compared with IVIg based on actual practice observations in all patients (n = 95) treated for chronic ITP with IVIg from April 2010 to March 2011 in two participating hospitals. The model included costs of: drug acquisition, drug preparation and administration, patient monitoring, and indirect costs. Healthcare practitioners were consulted regarding romiplostim and IVIg treatment algorithms and the resources involved in patient monitoring., Results: The average annual drug acquisition costs of romiplostim and IVIg were $48,024 and $98,868, respectively. Lower costs for drug preparation and administration ($309 vs $1245) and less time lost from work ($256 vs $2086) were attributed to romiplostim. The cost of follow-up monitoring was the same for both romiplostim and IVIg ($121). The total average annual per patient costs for romiplostim vs IVIg were, respectively, $48,710 and $102,320. The use of romiplostim was projected to save, on average, almost $54,000 per patient per year., Limitations: The study was conducted in two hospitals in Québec. Romiplostim may show different cost savings in other hospitals and other provincial and national jurisdictions., Conclusions: Scarce blood products must be used wisely. Romiplostim can allow for improved healthcare resource allocation by reserving IVIg for use in other areas of greater need while also providing cost savings for the overall provincial healthcare budget.

Romiplostim increases platelet counts and reduces the risk of bleeding in patients with immune thrombocytopenia (ITP). This post hoc analysis compared the effect of romiplostim versus medical standard of care (SOC) on clinically relevant bleeding-related episodes (BREs) in a 52-week open-label study of patients with ITP. BREs were defined as actual bleeding events and/or use of rescue medication. Nonsplenectomized adult patients with ITP were randomized to receive weekly subcutaneous injections of romiplostim (n = 157) or SOC (n = 77). The rate of all BREs (per 100 patient-weeks) was lower in patients treated with romiplostim (3.1) than in those treated with SOC (9.4); the relative rate (romiplostim/SOC) was 0.33 (95 % CI 0.27-0.40). The rate of BREs associated with immunoglobulin (Ig) rescue medication was also lower for romiplostim (0.2) than SOC (4.8); the relative rate (romiplostim/SOC) was 0.05 (95 % CI 0.03-0.08). BRE rates were lower in patients with platelet counts ≥50 × 10(9)/L, and patients treated with romiplostim spent more time with platelet counts ≥50 × 10(9)/L than did patients treated with SOC. Bleeding-related hospitalizations were rare in both groups. Thus, romiplostim treatment provided greater reductions in all BREs, as well as BREs involving Ig rescue medications, than did SOC.

Objective: In clinical studies of patients with severe thrombocytopenia, rescue treatments are used to prevent or stop bleeding. Estimating risk reductions of bleeding for clinical study medications can be challenging. This study evaluated a new and possibly more accurate way of assessing the effects of a treatment intervention on bleeding-related outcomes. We developed a composite endpoint, termed bleeding-related episodes (BRE)., Research Design and Methods: BREs were assessed in a post-hoc analysis of patients with chronic immune thrombocytopenia (ITP) who participated in two romiplostim, phase 3, placebo-controlled studies. Patients received romiplostim or placebo once weekly for 24 weeks. A BRE was defined as an actual bleeding event and/or the use of rescue medication. In total, 125 patients (41 placebo, 84 romiplostim) with platelet counts <30 K were enrolled., Clinical Trial Registration: NCT00102323/NCT00102336., Results: The rate of all BREs across all studies was reduced by 56% in patients receiving romiplostim compared with placebo. The rate of BREs using immunoglobulin (IVIg or anti-D Ig) was reduced by 89% in patients receiving romiplostim compared with placebo. BREs were more frequent in both groups at platelet counts <50 × 10(9)/L. Results were similar between splenectomized and nonsplenectomized patients. We believe that prior to the development of this tool, bleeding events were underdiagnosed. The BRE tool allowed the identification of multiple interventions within bleeding episodes, which may have required separate interventions and were therefore considered to be additional BREs., Conclusions: In this study, the composite endpoint of a bleeding event and the use of rescue medication within close proximity of the bleeding event appears to be feasible and informative. The BRE tool allows for more precise understanding of the effect of rescue therapies in ITP and has broader applications to future clinical trials where assessment of bleeding risk can be complicated or masked by rescue interventions., Limitations: This was a post hoc analysis. The assignment of platelet counts to a BRE was based on the platelet count on the first day of a BRE, which may not reflect the platelet count during the entire episode, and the assignment of platelet counts was based on the estimation required for events that occurred between weekly measurements.

Background: Childhood ITP can have a negative impact on the child and his/her family even though it is typically a benign disorder with low risk of serious bleeding. In adults and now children, romiplostim increases the platelet count without significant adverse effects. In this study, the impact of romiplostim treatment on the HRQoL of children with chronic ITP was assessed using the Kid's ITP Tools (KIT)., Procedure: Subjects 1-18 years old, with chronic ITP (>6 months), were enrolled in a multi-center, randomized, double-blind, placebo-controlled phase 1/2 treatment study with romiplostim (reported elsewhere). Subjects and/or proxies completed the KIT at baseline, week 5, and week 13. Scores were computed for child self-report (children >7 years), proxy-report, and parent impact. Changes in mean scores from baseline to week 13 were computed., Results: Twenty-two children (17 receiving romiplostim, 5 placebo) and/or their parents provided data. Change in mean scores demonstrated significant improvement in HRQoL for romiplostim versus placebo for parent impact (24 ± 17 vs. -6 ± 8; P = 0.008). Change scores for child self-report trended toward improvement with romiplostim and decreased with placebo (5 ± 10 vs. -7 ± 17; P = 0.29). Romiplostim proxy-report mean change scores were 6 points higher than placebo (8 ± 16 vs. 2 ± 12; P = 0.50)., Conclusions: Romiplostim significantly reduced parental burden in this study. Whether the same and/or additional improvements in HRQoL would be demonstrated by a larger, longer study of romiplostim-treated children with ITP remains to be determined. Pediatr Blood Cancer 2012; 58: 395-398. © 2011 Wiley Periodicals, Inc., (Copyright © 2011 Wiley Periodicals, Inc.)

Background: Immune thrombocytopenia (ITP) is a chronic, immune-mediated disease characterized by a transient or long-lasting decrease in platelet counts. ITP is associated with numerous serious clinical consequences. Discussed here are clinical aspects of ITP, the humanistic and economic burden of ITP, and current treatment options with a focus on romiplostim, a thrombopoietin (TPO) receptor agonist. The aim of this review is to provide decision-makers with the background information necessary to evaluate the value of romiplostim., Scope: PubMed was searched for relevant, English-language papers published from January 2006 through November 2011 relating to the epidemiology and treatment options of chronic ITP, and, focusing on the TPO mimetic romiplostim, patient-reported outcomes (PRO) and economic burden. Recent select conference abstracts were also reviewed., Findings: The initial clinical management of ITP (e.g., corticosteroids, immunoglobulins) is often associated with adverse events and recommended for short-term use only. Splenectomy, a potentially curative second-line treatment, is associated with increased risks of bleeding and infection, and patients often require additional long-term drug intervention. ITP and its sequelae are associated with a substantial burden on patients' health-related quality-of-life (HRQoL) and increased medical costs. Use of TPO receptor agonists in ITP patients may represent a more efficient use of healthcare resources than existing therapies., Conclusion: While this literature review is not a systematic review, e.g., it considers only approved therapies and published literature written in English, it provides a comprehensive overview of the clinical, humanistic, and economic factors that should be considered in treating ITP, particularly with new agents such as romiplostim. Among the limited number of safe and effective therapies currently available for chronic ITP, highly effective and well-tolerated medications such as romiplostim may reduce the healthcare resource utilization associated with ITP while improving patients' HRQoL.

Objective: To measure utility values associated with immune (idiopathic) thrombocytopenic purpura (ITP), as perceived by the United Kingdom (UK) general public., Research Design and Methods: A multi-step process, including clinical trial data, literature review, and patient focus group, was used to develop ITP health states valued in a web survey. Six ITP health states were defined based on platelet levels, risk of bleeding and key adverse events/disease complications. Clinical trial data on bleeding and ITP-specific quality of life data were key sources for developing health-state descriptions. 359 respondents, randomly selected from a managed web panel in the UK, completed the web-based Time Trade-Off survey. Wilcoxon signed-rank test was used to compare differences between each pair of health states., Results: Sample characteristics (mean age: 47.9 +/- 16.9 years; 54% female) were comparable to the UK general population. ITP health states were valued as significantly worse than perfect health. Experiencing bleeding episodes was a more important driver than low platelet levels in valuing a health state to be worse. Substantial disutilities were associated with surviving an intracranial haemorrhage. Mean (SD) utility values for each ITP health state are: HS1: platelets >or=50 x 10(9)/L, no outpatient bleed: 0.863 +/- 0.15; HS2: platelets >or=50 x 10(9)/L, outpatient bleed: 0.734 +/- 0.19; HS3: platelets <50 x 10(9)/L, no outpatient bleed: 0.841 +/- 0.19; HS4: platelets <50 x 10(9)/L, outpatient bleed: 0.732 +/- 0.19; HS5: intracranial haemorrhage (2-6 months): 0.038 +/- 0.46; HS6: steroid treatment adverse events: 0.758 +/- 0.20. Potential limitations relate to web user population characteristics and lack of comparative testing of web-based TTO methods., Conclusions: Results provide evidence that the UK general population associate substantial loss of value living with ITP, suggesting an important role for new ITP treatments. Utility values based on these health states may be useful in future cost-effectiveness studies of existing and/or new ITP treatments.

Splenectomy is a common therapy for adults with chronic idiopathic thrombocytopenic purpura (ITP). Thisstudy was designed to estimate both the short-term surgical non-response rate and the long-term relapse rate after laparoscopic splenectomy. A systematic review was conducted of articles published between January 1, 1991 and January 1, 2008. Selection criteria included: chronic ITP, study enrollment in 1990 or later, > or =12 months of follow-up, > or =15 patients with ITP, > or =75% of patients at least 14 years of age, not HIV positive, not undergoing a second splenectomy, and type of performed splenectomy clearly reported. Data were pooled across studies to estimate rates. We identified 170 articles, of which 23 met our inclusion criteria (all observational studies). These studies represent 1,223 laparoscopic splenectomies (71 or 5.6% were converted to open splenectomy during surgery). The pooled short-term surgical non-response rate among the 18 studies reporting data was 8.2% (95% CI 5.4-11.0). The pooled long-term relapse rate across all 23 studies was 43.6 per 1,000 patient years (95% CI 28.2-67.2). This translates to an approximate failure rate of 28% at 5 years for all patients undergoing splenectomy. Studies with shorter durations of follow-up had significantly higher pooled relapse rates than studies with longer follow-up (P = 0.04). Laparoscopicsplenectomy is effective for most patients. Splenectomy may have higher initial relapse rates, particularly, in the first 2 years after surgery, and the rate may decline over time. Am. J. Hematol. 2009. (c) 2009 Wiley-Liss, Inc.

Immune thrombocytopenic purpura (ITP) is associated with low platelet counts and, consequently, a high risk of adverse events leading to hospitalization. However, there are few data on the clinical and economic burden of hospitalizations for ITP. The Nationwide Inpatient Sample (NIS) database of discharges, a stratified 20% sample of all United States (US) community hospitals across all payers, was used to evaluate discharges in ITP patients. We developed nationally representative numbers of discharges in ITP patients from 2003 to 2006 based on diagnosis codes. Using appropriate weights for each NIS discharge, we created national estimates of average cost, length of stay, and in-hospital mortality for specific groups of ITP-related hospitalizations. Approximately 129,000 discharges occurred between 2003 and 2006 in ITP patients. The average cost associated with all discharges in 2008 dollars was 16,476, with a 6.4-day length of stay and in-hospital mortality of 3.8%. In contrast, the average cost of all hospitalizations in the US population during the same period was 10,039, the average length of stay was 4.8 days, and in-hospital mortality was 2.5%. Mortality risk was higher for ITP patients than for the standard US population adjusted for age and gender, with a relative mortality ratio of 1.5 (95% CI: 1.4-1.6). On the basis of a nationally representative sample of US discharge records from 2003 to 2006, hospitalization with ITP represents an economically and clinically important event. ITP was associated with higher costs, longer stays, and more in-hospital deaths on average than all other hospitalized patients combined., ((c) 2009 Wiley-Liss, Inc.)

Background: Corticosteroid (CS) therapy is effective in many patients with immune thrombocytopenic purpura (ITP), although it is associated with adverse effects., Objective: This study was conducted to describe the CS-related symptom experience of adult patients with ITP and to compare the symptom experience of current users of CS, previous users of CS, and those who have never used CS., Methods: In 2006, adult members of the Platelet Disorder Support Association (PDSA) who were listed in the organization's database, resided in the United States, and had a diagnosis of ITP were invited to participate in a Web-based survey. Symptom experience was assessed using 33 CS-related symptoms derived from a scale developed for use in patients undergoing organ transplantation. Symptom experience over the past 4 weeks was measured in terms of the occurrence of symptoms (rated on a 5-point scale from 1 [never occurring] to 5 [always occurring]) and the distress associated with those symptoms (rated on a 5-point Likert scale from 0 [not at all distressing] to 4 [extremely distressing]). Respondents were categorized according to 4 patterns of CS use: current users, nonusers, previous users who stopped CS use <6 months earlier, and previous users who stopped CS use >or=6 months earlier., Results: The survey was completed by 985 patients with ITP (8.2% of the PDSA membership). The median age of the sample was 47 years, and the ratio of women to men was 3:1. One hundred sixteen patients (11.8%) were current CS users, 171 (17.4%) were nonusers, 99 (10.1%) had stopped CS use <6 months earlier, and 599 (60.8%) had stopped CS use >or=6 months earlier. In all 4 groups, back pain, fatigue, sleep difficulties, muscle weakness, and difficulty seeing well were reported to be the most frequently occurring and most distressing symptoms. Current CS users and those who stopped CS treatment <6 months earlier also reported bruises to be among their most frequent and distressing symptoms. Twenty-five of the 33 symptoms occurred more frequently in current CS users than in nonusers, and 30 symptoms occurred more frequently in current users than in previous users who had stopped CS use >or=6 months earlier. Symptom occurrence was significantly greater for current users compared with those who stopped CS use <6 months earlier for puffy face (q = 0.003), excessive appetite (q = 0.002), changed facial features (q = 0.033), and buffalo hump (q = 0.048). Patients who had stopped CS use <6 months earlier reported 20 of the 33 symptoms significantly more often than those who had stopped CS use >or=6 months earlier (q < 0.05). The only symptoms reported significantly more often in patients who had stopped CS use >or=6 months earlier compared with nonusers were buffalo hump and bruises (q < 0.05). The distress associated with bruises was significantly higher in current users compared with nonusers and compared with previous users who had stopped CS use >or=6 months earlier (both, q = 0.047). Current users also reported significantly greater distress than nonusers for puffy face and excessive appetite (both, q = 0.047). Changed facial features was significantly more distressing in current users compared with those who had stopped CS use >or=6 months earlier (q = 0.047)., Conclusions: Different symptom profiles emerged based on the pattern of CS use. Patients who were currently using CS or who had stopped CS treatment <6 months earlier reported more symptoms than did patients who had never received CS or who had stopped CS treatment =6 months earlier.

Thrombocytopenia and platelet dysfunction contribute to hemorrhagic complications in the myelodysplastic syndromes (MDS). Reliable data regarding the frequency and consequences of thrombocytopenia in MDS are lacking. An extensive literature review indicated that the prevalence of thrombocytopenia (platelets<100x10(9)/L) in MDS ranged from 40% to 65%; the median frequency of thrombocytopenia prior to any MDS therapy was 65% (range, 23-93%). A retrospective review of patients who were referred to the University of Texas M. D. Anderson Cancer Center (MDACC) identified 1605 of 2410 patients (67%) with thrombocytopenia at referral. Of these, 1756 patients were classified using the International Prognostic Scoring System (IPSS), and 896 patients (51%) had intermediate-2 or high-risk disease. Treatment-related thrombocytopenia was observed in studies that involved azacitidine, tipifarnib, decitabine, lenalidomide, sirolimus, and combination chemotherapy with idarubicin, cytarabine, and topotecan. The reported incidence of hemorrhagic complications in the literature ranged from 3% to 53%, and the frequency of hemorrhagic deaths ranged from 14% to 24%. At MDACC, 460 patients had a coded cause of death: hemorrhage as a contributory cause of death, 20%; hemorrhage as the only cause of death, 10%. Thrombocytopenia was common in MDS, and there was an increased prevalence in higher risk IPSS categories. Many approved and investigational MDS therapies caused or exacerbated preexisting thrombocytopenia. The incidence of severe bleeding in MDS was greater than reported in current guidelines., (Copyright (c) 2007 American Cancer Society)

Goals of Work: The aim of this paper is to analyze the costs of chemotherapy-induced nausea and vomiting (CINV) in Italy., Materials and Methods: In this prospective observational study at seven public oncology centers, incidence and intensity of CINV daily for 8 days after chemotherapy in consecutive patients receiving cisplatin-containing chemotherapy were recorded. All costs related to CINV (direct medical, direct nonmedical, and indirect) were recorded (in 2003 euros)., Main Results: A total of 172 patients were enrolled; cost data were available for 168 patients. Thirty-seven percent of patients experienced acute CINV, and 57% experienced delayed CINV; 39% achieved total control, defined as no nausea, vomiting, or rescue therapy. Mean per-patient costs of acute and delayed CINV were 30.03 euro from the hospital perspective, 4.9 euro from the patient perspective, and 26.85 euro from the National Health Service (NHS) perspective. Costs of CINV were highly variable among oncology centers, largely because of differences in procedures for preventing delayed CINV. These costs were four times higher when antiemetic drugs were prescribed and paid for by the NHS than when antiemetic prophylaxis was provided directly from hospital pharmacies. Moreover, in the delayed phase, the NHS incurred a 94% increase in costs for patients without total control. Overall costs for patients who did not experience total control of CINV were 35.57 euro higher than for those who did (85% increase)., Conclusions: Costs of CINV for the Italian NHS could be reduced if hospitals furnished antiemetic prophylaxis directly to patients. Better control of both acute and delayed CINV would improve patient well-being as well as reduce the budgetary impact of CINV in Italy.

Background: Chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer therapy. We aimed to determine outcomes associated with use of aprepitant in outpatients undergoing highly emetogenic chemotherapy in Germany from a patient's and payer's perspective., Methods: A decision-analytic model compared an aprepitant regimen (aprepitant/ondansetron/dexamethasone) to a control regimen (ondansetron/dexamethasone) over a five days period. Clinical results and resource utilisation observed in aprepitant phase III clinical trials were assigned German unit cost data., Results: Complete response over one chemotherapy cycle was observed in 68% of patients in the aprepitant group (N=514) compared to 48% of patients in the control group (N=518). Patients were estimated to have gained an equivalent of 15 additional hours of perfect health per cycle (0.63 quality-adjusted life days) with aprepitant-based regimen compared to control regimen. Cost per quality-adjusted life year gained with aprepitant was estimated at euro28,891., Conclusions: Aprepitant substantially improved CINV-related health outcomes in patients undergoing highly emetogenic chemotherapy. Incremental benefits materialised in a cost-effective fashion.

Background: The major objective of the study was to determine the incidence and prevalence of acute and delayed chemotherapy-induced nausea and vomiting (CINV) among patients receiving chemotherapy and assess the accuracy with which medical providers perceive the incidence of CINV in their practice., Methods: Specialists, residents and nurses (medical providers) from two cancer centers in Taiwan estimated the incidence of acute and delayed CINV. Chemotherapy-naive patients from the same centers then completed a 5-day nausea and vomiting diary following highly and moderately emetogenic chemotherapy (HEC and MEC) to determine the actual incidence of acute and delayed CINV. Daily nausea ratings were recorded on a 100-mm visual analogue scale (VAS). No nausea was defined as a nausea VAS score <5 mm. Vomiting episodes were also recorded. Nausea and vomiting were defined as acute and delayed based on whether they occurred during the first 24 h after chemotherapy, or during days 2-5 after chemotherapy, respectively., Results: In the two oncology centers, 37 medical providers (13 specialists, 4 residents, 20 nurses) and 107 patients were enrolled. The mean patient age was 49.2 years with 76% female and 74% having breast cancer. Of the 107 patients, 39% received HEC and 61% received MEC, and 77% received a 5-HT3 receptor antagonist and 94% received dexamethasone. There were no significant differences between patients with acute CINV and delayed CINV in terms of demographics, chemotherapy treatment or antiemetic treatment. The proportion of patients without alcohol use was significantly higher among patients with delayed CINV than among those with non-delayed CINV. Good control of CINV during the acute period correlated with the control of delayed emesis. There were no significant differences between specialists', residents', and nurses' estimations of the incidence rates of CINV. For HEC given to chemotherapy-naïve patients, the medical providers estimated acute CINV to be 44/41% and delayed CINV to be 61/53%, respectively. However, patient diaries revealed acute CINV to be 43/21% and delayed CINV to be 64/60%, respectively. For MEC given to chemotherapy-naive patients, medical providers estimated acute CINV to be 39/36% and delayed CINV to be 44/39%, respectively. However, patient diaries revealed acute CINV to be 55/18% and delayed CINV to be 74/55%, respectively., Conclusions: Medical providers significantly overestimated the incidence of acute vomiting by 20% and 18% in HEC and MEC patients, respectively. While they correctly estimated the rate of delayed vomiting in HEC patients, they underestimated it by 16% in MEC patients. With respect to nausea, medical providers correctly estimated rates of both acute and delayed nausea in HEC patients, but significantly underestimated rates of acute and delayed nausea by 16% and 30%, respectively, in MEC patients.

In this study, we estimated the proportion of patients who experience chemotherapy-induced nausea and vomiting (CINV) in current practice and evaluated the impact of CINV on quality of life and cost in Canada. Patients receiving highly emetogenic chemotherapy were recruited from 4 Canadian oncology centers. Patients used diaries to record information on their activities, incidence of nausea and vomiting, and health resources consumed each day for 5 days following chemotherapy. They also completed the Functional Living Index-Emesis (FLIE) questionnaire and a health utility instrument before chemotherapy and 5 days later. Of the 323 patients recruited, 266 (82%) completed their diary. On day 1, 26% of patients reported nausea or vomiting (acute emesis). From day 2 to day 5 after chemotherapy, 44% reported nausea or vomiting (delayed emesis). Patients who experienced nausea or vomiting during the study period had a decrease in FLIE score of 22% and a decrease in health utility of 15%. Patients with nausea or vomiting reported an average of 19 hours per cycle during which they were unable to perform their normal activities. Also, friends or relatives spent an average of 10 hours helping these patients. Incremental medical costs per patient experiencing CINV were $61 Canadian. Including productivity losses, total incremental costs were $592 Canadian per patient. Despite use of antiemetics, CINV remains problematic, impacting the quality of life of patients with cancer and increasing costs.

Goals of Work: The aim of this study was to evaluate the occurrence of chemotherapy-induced nausea and vomiting (CINV) and its effect on patients' ability to carry out daily life activities following moderately to highly emetogenic, first-cycle chemotherapy in routine practice in cancer centers of four different European countries., Patients and Methods: This was a prospective, cross-sectional, nonrandomized, self-assessment study in 249 patients enrolled from cancer centers in Spain, Austria, Germany, and Switzerland. The study population consisted of 78% women, with a mean age of 54. Breast, lung, and ovarian cancers made up 75% of all cancers in the study. Patients received a mean of 2.0 chemotherapy agents and 2.5 antiemetic drugs., Main Results: A total of 450 emetic episodes experienced by 243 patients was recorded over 5 days following chemotherapy, with an average of 1.8 episodes per patient (range: 0-28). A higher percentage of patients (38%) suffered from delayed compared to acute emesis (13%). Between 42% and 52% of all patients suffered from nausea (visual analogue scale > or = 5 mm) on any one day, peaking at day 3. Using the Functional Living Index for Emesis (FLIE) questionnaire, 75% of patients with nausea and 50% with vomiting reported a negative impact of these conditions on performance of daily living., Conclusions: CINV remains a significant problem in routine practice, particularly in the delayed phase posttreatment. Overall, CINV had a negative impact on patients' daily life.