Treatment-related Hospitalizations Research Articles

Comparative Study of the Safety and Efficacy of First-Line Cisplatin and Carboplatin Chemotherapy in Elderly Patients with Metastatic Urothelial Carcinoma

Objectives: Platinum-based chemotherapy is the standard treatment for metastatic urothelial carcinoma (mUC). However, considering elderly patients often experience comorbidities and frailty, the utility of cisplatin-based chemotherapy for elderly patients is still debatable. We conducted this study to compare the safety and efficacy of carboplatin and cisplatin in elderly patients with mUC. Methods: This retrospective study enrolled elderly patients with mUC (defined as aged ≥70 years) who underwent first-line platinum-based chemotherapy between September 2001 and October 2018. The primary endpoints were chemotherapy-related adverse events (AEs), including treatment-related hospitalization or death. The secondary outcomes were overall survival (OS) and progression-free survival calculated by Kaplan-Meier analysis. Results: In total, 108 elderly patients with mUC were enrolled and allocated into the cisplatin or carboplatin group. Patients treated with carboplatin-based chemotherapy had a significantly higher incidence of all grade ≥3 AEs (78.8 vs. 50.0%, p = 0.008) than those on cisplatin. AE-related hospitalization (47.5 vs. 19.1%, p = 0.002) and treatment-related death (17.5 vs. 4.4%, p = 0.02) were significantly increased in the carboplatin group. In the univariate analysis, the median OS in the cisplatin group was significantly increased compared with the carboplatin group (13.6 vs. 7.2 months, p = 0.045). The Cox multivariate regression model indicated that leukocytosis (HR 3.17, 95% CI 1.84–5.46, p < 0.001) and anemia (HR 2.02, 95% CI 1.11–3.65, p = 0.02) were independent prognostic factors. Conclusion: Elderly patients with mUC treated with cisplatin-based chemotherapy had better survival and safety profiles than those treated with carboplatin. Age itself was not a crucial factor in determining cisplatin eligibility.

Prevalence and associated factors of hospitalization for dysglycemia among elderly type 2 diabetes patients: A nationwide study.

BACKGROUNDThe prevalence of older individuals with type 2 diabetes mellitus (T2DM) is increasing due to the aging population and improved medical care. These patients are very susceptible to disease and treatment-related hospitalizations, resulting in higher health care costs, morbidity, and decreased quality of life. However, data of treatment-related complications, especially dysglycemia-related hospitalizations, are lacking.AIMTo assess the prevalence and associated factors for dysglycemia-related hospitalizations among elderly diabetic patients in Thailand using nationwide patient sample.METHODST2DM patients aged ≥ 65 years who received medical care at public hospitals in Thailand in the year 2014 were included. The prevalence of hospitalization due to dysglycemia within one year was examined. Multivariable logistic regression was performed to assess the independent factors associated with hospitalization due to hypoglycemia and hyperglycemiaRESULTSA total of 11404 elderly T2DM patients were enrolled in this study. The mean age was 72.9 ± 5.5 years. The prevalence of hospital admissions due to diabetic ketoacidosis, hyperosmolar hyperglycemic state, hyperglycemic dehydration syndrome, and hypoglycemia among elderly T2DM patients in the year 2014 was 0.1%, 0.1%, 1.7% and 3.1%, respectively. Increased hospitalization due to hypoglycemia was associated with older age, female sex, had hypertension, dementia, lower body mass index, elevated hemoglobin A1C (HbA1C), decreased kidney function, insulin use. Increased hospitalization due to hyperglycemia was associated with dementia, depression, lower body mass index, elevated HbA1C, and insulin use.CONCLUSIONThe prevalence of dysglycemia-related hospitalization in elderly T2DM patients in Thailand was 4.9%. Close monitoring of blood glucose should be provided in high-risk patients for prevention and early detection for these complications.

CYP2B6 polymorphism and lipoprotein lipase expression in chronic lymphocytic leukemia: impact on the outcome of fludarabine–cyclophosphamide regimen

Background Chronic lymphocytic leukemia (CLL) is the most common type of leukemia and has a highly variable clinical course. Cyclophosphamide (CPA)-containing regimens are the standard of care for patients lacking the 17p deletion. CYP2B6 is a polymorphic cytochrome P450 isoform that converts CPA to its active form. Lipoprotein lipase (LPL) catalyzes the hydrolysis of triacylglycerol. Remarkably, a growing body of data emphasizes its role in the biology of different tumors. Objectives This study aimed to study CYP2B6 polymorphism and LPL expression in fludarabine cyclophosphamide (FC)-treated CLL patients lacking 17p deletion. Methods 46 treatment-naive CLL patients negative for 17p deletion and indicated to receive chemotherapy were enrolled. CYP2B6 genotyping and lipoprotein lipase mRNA expression were assayed by Realtime PCR. FC-protocol was given then treatment-related toxicities, response, and event free survival were traced. Results CYP2B6*6 allele was associated with lower rates of treatment-related anemia and hospital admission. The response to FC was affected only by CYP2B6 polymorphism. The event-free survival of responders was significantly higher in patients having low LPL expression. Conclusion CYP2B6*6 infers lower CPA efficacy with lower treatment-induced side effects and increased risk of nonresponding to FC chemotherapy in CLL. LPL expression is a predictor of outcome in CLL, indicating poor survival.

Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC)

Optimal primary febrile neutropenia (FN) prophylaxis (i.e. ciprofloxacin or granulocyte-colony stimulating factors [G-CSF]) for patients receiving docetaxel-cyclophosphamide (TC) chemotherapy is unknown. We assessed the feasibility of using a novel pragmatic comparative effectiveness trial to compare these standard-of-care options. Early-stage breast cancer patients receiving TC chemotherapy were randomised to either ciprofloxacin or G-CSF. Trial methodology consists of broad eligibility criteria, simply-defined endpoints, integrated consent model incorporating oral consent, and web-based randomisation in the clinic. Primary feasibility endpoints included patient and physician engagement (if > 50% of patients approached agree to participate and if > 50% of physicians approached patients for the study). Secondary clinical endpoints included the following: first occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process. Of 204 patients approached, 91.2% (186/204) agreed to randomisation. Sixteen of twenty (80%) participating medical oncologists randomised patients. Median patient age was 57.7 (range 31.8-84.1). The 186 patients received 557 cycles of chemotherapy. Overall incidences of first events by patient (n = 186) were as follows: FN (18/186, 21.43%), treatment-related hospitalisation (11/186, 13.10%), chemotherapy reduction (19/186, 22.62%), chemotherapy discontinuation (16/186, 19.05%), and chemotherapy delays (5/186, 5.95%). A total of 37.77% (69/186) of patients and 12.39% (69/557) of chemotherapy cycles had at least one of these first events. Patients were highly satisfied with the oral consent process. This study met its feasibility endpoints. This model offers a means of comparing standard-of-care treatments in a practical and cost-efficient manner. Trial registration: ClinicalTrials.gov : NCT02173262.

Prescribing patterns for FOLFIRINOX in the real world.

463 Background: FOLFIRINOX therapy is associated with improved outcome in patients with gastrointestinal cancers. The regimen can be associated with significant toxicity and empiric dose modifications are often used. We analyzed 1) real-world prescribing patterns of FOLFIRINOX and 2) toxicity of therapy. Methods: Patients undergoing FOLFIRINOX chemotherapy at an academic, NCI-Designated Comprehensive Cancer Center were identified and electronic medical records reviewed. Patients who received at least one dose of FOLFIRINOX were included. Chemotherapy dose, growth factor use and toxicity data was abstracted for the first 8 weeks. ‘Standard FOLFIRNOX’ was defined as the regimen utilized by Conroy et al (NEJM 2011). Any empiric reduction/withholding of drug dose for cycle 1 was classified as ‘modified FOLFIRINOX’. Bivariate analysis was performed on the data. Results: There were 111 patients seen between 5/2011-3/2017 and 94% had pancreatic cancer. Age range was 29-87 years and 52% were female. 59% received ‘modified FOLFIRINOX’ and 20% received empiric growth factors. Line of therapy for standard vs modified respectively was 71.1% vs 45.5% for 1st, 17.8% vs 36.4% for 2nd, and 11.1% vs 18.2% for beyond 2nd (p = 0.03). Patients with ‘modified FOLFIRINOX’ were more likely to have metastatic disease (p = 0.01), have received second line or beyond, and higher ECOG score (p = 0.03). Patients with ‘modified FOLFIRINOX’ had a trend toward fewer treatment-related ED visits or hospitalization vs ‘standard FOLFIRINOX’ (27.2% vs 42.2% p = 0.10) and fewer treatment delays (25.8% vs 42.2% p = 0.07). Conclusions: In the real world setting, a majority of patients on FOLFIRINOX receive empiric dose modifications. Although modified dose did not translate to a significant difference in ED visits, hospitalizations or treatment delays, there was a trend toward fewer events.

Primary Febrile Neutropenia Prophylaxis for Patients Who Receive FEC-D Chemotherapy for Breast Cancer: A Systematic Review.

PurposeDespite widespread use of fluorouracil, epirubicin, cyclophosphamide, docetaxel (FEC-D) chemotherapy in breast cancer, the optimal strategy for primary febrile neutropenia (FN) prophylaxis remains unknown. A systematic review was therefore performed.MethodsEmbase, Ovid MEDLINE, PubMed, Cochrane Database of Systematic Reviews, Cochrane Register of Controlled Trials, and conference proceedings were searched from 1946 to April 2016 for trials that reported the effectiveness of primary FN prophylaxis with FEC-D chemotherapy. Outcome measures were incidence of FN; treatment-related hospitalizations; chemotherapy dose delays, reductions, and discontinuations; and adverse events from prophylaxis.ResultsOf 2,205 identified citations, eight studies (n = 1,250) met our eligibility criteria. Three additional studies (n = 293) were identified from a prior systematic review. Three randomized controlled trials (n = 576), one phase IV single-arm trial (n = 69), one prospective observational study (n = 37), and six retrospective studies (n = 861) were identified. Agents investigated were pegfilgrastim (n = 108), filgrastim (n = 1,119), and ciprofloxacin (n = 89). The heterogeneity of studies meant that a narrative synthesis of results was performed. Median FN rates for patients who received FEC-D with and without primary prophylaxis were 10.1% (interquartile range [IQR], 3.9% to 22.6%) and 23.9% (IQR, 9.2% to 27.3%), respectively. In the absence of primary prophylaxis, FN was more common during docetaxel than during FEC. Data from six studies showed a median rate of dose reductions and delays of 6.1% (IQR, 3.1% to 14.3%) and 19.3% (IQR, 10.5% to 32.8%), respectively, that occurred as a consequence of FN. Toxicity from prophylaxis itself was rarely reported.ConclusionPrimary FN prophylaxis is effective in patients who receive FEC-D chemotherapy. The paucity of prospective data makes optimal recommendations about the choice and timing of prophylaxis challenging.

Population-based analysis of treatment toxicity among men with castration-resistant prostate cancer.

252 Background: There is little phase 4 data regarding the toxicity and effectiveness of contemporary metastatic castrate-resistant prostate cancer (mCRPC) treatments. We examined hospital admissions and emergency room (ER) visits and survival among patients in the Province of Ontario treated with abiraterone, enzalutamide, docetaxel, or cabazitaxel for mCRPC. Methods: We performed a population-based, retrospective cohort study of 2439 men over the age of 65 treated with abiraterone, enzalutamide, docetaxel, or cabazitaxel for mCRPC from 2003-2015 in Ontario, Canada. Outcomes were toxicity (hospitalizations and ER visits) and overall survival. We used multivariable Cox proportional hazards models with time-varying exposures to calculate hazard ratios (HR). Results: Among 2439 patients, cumulative exposure was greatest for docetaxel (n = 1886 (77.3%); 11,436 person-months), followed by abiraterone (n = 893 (36.6%); 5143 person-months), enzalutamide (n = 52 (2.1%); 351 person-months) and cabazitaxel (n = 18 (0.7%); 61 person-months). Abiraterone exposure was not significantly associated with any-cause (HR 0.88, 95% CI 0.72-1.07) or treatment-related (HR 1.09, 95% CI 0.87-1.37) hospitalizations or ER visits. Enzalutamide was not significantly associated with any-cause (HR 1.20, 95% CI 0.69-2.07) or treatment-related (HR 0.85, 95% CI 0.43-1.68) toxicity. Docetaxel exposure was associated with a significantly increased risk of any-cause (HR 1.29, 95% CI 1.15-1.44) and treatment-related (HR 1.52, 95% CI 1.33-1.74) toxicity. Cabazitaxel exposure was also associated with treatment-related (HR 5.94, 95% CI 1.87-18.92) but not any-cause (HR 2.37, 95% CI 0.59-9.63) toxicity. Patients who began CRPC treatment after the introduction of oral therapies had improved overall survival compared with those treated prior to their introduction (aHR 0.70, 95% CI 0.64-0.77). Conclusions: Among patients with metastatic CRPC, treatment with chemotherapy (docetaxel or cabazitaxel) is associated with an increased risk of hospitalizations and emergency room visits. We failed to show a significantly increased risk for patients treated with oral agents (abiraterone or enzalutamide).

Combination of rituximab and nonpegylated liposomal doxorubicin (R-NPLD) as front-line therapy for aggressive non-Hodgkin lymphoma (NHL) in patients 80years of age or older: a single-center retrospective study.

The incidence of non-Hodgkin lymphoma in patients 80years of age or older is 50 times higher than in 20- to 24-year-olds. Very elderly patients are often not treated with standard immunochemotherapy because of poor performance status, comorbidities, and toxicity concerns. We retrospectively analyzed data for 29 patients diagnosed with diffuse large B-cell lymphoma or grade 3B follicular lymphoma and treated with rituximab in combination with nonpegylated liposomal doxorubicin between January 2010 and August 2015. The median age was 84years. The overall 3-year survival, cause-specific survival, and progression-free survival rates were 46%, 55%, and 44%, respectively. Among prognostic factors, only the achievement of complete remission strongly correlated with overall survival, cause-specific survival, and progression-free survival rates. Treatment caused very mild toxicity, without treatment-related hospitalization or toxic deaths.

Optimal primary febrile neutropenia prophylaxis for patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer: a systematic review.

Due to the high rate of febrile neutropenia (FN) with docetaxel-cyclophosphamide (DC) chemotherapy, primary FN prophylaxis is recommended. However, the optimal choice of prophylaxis [i.e., granulocyte-colony stimulating factors (G-CSF) or antibiotics] is unknown. A systematic review was performed to address this knowledge gap. Embase, Ovid Medline, Pubmed, the Cochrane database of systematic reviews, and Cochrane register of controlled trials were searched from 1946 to April 2016 for studies evaluating primary prophylactic FN treatments in breast cancer patients receiving DC chemotherapy. Outcome measures evaluated included: incidence of FN and treatment-related hospitalizations, chemotherapy dose reduction/delays/discontinuations, and adverse events. Screening and data collection were performed by two independent reviewers. Of 2105 identified records, 7 studies (n=2535) met the pre-specified eligibility criteria. Seven additional studies (n=621) were identified from prior systematic reviews. There were 3 randomized controlled trials (RCTs) (n=2256) and 11 retrospective studies (n=900). Study sample sizes ranged from 30 to 982 patients (median 99.5), evaluating pegfilgrastim (n=1274), filgrastim (n=1758), and oral ciprofloxacin (n=108). Given the heterogeneity of patients and study design, a narrative synthesis of results was performed. Median FN rates with and without primary prophylaxis were 6.6% (IQR 3.9-10.6%) and 31.3% (IQR 25-33%), respectively. No FN-related deaths were reported. No RCT directly compared G-CSF with antibiotic interventions. Primary FN prophylaxis reduces the incidence of FN. Despite considerable cost and toxicity differences between G-CSF and antibiotics, there is insufficient data to make a recommendation of one strategy over another.

Predictive Comprehensive Geriatric Assessment in elderly prostate cancer patients: the prospective observational scoop trial results.

The Comprehensive Geriatric Assessment (CGA) represents the future of the geriatric oncology to reduce toxicities and treatment-related hospitalization in the elderly. Most patients receiving docetaxel for metastatic castration-resistant prostate cancer are in their seventies or older. We explored the efficacy of the CGA in predicting chemotherapy feasibility and response to docetaxel in a cohort of 24 patients aged at least 70. This was an observational, prospective study involving 24 patients who were 70 years of age or older and about to start chemotherapy with docetaxel for metastatic castration-resistant prostate cancer; we performed a CGA including five domains and divided our patients into 'healthy' and 'frail'; the relations between general condition and (i) early chemotherapy discontinuation and (ii) response to docetaxel were explored. We found a statistically significant relationship between frailty assessed by CGA and early docetaxel discontinuation; we also found an association between frailty and response to chemotherapy, but this did not reach statistical significance. A geriatric assessment before starting chemotherapy may help clinicians to recognize frail patients, and hence to reduce toxicities and early treatment discontinuation. Further analyses are required to simplify the CGA tools and to facilitate its incorporation into routine clinical practice.

Hospitalizations to Manage Complications of Modern Prostate Cancer Treatment in Older Men

To assess rates of treatment-related hospitalizations following surgery and radiotherapy in the treatment of clinically localized prostate cancer, given the importance of hospitalizations in healthcare resource utilization. We conducted a population-based retrospective cohort study of patients aged 65-79 years receiving radical prostatectomy (open or minimally invasive) or radiotherapy (brachytherapy or external beam) from 2001 to 2008 in the Surveillance, Epidemiology & End Results-Medicare linked databases. We assessed treatment-related hospitalizations. We analyzed the role of primary treatment on the number of complications per patient in each category using negative binomial regression. Among 60,476 men, 14,492 underwent primary surgery and 45,984 underwent primary radiotherapy. Over a median follow-up of 5.6 years, the surgery group had significantly lower rates of hospital admissions (8.9 vs 20.3/1000 person-years) than the radiation group. For both groups, admissions peaked within 2 years of treatment, but continued at a steady rate for 10 years. After adjustment for confounders, patients treated with radiation had higher incidence of hospital admissions (relative rate [RR] = 1.8, 95% confidence interval [CI]: 1.8-1.9, P < .0001), compared to those having surgery. Stratified analysis showed an increased rate of hospitalizations of 1 day and 2 or more days (RR 3.1, 95% CI: 2.7-3.7 and RR 1.6, 95% CI 1.4-1.8, respectively) for patients treated with radiotherapy. The use of adjuvant/salvage therapies significantly increased rates of hospitalization. The results were robust to analysis using propensity-score matching. Treatment-related hospitalizations are more common following radiotherapy than surgery in the treatment of clinically localized prostate cancer. Limitations include a lack of treatment detail and residual confounding due to observational study design.

Prevalence and Outcomes of Liver Transplantation in Children With Intellectual Disability.

We sought to describe the prevalence and outcomes of liver transplantation in children with intellectual disability (ID). We hypothesized that recipients with ID have comparable short-term outcomes compared with those without ID. We performed a retrospective cohort analysis of children receiving a first liver-alone transplant in the United Network for Organ Sharing dataset from 2008 to 2013. Recipients with definite or probable ID were compared to children without ID using χ tests. Kaplan-Meier curves were constructed for patient and graft survival. Cox proportional hazard models were used to estimate the association between ID and graft failure and patient survival. During the study period, 254 children with definite (115) or probable (139) ID underwent first liver transplant, accounting for 15% of all first pediatric liver transplants (1721). Recipients with definite ID tended to be male have a metabolic indication for transplant, a lower pediatric end-stage liver disease score at listing than recipients with no ID, and were less likely to receive a living donor transplant. Recipients with ID were more likely to have public insurance and had more treatment-related hospitalizations in the first year than those without ID. Functional status tended to improve in all recipients at follow-up. ID was not significantly associated with patient or graft survival. Children with ID form a significant portion of total liver transplant recipients, and their short-term graft and patient survival are comparable with children without ID. Further research is needed to examine long-term outcomes of transplant in this population.

Therapeutic efficacy of percutaneous microwave coagulation versus liver resection for single hepatocellular carcinoma ≤3 cm with Child-Pugh A cirrhosis

AimsThis study aimed to compare the therapeutic efficacy of liver resection (LR) and percutaneous microwave coagulation therapy (PMCT) for single hepatocellular carcinoma ≤3 cm (HCC) in cirrhotic livers. MethodsIn this study, 190 patients with single HCC ≤3 cm and Child-Pugh A cirrhosis were retrospectively reviewed. Among these patients, 122 patients underwent LR, and 68 patients received PMCT. The therapeutic efficacy and complications were compared between the two procedures. ResultsThere was no treatment-related hospital mortality in either group. Major complications were significantly more frequent in the LR group compared to the PMCT group (22.1% vs 5.9%, p = 0.004). The 1-, 3-, and 5-year OS rates for the LR group and PMCT group were 98.4%, 93.6%, 55.2% and 97.1%, 87.7%, 51%, respectively. There was no significant difference in OS rates between the LR group and PMCT group (p = 0.153). The 1-, 3-, and 5-year DFS rates were 96.7%, 70.5% and 43.7%, respectively, in the LR group, which were significantly higher compared to the PMCT group (92.6%, 50.5% and 26.3%, p = 0.006). Subgroup analyses revealed that HCC patients with portal hypertension (PH), OS and DFS were similar between the two groups. ConclusionsLR may provide better DFS and lower recurrence rates than PMCT for single HCC ≤3 cm and Child-Pugh A cirrhosis. For HCC patients with PH, PMCT may provide therapeutic effects that are similar to LR.

Effect of radical prostatectomy surgeon volume on complication rates from a large population-based cohort.

Surgical volume can affect several outcomes following radical prostatectomy (RP). We examined if surgical volume was associated with novel categories of treatment-related complications following RP. We examined a population-based cohort of men treated with RP in Ontario, Canada between 2002 and 2009. We used Cox proportional hazard modeling to examine the effect of physician, hospital and patient demographic factors on rates of treatment-related hospital admissions, urologic procedures, and open surgeries. Over the study interval, 15 870 men were treated with RP. A total of 196 surgeons performed a median of 15 cases per year (range: 1-131). Patients treated by surgeons in the highest quartile of annual case volume (>39/year) had a lower risk of hospital admission (hazard ratio [HR]=0.54, 95% CI 0.47-0.61) and urologic procedures (HR=0.69, 95% CI 0.64-0.75), but not open surgeries (HR=0.83, 95% CI 0.47-1.45) than patients treated by surgeons in the lowest quartile (<15/year). Treatment at an academic hospital was associated with a decreased risk of hospitalization (HR=0.75, 95% CI 0.67-0.83), but not of urologic procedures (HR=0.94, 95% CI 0.88-1.01) or open surgeries (HR=0.87, 95% CI 0.54-1.39). There was no significant trend in any of the outcomes by population density. The annual case volume of the treating surgeon significantly affects a patient's risk of requiring hospitalization or urologic procedures (excluding open surgeries) to manage treatment-related complications.

A retrospective analysis of treatment-related hospitalization costs of pediatric, adolescent, and young adult acute lymphoblastic leukemia.

This retrospective study examined the longitudinal hospital outcomes (costs adjusted for inflation, hospital days, and admissions) associated with the treatment of pediatric, adolescent, and young adult acute lymphoblastic leukemia (ALL). Patients between one and 26years of age with newly diagnosed ALL, who were treated at Primary Children's Hospital (PCH) in Salt Lake City, Utah were included. Treatment and hospitalization data were retrieved from system-wide cancer registry and enterprise data warehouse. PCH is a member of the Children's Oncology Group (COG) and patients were treated on, or according to, active COG protocols. Treatment-related hospital costs of ALL were examined by computing the average annual growth rates (AAGR). Longitudinal regressions identified patient characteristics associated with costs. A total of 505 patients (46.9% female) were included. The majority of patients had B-cell lineage ALL, 6.7% had T-ALL, and the median age at diagnosis was 4years. Per-patient, first-year ALL hospitalization costs at PCH rose from $24,197 in 1998 to $37,924 in 2012. The AAGRs were 6.1, 13.0, and 7.6% for total, pharmacy, and room and care costs, respectively. Average days (AAGR=5.2%) and admissions (AAGR=3.8%) also demonstrated an increasing trend. High-risk patients had 47% higher costs per 6-month period in the first 5years from diagnosis than standard-risk patients (P<0.001). Similarly, relapsed ALL and stem cell transplantations were associated with significantly higher costs than nonrelapsed and no transplantations, respectively (P<0.001). Increasing treatment-related costs of ALL demonstrate an area for further investigation. Value-based interventions such as identifying low-risk fever and neutropenia patients and managing them in outpatient settings should be evaluated for reducing the hospital burden of ALL.

PTU-105 Real world effectiveness, safety and cost per cure in hepatitis C patients treated with protease inibitor based therapy: results from the HCV research UK cohort

Introduction To estimate real world effectiveness, safety and cost per sustained virological response (SVR) of 1stgeneration protease inhibitor (PI)- based therapies for GT1 chronic HCV infection (CHC) in clinical practice in the UK. Method Patients treated with telaprevir (TPV) or boceprevir (BOC) (stratified 2:1), pegylated interferon and ribavirin (PR) with available outcome data were randomly selected from the HCV Research UK database. Healthcare utilisation and adverse events (AEs) requiring intervention were identified from case note review. Cost of drugs, visits, diagnostics, and AE management were estimated from published sources. Causality of treatment regimen in relation to AE was independently assessed by 2 clinicians. Cost per SVR was calculated as total median cost divided by SVR rate. Sensitivity analyses exploring the impact of SVR rate, discontinuations, inclusion of unclassifiable AEs/hospitalisations and PI price on cost per SVR were undertaken. Results 154 patients from 35 UK centres were analysed. Baseline characteristics: median age 50y (IQR 44–56), male 73%, cirrhotic 21%, 52% treatment experienced (TE). Overall SVR was 62.3% (range 25% in cirrhotic prior null responders, to 86.2% in non-cirrhotic prior relapsers). 53/154 (34.4%) patients discontinued therapy prematurely (50.9% physician withdrew, 26.4% patient withdrew, 22.6% failed stopping rules). 36% (55/154) experienced treatment-related AEs requiring intervention, leading to treatment discontinuation in 25.4% (14/55). 8.4% (13/154) patients required hospitalisation for treatment related AEs. Total treatment related costs for cohort were £4,288,802 (PI: 68.3%, PR: 26.3%, AE management and follow-up: 5.4%). Median total cost per cure was £44,852 (range £35,492 TN non-cirrhotic to £107,288 in cirrhotic prior NR). ![Abstract PTU-105 Table 1][1] Abstract PTU-105 Table 1 Conclusion This is the first UK multicentre study estimating outcomes and costs of PI based regimen in clinical practice. There was substantial variation in SVR and cost per SVR among patient subgroups. These cost per SVR estimates are conservative as retreatment costs for patients not achieving SVR are not included. The high discontinuation rate and HCV treatment-related AEs and hospitalisations suggest a substantial additional burden. Disclosure of interest S. Barclay Grant/ Research Support from: Gilead, Janssen, MSD, Consultant for: Abbvie, BMS, Gilead, Janssen, MSD, Speaker Bureau of: Gilead, Janssen, MSD, Roche, G. Cooke Grant/ Research Support from: Janssen, BMS and Gilead, Consultant for: Janssen, BI, Gilead and Merck, W. Irving Grant/ Research Support from: Pfizer, GSK, Gilead; Educational grants: BI, Gilead, Merck, Consultant for: Merk, Novartis, BMS, Speaker Bureau of: Janssen, E. Holtham: None Declared, M. Bec Conflict with: conducted the statistical analyses funded by Gilead, J. Schwarzbard Conflict with: conducted the statistical analyses funded by Gilead. [1]: pending:yes

Frequency and predictors of hospitalization during chemotherapy: a systematic review.

6583 Background: Hospitalization during chemotherapy is a significant event from both the patient and healthcare system perspectives but little is known about how often it occurs and in which settings. We conducted a systematic review to define the frequency of and factors associated with treatment-related hospitalization among cancer patients (pts) undergoing chemotherapy. Methods: A systematic search of Medline and EMBASE databases, from 1946 to September 2013, was undertaken to identify articles reporting rates of hospitalization in pts with cancer undergoing chemotherapy. Observational studies and clinical trials were eligible but results were analysed separately for each group. Summary statistics were used to describe the results and the Chi-square test was used to compare the groups. Results: Sixty articles met inclusion criteria: 44 observational studies comprising 189,342 pts and 16 randomized controlled trials comprising 13,086 pts. The majority of articles (80%) focused on chemotherapy given wit...

Treatment-related hospitalization costs of pediatric acute lymphoblastic leukemia.

e17768 Background: Pediatric cancer hospitalizations cost five times as much as other pediatric hospitalizations in the United States. Yet, studies that evaluate the longitudinal costs of pediatric...

Impact of time to treatment of oseltamivir on influenza hospitalization cost among Korean children.

Although oseltamivir is a common influenza treatment, there is a lack of data on the economic benefits of timely oseltamivir treatment. From February 2004 through June 2007, 116 hospitalized children ≤ 15 years of age with laboratory-confirmed influenza who received oseltamivir were identified via retrospective medical chart review. Demographic, clinical, and cost data were abstracted and multivariate linear regression was used to assess the association between oseltamivir time to treatment and treatment-related costs among hospitalized children with laboratory-confirmed influenza. Overall, 28% (n = 33) of patients were treated with oseltamivir ≥ day 3 of admission. Rapid influenza diagnostic test was used in a significantly lower proportion of patients treated with oseltamivir ≥ day 3 of admission compared with those who received oseltamivir earlier. On multivariate linear regression, initiation of oseltamivir ≥ day 3 of admission was associated with a 60.84% increase (95%CI: 32.59-95.11) in treatment-related hospital costs, compared with initiation on admission. Delayed initiation of oseltamivir was found to be associated with increased treatment-related hospital costs among children hospitalized with laboratory-confirmed influenza.

FOLFIRINOX for advanced pancreatic cancer: The Princess Margaret experience.

417 Background: The FOLFIRINOX regimen has been shown to significantly increase both overall (OS) and progression free (PFS) survival in metastatic pancreas cancer (MPC), albeit with an increase in adverse events (AEs). It is not known whether initial dose reductions compromise FOLFIRINOX efficacy and there are limited data regarding treatment of locally advanced pancreatic cancer (LAPC). Methods: We conducted a retrospective review of patients (pts) treated with FOLFIRINOX for MPC or LAPC at Princess Margaret Cancer Centre, and began treatment between Dec 2011 and April 2014. The primary objective was to evaluate the efficacy and safety of FOLFIRINOX when used with dose modifications. Results: 102 pts were identified; 66 MPC and 36 LAPC. Median age was 65 years. 72% of pts had pancreatic head tumors. At baseline 95% of pts had an ECOG performance status of 0 or 1; 95% had bilirubin &lt; 1.5 ULN and 45% had a biliary stent. 68% of pts initiated treatment with a dose reduction (93% reduction or omission of bolus 5FU, 88% reduction in Irinotecan, 68% reduction in Oxaliplatin and 66% reduction in infusional 5FU). Median number of cycles was 6 (1-31); 25% of pts received &lt;4 cycles. Median OS in metastatic pts was 12.9 months (mo) and 23 mo in LAPC; Median PFS was 8.7 mo (metastatic) and 11.1 mo in LAPC. There was no significant difference in PFS (10.9 vs. 10.3 mo; p=0.60) or OS (11.1 vs. 14.0 mo; p=0.19) between the full starting dose and reduced starting dose groups respectively. Partial response or stable disease was achieved in 57% of pts; 11% of the LAPC pts had a surgical resection. Grade 3/4 hematologic AEs were observed in 43% of pts (febrile neutropenia in 6%). Only 13% of pts received G-CSF support. Grade 3/4 non-hematologic AEs were observed in 28% of pts, including vomiting (19%), nausea (16%) and diarrhea (16%). 18% of pts had a treatment related hospitalization (5% neutropenic sepsis, 13% GI toxicity/dehydration.) There was one treatment related death. Pt wellbeing (scored on a validated questionnaire) significantly improved from baseline to cycle 4 (p=0.002). Conclusions: Modest dose reductions do not appear to compromise efficacy of FOLFIRINOX. Our median PFS, OS and AEs are comparable to other studies using FOLFIRINOX in both LAPC and metastatic disease.