Objective We provide a real‐world overview of multiple myeloma (MM) treatment patterns, outcomes and healthcare resource use (HRU) in Portugal. Methods Data were collected retrospectively from consecutive patients diagnosed/treated at the Portuguese Oncology Institute of Porto (IPO‐Porto) between 2012 and 2015. Primary objectives were progression‐free survival (PFS) and overall survival (OS), with treatment patterns and HRU secondary. Analysis was by line of therapy (LOT), and post hoc by age (<65/≥65 years). Results 165, 73 and 32 patients received first, second and third LOTs respectively (N = 187). OS probabilities were 91.5%, 83.2% (<65 years) and 86.6%, 65.3% (≥65 years) at 12, 24 months respectively. PFS decreased from the start of each LOT for both age groups and was less for patients ≥65 years. Younger patients received more combination treatment (immunomodulatory drugs + proteasome inhibitors) and stem cell transplants, and had higher mean costs than older patients (€81,213 vs. €36,864 where three LOTs were received). Cost drivers were medications, transplantations and hospitalisations. Conclusion Our results suggest divergence between younger and older MM patients. Older patients had lower OS and PFS probabilities, HRU costs and fewer stem cell transplantations. The treatment patterns in each LOT may differ from other countries’ findings, suggesting treatment heterogeneity.
Objectives: To characterize real-world prescribing patterns and their clinical and healthcare resource utilization (HRU) implications in patients with metastatic renal cell carcinoma (mRCC) treated in Germany. Methods: Eligible individuals were enrolled in the "Bundesverband der Betriebskrankenkassen" claims database and received targeted mRCC therapy between 1 January 2008 and 31 December 2016. Prescribing patterns and HRU were characterized by treatment line and summarized by descriptive statistics. Proxy progressionfree survival (PFS) and overall survival (OS) were estimated using Kaplan-Meier curves. Results: 536 patients receiving mRCC treatment were included. The median treatment duration was 4.2 months (interquartile range [IQR]: 1.7-9.3) for first-line therapy and 3.8 months (IQR: 1.7-9.1) for secondline therapy. Median PFS and OS estimates were similar for the first-and second-line treatments: PFS, 7.4 versus 7.2 months; OS, 14.9 versus 13.6 months. Mean HRU costs were higher for patients receiving first-line therapy (€7,253.2) compared with those receiving second-line therapy (€6,242.9). Exploratory stratification of outcomes by centre expertise suggested a possible trend towards improved OS in the 10 most experienced centres versus all-others: firstline, 18.4 versus 13.2 months; second-line, 16.4 versus 12.4 months. Conclusions: In routine care, German clinicians make rational prescribing decisions; possible variations in outcomes between centres warrant further investigation.
Introduction:SIMPLICITY (NCT01244750) is an ongoing observational study of CP-CML pts in routine clinical practice receiving first-line (1L) imatinib (IM) prior to 2010 (retrospective) or 1L IM, dasatinib (DAS) or nilotinib (NIL) since 2010 (prospective) in the US and Europe. Methods: This analysis was designed to identify baseline characteristics associated with TKI switching in pts pooled from the prospective and retrospective cohorts. Pts were characterized as 'early switchers' (who discontinued 1L TKI and switched to a second-line [2L] TKI within 3 months of TKI initiation) or 'late switchers' (who discontinued 1L TKI and switched to a 2L TKI between 3 and 12 months after TKI initiation). A comparator group of 'non-switcher' pts did not discontinue 1L TKI within 12 months of TKI initiation; 'early non-switchers' did not switch 1L TKI within the first 3 months and 'late non-switchers' did not switch 1L TKI between 3 and 12 months after TKI initiation. Logistic regression analysis was used to identify factors associated with early vs. late switching (gender, age at diagnosis ≥65 years, 1L TKI, region, reason for discontinuation). Results: By March 07 2016, 1494 pts were enrolled at 197 sites in 7 countries. Within 12 months of initiating 1L TKI 238 pts (16%) had switched to 2L TKI. Of switchers, 31% and 69% were early and late, respectively. Of the overall cohort, 1189 pts were early non-switchers and 1146 were late non-switchers. Most early switchers received IM as 1L TKI (49%), followed by NIL (32%) and DAS (19%); most late switchers received IM (56%), followed by DAS (26%) and NIL (18%). Fewer early non-switchers than switchers received IM as 1L TKI (43%), followed by NIL (28%) and DAS (28%); fewer late non-switchers than switchers received IM (44%), followed by DAS (28%) and NIL (28%). Most switchers were female; a higher proportion of female switchers was early vs. late (63% vs. 52%, respectively). In comparison, 43% of pts in both non-switching groups were female. Median ages of early and late switchers were 54 (interquartile range [IQR]: 46-68) and 58 (IQR: 46-69) years, respectively; median ages of early and late non-switchers were 56 (IQR: 46-68) and 56 (IQR: 45-67) years, respectively. Logistic regression analysis showed that pts who switched due to intolerance had greater odds of switching early compared with those who switched due to resistance (odds ratio = 3.49; 95% confidence interval: 1.11-10.98; p=0.0323). Among the 238 pts who switched 1L TKI, the main reason for 1L TKI discontinuation was intolerance (early switchers: 76%; late switchers: 71%; Figure). The most common intolerances leading to changes in early and late switchers varied by 1L TKI. Most common for IM early switchers (n=26) was general disorders/administration site conditions (including fatigue, edema, pain) and skin/subcutaneous disorders; for IM late switchers (n=53), gastrointestinal (GI) disorders, general disorders/administration site conditions and skin/subcutaneous disorders. Most common for DAS early switchers (n=10) was GI disorders; for DAS late switchers (n=36), respiratory/thoracic/ mediastinal disorders. Most common for NIL early switchers (n=19) was GI disorders; for NIL late switchers (n=25), GI disorders, general disorders/administration site conditions and skin/subcutaneous disorders. TKI resistance less commonly contributed to 1L TKI discontinuation. Primary and acquired resistance were seen in higher proportions of late than early switchers (Figure). In late switchers, primary resistance was a more common reason for discontinuation in IM pts vs. DAS pts or NIL pts (22%, 5% and 4%, respectively). Acquired resistance was only reported as a reason for discontinuation in IM-treated pts (early switchers: 0.3%; late switchers: 11%). Conclusions: Of pts switching or discontinuing 1L TKI in the first 12 months of therapy, around one third switched within the first 3 months; compared with late switchers and non-switchers these pts were more likely to be younger and female. TKI intolerance was the main reason for switching and was significantly associated with early switching. Resistance was a less common reason for changing TKI therapy and was seen more frequently after 3 months and among pts treated with IM. More research is necessary to make definitive conclusions about comparisons between TKI groups, given the small numbers of pts in the TKI cohorts and the non-controlled nature of the trial. Disclosures Goldberg: COTA Inc: Employment; Novartis: Consultancy; Neostem: Equity Ownership; Pfizer: Honoraria; Bristol-Myers Squibb: Speakers Bureau; Novartis: Speakers Bureau. Michallet:Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Astellas Pharma: Consultancy, Honoraria; MSD: Consultancy, Honoraria; Genzyme: Consultancy, Honoraria. Hehlmann:Bristol-Myers Squibb: Consultancy; Novartis: Research Funding; German CML-Group: Research Funding. Zyczynski:Bristol-Myers Squibb: Employment. Foreman:ICON Clinical Research: Employment. Calimlim:ICON Clinical Research: Employment. Paquette:Incyte: Consultancy, Honoraria; Novartis: Consultancy; Ariad: Consultancy. Gambacorti:Pfizer: Honoraria, Research Funding. Cortes:ARIAD: Consultancy, Research Funding; Bristol-Myers Squib: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Teva: Research Funding. Zagorska:Bristol-Myers Squibb: Employment. Rong:Bristol-Myers Squibb: Employment. Mauro:BMS: Consultancy; Ariad: Consultancy; Pfizer: Consultancy; Novartis: Consultancy.
Objectives: Adverse Events (AEs) associated with existing and future treatments in Non-Small Cell Lung Cancer (NSCLC) are frequent, and may impact should be accounted for in health economic models. In addition to utility decrements, appropriate costing of AE management is needed. In the case of NSCLC which affects 45 200 patients in France, published data are scarce and not always complete. It was therefore thought of importance to assess resource use and costs associated with AEs. MethOds: When looking at the grade 3 and4 AEs appearing for at least 1% of patients in the clinical trials for erlotinib (TITAN, LUX-LUNG 8), ramucirumab plus docetaxel (REVEL), docetaxel and pembrolizumab (KEYNOTE 010) a list of 20 grade 3 and 4 AEs was identified as relevant for Health Economic analysis. Among them, 7 did not had cost data available in the literature. Three French oncology experts were consulted. A questionnaire was sent before the meeting with the experts, asking for, according to the grade, insight on resource use (hospitalisation, follow-up visits, diagnosis exams, treatments). Results were discussed during the meeting in order to reach a consensus. Total cost per AE, expressed in 2016 Euros, was then calculated from a national health insurance perspective based on public and private weighted tariffs and 2014 PMSI database. Results: The mean AE cost was € 206 for thrombocytopenia, € 263 for ocular toxic effect, € 2,332 for arthralgia, € 3,282 for venous thromboembolism, € 3,732 for pulmonary bleeding, € 5,176 for dehydration, € 5,751 for pneumonia, infiltration or pneumonitis. Hospitalization costs corresponded to 46% to 100% of total AE cost. These AE costs were in line with the costs of other grade ¾ AEs previously published for NSCLC therapies. cOnclusiOns: Among the seven AEs, four appear to have an important economic impact, with a management cost of at least € 3,000.
A 3 4 7 -A 7 6 6 A751 1st line of MM treatment during the study; 2nd and 3rd lines were initiated by 282 and 146 patients respectively. Median age across treatment lines was 72-74 years; 54-59% were male. Most patients received novel immunomodulatory drugs (1st line: 62%; 2nd: 43%; 3rd: 56%), followed by novel protease inhibitors (1st line: 27%; 2nd: 42%; 3rd: 32%). The most commonly received 1st line therapies were thalidomide-based (60%); 2nd line: bortezomib-based (42%); 3rd line: lenalidomide-based (45%). Patients initiating 1st or 2nd lines had 2.2 hematologist outpatient visits/month; 2.3 visits/month for a 3rd line. There were 1.8 inpatient days/month for the 1st line; 2nd line: 1.5; 3rd line: 2.5. Monthly costs/patient associated with HCRU were estimated at € 1,734 for the 1st line, € 1,524 for the 2nd and € 2,139 for the 3rd. Costs were mainly driven (> 60%) by inpatient days. Resource use was skewly distributed and the ranges of average HCRU/month were large. Mean inpatient days/month was relatively high due to a small number of patients with long hospital admissions. ConClusions: This study provides recent real-world evidence on patient and treatment characteristics, HCRU, and treatment costs of MM in the Netherlands. Future analyses should include larger sample sizes, longer patient follow-up, and new MM treatments.
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