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Objective: To estimate the costs of adverse events (AEs) in patients aged ≥65 years with metastatic renal cell carcinoma (mRCC)., Methods: Retrospective study using the linked Surveillance, Epidemiology and End Results (SEER) Medicare database. Study subjects consisted of persons in SEER-Medicare, aged ≥65 years, with evidence of newly diagnosed mRCC between January 1, 2007 and December 31, 2007. Adverse events of interest consisted of Grade 3 or 4 toxicities that have been reported with frequency ≥5% in randomized controlled trials of sunitinib, sorafenib, bevacizumab, and pazopanib (i.e., targeted therapies for mRCC), and included abdominal pain, back pain, diarrhea, dyspnea, extremity pain, fatigue/asthenia, hand-foot syndrome, hypertension, lymphopenia, nausea/vomiting, neutropenia, proteinuria, and thrombocytopenia. Patients in SEER-Medicare with these events were identified based on ICD-9-CM diagnosis codes on Medicare claims. For each AE of interest, costs were tallied among evented patients over 30 days, beginning with the date of each patient's first mention of the AE, and were compared with those of non-evented patients over a similar 30-day period beginning with an identical 'shadow' index date. Total costs were compared on an unadjusted basis and with adjustment for differences in baseline characteristics using a generalized linear model., Results: A total of 881 patients with mRCC met study entry criteria; 60% of these patients had Medicare claims with mention of one or more AEs of interest. Events occurring with frequency >20% included abdominal pain, dyspnea, and fatigue/asthenia; 10-20% of study subjects had encounters for back pain, extremity pain, and nausea/vomiting. Mean (standard deviation) total cost of care over 30 days was substantially higher among patients with AEs ($13,944 [$14,529]) compared with those without mention of these events ($1878 [$5264]). Adjusting for differences in baseline characteristics, the mean (95% confidence interval) difference in costs between evented and non-evented patients was $12,410 ($9217-$16,522). Study limitations include problems in event ascertainment due to inaccuracies in ICD-9-CM coding on Medicare claims data, and restriction of the study population to patients with metastatic involvement at initial diagnosis of RCC., Conclusions: Costs of care are substantially higher in patients aged ≥65 years with mRCC who experience AEs commonly associated with sunitinib, sorafenib, bevacizumab, and pazopanib. Efforts to prevent and/or better manage these events potentially can reduce healthcare costs.

Background: In a phase 3, randomized, open-label trial (Pazopanib versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma, COMPARZ; NCT00720941), pazopanib was found to be noninferior to sunitinib in terms of progression-free survival in patients with metastatic renal cell carcinoma with no prior therapy. Overall treatment differences were evaluated in a post hoc analysis with a quality-adjusted time without symptoms or toxicity (Q-TWiST) methodology.Methods: Each patient's overall survival was partitioned into 3 mutually exclusive health states: time with grade 3 or 4 toxicity (TOX), time without symptoms of disease or grade 3/4 toxicity of treatment, and time after tumor progression or relapse (REL). The time spent in each state was weighted by a health-state utility associated with that state and summed to calculate the Q-TWiST. A threshold utility analysis was used, and utilities were applied across the range of 0 (similar to death) to 1 (perfect health).Results: A total of 1110 patients were enrolled (557 on pazopanib and 553 on sunitinib). The mean TOX was 31 days (95% confidence interval, 13-48 days) longer for sunitinib versus pazopanib. In the threshold utility analysis, the difference in the Q-TWiST ranged from -11 days (utility for TOX, 1; utility for REL, 0) to 43 days (utility for TOX, 0; utility for REL, 1) in favor of pazopanib across most utility combinations. Differences were significant in less than half of the utility combinations examined, and this typically occurred when the utility for TOX was lower than the utility for REL.Conclusions: Patients randomized to pazopanib had a slightly longer Q-TWiST in comparison with sunitinib patients, and this was primarily due to the reduced length of TOX. [ABSTRACT FROM AUTHOR]

Background. The most common chemotherapies inmetastatic sot tissue sarcoma (mSTS) require intravenous (IV) administration. his often requires patients to make multiple outpatient visits per chemotherapy cycle, possibly impeding patients' daily activities and increasing caregiver burden and medical costs. This study investigated costs associated with IV cancer therapy administration in mSTS from the payer perspective of the health care system. Patients and Methods. From the Experian Healthcare database, 1,228 mSTS patients were selected. Data were analyzed on outpatient visits during 2005-2012 involving IV cancer therapy administration. Costs were estimated on a per patient per visit (PPPV) and per patient permonth (PPPM) basis. Results. The mean (median) cost of IV therapy was $2,427 ($1,532) PPPV and $5,468 ($4,310) PPPM, of which approximately 60% was IV drug costs. IV administration costs averaged $399 PPPV and $900 PPPM, representing 16.5% of total visit costs. Anthracycline and alkylating-agents-based therapies had the highest PPPV and PPPM IV administration costs, respectively (mean $479 and $1,336, resp.). Patients with managed care insurance had the highest IV administration costs (mean $504 PPPV; $1,120 PPPM). Conclusions. IV administration costs constitute a considerable proportion of the total costs of receiving an IV cancer therapy to treat mSTS. [ABSTRACT FROM AUTHOR]