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Latency of potential treatment-related adverse events among patients treated with TKI/VEGF-directed therapy for metastatic renal cell carcinoma (mRCC) Jun Gong, Daniel George, Herschel Wallen, Shivani Mhatre, Shih-Wen Lin, Sarika Ogale, Rini Vohra, Andy Surinach, Joe Simpson, Sumanta Kumar Pal Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Disclosures • None Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Background/objective • Toxicities associated with TKI/VEGF-directed therapies for mRCC are well defined o There is little published data reflecting their potential latency (time of 1L mRCC treatment start and time of AE onset) • Multiple studies assessing TKI/VEGF-directed therapies in combination with cancer immunotherapy checkpoint inhibitors are ongoing o It is important to characterize relevant toxicities to provide real-world context for future studies of these combination regimens • We conducted an analysis of claims for patients initiating first-line (1L) TKI/VEGF-directed therapy for mRCC from 2011 - 2013 to identify associated toxicities in a real-world setting mRCC, metastatic renal cell carcinoma; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Methods Data Source Patient selection Outcomes Assessment MarketScan US claims database with ≈ 40 million patients with employer-sponsored insurance Patients initiating 1L TKI/VEGF-directed therapy for mRCC 2011 - 2013 Exclusions: Non-RCC histologies and previous primary cancers Identification of selected AEs commonly reported for anti-angiogenesis and cancer immunotherapy ICD-9 codes occurring between first mRCC drug claim and < 30 days after the last drug claim Assessments Prevalence, incidence, and median time of AE onset (time between treatment initiation and first AE claim) AE, adverse event; ICD, international classification of diseases. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Demographics Age, median (SD) Sex, n (%) Male Female 1L treatment duration, median (Q1, Q3) Insurance type Commercial Medicare Baseline comorbidities Diabetes Chronic kidney disease Liver disease COPD TKI/VEGF N = 1094 62 y (11) 767 (70%) 327 (30%) 201 d (92, 394) 704 (64%) 390 (36%) 302 (28%) 209 (19%) 179 (16%) 135 (12%) COPD, chronic obstructive pulmonary disease; Q, quartile; SD, standard deviation. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Results Potential treatment-related AEs during or < 30 days after 1L TKI/VEGF therapy (N = 1094) Nausea/vomiting Fatigue/asthenia Thyroid disorders Abdominal pain Diarrhea Pneumonitis Hepatitis/hepatic dysfunction Adrenal insufficiency Neutropenia Colitis Median time to first claim, Days (range) Prevalence, % Incidence (per 100 patient-years) 26 (0, 966) 80 (0, 1141) 121 (0, 1090) 104 (0, 690) 110.5 (0, 859) 82 (0, 800) 140 (0, 1253) 108 (0, 600) 116 (11, 713) 66 (43, 139) 50.5 28.2 22.0 20.2 18.3 17.9 9.1 6.3 3.3 0.3 101.7 42.8 33.0 29.2 26.6 24.6 12.1 8.2 4.2 0.3 Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Conclusions • Selected toxicities commonly reported for anti-angiogenesis therapies and cancer immunotherapies are observed during treatment and immediately after treatment with 1L TKI/VEGF-directed therapies in patients with mRCC • The prevalence in this real-world study was lower than in clinical trials, possibly because of differing monitoring practices and treatment duration and because claims only reflect AEs requiring healthcare utilization • Substantial latency was observed with the onset of toxicities typically observed with initiation of antiangiogenesis therapies • This analysis provides some real-world context for future anti-angiogenesis/immunotherapy combination drug studies, as it suggests that attributing toxicities to anti-angiogenesis therapy versus cancer immunotherapy may be challenging due to overlapping toxicities Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com