Latency of potential treatment-related adverse events among patients treated with TKI/VEGF-directed therapy for metastatic renal cell carcinoma (mrcc)

Transcription

1 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

2 Disclosures None

3 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 to identify associated toxicities in a real-world setting mrcc, metastatic renal cell carcinoma; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.

4 Methods Data Source MarketScan US claims database with 40 million patients with employer-sponsored insurance Patient selection Patients initiating 1L TKI/VEGF-directed therapy for mrcc Exclusions: Non-RCC histologies and previous primary cancers Outcomes 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 Assessment 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.

5 Demographics TKI/VEGF N = 1094 Age, median (SD) 62 y (11) Sex, n (%) Male 767 (70%) Female 327 (30%) 1L treatment duration, median (Q1, Q3) 201 d (92, 394) Insurance type Commercial 704 (64%) Medicare 390 (36%) Baseline comorbidities Diabetes 302 (28%) Chronic kidney disease 209 (19%) Liver disease 179 (16%) COPD 135 (12%) COPD, chronic obstructive pulmonary disease; Q, quartile; SD, standard deviation.

6 Results Potential treatment-related AEs during or < 30 days after 1L TKI/VEGF therapy (N = 1094) Median time to first claim, Days (range) Prevalence, % Incidence (per 100 patient-years) Nausea/vomiting 26 (0, 966) Fatigue/asthenia 80 (0, 1141) Thyroid disorders 121 (0, 1090) Abdominal pain 104 (0, 690) Diarrhea (0, 859) Pneumonitis 82 (0, 800) Hepatitis/hepatic dysfunction 140 (0, 1253) Adrenal insufficiency 108 (0, 600) Neutropenia 116 (11, 713) Colitis 66 (43, 139)

7 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