Download Latency of potential treatment-related adverse events among

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