Costs associated with adverse events in patients with metastatic renal cell carcinoma

Figures & data

Table 1. Sample selection—patients with advanced renal cell carcinoma (RCC) in IH CIS (2000–2009).

Criteria	Count
Two or more diagnosis of kidney cancer (kidney or pelvis)	58,210
Two or more diagnosis of secondary malignant neoplasm, not more than 120 days apart	10,292
Exclusions:
Evidence of TCC	1431
Evidence of other primary cancer during 12-month  period prior to index date	4616
No continuous eligibility for comprehensive benefits  during 12-month prior index date	3561
Age <18 as of index date	40
On Medicaid	37
Age >64 and not on Medicaid Risk Plan	4546
Total excluded	8622
Patients remaining	1670

Table 2. Number (percentage) of patients with metastatic RCC receiving targeted therapy with evidence of selected adverse events.

Adverse events	No. of cases	%
Abdominal pain	267	50.1
Fatigue/asthenia	252	47.3
Dyspnea	236	44.3
Back pain	199	37.3
Nausea and/or vomiting	194	36.4
Extremity pain	186	34.9
Diarrhea	97	18.2
Proteinuria	19	3.6
Hand–foot syndrome	18	3.4
Hypertension	11	2.1
Neutropenia	11	2.1
Lymphopenia	1	0.2

Table 3. Mean total cost (US$) of medical-care services (excluding cost of targeted therapy) during 30-day, post-event period* among patients with metastatic renal cell carcinoma receiving targeted therapy.

Adverse events	Mean time to event (days)	With adverse event				Without adverse event
		n	Mean	SD	95% CI	n	Mean	SD	95% CI
Abdominal pain	170	267	12,236	19,726	6361–16,208	221	3482	6281	1893–5191
Fatigue/asthenia	169	199	8415	15,844	5961–12,615	219	4214	6319	2236–4612
Dyspnea	326	97	6561	6983	2392–7492	308	3714	6846	2681–5119
Back pain	220	236	14,348	22,342	7458–24,326	178	3593	7127	1897–4382
Nausea and/or vomiting	228	186	12,386	18,008	6672–21,980	228	4746	9167	2437–5729
Extremity pain	229	252	7902	9782	4921–11,324	153	3340	4574	3146–4273
Diarrhea	217	18	11,629	17,532	−2854–25,384	351	4622	9413	2601–6397
Proteinuria	298	11	2827	1284	−1292–7361	372	5173	11,706	3646–7195
Hand–foot syndrome	277	194	10,192	15,014	5304–17,742	171	3244	4889	1915–3962
Hypertension	190	11	3207	1545	1314–6299	385	5150	10,618	4150–6918
Neutropenia	309	19	9894	12,156	2505–17,292	178	4378	8221	2115–6841
Lymphopenia	202	418	10,101	16,290	8462–13,770	115	4519	9519	2381–6936

*For patients with adverse events, the 30-day post event period started on the first date of the adverse event. For patients without the particular adverse event under consideration, the period started on the mean event day among patients with adverse events. Patients without adverse event under consideration with a follow-up period ending prior to the mean event day were excluded.

Table 4. Estimated increase in mean total cost of medical-care services (excluding cost of study medications) during 30-day post-event period* due to evidence of treatment-related adverse events among patients with advanced renal cell carcinoma receiving sunitinib, sorafenib, bevacizumba, or pazopanib (estimates adjustment for differences in baseline characteristics).

Adverse events	Estimated increase in cost associated with adverse event $, (95% CI)
	$	95% CI
Abdominal pain	9462	3818–18,927
Fatigue/asthenia	6404	2294–15,473
Dyspnea	4847	1292–16,948
Back pain	11,355	5195–22,618
Nausea and/or vomiting	10,040	3817–19,937
Extremity pain	8562	3971–16,295
Diarrhea	12,607	2849–68,419
Proteinuria	5853	−1194–33,947
Hand–foot syndrome	9057	1899–21,947
Hypertension	1920	1130–14,196
Neutropenia	3115	−2195–28,632
Lymphopenia	9807	4386–22,947

*For patients with adverse events, the 30-day post event period started on the first date of the adverse event. For patients without adverse events, the period started on the mean event day among patients with adverse events. Patients without adverse events with a follow-up period ending prior to the mean event day were excluded.