First-line pazopanib in patients with advanced non-clear cell renal carcinoma: An Italian case series

Table 1 Characteristics of patients, n (%)

Baseline characteristic	n = 48
Age, median (range)	70 (27-86)
Sex
Males	36 (75)
Females	12 (25)
Histology
Papillary	24 (50)
Chromophobe	9 (10.8)
Xp11 translocation	1 (2.1)
Unclassified	6 (12.5)
Mixed1	8 (16.7)
Grade (Fuhrman/ISUP)
1-2	6 (12.5)
3	15 (31.3)
4	4 (8.3)
NA	23 (47.9)
Stage at diagnosis
I-III	33 (68.8)
IV	15 (31.3)
Previous nephrectomy
Yes	41 (85.4)
No	7 (14.6)
Metastasectomy
Yes	7 (14.6)
No	41 (85.4)
ECOG PS
0	37 (77.1)
1	11 (22.9)
IMDC score risk group
Good	19 (39.6)
Intermediate	25 (52.1)
Poor	2 (4.2)
NA	2 (4.2)
Starting dose of pazopanib
800 mg	31(64.6)
600 mg	10 (20.8)
400 mg	7 (14.6)

¹Four tumors had mixed histology (clear-cell/papillary) with papillary histology prevalence and four tumors had mixed histology (clear-cell/chromophobe) with chromophobe histology prevalence.

NA: Not assessed/available; IMDC: International Metastatic Renal Cell Carcinoma Database Consortium; ECOG PS: Eastern Cooperative Oncology Group Performance Status; ISUP: International Society of Urological Pathology.

Table 2 Adverse events according to Common Terminology Criteria for Adverse Events (version 4.0)

Adverse event	Grade 1/2, n (%)	Grade 3, n (%)
Fatigue	24 (50.0)
Diarrhea	15 (31.3)	2 (4.2)
Mucositis	9 (18.8)
Hypertransaminasemia	7 (14.6)	4 (8.3)
Thrombocytopenia	6 (12.5)
Anemia	15 (31.2)	2 (4.2)
Neutropenia	5 (10.4)
Hypothyroidism	15 (31.3)
Disgeusia	5 (10.4)	1 (2.1)
Cutaneous toxicity1	8 (16.7)
Nausea/vomiting	14 (29.2)
Heart failure	1 (2.1)
Renal failure	5 (10.4)	1 (2.1)
Other2	16 (33.3)

¹Including discoloration of hairs and cutis, hand-foot syndrome, and dermatitis.

²Including bleeding, sleepiness, hypertrigliceridemia, hypophosphoremia, hyperbilirubinemia, loss of appetite/hyporexia, dyspepsia/epigastralgia, and hypertension.

Table 3 Objective response rate, progression-free survival, and overall survival outcomes

Effectiveness outcome	All patients (n = 48)	Papillary RCC (n = 24)	Chromophobe RCC (n = 9)
Response rate (RECIST 1.1), n (%)
Partial responses	13 (27.1)	6 (25.0)	2 (22.2)
Complete responses	0 (0.0)	0 (0.0)	0 (0.0)
Stable disease	27 (56.3)	14 (58.3)	5 (55.5)
Progressions of disease	6 (12.5)	3 (12.5)	1 (11.1)
Not evaluable	2 (4.2)	1 (4.2)	1 (11.1)
Disease control rate	40 (83.3)	20 (83.3)	7 (77.8)
PFS
Median (mo) (95%CI)	12.3 (3.6-20.9)	-	-
Rate of patients progression free at 6 mo	67.8%	-	-
Rate of patients progression free at 12 mo	49.0%	-	-
OS
Median (mo) (95%CI)	27.6 (18.3-37.1)	-	-
Rate of patients alive at 12 mo	82.7%	-	-
Rate of patients alive at 24 mo	62.0%	-	-

RCC: Renal cell carcinoma; PFS: Progression free survival; OS: Overall survival; RECIST 1.1: Response Evaluation Criteria in Solid Tumours version 1.1.