Safety and efficacy of pazopanib in heavily pretreated and treatment-naive patients with metastatic renal cell carcinoma (mRCC): A single center experience of the Medical University of Vienna, Austria.

• DOI: 10.1200/jco.2012.30.15_suppl.e15090
• Publication Date: 2020-03-11T15:15:23Z
• Authors: Manuela Schmidinger; Marija Bojic; Ursula Maria Vogl; Christoph Klingler; Gero Kramer; Christoph Zielinski
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

e15090 Background: Treatment with pazopanib was shown to improve objective response rates (ORR) and progression free survival (PFS) when compared to placebo in treatment-naïve or cytokine-pretreated patients with mRCC. We assessed the efficacy and safety of pazopanib in an unselected group of mRCC-patients at the Medical University of Vienna. Methods: Medical records of all patients who were treated with pazopanib between June 2010 and January 2012 were retrospectively reviewed. Pazopanib was prescribed at a dose of 800 mg daily. Treatment was given until disease progression or unacceptable toxicity. ORR was assessed by RECIST criteria. PFS and overall survival (OS) were calculated from the first day of pazopanib until progression and/or death, respectively. Results: Forty patients with a median age of 69 years (range 47-82) are currently evaluable for this analysis. The majority of patients (61%) presented with an ECOG Performance status of 0 and were classified as intermediate risk (55%) according to the MSKCC risk group classification. All patients had undergone nephrectomy and the majority (75%) had predominantly clear cell tumors. Most of the patients (66%) were diagnosed with three or more metastatic sites. Eighty percent of the patients were heavily pretreated, most commonly with three or more different types of targeted agents. Eight patients (20%) received pazopanib in first-line. Objective remission and disease stabilization were observed in 27% and 30% of the entire population. PFS and OS were 5 months (95%CI 3.07-6.86) and not reached, respectively. The most commonly observed all grade toxicities included fatigue (97%), anorexia (78%), hypertension (82%), diarrhoea (73%), nausea (62%) and vomiting (54%). The most common grade 3 or 4 toxicities were fatigue (68%), hypertension (47%) and diarrhoea (29%). Conclusions: Pazopanib appears effective in the setting of extensively pretreated patients. A later stage of the disease might have led to the unexpected higher incidence of off-target side effects such as fatigue and gastro-intestinal symptoms.