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A Study of Pazopanib Safety and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma and ECOG
Anjali Zarkar1, Sarah Pirrie2, Clive Stubbs3
1Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.
Aim:
Patients with advanced renal cell carcinoma and poor performance status (PS≥2) are often deemed unsuitable for treatment. The Pazo2 trial aimed to assess tolerability and efficacy of pazopanib as first-line treatment in renal cancer patients with ECOG PS2.
Methods:
Pazo2 was a prospective, single arm, open label, multicentre, phase II trial, conducted in 26 UK centres. Eligible patients were aged ≥18 years, with advanced or metastatic renal cancer and a clear cell component (aRCC), measurable disease as per RECIST Criteria 1.1, and ECOG PS2. Co-primary outcomes, assessed at 6-months after patients entered the trial, were tolerability, defined as the proportion of patients who did not develop "intolerable" adverse events, and efficacy, defined as the proportion of all patients who were progression-free and alive.
Results:
Between February 21, 2013 and August 12, 2016, 75 patients were registered. Median age was 68.6 years (IQR 64.6-76.0), 100% ECOG PS2, 62.7% 'poor risk' (International Metastatic Renal-Cell Carcinoma Database Consortium). Of the 65 evaluable patients, 70.8% (95% CI: 58.8, 80.4) did not develop "intolerable" adverse events and 56.9% (95% CI: 44.8, 68.2) were still alive and progression-free 6 months after starting pazopanib. Twenty-seven patients developed serious adverse events deemed to be related to pazopanib.
Conclusion:
These data suggests that pazopanib is tolerated and effective in aRCC patients with PS2 and represents a treatment option for patients who cannot receive or tolerate immune checkpoint inhibitors.
Insights
Pazopanib shows tolerability and efficacy in advanced renal cell carcinoma patients with poor performance status (PS2). This offers a new treatment option for patients unable to receive other therapies.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Advanced renal cell carcinoma (aRCC) with poor performance status (PS≥2) often limits treatment options.
- Patients with PS2 are typically excluded from clinical trials due to perceived unsuitability for therapy.
Purpose of the Study:
- To evaluate the tolerability and efficacy of pazopanib as a first-line treatment for patients with advanced renal cell carcinoma and ECOG performance status 2.
- To determine if pazopanib can be a viable treatment option for a patient population often considered untreatable.
Main Methods:
- A prospective, single-arm, open-label, multicenter Phase II trial (Pazo2) involving 75 patients with aRCC and ECOG PS2.
- Co-primary outcomes assessed at 6 months: tolerability (absence of intolerable adverse events) and efficacy (progression-free survival and alive status).
Main Results:
- 70.8% of evaluable patients did not experience intolerable adverse events, indicating good tolerability.
- 56.9% of patients were alive and progression-free at 6 months, demonstrating significant efficacy.
- 27 patients experienced serious adverse events potentially related to pazopanib.
Conclusions:
- Pazopanib is a tolerated and effective first-line treatment for advanced renal cell carcinoma patients with ECOG PS2.
- Pazopanib represents a crucial treatment alternative for patients with PS2 who cannot receive or tolerate immune checkpoint inhibitors.
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