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[First Hungarian experience with pazopanib therapy for patients with metastatic renal cancer]
Anikó Maráz1, István Bodrogi, András Csejtei
1Onkoterápiás Klinika, Szegedi Tudományegyetem, Szeged, Hungary.
Abstract:
Pazopanib, a tyrosine kinase inhibitor, is one of the new registered first-line therapeutic options in the treatment of metastatic clear cell renal carcinoma. Our aim was to evaluate the efficiency and toxicity of first-line pazopanib therapy administered for patients with metastatic clear cell renal carcinoma with good- and medium prognosis according to MSKCC criteria. Between January and May, 2011, 24 patients have been treated with pazopanib in 8 oncology centers in Hungary, out of them 21 patients' data were analyzed. The mean age was 65.3 (49-81) years, 10 males and 11 females. According to MSKCC the prognosis was good and medium in 3 and 18 cases, respectively. Daily dose of pazopanib was 800 mg administered continuously in 28 day cycles. Dose reduction was performed according to the instructions of the registration study. Tumor response was evaluated according to RECIST 1.0. Currently 6 (28.6%) patients are on treatment. Dose reduction was necessary in 6 (28.6%) cases with an average duration of 14.55 (7-150) days. Mean±SE daily dose was 692.97±13.67 (400-800) mg. Median PFS was 12.41 months (95% CI 11.52-12.94 months). Complete remission (CR), as the best tumor response occurred in 2 (9.5%) cases. Partial remission (PR), stable disease (SD) and progression was observed in 6 (28.6%), 10 (47.6%) and 3 (14.3%) cases, respectively. Objective tumor response was observed in 8 pts (38%). Median survival could not be statistically analyzed yet due to the insignificant number of fatal outcomes. Median follow-up was 25.22 months (95% CI 2.47-28.1 months). As common side-effect fatigue, weakness and diarrhea occurred in 11 (52.4%), 9 (42.9%) and 8 (38%) cases, respectively. Besides these, worsening of high blood pressure and ALT/AST elevation was observed in 5 (23.8%) and 6 (28.6%) cases, respectively. Based on the initial Hungarian experiences, pazopanib is a well tolerable product and can be administered safely. According to our results its efficiency in terms of tumor response and progression-free survival is comparable to the results of the registration study.
Insights
Pazopanib is an effective first-line treatment for metastatic clear cell renal carcinoma, showing comparable efficacy and good tolerability in Hungarian patients. This study evaluated its safety and effectiveness in managing advanced kidney cancer.
Area of Science:
- Oncology
- Pharmacology
- Nephrology
Background:
- Metastatic clear cell renal carcinoma (mccRCC) is a significant cause of cancer-related mortality.
- Pazopanib, a tyrosine kinase inhibitor, has emerged as a new therapeutic option for first-line treatment of mccRCC.
- Evaluating real-world effectiveness and toxicity is crucial for optimizing patient care.
Purpose of the Study:
- To assess the efficacy and toxicity of first-line pazopanib in patients with metastatic clear cell renal carcinoma.
- To analyze treatment outcomes based on Memorial Sloan Kettering Cancer Center (MSKCC) prognostic criteria.
- To provide initial Hungarian clinical experience with pazopanib therapy.
Main Methods:
- A prospective study involving 21 patients with metastatic clear cell renal carcinoma treated with pazopanib (800 mg daily) across 8 Hungarian oncology centers.
- Tumor response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0).
- Progression-free survival (PFS) and toxicity profiles were monitored, with dose reductions managed per study guidelines.
Main Results:
- Objective tumor response (CR+PR) observed in 38% of patients (2 Complete Remissions, 6 Partial Remissions).
- Median progression-free survival (PFS) was 12.41 months.
- Common adverse events included fatigue (52.4%), weakness (42.9%), and diarrhea (38%); dose reductions occurred in 28.6% of cases.
Conclusions:
- Pazopanib demonstrates good tolerability and can be safely administered as a first-line treatment for metastatic clear cell renal carcinoma in the Hungarian population.
- The observed efficacy in terms of tumor response and PFS is comparable to findings from the pivotal registration study.
- Pazopanib represents a valuable therapeutic option for patients with good and medium prognosis according to MSKCC criteria.
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