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Axitinib-induced proteinuria and efficacy in patients with metastatic renal cell carcinoma
Masahiro Nozawa1, Koichi Sugimoto2, Takayuki Ohzeki2
1Department of Urology, Kinki University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan. nozawa06@med.kindai.ac.jp.
Background:
No report has evaluated axitinib-induced proteinuria as a biomarker for predicting treatment efficacy and survival of patients with metastatic renal cell carcinoma (mRCC).
Methods:
The subjects were patients with mRCC treated with axitinib at Kinki University Hospital from February 2008 to November 2014. Clinical records were retrospectively reviewed including baseline patient characteristics, time-dependent changes of urinary protein status, computed tomography scans of metastatic lesions, treatment duration with axitinib, and survival time.
Results:
A total of 45 patients were evaluable. Median tumor shrinkage rates were 32.3 and 35.0 % in patients with urinary protein increases ≥+2 and <+2, respectively (p = 0.496). Objective response rates were also similar between the two groups. Median progression-free survival (PFS) times with axitinib were 13.5 months [95 % confidence interval (CI) 0.0-27.5] and 11.0 months (95 % CI 0.0-26.7) in patients with urinary protein increases ≥+2 and <+2, respectively (p = 0.975). The maximum tumor shrinkage rate with axitinib was significantly associated with PFS with axitinib as a result of multivariate analysis (p = 0.002). Median overall survival (OS) times were 39.8 months (95 % CI 12.7-67.0) and 25.4 months (95 % CI 11.2-39.6) in patients with axitinib-induced urinary protein increases ≥+2 and <+2, respectively (p = 0.250). The number of metastatic sites (p = 0.006), the MSKCC risk (p = 0.009), and the maximum tumor shrinkage rate with axitinib (p = 0.019) were significantly associated with OS as a result of multivariate analysis.
Conclusions:
The degree of urinary protein increase during axitinib treatment was not associated with objective response, PFS, and OS in mRCC patients treated with axitinib.
Insights
Axitinib-induced proteinuria did not predict treatment efficacy or survival in metastatic renal cell carcinoma (mRCC) patients. Urinary protein levels did not correlate with objective response, progression-free survival, or overall survival in this study.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic renal cell carcinoma (mRCC) is a complex cancer with varied treatment responses.
- Axitinib is a targeted therapy used for mRCC, but predictive biomarkers are needed.
- The role of axitinib-induced proteinuria as a predictive biomarker in mRCC remains unevaluated.
Purpose of the Study:
- To investigate whether axitinib-induced proteinuria can serve as a biomarker for predicting treatment efficacy and survival in patients with mRCC.
- To analyze the association between urinary protein changes and clinical outcomes in mRCC patients receiving axitinib.
Main Methods:
- Retrospective review of clinical records for 45 mRCC patients treated with axitinib.
- Analysis of baseline characteristics, urinary protein status, tumor response, progression-free survival (PFS), and overall survival (OS).
- Multivariate analysis to identify significant predictors of PFS and OS.
Main Results:
- No significant difference in tumor shrinkage rates or objective response rates between patients with urinary protein increases ≥+2 and <+2.
- Median PFS and OS times were similar between the two urinary protein groups.
- Maximum tumor shrinkage rate, number of metastatic sites, and MSKCC risk were significantly associated with PFS and OS.
Conclusions:
- The degree of urinary protein increase during axitinib treatment is not associated with objective response, PFS, or OS in mRCC patients.
- Axitinib-induced proteinuria is not a reliable biomarker for predicting treatment outcomes in this patient cohort.
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