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The optimal treatment for patients with metastatic non-clear cell renal cell carcinoma (nccRCC) remains largely unknown, since this subtype has largely been excluded from clinical trials exploring approved therapies. Approximately 10% to 15% of patients with metastatic RCC have non-clear cell histology, making it a smaller and underserved subset compared.
Studies have indicated that the standard treatments for patients with clear cell histology are not as effective in patients with nccRCC, notes Nizar M. Tannir, MD. In a single-arm phase II study, sunitinib was examined as a treatment for patients with non-clear cell histology. The overall response rate (ORR) was 5% and the median progression-free survival (PFS) was 2.7 months. Overall, the results from this study were surprising, Tannir believes.
To explore treatments for nccRCC further, the phase II ASPEN study is designed to compare everolimus with sunitinib as a treatment for patients with papillary, chromophobe, or poorly differentiated histology, notes Daniel J. George, MD. The primary endpoint of the study is PFS. Ideally, results from the investigation will establish a standard of care in nccRCC that can be used as the baseline for future drug development, George notes.
In addition to the exploration of TKIs, the phase II ECOG 8802 trial examined the efficacy of doxorubicin and gemcitabine in RCC with sarcomatoid features, notes Sumanta Kumar Pal, MD. The ORR was 16%, the median overall survival was 8.8 months, and the median PFS was 3.5 months. This study suggests the combination of doxorubicin and gemcitabine is a reasonable first-line option for patients with nccRCC, Pal suggests.