Off-Protocol Patients Differ

“Off protocol, oncologists are able to treat many more patients,” Dr. Singer told Cancer Therapy Advisor. “However, many of these patients may be sicker or have non-clear-cell histologies that were not included in the original pivotal trials.” All of the targeted therapies approved by the U.S. Food and Drug Administration have been tested predominantly in patients with clear-cell mRCC, he said, adding that approximately 25% of mRCC patients have non-clear-cell histology.

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“We must continue to study non-clear-cell tumors … if we are going to be able to make significant progress against mRCC,” he said.

Dr. Singer was part of a research team that recently published study findings showing that high-dose interleukin-2 therapy is now used infrequently for mRCC in the United States and that its use has decreased with the uptake of targeted therapy.

The study evaluated trends in high-dose interleukin-2 therapy use from 2004 to 2012. The use decreased from 444 patients in 2004 to 135 in 2008, than increased to 230 in 2012.2

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The findings of this study are in line with those reported recently by another research team.3 In a study of 25,186 patients with mRCC, Elizabeth K. Ferry, MD, of University Hospitals Case Medical Center in Cleveland, OH, and colleagues found that the use of immunotherapy decreased from 30.3% of patients in 1998 to 3.8% in 2011, whereas the use of chemotherapy increased from 16.2% to 54% during the same period.


  1. Macleod LC, Tykodi SS, Holt SK, et al. Trends in metastatic kidney cancer survival from the cytokine to the targeted therapy era. [published online ahead of print July 18, 2015]. Urology. doi: 10.1016/j.urology.2015.05.008.
  2. Allard CB, Gelip-Hammerschmidt F, Harshman LC, et al. Contemporary trends in high-dose interleukin-2 use for metastatic renal cell carcinoma in the United States. [published online ahead of print July 22, 2015]. Urol Oncol. doi: 10.1016/j.urolonc.2015.06.014.
  3. Ferry EK, Minnillo BJ, Maurice MJ, Abouassaly R, Zhu H. Trends of systemic therapy use for renal cell carcinoma in the United States. Urology. 2015;85(6):1399-1403.