Real-World Outcomes Show Benefits of Immune Checkpoint Inhibitors in Patients with Kidney Cancer

April 2017, Vol 8, No 2

Orlando, FL—Clinical trials involving immunotherapy have increased in the past few years, and the oncology community is eagerly awaiting the results. However, not so well-known is what happens to patients who receive immunotherapy outside of the clinical trial setting, including those who are not eligible for clinical trials.

A study presented at the 2017 Genitourinary Cancers Symposium sheds light on the real-world experience of patients with metastatic renal-cell carcinoma (RCC) who receive immunotherapy drugs. The study was an initiative of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), and was designed to determine real-world outcomes in this patient population who received immune checkpoint inhibitors, explained lead investigator Steven M. Yip, MD, MSc, Tom Baker Cancer Centre, University of Calgary, Alberta, Canada.

“We found that [metastatic] RCC patients in the real world respond quite similarly whether first, second, third, or fourth line. Overall response rates were about 25% to 30%. However, duration of response in our study was longer than is observed in clinical trials,” said Dr Yip.

The longer duration of response in the real-world setting may be because the patients in this study received treatment for longer durations than patients in clinical trials.

“Patients were kept on immunotherapy if they were clinically stable. In Canada, where we have limited resources, if a drug is working, we keep patients on it to optimize response,” he said.

“Our study showed that immunotherapy with checkpoint inhibitors is applicable to patients who are excluded from clinical trials, including those with brain metastasis and the elderly,” added Dr Yip.

Real-World Data

This retrospective analysis was based on data from the IMDC database with 35 international centers. The study included 7713 patients; of these, 255 patients with metastatic RCC had received immune checkpoint inhibitors, including atezolizumab (Tecentriq), avelumab, ipilimumab (Yervoy), nivolumab (Opdivo), and pembrolizumab (Keytruda).

Patients were included in the analysis if they received monotherapy, combination therapy with a targeted agent, or an immune checkpoint inhibitor as the first-, second-, third-, or fourth-line treatment.

Many patients had multiple lines of therapy, “as many as 10 targeted therapies,” said Dr Yip.

Patients were stratified based on several prognostic factors, including <80% Karnofsky Performance Status, less than 1 year from the time of diagnosis to the start of targeted therapy, anemia, hypercalcemia, neutrophilia, and thrombocytosis.

Patients who received an immune checkpoint inhibitor in the second-line setting were stratified into 3 risk categories, including favorable (low), intermediate, and poor risk, using the IMDC criteria. The median treatment duration rates were not reached in the group with low risk, 8.6 months for those with intermediate risk, and 1.9 months for high-risk patients (P <.0001).

Although the IMDC criteria were applied only to the second-line treatment group in this study, “IMDC criteria should be applicable in all lines of therapy,” said Dr Yip. The data were too premature for the evaluation of overall survival, he added.

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