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Matthew D. Galsky, MD, director, Genitourinary Medical Oncology, The Tisch Cancer Institute, Mount Sinai Hospital, discusses results from the HCRN GU14-182 study, which examined maintenance pembrolizumab versus placebo in patients with metastatic urothelial cancer.
Matthew Galsky, MD, director, Genitourinary Medical Oncology, The Tisch Cancer Institute, Mount Sinai Hospital, discusses results from the HCRN GU14-182 study, which examined maintenance pembrolizumab (Keytruda) versus placebo in patients with metastatic urothelial cancer.
Response rate was a secondary endpoint of the study. In a maintenance study, patients can enter the study having had a complete response (CR) to first-line chemotherapy, Galsky explains. There are differing opinions regarding whether those patients should receive a switch maintenance treatment approach. One side of the argument is that a switch maintenance approach could lead to a real durable complete response in this group of patients, according to Galsky.
However, if chemotherapy has done a really good job, the other argument is those patients should be offered a treatment-free interval. The numbers will be small, but ultimately, physicians will be able to look at the subset of patients who had a CR going into the study and were randomized to pembrolizumab versus placebo, says Galsky. Although, researchers need to be aware because patients who are in a CR when entering the study need to be taken out of the objective response analysis; this is because there's nothing to measure in terms of the response assessment, Galsky explains.