This formal definition is really important because it lays a framework for other agents to be tested, and then the FDA can look at that for regulatory approval.” But earlier data that established BCG showed a course of maintenance can induce response in carcinoma in situ, so they just needed more BCG. “It was never really codified in terms of what this progression means - did they ever receive adequate BCG? For instance, there are some patients who get a course of induction of BCG and they may have persistent disease and are taken to radical cystectomy.
#Keynote 057 trial
“There was really never a formal definition of BCG-unresponsive bladder cancer, and for regulatory and clinical trial purposes, we sometimes give one or two installations of BCG and then determine that patient to be BCG refractory or intolerant,” Balar told HemOnc Today. Patients received a median of 12 prior BCG installations.
The analysis included 102 patients (median age, 73 years) with histologically confirmed high-risk, BCG-unresponsive carcinoma in situ with or without (71.8%) papillary disease, who received adequate BCG therapy and could not or did not wish to undergo radical cystectomy.īalar and colleagues defined adequate BCG therapy as receiving at least five of six doses of an initial induction course, followed by at least two of three doses of maintenance therapy or at least two of six doses of a second infusion course. “Now, the question is, can we use pembrolizumab in nonmuscle-invasive disease and can it help delay, or maybe prevent, needing a cystectomy?” Balar said. Thus, Balar and colleagues evaluated the use of the PD-1 antibody pembrolizumab (Keytruda, Merck), which has shown significant activity for patients with metastatic bladder cancer. It has a major impact on quality of life, and it takes about 3 months before patients have recovered from the surgery.” That is a very tough surgery for patients to undergo, and about two-thirds will suffer a major complication. “For many patients, urologists will often just recommend a radical cystectomy. “These can induce another response in the bladder, but again, the durability for these agents is not very good, either,” he said. Options for these patients include intravesical mitomycin with interferon, or intravesical valrubicin (Valstar, Endo Pharmaceuticals), Balar said. “At least one-third or more will develop recurrent disease or progress straight through BCG.” Balar, MD, director of the genitourinary medical oncology program at NYU Langone’s Perlmutter Cancer Center, told HemOnc Today. “BCG is very effective at getting a response but, for many of these patients, that response is not durable,” Arjun V. Bacillus calmette-guérin (BCG) has been used since the 1970s for these patients, inducing a complete response in about 70% of those treated. Patients with high-grade nonmuscle-invasive bladder cancer have high risk for developing muscle-invasive and metastatic disease. SAN FRANCISCO - Pembrolizumab induced durable complete responses among patients with high-risk, nonmuscle-invasive, bacillus calmette-guérin-unresponsive bladder carcinoma in situ with or without papillary tumors, according to updated interim results from cohort A of the phase 2 KEYNOTE-057 trial presented at Genitourinary Cancers Symposium.
0 kommentar(er)
