A new immunotherapy may help to improve outcomes of patients with metastatic bladder cancer, according to the results of a Phase II study.
Bladder cancer is one of the most common and deadly forms of cancer for men in the United States, with about 74,000 new cases and 16,000 deaths per year. Most cases of bladder cancer occur in older men, with 9 out of 10 cases presenting in those over the age of 55 years and the average age at diagnosis being 73 years.
As methods for detecting and treating bladder cancer have improved, so have survival rates of patients: when the cancer is found early, more than 98% of patients survive longer than 5 years. Although survival rates can be relatively high for those with later stage cancers as well, better treatments are needed for those whose cancer has continued to progress after first-line treatment with platinum-based chemotherapy.
In a new study, researchers tested the benefits of a personalized peptide vaccination (PPV) in addition to best supportive care (BSC) in 80 patients with progressive bladder cancer unresponsive to platinum-based chemotherapy. The peptides used in each patient’s vaccine were chosen from 31 candidate peptides, based on the patient’s human leukocyte antigen types and immune responses to the peptides detected in the patient’s blood. Each patient was administered 12 total injections of the vaccine.
Findings from the study showed that the vaccine had no effect on progressive-free survival, the primary endpoint of the study, but it did boost overall survival (7.9 months vs 4.1 months with BSC alone) and was well tolerated, with no serious adverse events occurring.
The study was limited by its small size and the lack of a blinded study design. To address these concerns, lead author Masanori Noguchi, MD, PhD (Clinical Research Division, Kurume University Research Center for Innovative Cancer Therapy, Japan) said that he and his team are already planning a larger double-blinded, placebo-controlled, randomized Phase II study to verify the results of the trial.
The researchers hope that the vaccine could be implemented as part of general treatment guidelines for patients with progressive bladder cancer in order to improve overall survival.
The study was published in Clinical Cancer Research, a journal of the American Association for Cancer Research.
