This article is more than 5 years old. Information may no longer be current.
Keyhole limpet hemocyanin inferior to mitomycin for bladder cancer recurrence
Click Here to Manage Email Alerts
Despite a different safety profile, keyhole limpet hemocyanin failed to prove superior or equivalent to mitomycin for recurrence of non-muscle invasive bladder cancer, according to the results of a phase 3 trial.
Recurrence and adverse events are common among patients with non-muscle invasive bladder cancer, according to the researchers. In addition, previous studies had shown that keyhole limpet hemocyanin — a glycoprotein from the gastropod mollusk Megathura crenulata — may have a potential benefit in this patient population.
Therefore, the researchers undertook the trial to compare the efficacy and safety of keyhole limpet hemocyanin to mitomycin in 553 patients with non-muscle invasive bladder cancer.
Patients were randomly assigned to 16 adjuvant intravesical instillations with keyhole limpet hemocyanin after pre-immunization (n=283), or 11 adjuvant intravesical instillations with mitomycin (n=270). For the efficacy analysis, only 267 patients from the keyhole limpet hemocyanin arm and 256 patients from the mitomycin arm were included.
At the conclusion of the trial, more patients assigned to mitomycin had pT1 tumors compared with keyhole limpet hemocyanin (P=.01). More patients in the keyhole limpet hemocyanin group developed a recurrence than in the mitomycin group (61% vs. 34%; P<.001). The median recurrence-free survival in the keyhole limpet hemocyanin group was 106 weeks compared with 297 weeks for mitomycin (P<.001).
Significantly more patients assigned to mitomycin progressed compared with keyhole limpet hemocyanin. In addition, a univariate analysis showed that keyhole limpet hemocyanin more effectively prevented progression, but results for a multivariate analysis did not show similar results.
Seventy-two percent of patients experienced some adverse event, but they were generally mild. No difference in adverse events was found between the two treatment groups. Mild symptoms more commonly reported in patients assigned to keyhole limpet hemocyanin included fever, flu-like symptoms and fatigue.
“More research is needed to clarify the immunologic effects of keyhole limpet hemocyanin and the effects of keyhole limpet hemocyanin on progression,” the researchers concluded.
Collapse
Click Here to Manage Email Alerts