MADRID, 14 (EUROPA PRESS)
A new drug-delivery system, TAR-200, from Johnson & Johnson eliminated high-risk non-muscle-invasive bladder tumors in 82 percent of patients treated in a Phase 2 clinical trial at the University of Southern California (USA) who had not responded to other previous therapies.
The study's findings, published in the Journal of Clinical Oncology, highlight that in most cases, the cancer disappeared after just three months of treatment, and nearly half of the patients were cancer-free one year later.
"Traditionally, these patients have had very limited treatment options. This new therapy is the most effective reported to date for the most common type of bladder cancer," said senior study author Sia Daneshmand, MD, director of urologic oncology at Keck Medicine of USC.
According to the researchers, TAR-200 is a miniature, pretzel-shaped pharmacological device containing gemcitabine, a chemotherapy drug. It is inserted into the bladder via a catheter. Once inside the bladder, TAR-200 slowly and steadily releases gemcitabine into the organ over three weeks per treatment cycle.
Previously, gemcitabine was administered to the bladder as a liquid solution and only remained in the organ for a few hours, thus having limited anticancer effects, Daneshmand explained. The goal was to ensure that gemcitabine remained in the bladder longer to achieve a greater impact.
PARTICIPATION OF 85 PATIENTS
The clinical trial, known as SunRISe-1, was conducted at 144 centers worldwide and included 85 patients with high-risk non-muscle-invasive bladder cancer. All of them had received prior treatment with the standard bacillus Calmette-Guérin, but their cancer had recurred.
"The standard treatment plan for these patients was surgery to remove the bladder and surrounding tissue and organs, which carries many health risks and can negatively impact patients' quality of life," Daneshmand noted.
Instead, oncologists treated patients with TAR-200 every three weeks for six months and then four times a year for the next two years. In 70 of the 85 patients, the cancer disappeared, and in almost half of the cases, it was still gone a year later. The treatment was well tolerated and had minimal side effects.
Daneshmand expressed optimism about the results obtained for TAR-200, which continues to be tested in other clinical trials. "We are at an exciting moment in history," he stated.
