Newswise — Roswell Park Cancer Institute (RPCI) announced this week that the US Food and Drug Administration (FDA) has approved PHOTOFRIN photodynamic therapy (PDT) in the treatment of high-grade dysplasia associated with Barrett's esophagus.
Thomas J. Dougherty, PhD, and colleagues at RPCI, developed PHOTOFRIN and PDT and Hector Nava, MD, RPCI, was the first to apply PDT with PHOTOFRIN to patients with this potentially life-threatening disease.
The clinical study for the FDA showed that patients receiving PDT were more likely to achieve complete reversal of their pre-cancerous lesions in Barrett's esophagus compared to those who did not receive PDT. Two-year follow-up data indicated that patients had an 80% chance of being cancer-free after PDT, whereas patients who did not receive PDT had a 50% chance of being cancer-free.
"This is an important milestone as the therapeutic applications for PDT continue to evolve and expand around the world," said Thomas Dougherty, PhD, Chief Emeritus, PDT Center, RPCI. "PDT can now be used to prevent esophageal cancer, a devastating disease." PDT also is used at Roswell Park for the treatment of mesothelioma, lung, skin, breast, brain, colorectal and gynecologic cancers.
PDT is a two-step process that begins with the intravenous injection of a non-toxic drug (PHOTOFRIN) which is absorbed by both normal and malignant cells. However, two to three days later, PHOTOFRIN concentrates in cancer cells and is reduced in normal cells near many cancers. Non-thermal red light, which is generated by a laser, is applied to the tumor. This light activates the PHOTOFRIN causing activation of the oxygen in the tumor which attacks the cancer cell causing its destruction.
Barrett's esophagus is a condition in which the normal lining of the lower part of the esophagus is replaced over time by another type of lining, normally present in the stomach. While Barrett's esophagus may cause no symptoms itself, a small number of people with this condition develop pre-cancerous lesions that progress to an often deadly type of cancer of the esophagus -? esophageal adenocarcinoma. An estimated 700,000 adults in the United States will be diagnosed with Barrett's esophagus this year and the disease is associated with the common condition known as gastroesophageal reflux disease or GERD.
Axcan Scandipharm Inc., of Birmingham, AL., is the sponsor of the New Drug Application for PHOTOFRIN.
Roswell Park Cancer Institute, founded in 1898, is the nation's first cancer research, treatment and education center, and is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. For information, visit the RPCI website at www.roswellpark.org.
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