Long-Term Doxorubicin Linked to Secondary Oral CancersPosted in Product Liability Keith Belt
The utilization of new and powerful drugs can cause unanticipated adverse reactions to patients due to the unique composition of each person and the other medical treatments they may be receiving, says Alabama liability attorney Keith T. Belt
June 10, 2011
Pegylated liposomal doxorubicin (PLD), used alone or in combination with other agents, is part of the treatment regimen for both platinum-sensitive and platinum-resistant recurrent epithelial ovarian cancer. However, the long-term use of PLD might carry a risk for secondary cancer of the oral cavity, according to data presented here at the American Society of Clinical Oncology 2011 Annual Meeting. Although the numbers are small, the data are nevertheless compelling, explained first author Timothy Cannon, MD, a hematology/oncology fellow at the New York University (NYU) Cancer Institute in New York City.
“Most patients who receive doxorubicin only get it for 6 cycles, and oral cancers have not been observed in those patients,” he told Medscape Medical News. The study patients “are from NYU and are part of a series in which they received it for 30 months. Among these patients, there obviously is a very high incidence of oral cancers.”
Four patients who received long-term PLD for advanced-stage ovarian cancer developed malignant and/or premalignant lesions of the tongue and/or oral cavity. Dr. Cannon points out that there were only about 16 patients who received PLD for an extended period of time, “so 4 out of 16 patients is quite high.”
All 4 of the patients had received maintenance therapy with PLD for at least 3 years. Of this group, 3 women were subsequently diagnosed with squamous cell carcinoma (SCC) of the tongue and/or oral cavity, and 1 patient was diagnosed with sublingual mucosa high-grade dysplasia. All 3 cases of SCCs were negative for human papillomavirus.
“I don’t think this is a coincidence, that 4 of 16 patients receiving this treatment developed oral cancers,” he said. “If this treatment for ovarian cancer becomes more popular, then this is something that should become known. Early dental screening would need to be initiated, and the treatment may need to be stopped after a certain time period.”
It is relatively uncommon for ovarian cancer patients to receive PLD for this length of time, but among the NYU patients, the regimen has been very successful. “Of the patients who developed oral cancer, all had been free of ovarian cancer for a long time,” Dr. Cannon explained. “Obviously, we had this serious and unanticipated adverse event.”