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Paclitaxel, Cisplatin and 5-FU: A New Standard in Oral Cancer Treatment?

Oral cancer responds well to chemotherapy. For some time, the standard treatment has been a combination of cisplatin and 5-fluorouracil (5-FU). A Phase III clinical trial completed in Spain suggests that adding paclitaxel to the combination may yield impressive tumor-fighting results and improve quality of life.

Dr. Richardo Hitt led the study, which took place at Hospital 12 de Octubre, in Madrid, Spain. Dr. Hitt presented the study's findings at the 39th annual meeting of the American Society of Clinical Oncology.

According to Dr. Hitt, adding paclitaxel to cisplatin and 5-FU caused the complete disappearance of tumors in a significant percent of trial participants. Additionally, the treatment appears more likely to spare the larynx and throat than cisplatin and 5-FU alone, providing a greater chance that the patient will be able to speak and swallow after chemotherapy.

A total of 384 patients took part in the Phase III trial. The average age of participants was 56. Thirty-five percent of the participants had resectable tumors, meaning that the tumor could be removed surgically, and 84.1 percent had advanced Stage IV cancer. Participants had a variety of head and neck cancers, including oral cavity cancers and larynx tumors. Participants were randomly selected for the group receiving cisplatin and 5-FU (control group) or for cisplatin and 5-FU combined with paclitaxel (test group).

Test results were mixed. Fifty percent of the test group showed signs of partial response: the tumor shrank, but was not destroyed. In comparison, 48 percent of the control group experienced partial response, a negligible difference.

However, a significant difference in numbers occurred in patients who experienced a complete disappearance of the tumor. While tumors disappeared entirely in only 13 percent of the control group, the rate rose to 32 percent for participants taking the paclitaxel, cisplatin, and 5-FU combination.

In addition, 88 percent of patients treated with the paclitaxel combination retained functional larynxes, tongues and pharynxes, as opposed to 75 percent of the control group. This alone was a promising result, indicating that paclitaxel use could improve post-treatment quality of life. Tolerance levels and side effects for both groups were deemed similar.

The study suggests that adding paclitaxel to standard oral chemotherapy significantly increases the chances of complete tumor remission, and with a higher quality of life after treatment. Further studies will examine the long-term benefits of the new treatment.

Paclitaxel Facts

Paclitaxel is based on a compound found naturally in Pacific yew trees. It has been used to treat a variety of cancers. The medication is systemic: it affects both healthy and cancerous cells. Paclitaxel works by interfering with cell growth, and initiating apoptosis, when a cell signals its own destruction.



Resources

Laino, C. (2003). Paclitaxel-based regimen effective for head and neck cancer. Retrieved June 11, 2003, from
www.oralcancerfoundation.org/news/news.asp.

Medlineplus. (Updated 2003). Paclitaxel (systemic). Retrieved June 11, 2003, from
www.nlm.nih.gov/medlineplus/druginfo/uspdi/202682.html.

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