• 8/13/2003
  • Chicago
  • Journal of Hem / Onc

Adding paclitaxel to a cisplatin and 5-fluorouracil (5-FU) regimen led to significantly longer survival in patients with locally advanced head and neck cancer, according to a phase-3 study presented here at the 39th Annual Meeting of ASCO. “This new chemotherapy combination may soon become the standard treatment option for some patients with head and neck cancer,” said lead researcher Ricardo Hitt, MD, from the Hospital ‘12 de Octubre’ in Madrid. The expanded combination also halted tumor progression more effectively than the standard regimen, and patients who received the three-drug combination were more likely to retain the ability to speak and swallow, as well as exhibit less mucocitis.

The study involved 384 patients who had various types of head and neck cancer, particularly tumors of the oropharynx, larynx and oral cavity. All patients were treatment naive. In the standard arm, patients received 100 mg/m2 of cisplatin daily, and 1 gm/m2 of 5-FU on days 1 through 5 of a 21-day cycle. In the expanded regimen, patients received 100 mg/m2 of cisplatin daily, 500 mg/m2 of 5-FU on days 1 through 5, and 175 mg/m2 of paclitaxel on the first day of a 21-day cycle.

The trial “appeared to demonstrate a superior outcome and far better tolerability by adding paclitaxel to 5-FU and cisplatin for head and neck cancer in a dose schedule associated with less toxicity,” said Robert Mayer, MD, the director of the Center for Gastrointestinal Oncology at Dana-Farber Cancer Institute in Boston.