Long-term follow-up data from the TAX 324 clinical trial showed that adding docetaxel to standard cisplatin plus fluorouracil induction chemotherapy (TPF) reduced the risk for death among patients with head and neck cancer by 26% during a 6-year period.
“Patients who are candidates for induction chemotherapy should be treated with TPF,” Jochen H. Lorch, MD, of Dana Farber Cancer Institute, in Boston, and colleagues wrote in Lancet Oncology.
They found that median overall survival was significantly better in patients treated with the TPF (70.6 months, 95% CI: 49.0-89.0) compared with those assigned to cisplatin plus fluorouracil only (PF; 34.8 months, 95% CI: 22.6-48.0).
At five-year follow-up, patients assigned to TPF had a 52% survival rate vs. a 42% survival rate in patients assigned to PF (HR=0.74, 95% CI: 0.58-0.94). Progression free survival was also significantly better (median 38.1 months, 95 CI: 19.3-66.1 vs. median 13.2 months, 95% CI: 10.6-20.7; HR=0.75, 95% CI: 0.60-0.94).
TAX 324 involved 501 patients (TPF, n=255; PF, n=246) recruited from 55 centers in Argentina, Canada, Europe and the United States between May 1999 and December 2003.
Patients in the TPF group were assigned to three cycles of docetaxel (75 mg/m2), followed by IV cisplatin (100 mg/m2) and fluorouracil (1,000 mg/m2) per day, administered as a continuous 24-hour infusion for four days.
Patients in the PF group were assigned to three cycles of IV cisplatin (100 mg/m2) with fluorouracil (1,000 mg/m2) per day, administered as a 24-hour continuous infusion for five days. Initial results for TPF therapy at two-year follow-up were promising, with therapy extending survival benefits.
“The updated results of our study suggest that the survival benefit of sequential therapy with TPF continues well beyond the two years of the original analysis and was sustained at the same level,” the researchers wrote.
Despite the positive findings, June Corry, MD, and Danny Rischin, MD, of the Peter MacCallum Cancer Centre in Melbourne, cautioned that the role of induction chemotherapy in advanced head and neck cancer remains unclear in an accompanying editorial.
“Use of TPF requires a subsequent compromise in dose intensity of the chemotherapy that can be given concomitantly with radiation,” Corry and Rischin wrote. “[T]here are concerns that subjecting patients to a protracted course of treatment might compromise the delivery of the concomitant component, which has been shown to have the largest effect on locoregional control and overall survival.”
More trials are needed to determine whether there is a role for TPF-induction chemotherapy in head and neck cancer treatment, they wrote.