Long term (Five-year) results of Tax324: A Phase III Trial of Sequential Therapy comparing TPF with PF in Patients with locally advanced squamous cell cancer of the head and neck
Background: In the original TAX324 report, after a minimum follow up of two years and a median of 42 months, sequential chemotherapy with Taxotere, cisplatin and 5FU (TPF) significantly improved survival by 30% compared with cisplatin and 5FU (PF). TAX324 and TAX 323 established Induction and Sequential therapy with TPF as treatment standards for patients with Locally Advanced Head and Neck Cancer (LAHNC). We are now presenting the long term results of the TAX324 study.
Material and Methods: After IRB approval, the study group used the anonymous study codes of the patients who were alive or lost to follow up in the 2005 analysis to gather current data from the study sites. With a minimum follow up through December 1, 2008, data on survival, progression free survival and other factors were gathered and analyzed by summary statistics.
Results: The initial demographics, therapy and toxicity were previously reported. Data of 85% of 501 subjects randomized to either TPF or PF treatment on TAX 324 was collected. With a median follow up of 71 months and a minimum of 5 years, the overall survival in the TPF group was significantly longer than in the PF group (HR 0.74; 95% CI 0.58-0.94; p=0.013). Median survival was 71 and 30 months respectively, and mortality was reduced 24% in the TPF arm compared with PF. At 5 years 52% and 42% of the TPF and PF patients are alive (p=0.06). Subset analysis showed that the median survival was improved across all sites with TPF. Median survival was not reached in patients with oropharyngeal tumor locations who were treated with TPF while it was 68 months in the PF group (HR 0.71, 95% CI 0.5-1.97; p=0.07). The complete data set including the rate of tracheostomy and enteral feeding tube dependence among survivors will be presented at the meeting.
Conclusion: The benefit of induction chemotherapy with TPF is significantly superior to PF beyond 5 years and has been maintained at essentially the same level of impact as in the 2 year follow up. These data support the long term efficacy of TPF and sequential therapy in the management of appropriate patients with locally advanced head and neck cancer.