Long-term results from EORTC24971/TAX323: Comparing TPF to PF in patients with unresectable squamous cell carcinoma of the head and neck (SCCHN).

5530 Background: At a median follow-up (FU) of 32.5 months, the original EORTC24971/TAX323 study showed that compared with standard cisplatin/infusional fluorouracil (PF), induction chemotherapy (ICT) with the addition of docetaxel (TPF) prior to radiotherapy significantly improved progression-free survival (PFS) and overall survival (OS) with less toxicity and an improved quality of life in patients with unresectable SCCHN (NEJM 2007; 357: 1695; BJC 2010; 103: 1173). The present report describes survival data after a median FU of 8.6 years and long-term side effects (feeding tube dependency, tracheostomy, gastrostomy and second malignancies). Methods: Data were collected in a long-term FU form and analyzed in the intent-to-treatment population, using a Cox PH model adjusted for treatment, tumor site, T&N stage and performance status. The two treatment arms were also compared with an unstratified logrank test at a 2-sided 5% significance level. The clinical database was locked on January 10, 2011. Results: FU forms were obtained from 308 (86%) of the 358 randomized patients (156 TPF, 152 PF). PFS remained significantly better with TPF compared with PF (hazard ratio [HR] unadjusted 0.71 (95% CI, 0.57-0.89), p=0.003, medians of 12.7 vs 8.6 months, and 5-years PFS 22.9% vs 13.5%, mainly due to less locoregional progression). A similar picture was observed for OS (HR unadjusted 0.74 (95% CI, 0.59-0.94), p=0.011, medians of 18.8 vs 14.5 months, 5-years OS 27.5 vs 18.6%). These data were confirmed in the Cox PH model. Long-term side effects in TPF/ PF arms were: tracheostomy 13/9 ; feeding tube dependency 6/10; gastrostomy 19/19; second malignancy 14/6 (of which lung 42.9%/50%; H&N 42.9%/33.3%, and GI 14.3%/16.7%). Conclusions: This long-term update supports the conclusions of the final analysis that TPF is superior to PF as ICT for patients with unresectable SCCHN.