Abstract
5515 Background: HNSCC is the 5th most common cancer in the United States. A majority abuse tobacco which leads to higher relapse rates and second primary tumors (SPT). Methods: We reported results of a randomized chemoprevention study (FRK ASCO 2003) in which pts received isotretinoin or placebo. This analysis focuses on the placebo group and prognostic characteristics related to prior therapy, site of disease, stage, and smoking status. Results: From 1991 to 1999, 600 pts were enrolled into the placebo arm: stage I (n=389), II (211); primary tumor of larynx (L; 343), oral cavity (OC; 187), pharynx (P; 70); prior therapy of radiation (RT; 353), surgery (S; 158), both (86); and smoking status of current (220), former (296), never (84). The median follow-up is 6 years and 5-year survival is 0.83 (0.80, 0.87). We compared the above pts in statistical models to identify prognostic markers, which may impact recurrence, smoking-related (sm) SPT development, disease-free (DFS), and overall survival (OS). Smoking status was found to be associated with site: OC primaries with more nonsmokers, L with more former smokers, and P with more current smokers. Site of disease was associated with stage as more L pts presented in stage I and P stage II. Treatment related with site of disease: L received more RT, OC received more S, and P received more of both. Treatment also related with stage: more single therapy for stage I and combination for II.Significant observations included worse recurrence-free and sm-DFS for OC as compared to L (P=0.0003 and 0.007, respectively), worse recurrence-free survival in pts with prior RT as compared to S (P=0.007) which was also marginally significant for survival (P=0.06); and higher sm-SPT survival for P primaries as compared to L (p=0.02). After adjusting by stage, site, and smoking status, sm-SPT survival and OS for current smokers was worse (p=0.04, p=0.008). Conclusion: Smoking status did not predict recurrence but current smoking status was the most significant predictor for poor survival. Further studies are needed to investigate the interaction between smoking and primary treatment modality early stage HNSCC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca Pfizer Pfizer AstraZeneca; Aventis Trial was funded by NCI-PO1 grant; this is a subset analysis of the trial
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