A Non-Randomized Single-Center Comparison Of Induction Chemotherapy (Ic) Followed By Chemoradiation (Crt) Versus Crt For Locally Advanced (La) Squamous Cell Carcinoma Of The Head And Neck (Scchn)

17004 Background: Gemcitabine (GEM) is a potent radiosensitizer with activity in SCCHN. CRT is still the standard treatment for LA-SCCHN. CRT improves local control and overall survival (OS) when compared to radiotherapy (RT) alone. IC reduces the risk of distant metastases (DM) and improves OS by 5 % whith the use of cisplatin/5 fluorouracil (PF) in meta-analysis. Adding a taxane to PF confers a better outcome. Sequential treatment (ST) of IC followed by CRT is under active investigation in multiple phase III trials. Methods: We compared the outcome of two cohorts of patients (pts) with LA-SCCHN treated at our institution by CRT (12/98–09/05) or ST (03/98–09/06), respectively. Treatment: CRT: GEM 100 mg/m2 weekly + conventional RT (70 gy); ST: same CRT preceded by IC, which included DIP (docetaxel, ifosfamide, P)[16/31], TPF (docetaxel, P, F) [10/31], TPF + cetuximab [3/31] or PF [2/31]. Results: Response to IC: complete: 8, partial: 20, stable 1, progressive 1, not evaluable: 1. Median follow up (FUP) of the surviving pts: CRT: 60 months (mos), ST: 32 mos. Median time to distant metastasis (TDM): CRT: 23.5 mos, ST: not reached (NR); median OS: CRT: 20.2 mos, ST: 24.6 mos. Kaplan Meier estimate of TDM was significantly longer in the ST cohort (p= 0.013). Cox regression analysis, taking into account tumor site and nodal status, showed a hazard ratio with ST of 0.244 for TDM (p = 0.013), 0.529 for OS (p = 0.092) and 1.480 for median time to local failure (p= 0.397). Conclusions: TDM was significantly longer in the ST cohort. There was no difference in OS although there was a trend in favor of the ST cohort. These data are to be interpreted with extreme caution as this is a non-randomized single-center comparison of two rather small cohorts of pts with a different duration of FUP which were not balanced for tumor site or other prognostic factors. ST is not an accepted standard approach; the outcome of phase III trials has to be awaited. Patient Characteristics Cohort # pts Age OP HP L Other T4 N2 N3 CRT 27 57 7 17 1 2 15 13 5 ST 31 58 14 9 4 4 19 21 6 # pts = number of patients; Age = median age in years; OP = oropharynx, HP = hypopharynx, L = larynx. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen, Lilly Oncology, Merck, OXiGENE, sanofi-aventis Merck, sanofi-aventis