Low-dose fractionated radiation (LDFRT) plus paclitaxel (P) and carboplatin (CBCDA) as induction therapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN): Two-year follow-up

Abstract

5593 Background: LDFRT (< 100cGy) induces cell death through a unique mechanism, hyper-radiosensitivity. Based on demonstrated synergy with chemotherapy, LDFRT was combined with P and C as induction therapy in locally advanced SSCHN. Methods: In this phase II trial, 39 patients with locally advanced SCCHN (77.5% stage IV, 45% T4 and 60% advanced neck disease) received P 225mg/m2 (Day 1), CB AUC 6 (Day 1), and four 80 cGy fractions of radiation (two each on Day 1 & 2) for two cycles. Definitive therapy began 3 weeks after the last dose of induction therapy and was based on response to induction and the decision of a multidisciplinary team. Nineteen patients (49%) received concurrent chemotherapy and radiation, 16 (41%) patients received radiation alone and 4 patients (10%) had surgery. Results: Median follow-up is 26 months. Overall response rate to induction was 82% (90% RR at the primary site). At two years, overall survival was 72%, DFS was 77%. The local control rate was 79% (the majority of failures occurred within the first year) and distant control 88%. Conclusions: Induction LDFRT, P and CB appears to improve distant control rates in patients with locally advanced SCCHN. OS and DFS compare favorably to other aggressive chemoradiotherapy strategies in SCCHN. These results confirm the efficacy of induction LDFRT and chemotherapy followed by aggressive definitive therapy in SCCHN. Supported by a grant from Bristol-Myers Squibb. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Pharmaceuticals Bristol-Myers Squibb