Clinical response rate at primary tumor site (PTS) following a novel induction chemotherapy (IC) regimen of weekly nanoparticle albumin-bound (nab-)paclitaxel and cetuximab with every-3-week cisplatin and 5-FU (ACCF) versus docetaxel, cisplatin, 5-FU, and cetuximab (TPF + C) in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

5560 Background: Achievement of a complete (CR) or partial (PR) response at the PTS to IC with cisplatin and 5-FU correlates with disease control after subsequent definitive radiation-based therapy (RT) in patients with HNSCC. The likelihood of CR/PR after IC is high in T1/2 and low in T3/4 tumors. SPARC, an albumin binding protein that is commonly overexpressed in HNSCC, may facilitate preferential accumulation of nab-paclitaxel at PTS compared to other formulations of taxanes. Methods: The primary objective of the prospective phase II trial was to determine the clinical CR and PR rate at the PTS to an IC regimen of weekly nab-paclitaxel (100 mg/m2) and cetuximab (250 mg/m2) with every 3 week cisplatin (75 mg/m2) and 5-FU (750 mg/m2 per day x3 CIVI) (ACCF) given for two cycles in patients with HNSCC. PTS response assessment was performed by clinical exam using categorical outcomes [CR: 100%↓, near CR: 95%↓, PR: 50-94%↓, or progression]. All patients were treated with a third cycle of ACCF, then definitiv...