Phase I study of weekly nab-paclitaxel + weekly cetuximab + intensity-modulated radiation therapy (IMRT) in patients with stage III–IVB head and neck squamous cell carcinoma (HNSCC)

was deemed the MTD. Among 23 assessable patients, the most common ≥g3 AEs were lymphopenia 100%, functional mucositis 65%, and pain in throat/oral cavity 52%. At a median follow-up of 33 months, 2-year failure-free survival (FFS) is 65% [95% confidence interval (CI) 42% to 81%] and 2-year overall survival (OS) is 91% (95% CI 69–97). Conclusion: The recommended phase II dose for nab-paclitaxel is 60 mg/m 2 weekly when given standard weekly cetuximab and concurrent IMRT. This regimen merits further studyas a nonplatinum alternative to IMRT+cetuximab alone. Clinicaltrials.gov ID: NCT00736619.