Phase I study of nab- paclitaxel-based induction followed by nab -paclitaxel-based concurrent chemotherapy and re-irradiation in previously treated head and neck squamous cell carcinoma

Background Recurrent head and neck squamous cell carcinoma (HNSCC) is associated with poor overall survival (OS). Prior studies suggested incorporation of nab -paclitaxel (A) may improve outcomes in recurrent HNSCC. Methods This Phase I study evaluated induction with carboplatin and A followed by concomitant FHX (infusional 5-fluorouracil, hydroxyurea and twice-daily radiation therapy administered every other week) plus A with cohort dose escalation ranging from 10–100 mg/m 2 in recurrent HNSCC. The primary endpoint was maximally tolerated dose (MTD) and dose-limiting toxicity (DLT) of A when given in combination with FHX (AFHX). Results Forty-eight eligible pts started induction; 28 pts started AFHX and were evaluable for toxicity. Two DLTs occurred (both Grade 4 mucositis) at a dose level 20 mg/m 2 . No further DLTs were observed with subsequent dose escalation. The MTD and recommended Phase II dose (RP2D) of A was 100 mg/m 2 . Conclusions In this Phase I study, the RP2D of A with FHX is 100 mg/m 2 (AFHX). The role of re-irradiation with immunotherapy warrants further investigation. Clinical trial information This clinical trial was registered with ClinicalTrials.gov identifier: NCT01847326.