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Clinical Trial
. 2016 Oct:61:1-7.
doi: 10.1016/j.oraloncology.2016.07.015. Epub 2016 Jul 29.

nab-Paclitaxel, cisplatin, and 5-fluorouracil followed by concurrent cisplatin and radiation for head and neck squamous cell carcinoma

Douglas Adkins  1 , Jessica Ley  2 , Loren Michel  3 , Tanya M Wildes  3 , Wade Thorstad  4 , Hiram A Gay  4 , Mackenzie Daly  4 , Jason Rich  5 , Randal Paniello  5 , Ravindra Uppaluri  5 , Ryan Jackson  5 , Kathryn Trinkaus  6 , Brian Nussenbaum  5
Affiliations
Clinical Trial

nab-Paclitaxel, cisplatin, and 5-fluorouracil followed by concurrent cisplatin and radiation for head and neck squamous cell carcinoma

Douglas Adkins et al. Oral Oncol. 2016 Oct.

Abstract

Objectives: We previously reported the efficacy of nab-paclitaxel added to cisplatin, 5-FU, and cetuximab (APF-C) followed by concurrent high dose bolus cisplatin and radiation therapy (CRT) in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). In this phase II trial, we determined the efficacy of APF (without cetuximab) followed by CRT in similar patients.

Materials and methods: Eligible patients had stage III-IV oropharynx (OP), larynx, or hypopharynx SCC and adequate organ function and performance status. T1 tumors were excluded. Patients were treated with three cycles of APF followed by CRT. Efficacy endpoints included two-year disease-specific survival (DSS), progression-free survival (PFS), overall survival (OS), and relapse rate.

Results: Thirty patients were enrolled. Most patients were smokers (77%) with bulky T3/4 (73%) and N2/3 (83%) tumors. Analyses were stratified for human papilloma virus (HPV) status: HPV-related OPSCC (n=17; 57%) and HPV-unrelated HNSCC (n=13; 43%). With a minimum follow-up of 21months, relapse occurred in 1 (3%) patient. Two-year DSS was 94% in HPV-related OPSCC and 100% in HPV-unrelated HNSCC. Two-year PFS was 94% in HPV-related OPSCC and 100% in HPV-unrelated HNSCC. Two-year OS was 94% in HPV-related OPSCC and 92% in HPV-unrelated HNSCC. Causes of death were relapse (1), treatment-related mortality (1), and co-morbidity (1). Two patients with HPV-unrelated HNSCC treated with APF declined CRT and remained free of relapse at 36 and 28months of follow-up.

Conclusion: This phase II trial demonstrated favorable two-year DSS, PFS, and OS and a low relapse rate in HPV-unrelated HNSCC and HPV-related OPSCC treated with APF followed by CRT.

Keywords: 5-Fluorouracil; Chemotherapy; Cisplatin; Head and neck cancer; Induction; nab-Paclitaxel.

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Figures

Fig. 1
Fig. 1
Survival curves: 1. DSS, stratified by p16 (HPV) status. 2. PFS, stratified by p16 (HPV) status. 3. OS, stratified by p16 (HPV) status.
See this image and copyright information in PMC

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