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



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.



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.



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.
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States. Electronic address: dadkins@dom.wustl.edu.
Douglas
D
Adkins
Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.
Jessica
J
Ley
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.
Loren
L
Michel
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.
Tanya M
TM
Wildes
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO, United States.
Wade
W
Thorstad
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO, United States.
Hiram A
HA
Gay
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO, United States.
Mackenzie
M
Daly
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Otolaryngology, Washington University School of Medicine, St. Louis, MO, United States.
Jason
J
Rich
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Otolaryngology, Washington University School of Medicine, St. Louis, MO, United States.
Randal
R
Paniello
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Otolaryngology, Washington University School of Medicine, St. Louis, MO, United States.
Ravindra
R
Uppaluri
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Otolaryngology, Washington University School of Medicine, St. Louis, MO, United States.
Ryan
R
Jackson
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, United States.
Kathryn
K
Trinkaus
Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Department of Otolaryngology, Washington University School of Medicine, St. Louis, MO, United States.
Brian
B
Nussenbaum
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D017239:Paclitaxel / Q000008:administration & dosage; D000077195:Squamous Cell Carcinoma of Head and Neck
D017239:Paclitaxel; D002945:Cisplatin; D005472:Fluorouracil
5-Fluorouracil; Chemotherapy; Cisplatin; Head and neck cancer; Induction; nab-Paclitaxel
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