A Phase I/II Study of Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Squamous Cell Cancer of the Head and Neck

Stephen G Chun; Randall Hughes; Baran D Sumer; Larry L Myers; John M Truelson; Saad A Khan; Tsung-Wei Ma; Yang Xie; John S Yordy; Susan Cooley; Jean Wu; Hak Choy; Lucien A Nedzi

doi:10.1080/07357907.2016.1213275

A Phase I/II Study of Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Squamous Cell Cancer of the Head and Neck

Cancer Invest. 2017 Jan 2;35(1):23-31. doi: 10.1080/07357907.2016.1213275. Epub 2016 Nov 28.

Authors

Stephen G Chun¹, Randall Hughes², Baran D Sumer³, Larry L Myers³, John M Truelson³, Saad A Khan², Tsung-Wei Ma⁴, Yang Xie⁴, John S Yordy⁵, Susan Cooley⁶, Jean Wu⁶, Hak Choy⁶, Lucien A Nedzi⁶

Affiliations

¹ a Division of Radiation Oncology, M.D. Anderson Comprehensive Cancer Center , Houston , TX , USA.
² b Division of Hematology and Oncology, Department of Internal Medicine, Harold C. Simmons Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA.
³ c Department of Otolaryngology , University of Texas at Southwestern Medical Center , Dallas , TX , USA.
⁴ d Department of Clinical Sciences , University of Texas at Southwestern Medical Center , Dallas , TX , USA.
⁵ e Valley Radiation Therapy Center , Anchorage , AK , USA.
⁶ f Department of Radiation Oncology , Harold C. Simmons Comprehensive Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA.

PMID: 27892728
DOI: 10.1080/07357907.2016.1213275

Abstract

Nab-paclitaxel might impact efficacy of radiation for head and neck (H&N) cancer. Nab-paclitaxel, cisplatin, cetuximab, and radiation were evaluated in patients with locally advanced head and neck cancer in this phase I/II trial. Median follow-up was 24 months for 34 patients. The maximum tolerated dose of nab-paclitaxel was 20 mg/m² with 20 mg/m² cisplatin and 250 mg/m² cetuximab. The 2-year progression-free survival (PFS) was 60% (95% confidence interval (CI) 0.42, 0.78), local control 71% (95% CI 0.55, 0.87), and overall survival 68% (95% CI 0.50, 0.86). This is the first study evaluating these agents with radiation in humans, with similar 2-year PFS as historic control.

Keywords: Abraxane; cisplatin; erbitux; head and neck cancer; radiation therapy.

Publication types

Clinical Trial, Phase I
Clinical Trial, Phase II

MeSH terms

Aged
Albumins / administration & dosage
Albumins / therapeutic use
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Carcinoma, Squamous Cell / drug therapy*
Cetuximab / administration & dosage
Cetuximab / therapeutic use
Cisplatin / administration & dosage
Cisplatin / therapeutic use
Combined Modality Therapy
Female
Head and Neck Neoplasms / drug therapy*
Head and Neck Neoplasms / radiotherapy*
Humans
Male
Maximum Tolerated Dose
Middle Aged
Paclitaxel / administration & dosage
Paclitaxel / therapeutic use
Survival Analysis
Treatment Outcome

Substances

130-nm albumin-bound paclitaxel
Albumins
Paclitaxel
Cetuximab
Cisplatin