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.

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