Efficacy and safety of a cisplatin and paclitaxel induction regimen followed by chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinoma

Head Neck. 2016 Apr:38 Suppl 1:E970-80. doi: 10.1002/hed.24137. Epub 2015 Jul 18.

Abstract

Background: The purpose of this phase II trial was to evaluate the tolerability, safety, and efficacy of a non-5-fluorouracil (5-FU)-based induction chemotherapy followed by chemoradiotherapy (CRT) for patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Methods: Sixty patients with stage III to IV HNSCC were treated with induction paclitaxel and cisplatin (TP; paclitaxel 175 mg/m(2) and cisplatin 80 mg/m(2) , 3 cycles) followed by CRT (cisplatin 100 mg/m(2) ; D1, 22, and 43 of radiotherapy).

Results: Fifty-six patients (93.3%) completed 3 cycles of induction TP (no treatment-related deaths), 52 (86.7%) completed definitive CRT per protocol (adverse event [AE] grade ≥2 in 53.3%). The overall response rate after induction TP was 82.5% for patients with resectable disease and 55.5% for unresectable disease (p = .023), and complete response (CR) rate after CRT was 70.0% for patients with resectable disease and 30.0% for unresectable disease (p = .005).

Conclusion: Induction TP followed by cisplatin based-CRT was well-tolerated, safe, and had high overall response rate in selected patients with locally advanced HNSCC. © 2015 Wiley Periodicals, Inc. Head Neck 38: E970-E980, 2016.

Keywords: chemoradiation therapy; head and neck cancer; induction chemotherapy; organ preservation; squamous cell carcinoma.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / therapy*
  • Chemoradiotherapy*
  • Cisplatin / therapeutic use*
  • Female
  • Fluorouracil
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel / therapeutic use*
  • Prospective Studies

Substances

  • Paclitaxel
  • Cisplatin
  • Fluorouracil