Phase II trial: concurrent radio-chemotherapy with weekly docetaxel for advanced squamous cell carcinoma of head and neck

Clin Transl Oncol. 2007 Apr;9(4):244-50. doi: 10.1007/s12094-007-0047-y.

Abstract

Introduction: Standard fractionation radiation therapy (RT) combined with concomitant chemotherapy (CT) based on cisplatin schemes is actually the standard treatment for locally advanced non-resectable squamous cell carcinoma of head and neck (SCCHN). The appearance of taxoids has introduced a new kind of treatment with high antitumoral power. The aim of this study is to add more information about the role of this new approach.

Materials and methods: Twenty-six patients with locally advanced non-resectable SCCHN were recruited at six institutions in Spain, between January 2001 and January 2003. Docetaxel was administered weekly, for 6 weeks, concurrently with RT.

Results: The mean total delivered dose of RT was 70'2 Gy (range 64-74 Gy). The median and mean duration of time were 63 days and 61 days (range 49-103 days) respectively. After a median time control of 19 months (range 3.3-42.2 months), the response rate was 83.4%. The median time to local progression was 16.4 months (95% confidence interval [CI]=4.4-28.4 months). The median survival time was 26.9 months, with one- and two-year overall survival of 66.9% (95% CI=48.1-85.7%) and 57.5% (95% CI=37.3-77.7%) respectively. The median duration time response was 15.1 months (95% CI=3.7-26.5 months). The median time until treatment failure was 9.4 months (95% CI=4.7-14.1). Incidence of grade III-IV mucositis was 88%, neutropenia 72% and skin toxicity 92% (24% grade III-IV). The incidence of severe late toxicity (grade III and IV) due to RT/CT was 31.4%.

Conclusions: Although therapeutics results are equivalent to cisplatin schemes of concurrent CT-RT, mucositis and cutaneous toxicity registered in this trial must be considered as limiting factors to application of this new approach.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / mortality
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / radiotherapy*
  • Combined Modality Therapy
  • Confidence Intervals
  • Docetaxel
  • Female
  • Head and Neck Neoplasms / drug therapy*
  • Head and Neck Neoplasms / mortality
  • Head and Neck Neoplasms / pathology
  • Head and Neck Neoplasms / radiotherapy*
  • Humans
  • Kaplan-Meier Estimate
  • Karnofsky Performance Status
  • Laryngeal Neoplasms / drug therapy
  • Laryngeal Neoplasms / mortality
  • Laryngeal Neoplasms / pathology
  • Laryngeal Neoplasms / radiotherapy
  • Larynx / pathology
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Neoplasms, Multiple Primary / drug therapy
  • Neoplasms, Multiple Primary / mortality
  • Neoplasms, Multiple Primary / radiotherapy
  • Pharyngeal Neoplasms / drug therapy
  • Pharyngeal Neoplasms / mortality
  • Pharyngeal Neoplasms / pathology
  • Pharyngeal Neoplasms / radiotherapy
  • Pharynx / pathology
  • Radiotherapy / adverse effects
  • Radiotherapy Dosage
  • Taxoids / administration & dosage
  • Taxoids / adverse effects
  • Taxoids / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Taxoids
  • Docetaxel