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

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.

• Authors: A Biete Solà, J Marruecos Querol, F A Calvo Manuel, E Verger Fransoy, A Rovirosa Casino, J J Grau de Castro, M de Las Heras González, A Ramos Aguerri, A Palacios Eito, C Veiras Candal, Maria V Solano López
• Journal: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico (Clin Transl Oncol) Vol. 9 Issue 4 Pg. 244-50 (Apr 2007) ISSN: 1699-048X [Print] Italy
• PMID: 17462977 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Taxoids
• Docetaxel

Topics

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