Annals of Oncology Advance Access originally published online on September 6, 2007
Annals of Oncology 2007 18(11):1856-1860; doi:10.1093/annonc/mdm346
© 2007 European Society for Medical Oncology
head and neck cancer |
Phase II feasibility study of concurrent radiotherapy and gemcitabine in chemonaive patients with squamous cell carcinoma of the head and neck: long-term follow up data
1 Department of Medical Oncology, University Hospital Antwerp, Edegem
2 Department of Radiotherapy, Campus Middelheim, ZNA Hospital Network, Antwerp
3 Department of Otolaryngology, University Hospital Antwerp, Edegem
4 Epidemiology and Community Medicine, Center for Cancer Prevention, University of Antwerp, Edegem
5 Department of Medical Oncology Campus Middelheim, ZNA Hospital Network, Antwerp, Belgium
* Correspondence to: Dr P. Specenier, University Hospital Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium. Tel: +32 3 8214014; Fax: +32 2 2694547; E-mail: pol.specenier{at}uza.be
Background: Radiotherapy (RT) with concurrent chemotherapy is the current standard of care for patients with unresectable locally advanced squamous cell carcinoma of the head and neck (SCCHN). Gemcitabine (GEM) is a potent radiosensitizer and in addition has activity as an anticancer agent in SCCHN.
Patients and methods: Twenty-six patients with locally far advanced SCCHN were enrolled in a chemoradiation feasibility study between November 1998 and September 2003. Use was made of conventionally fractionated RT and GEM 100 mg/m2, which was given within 2 h prior to radiotherapy on a weekly basis starting on day 1 of RT. Response was assessed according to WHO criteria, toxicity according to NCI-CTC version 2.
Results: The patients received a median of 7 (2–8) weekly cycles of gemcitabine and a median cumulative RT dose of 70 Gy (66–84.75). Hematologic toxicity was mild, but non-hematologic toxicity was severe: grade 3–4 stomatitis occurred in 85% of patients, dermatitis in 69%, pharyngitis/esophagitis in 81% and 80% of the patients needed a feeding tube during treatment. All 22 evaluable patients responded (50% complete, 50% partial). Median follow up of the surviving patients is 46 months. Median disease-free and overall survival is 13 months and 19 months, respectively; 27% of the patients are alive without evidence of recurrence beyond 3 years.
Conclusions: Conventionally fractionated RT in combination with GEM 100 mg/m2 weekly is feasible and highly active in the treatment of locally advanced SCCHN. In particular, long-term local control rate is promising. Acute mucosal toxicities are significant but manageable. Long-term toxicity interferes with normal food intake.
Key words: chemoradiation, gemcitabine, head and neck cancer, squamous cell carcinoma
Received for publication May 6, 2007. Revision received June 4, 2007. Accepted for publication June 5, 2007.