Annals of Oncology Advance Access published online on September 6, 2007
Annals of Oncology, doi:10.1093/annonc/mdm346
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© 2007 European Society for Medical Oncology
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.
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.