Annals of Oncology 15:301-306, 2004
© 2004 European Society for Medical Oncology
Original Paper |
Phase II trial of gemcitabine concurrent with radiation for locally advanced squamous cell carcinoma of the head and neck
Received 20 May 2003; revised 28 October 2003; accepted 31 October 2003Background:
Concurrent chemoradiation is the current standard of treatment for patients with advanced unresectable head and neck squamous cell carcinoma (HNSCC). Due to the potent radiosensitizing properties of gemcitabine, we decided to assess its efficacy and toxicity with concurrent radiation in patients with advanced HNSCC.
Patients and methods:
From January 1997 to December 2001, 27 patients with locally advanced HNSCC (stage III, 37%; stage IV, 63%) were enrolled. All received a course of radiotherapy (70 Gy over 7 weeks) concurrent with weekly infusions of gemcitabine at 100 mg/m2 or 50 mg/m2.
Results:
All patients were assessable for toxicity and 26 for response. Severe mucositis (grade 3–4) was observed in 74% of patients (grade 4, 41%). Severe hematological toxicity was uncommon. Mild and moderate xerostomy was the most common late toxicity in 23 patients (85%). The median radiation dose delivered was 70 Gy (40–80 Gy), 25 patients (93%) received 
80% of the intended dose. Gemcitabine dose intensity was 80% in only 13 (48%) patients. The rate of complete and partial responses were 61% and 27%, respectively, for an overall response rate of 88%. At a median follow-up of 13 months (range 6–62), the actuarial 3-year progression-free survival (PFS) and overall survival (OS) were 37% and 33%, respectively. The only variable associated with prolonged survival (P = 0.0001) was the degree of response. No difference was observed in response or toxicity with either gemcitabine 50 or 100 mg/m2.
Conclusions:
The concurrent use of radiotherapy and gemcitabine is effective but produces manageable severe mucositis in a high percentage of patients.
Departments of 1 Medical Oncology, 2 Surgery and 3 Radiation, Instituto Nacional de Cancerología, Mexico City; 4 Department of Hematology and Oncology, Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán, Mexico City; 5 Unidad de Investigación Biomédica en Cáncer, Inst. Inv. Biomédicas, UNAM/Instituto Nacional de Cancerología, Mexico City; 6 Postgraduate Medicine Unit Escuela Superior de Medicina, Instituto Politécnico Nacional, Mexico City, México
Key words: chemoradiation, gemcitabine, head and neck cancer, locally advanced
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