Phase II trial of gemcitabine concurrent with radiation for locally advanced squamous cell carcinoma of the head and neck

• Published in: Annals of oncology Vol. 15; no. 2; pp. 301 - 306
• Main Authors: Aguilar-Ponce, J., Granados-García, M., Villavicencio, V., Poitevin-Chacón, A., Green, D., Dueñas-González, A., Herrera-Gómez, Á., Luna-Ortiz, K., Alvarado, A., Martínez-Said, H., Castillo-Henkel, C., Segura-Pacheco, B., De la Garza, J.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.02.2004
• Subjects: Adult; Aged; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - pharmacology; Antineoplastic agents; Biological and medical sciences; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - radiotherapy; chemoradiation; Combined Modality Therapy; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - pharmacology; Disease-Free Survival; Female; gemcitabine; head and neck cancer; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - radiotherapy; Humans; Infusions, Intravenous; locally advanced; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Radiation Injuries; Ribonucleotide Reductases - antagonists & inhibitors; Treatment Outcome; Tumors; Skin disease; Squamous cell carcinoma; Gemcitabine; head and neck cancer; Concurrent; Malignant tumor; Antimetabolic; Phase II trial; Head and neck; Advanced stage; locally advanced; Fluorine Organic compounds; Pyrimidine nucleoside; chemoradiation
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdh071

Background: 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.