Gemcitabine and cisplatin in a concomitant alternating chemoradiotherapy program for locally advanced head-and-neck cancer: A pharmacology-guided schedule
- Medical Oncology, S. Croce General Hospital, Cuneo (Italy)
- Radiation Oncology Unit, S. Croce General Hospital, Cuneo (Italy)
- Otolaringology Unit, S. Annunziata Hospital, Savigliano (Italy)
- Otolaringology Unit, SS. Arrigo e Biagio Hospital, Alessandria (Italy)
- Clinical Nutrition Unit, S. Croce General Hospital, Cuneo (Italy)
Purpose: Administration of gemcitabine together with cisplatin at cytotoxic doses in a chemoradiotherapy regimen is hampered by a high degree of local toxicity. Using the pharmacologic properties of the drug we designed a modified schedule aimed at reducing toxicity while preserving activity. Methods and Materials: Patients with squamous cell carcinomas of the oral cavity, pharynx and larynx, bulky T4, and/or N2 to N3 were eligible. Gemcitabine was administered at a dose of 800 mg/m{sup 2} on Days 1 and 12 and cisplatin at a dose of 20 mg/m{sup 2} on Days 2 to 5, every 21 days for 3 courses. Radiotherapy, delivered with standard fractionation, was given on Days 8 to 12 and 15 to 19 and was repeated 3 times up to a total dose of {>=}60 Gy. Results: A total of 28 patients were selected. Grade 3 to 4 stomatitis was recorded in 25 patients (89%). Thirteen patients (46%) experienced Grade 3 to 4 neutropenia. Febrile neutropenia occurred in 8 patients (29%) and in 2 was complicated by infection and death. The overall complete response rate was 79%. At a median follow up of 71 months, 11 patients had a locoregional relapse (3-year locoregional control, 64%); 6 patients had distant metastases, among whom only 2 were without locoregional recurrence. The 3-year progression-free survival is 39% and 3-year overall survival has been 43%. Conclusion: The schedule modification did not attenuate local toxicity. Moreover, infections and especially pneumonia, were a major problem. The high activity of gemcitabine when combined with radiotherapy would most likely be better exploited in the context of modified radiation schemes.
- OSTI ID:
- 20850157
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 66, Issue 3; Conference: 48. annual meeting of the American Society for Therapeutic Radiology and Oncology, Pennsylvania, PA (United States), 5-9 Nov 2006; Other Information: DOI: 10.1016/j.ijrobp.2006.05.059; PII: S0360-3016(06)00998-9; Copyright (c) 2006 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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