Maintenance immunotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck

• Published in: Journal of immunotherapy (1997) Vol. 31; no. 4; p. 413
• Main Authors: Recchia, Francesco, Candeloro, Giampiero, Di Staso, Mario, Necozione, Stefano, Bisegna, Roberta, Bratta, Massimo, Tombolini, Vincenzo, Rea, Silvio
• Format: Journal Article
• Language: English
• Published: United States 01.05.2008
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - immunology; Carcinoma, Squamous Cell - immunology; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - therapy; CD4-CD8 Ratio; Cisplatin - administration & dosage; Cisplatin - adverse effects; Disease-Free Survival; Female; Head and Neck Neoplasms - immunology; Head and Neck Neoplasms - pathology; Head and Neck Neoplasms - therapy; Humans; Ifosfamide - administration & dosage; Ifosfamide - adverse effects; Immunotherapy - adverse effects; Killer Cells, Natural - drug effects; Killer Cells, Natural - immunology; Male; Middle Aged; Neoplasm Metastasis; Neoplasm Recurrence, Local; T-Lymphocytes - drug effects; T-Lymphocytes - immunology; Taxoids - administration & dosage; Taxoids - adverse effects
• ISSN: 1524-9557
• DOI: 10.1097/CJI.0b013e31816d1d8e

The purpose of this study was to determine the efficacy and safety of a maintenance immunotherapy regimen administered to patients with recurrent/metastatic squamous cell carcinoma of the head and neck (RMHN) who showed clinical benefit from docetaxel, ifosfamide, and cisplatin chemotherapy (DIP). Every 4 weeks, patients with RMHN received 60 mg/m docetaxel on day 1, and 1200 mg/m ifosfamide and 20 mg/m cisplatin on days 1 to 4. Low-dose subcutaneous interleukin-2 and oral 13-cis-retinoic acid were administered as maintenance immunotherapy to patients who showed a clinical benefit (complete or partial response, disease stability). The primary end point was response; secondary end points were progression-free survival, overall survival, toxicity, and evaluations of lymphocytes, natural killer cells, and serum vascular endothelial growth factor (VEGF). After a median follow-up of 22 months, 263 courses of chemotherapy were administered to the 54 patients. The overall response rate was 59%. Forty-two patients (78%) had a clinical benefit and received 185 courses of maintenance immunotherapy. Median progression-free survival and overall survival were 11.1 and 21.8 months, respectively. Statistically significant, progressive increases in lymphocytes and natural killer cells and a decrease in VEGF were observed in patients treated with maintenance immunotherapy. The toxicity was relatively well tolerated and caused no death. Outpatient administration of DIP, followed by low-dose interleukin-2 and 13-cis-retinoic acid, was generally well tolerated and showed promising activity against RMHN. Longitudinal changes in lymphocytes, natural killer cells, and VEGF might be useful biomarkers for response and survival.