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Long-term Follow-up

Jose A. Seixas-Silva, Jr, MD; Thomas Richards, PhD; Fadlo R. Khuri, MD; H. Samuel Wieand, PhD; Ed Kim, MD; Barbara Murphy, MD; Marites Francisco, RN; Waun Ki Hong, MD; Dong M. Shin, MD

Arch Otolaryngol Head Neck Surg. 2005;131:304-307.

Objective  To evaluate the long-term effects of the combination of isotretinoin, interferon alfa-2a, and vitamin E in locally advanced squamous cell carcinoma of the head and neck.

Design  Phase 2 prospective study.

Setting  Tertiary care academic medical centers.

Patients  Forty-five patients entered this study. All patients had stage III or IV squamous cell carcinoma of the head and neck and had been treated with surgical resection, radiation, or both. All patients were then treated with bioadjuvant chemopreventive treatment for 12 months. We previously reported a 24-month median follow-up of this phase 2 trial of the combination of isotretinoin, interferon alfa-2a, and vitamin E as bioadjuvant therapy after definitive local therapy. In that study, all 45 patients completed treatment, but 1 patient was excluded from analysis of recurrence and development of second primary tumors.

Main Outcome Measure  Longer-term (49.4-month median) follow-up.

Results  Among the 45 patients treated under the protocol, only 7 patients (16%) had died. Nine (20%) of 45 patients experienced progressive disease. Only 1 second primary tumor (acute promyelocytic leukemia) occurred during follow-up, and no aerodigestive second primary tumors occurred among the 45 patients. The 5-year progression-free survival and overall survival percentages were 80% (95% confidence interval, 65.1%-89.1%) and 81.3% (95% confidence interval, 63.7%-90.9%), respectively. These results are significantly better than the historical 5-year overall survival for advanced squamous cell carcinoma of the head and neck (approximately 40%).

Conclusion  The bioadjuvant combination is highly effective in preventing recurrence and second primary tumors, and its role as standard therapy in advanced squamous cell carcinoma of the head and neck is being investigated in a randomized phase 3 study.

Author Affiliations: University of Pittsburgh Cancer Institute, Pittsburgh, Pa (Drs Seixas-Silva, Richards, and Wieand); Winship Cancer Institute, Emory University, Atlanta, Ga (Drs Khuri and Shin); M. D. Anderson Cancer Center, Houston, Tex (Drs Kim and Hong and Ms Francisco); and Vanderbilt University Ingram Cancer Center, Nashville, Tenn (Dr Murphy).

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