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Randomized Trial of Adjuvant 13-cis-Retinoic Acid and Interferon Alfa for Patients With Aggressive Skin Squamous Cell Carcinoma

Abenaa M. Brewster, J. Jack Lee, Gary L. Clayman, John L. Clifford, Mary Jo T. Necesito Reyes, Xian Zhou, Anita L. Sabichi, Sara S. Strom, Robert Collins, Christina A. Meyers, Scott M. Lippman

From the Departments of Clinical Cancer Prevention, Biostatistic and Applied Mathematics, Head and Neck Surgery, Thoracic/Head and Neck Medical Oncology, Epidemiology and Neuro-oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX; and the Department of Biochemistry and Molecular Biology, Louisiana State University Health Sciences Center and Feist-Weiller Cancer Center, Shreveport, LA

Address reprint requests to Scott M. Lippman, MD, Department of Thoracic and Head and Neck Medical Oncology, Unit 432, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77230-1439; e-mail: slippman{at}mdanderson.org

Purpose: To conduct a phase III trial of adjuvant 13-cis-retinoic acid (13cRA) plus interferon alfa (IFN-) for preventing tumor recurrence and second primary tumors (SPTs) of skin squamous cell carcinoma (SCC) among patients with aggressive skin SCC.

Patients and Methods: Sixty-six patients with aggressive skin SCC were randomly assigned to receive either 6 months of combined 13cRA (1 mg/kg/d orally) and IFN- (3 x 10⁶ U subcutaneously three times per week) or no adjuvant therapy (control group) after SCC surgery and/or radiation.

Results: At 21.5 months median follow-up, treatment did not improve the time to tumor recurrence and SPT versus control (hazard ratio [HR], 1.13; 95% CI, 0.53 to 2.41), time to tumor recurrence (HR, 1.08; 95% CI, 0.43 to 2.72), or time to SPT (HR, 0.89; 95% CI, 0.27 to 2.93). Adjuvant 13cRA and IFN- was moderately tolerable; 29% of patients in the treatment arm required dose reductions for grade 3 or 4 toxicities.

Conclusion: Results of this phase III trial do not support 13cRA plus IFN- for adjuvant therapy of aggressive skin SCC. With high rates of tumor recurrence and SPTs, patients with aggressive skin SCC continue to have an unmet medical need, with devastating mortality, morbidity, and financial consequences. Promising agents with preclinical and early clinical results relevant to aggressive skin SCC deserve a high priority for future clinical drug development.

Supported by Grants No. P01-5P01CA68233 and CA16672 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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• Skin Squamous Cell Cancer: The Time Is Right for Greater Involvement of the Medical Oncologist
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