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Chemoprevention of head and neck cancer with retinoids: a negative result

Lookup NU author(s): Emeritus Professor Elaine Perry

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Abstract

OBJECTIVE: To determine whether isotretinoin (or 13-cis-retinoic acid) decreases the risk of second primary cancers in patients previously treated for cure of head and neck squamous cell carcinoma. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Two head and neck multidisciplinary cancer clinics in university teaching hospitals taking cases from 4 to 5 million people in Queensland, Australia, combined to enter appropriate patients into this trial. PATIENTS: One hundred fifty-one patients with their first head and neck squamous cell carcinoma treated with high expectation for cure and living close by. They were randomized into 3 arms to receive 3 years of treatment. INTERVENTIONS: Patients took isotretinoin at a high dose (1.0 mg/kg per day) or a moderate dose (0.5 mg/kg per day) or placebo. Group 1 took the high dose for 1 year and then the moderate dose for 2 years. Group 2 took the moderate dose for 3 years. Group 3 took placebo for 3 years. MAIN OUTCOME MEASURES: The diagnosis of a second primary malignancy of the head and neck, lung, or bladder was regarded as the end point signifying failure of therapy. Issues of drug adverse effect profile and impact on survival were measured. RESULTS: There was no significant difference in the occurrence of second primary disease (P = .90), the recurrence of primary disease (P = .70), or disease-free time (P = .80) between the treatment and nontreatment arms. Numbers were too small to find differences in survival. CONCLUSION: With evidence that retinoid treatment adversely affects survival of lung cancer and with this drug not significantly decreasing the incidence of second primary tumors of head and neck squamous cell carcinoma, the use of this drug in head and neck cancer patients for second cancer prophylaxis is not indicated.


Publication metadata

Author(s): Perry CF, Stevens M, Rabie I, Yarker ME, Cochrane J, Perry E, Traficante R, Coman W

Publication type: Article

Publication status: Published

Journal: Archives of Otolaryngology: Head & Neck Surgery

Year: 2005

Volume: 131

Issue: 3

Pages: 198-203

ISSN (print): 0886-4470

ISSN (electronic): 1538-361X

Publisher: American Medical Association

URL: http://dx.doi.org/10.1001/archotol.131.3.198

DOI: 10.1001/archotol.131.3.198

Notes: 0886-4470 Clinical Trial Journal Article Randomized Controlled Trial


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