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

Perry, Christopher F., Stevens, Maurice, Rabie, Ibrahim, Yarker, Mary-Ellen, Cochrane, Julie, Perry, Emily, Traficante, Robert and Coman, William (2005) Chemoprevention of head and neck cancer with retinoids: a negative result. JAMA Otolaryngology. Head & Neck Surgery, 131 3: 198-203. doi:10.1001/archotol.131.3.198

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Author Perry, Christopher F.
Stevens, Maurice
Rabie, Ibrahim
Yarker, Mary-Ellen
Cochrane, Julie
Perry, Emily
Traficante, Robert
Coman, William
Title Chemoprevention of head and neck cancer with retinoids: a negative result
Journal name JAMA Otolaryngology. Head & Neck Surgery   Check publisher's open access policy
ISSN 2168-6181
Publication date 2005
Sub-type Article (original research)
DOI 10.1001/archotol.131.3.198
Open Access Status File (Publisher version)
Volume 131
Issue 3
Start page 198
End page 203
Total pages 6
Place of publication Chicago, IL 60611 United States
Publisher American Medical Association
Collection year 2005
Language eng
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 I 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.
Keyword Otorhinolaryngology
Squamous-cell Carcinoma
2nd Primary Tumors
13-cis-retinoic Acid
Oral Leukoplakia
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
2006 Higher Education Research Data Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 11 times in Thomson Reuters Web of Science Article | Citations
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Created: Wed, 15 Aug 2007, 07:40:45 EST