Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251)

Cancer

Volumn 118, Issue 8, 2012, Pages 2128-2137

  Kadakia, Kunal C ^a   Barton, Debra L ^a   Loprinzi, Charles L ^a   Sloan, Jeff A ^a   Otley, Clark C ^a   Diekmann, Brent B ^a   Novotny, Paul J ^a   Alberts, Steven R ^a   Limburg, Paul J ^a   Pittelkow, Mark R ^a  

^a MAYO CLINIC   (United States)

Author keywords

acitretin; basal cell carcinoma; chemoprevention; clinical trials; squamous cell carcinoma

Indexed keywords

ETRETIN; PLACEBO;

ADULT; AGED; ALOPECIA; ARTHRITIS; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BASAL CELL CARCINOMA; CHI SQUARE TEST; CONFIDENCE INTERVAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG WITHDRAWAL; DYSPEPSIA; FATIGUE; FEMALE; HEADACHE; HUMAN; HYPERTRIGLYCERIDEMIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; NAUSEA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SIDE EFFECT; SKIN CANCER; SKIN DISEASE; SQUAMOUS CELL CARCINOMA; STATISTICAL SIGNIFICANCE; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT REFUSAL;

ACITRETIN; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, BASAL CELL; CARCINOMA, SQUAMOUS CELL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS, SECOND PRIMARY; PLACEBOS; RETINOIDS; RISK; SKIN NEOPLASMS; TIME FACTORS;

EID: 84859633892     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.26374     Document Type: Article

References (31)

1. American Cancer Society. Cancer Facts & Figures 2010. Atlanta, GA: American Cancer Society; 2010.
2. Ridky TW,. Nonmelanoma skin cancer. J Am Acad Dermatol. 2007; 57: 484-501.
3. Leiter U, Garbe C,. Epidemiology of melanoma and nonmelanoma skin cancera-the role of sunlight. Adv Exp Med Biol. 2008; 624: 89-103.
4. Otley CC, Stasko T, Tope WD, Lebwohl M,. Chemoprevention of nonmelanoma skin cancer with systemic retinoids: practical dosing and management of adverse effects. Dermatol Surg. 2006; 32: 562-568.
5. Marghoob A, Kopf AW, Bart RS, et al. Risk of another basal cell carcinoma developing after treatment of a basal cell carcinoma. J Am Acad Dermatol. 1993; 28: 22-28.
6. Czarnecki D, Mar A, Staples M, Giles G, Meehan C,. The development of non-melanocytic skin cancers in people with a history of skin cancer. Dermatology. 1994; 189: 364-367.
7. Bavinck JN, Tieben LM, Van der Woude FJ, et al. Prevention of skin cancer and reduction of keratotic skin lesions during acitretin therapy in renal transplant recipients: a double-blind, placebo-controlled study. J Clin Oncol. 1995; 13: 1933-1938.
8. De Graaf YG, Euvrard S, Bouwes Bavinck JN,. Systemic and topical retinoids in the management of skin cancer in organ transplant recipients. Dermatol Surg. 2004; 30 (4 pt 2): 656-661.
9. de Sevaux RG, Smit JV, de Jong EM, van de Kerkhof PC, Hoitsma AJ,. Acitretin treatment of premalignant and malignant skin disorders in renal transplant recipients: clinical effects of a randomized trial comparing 2 doses of acitretin. J Am Acad Dermatol. 2003; 49: 407-412.
10. George R, Weightman W, Russ GR, Bannister KM, Mathew TH,. Acitretin for chemoprevention of non-melanoma skin cancers in renal transplant recipients. Australas J Dermatol. 2002; 43: 269-273.
11. Kraemer KH, DiGiovanna JJ, Moshell AN, Tarone RE, Peck GL,. Prevention of skin cancer in xeroderma pigmentosum with the use of oral isotretinoin. N Engl J Med. 1988; 318: 1633-1637.
12. Nijsten TE, Stern RS,. Oral retinoid use reduces cutaneous squamous cell carcinoma risk in patients with psoriasis treated with psoralen-UVA: a nested cohort study. J Am Acad Dermatol. 2003; 49: 644-650.
13. Levine N, Moon TE, Cartmel B, et al. Trial of retinol and isotretinoin in skin cancer prevention: a randomized, double-blind, controlled trial. Southwest Skin Cancer Prevention Study Group. Cancer Epidemiol Biomarkers Prev. 1997; 6: 957-961.
14. Moon TE, Levine N, Cartmel B, et al. Effect of retinol in preventing squamous cell skin cancer in moderate-risk subjects: a randomized, double-blind, controlled trial. Southwest Skin Cancer Prevention Study Group. Cancer Epidemiol Biomarkers Prev. 1997; 6: 949-956.
15. Bath-Hextall F, Leonardi-Bee J, Somchand N, Webster A, Delitt J, Perkins W,. Interventions for preventing non-melanoma skin cancers in high-risk groups. Cochrane Database Syst Rev. 2007;(4): CD005414.
16. Tangrea JA, Edwards BK, Taylor PR, et al. Long-term therapy with low-dose isotretinoin for prevention of basal cell carcinoma: a multicenter clinical trial. Isotretinoin-Basal Cell Carcinoma Study Group. J Natl Cancer Inst. 1992; 84: 328-332.
17. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD: United States Department of Health and Human Services, National Institutes of Health, National Cancer Institute; 1999.
18. Agresti A,. A survey of exact inference for contingency tables. Stat Sci. 1992; 7: 131-153.
19. Moses LE, Emerson JD, Hosseini H,. Analyzing data from ordered categories. N Engl J Med. 1984; 311: 442-448.
20. Hosmer DW, Lemeshow S,. Applied Logistic Regression. Second ed. Wiley Series in Probability and Statistics. New York: John Wiley & Sons, Inc.; 2004.
21. Hosmer DW, Lemeshow S,. Applied Survival Analysis: Regression Modeling of Time to Event Data. Wiley Series in Probability and Statistics. New York: John Wiley & Sons, Inc.; 1999.
22. O'Brien PC,. Procedures for comparing samples with multiple endpoints. Biometrics. 1984; 40: 1079-1087.
23. O'Brien PC,. Comparing 2 samples: extensions of the t, rank-sum, and log-rank tests. J Am Stat Assoc. 1988; 83: 52-61.
24. Gibson GE, O'Grady A, Kay EW, Murphy GM,. Low-dose retinoid therapy for chemoprophylaxis of skin cancer in renal transplant recipients. J Eur Acad Dermatol Venereol. 1998; 10: 42-47.
25. Kelly JW, Sabto J, Gurr FW, Bruce F,. Retinoids to prevent skin cancer in organ transplant recipients. Lancet. 1991; 338: 1407.
26. Shuttleworth D, Marks R, Griffin PJ, Salaman JR,. Treatment of cutaneous neoplasia with etretinate in renal transplant recipients. Q J Med. 1988; 68: 717-725.
27. Tangrea JA, Adrianza E, Helsel WE, et al. Clinical and laboratory adverse effects associated with long-term, low-dose isotretinoin: incidence and risk factors. The Isotretinoin-Basal Cell Carcinomas Study Group. Cancer Epidemiol Biomarkers Prev. 1993; 2: 375-380.
28. Lee JS, Lippman SM, Benner SE, et al. Randomized placebo-controlled trial of isotretinoin in chemoprevention of bronchial squamous metaplasia. J Clin Oncol. 1994; 12: 937-945.
29. Lippman SM, Lee JJ, Karp DD, et al. Randomized phase III intergroup trial of isotretinoin to prevent second primary tumors in stage I non-small-cell lung cancer. J Natl Cancer Inst. 2001; 93: 605-618.
30. Weinstock MA, Bingham SF, Lew RA, et al. Topical tretinoin therapy and all-cause mortality. Arch Dermatol. 2009; 145: 18-24.
31. Bardia A, Tleyjeh IM, Cerhan JR, et al. Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. 2008; 83: 23-34.