Randomized, surgical adjuvant clinical trial of recombinant interferon alfa-2a in selected patients with malignant melanoma

Journal of Clinical Oncology

Volumn 13, Issue 11, 1995, Pages 2776-2783

  Creagan, Edward T ^a   Dalton, Robert J ^b   Ahmann, David L ^b   Jung, Sin Ho ^b   Morton, Roscoe F ^b   Langdon Jr , Robert M ^b   Kugler, John ^b   Rodrigue, Lionel J ^b  

^a MAYO CLINIC   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT ALPHA2A INTERFERON;

ADULT; AGED; ARTICLE; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; INFLUENZA; INTRAMUSCULAR DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MELANOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; WEIGHT REDUCTION;

EID: 0028872887     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1995.13.11.2776     Document Type: Article

References (34)

1. Clark WH Jr, From L, Bernardino EA, et al: The histogenesis and biologic behavior of primary human malignant melanoma of the skin. Cancer Res 29:705-726, 1969
2. Breslow A: Thickness, cross-sectional areas and depth of invasion in the prognosis of cutaneous melanoma. Ann Surg 182:572-575, 1975
3. Balch CM, Soong SJ, Murad TM: A multifactorial analysis of melanoma. II. Prognostic factors in patients with stage I (localized) melanoma. Surgery 86:343-351, 1979
4. Wanebo HJ, Fortner JG, Woodruff J, et al: Selection of the optimum surgical treatment of stage I melanoma by depth of microinvasion: Use of the combined microstage technique (Clark-Breslow). Ann Surg 182:302-315, 1975
5. Day CL, Jr, Lew RA, Mihm MC, et al: The natural break points for primary tumor thickness in clinical stage I melanoma. N Engl J Med 305:1155, 1981
6. DeVita VT Jr, Fisher RJ: Natural history of malignant melanoma as related to theory. Cancer Treat Rep 60:153-157, 1976
7. Karakousis CP, Seddiq M, Moore R: Prognostic value of lymph node dissection in malignant melanoma. Arch Surg 115:719-722, 1980
8. Day CL Jr, Sober AJ, Lew RA, et al: Malignant melanoma patients with positive nodes and relatively good prognoses: Microstaging retains prognostic significance in clinical stage I melanoma patients with metastases to regional nodes. Cancer 47:955-962, 1981
9. Balch CM, Soong SJ, Murad TM, et al: A multifactorial analysis of melanoma. III. Prognostic factors in melanoma patients with lymph node metastases (Stage II). Ann Surg 193(3):377-388, 1981
10. Callery C, Cochran AJ, Roe DJ, et al: Factors prognostic for survival in patients with malignant melanoma spread to the regional lymph nodes. Ann Surg 196:69-75, 1982
11. Koh HK, Sober AJ, Day CL Jr, et al: Prognosis of clinical stage I melanoma patients with positive elective regional node dissection. J Clin Oncol 4:1238-1244, 1986
12. Eilber FR, Morton DL, Holmes EC, et al: Adjuvant immunotherapy with BCG in the treatment of regional-lymph-node metastases from malignant melanoma. N Engl J Med 294:237-240, 1976
13. Banzet P, Jacquillet C, Civatte J, et al: Adjuvant chemotherapy in the management of primary malignant melanoma. Cancer 41:1240-1248, 1978
14. Morton DL, Holmes EC, Eilber FR, et al: Adjuvant immunotherapy of malignant melanoma: Preliminary results of a randomized trial in patients with lymph node metastases, in Terry WD, Windhorst D (eds): Immunotherapy: Current Status of Trials in Man. New York, NY, Raven, 1978, pp 35-56
15. Spitler LE, Sagebiel R: A randomized trial of levamisole versus placebo as adjuvant therapy in malignant melanoma. N Engl J Med 303:1143-1147, 1980.
16. Hilal EY, Pinsky CM, Hirshaut Y, et al: Surgical adjuvant therapy of malignant melanoma with Corynebacterium parvum. Cancer 48:245-251, 1981
17. Karakousis CP, Didolkar MS, Lopez R, et al: Chemoimmunotherapy (DTIC and Corynebacterium parvum) as adjuvant treatment in malignant melanoma. Cancer Treat Rep 63:1739-1743, 1979
18. Creagan ET, Cupps RE, Ivins JC, et al: Adjuvant radiation therapy in the treatment of regional lymph node metastases from malignant melanoma: A randomized prospective study. Cancer 42:2206-2210, 1978
19. Pinsky CM, Hirshaut Y, Wanebo HJ, et al: Randomized trial of bacillus Calmette-Guerin (percutaneous administration) as a surgical adjuvant immunotherapy for patients with stage II melanoma. Ann NY Acad Sci 277:187-194, 1976
20. Immunotherapy of Cancer: Present Status of Trials in Man. Second International Conference, National Institutes of Health, Bethesda, MD, 1980
21. Koh HK, Sober AJ, Harmon DC, Lew RA, Carey RW: Adjuvant therapy of cutaneous malignant melanoma: A critical review. Med Pediatr Oncol 13:244-260, 1985
22. Lejeune FJ: Phase III adjuvant studies in operable malignant melanoma (review). Anticancer Res 7:701-705, 1987
23. Rumke P: Malignant melanoma, in Pinedo HM, Chabner BA (eds): Cancer Chemotherapy 7. New York, NY, Elsevier, 1985, pp 417-425
24. Creagan ET, Schaid DJ, Ahmann DL, et al: Recombinant interferons in the management of advanced malignant melanoma. Am J Clin Oncol 11:652-659, 1988
25. Creagan ET, Ahmann DL, Frytak S, et al: Recombinant leukocyte A interferon (rIFN-A) in the treatment of disseminated malignant melanoma: Analysis of complete and long-term responding patients. Cancer 58:2576-2578, 1986
26. Legha SS: Interferons in the treatment of malignant melanoma: A review of recent trials. Cancer 57:1675-1677, 1986
27. Kerr R, Ayoob M, Goldberg R, et al: Treatment of metastatic malignant melanoma (MMM) with human leukocyte interferon (IFN): Profile of 5 complete responders. Proc Am Soc Clin Oncol 4:231, 1985 (abstr)
28. Jones GJ, Itri LM: Safety and tolerance of recombinant interferon alfa-2a (Roferon-A) in cancer patients. Cancer 57:1709-1715, 1986
29. Pocock SJ, Simon R: Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31:103-115, 1975
30. Kaplan BL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-461, 1958
31. Mantal N: Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50: 163-170, 1966
32. Cox DR: Regression models and life tables. J R Stat Soc B 34:187-220, 1972
33. Kirkwood J, Hunt M, Smith T, et al: A randomized controlled trial of high-dose IFN alfa-2b for high-risk melanoma: The ECOG trial Est-1684. Proc Am Soc Clin Oncol 12:390, 1993 (abstr)
34. Cascineilli N, Bufalino, Morabito A, et al: Results of adjuvant interferon study in WHO melanoma programme. Lancet 345:913, 1994