Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma.

作者: Edward T. Creagan , Vera J. Suman , Robert J. Dalton , Henry C. Pitot , Harry J. Long

DOI: 10.1200/JCO.1999.17.6.1884

关键词: SurgeryTamoxifenDacarbazineAntiestrogenUrologyCisplatinRegimenMedicineCarmustineChemotherapyMelanoma

摘要: PURPOSE: A prospective randomized phase III clinical trial was conducted to assess whether the addition of tamoxifen (TAM) three-agent regimen cisplatin (CDDP), dacarbazine (DTIC), and carmustine (BCNU) significantly increased progression-free survival overall patients with advanced malignant melanoma. PATIENTS AND METHODS: Patients melanoma were treated CDDP + DTIC BCNU (CDB) or without TAM. The dose schedule 25 mg/m2 given intravenously (IV) for 30 45 minutes in 500 mL dextrose ½ normal saline (NS) on days 1 3 a 3-week cycle; 220 IV hour NaCl 150 2 hours 750 to1,000 5% water onday every odd TAM 20 mg taken orally morning. RESULTS: There 184 eligible enrolled. These observed until death minimum 1.3 years. At last contact, 12 ...

参考文章(17)
P. Lemarbre, J. Ódonnell, L. H. Maurer, R. J. Forcier, S. A. Del Prete, Combination chemotherapy with cisplatin, carmustine, dacarbazine, and tamoxifen in metastatic melanoma. Cancer treatment reports. ,vol. 68, pp. 1403- 1405 ,(1984)
Sir Ronald Aylmer Fisher, Statistical Methods for Research Workers ,(1925)
David R. Cox, Regression Models and Life-Tables Springer Series in Statistics. ,vol. 34, pp. 527- 541 ,(1992) , 10.1007/978-1-4612-4380-9_37
J J Rusthoven, I C Quirt, N A Iscoe, P B McCulloch, K W James, R C Lohmann, J Jensen, S Burdette-Radoux, A J Bodurtha, H K Silver, S Verma, G R Armitage, B Zee, K Bennett, Randomized, double-blind, placebo-controlled trial comparing the response rates of carmustine, dacarbazine, and cisplatin with and without tamoxifen in patients with metastatic melanoma. National Cancer Institute of Canada Clinical Trials Group. Journal of Clinical Oncology. ,vol. 14, pp. 2083- 2090 ,(1996) , 10.1200/JCO.1996.14.7.2083
E. L. Kaplan, Paul Meier, Nonparametric Estimation from Incomplete Observations Springer Series in Statistics. ,vol. 53, pp. 319- 337 ,(1992) , 10.1007/978-1-4612-4380-9_25
Stuart J. Pocock, Richard Simon, Sequential Treatment Assignment with Balancing for Prognostic Factors in the Controlled Clinical Trial Biometrics. ,vol. 31, pp. 103- 115 ,(1975) , 10.2307/2529712
CJA Punt, CML van Herpen, RLH Jansen, G Vreugdenhil, EW Muller, PHM de Mulder, Chemoimmunotherapy with bleomycin, vincristine, lomustine, dacarbazine (BOLD) plus interferon alpha for metastatic melanoma: a multicentre phase II study British Journal of Cancer. ,vol. 76, pp. 266- 269 ,(1997) , 10.1038/BJC.1997.374
Edward F. McClay, Michael J. Mastrangelo, John D. Sprandio, Robert E. Bellet, David Berd, The importance of tamoxifen to a cisplatin‐containing regimen in the treatment of metastatic melanoma Cancer. ,vol. 63, pp. 1292- 1295 ,(1989) , 10.1002/1097-0142(19890401)63:7<1292::AID-CNCR2820630711>3.0.CO;2-I
Johan Hansson, Systemic therapy of malignant melanoma. Medical Oncology. ,vol. 14, pp. 73- 81 ,(1997) , 10.1007/BF02990951