BACKGROUND: Metastatic melanoma is a disease associated with a poor prognosis, and dacarbazine is still the reference agent. The authors conducted a randomized trial to test the benefit of adding tamoxifen to dacarbazine and carboplatin chemotherapy for previously untreated patients with metastatic melanoma. METHODS:Eligible patients with histologically confirmed, measurable metastatic melanoma were randomized to carboplatin 300 mg/m2 and dacarbazine 1 g/m2 administered intravenously on Day 1 with or without tamoxifen 20 mg/day administered orally throughout the treatment period (C + D +/- T). Chemotherapy was repeated in 28-day treatment cycles for a minimum of 2 cycles or until disease progression. The study was designed to be stopped after accrual of 28 patients per treatment arm based on 80% power to detect an improvement in response from 20% to 40% among patients treated with tamoxifen. RESULTS: A total of 56 patients were randomized; all were evaluable for response and survival. The 2 treatment groups were well balanced for various prognostic factors; 75% of patients had predominant visceral disease. Complete and partial responses combined were 10.7% in the C + D arm and 14.3% in the C + D + T arm (P=1.0). Median survival was 7 months for C + D and 4.6 months for C + D + T (the difference was not significant). The median time to disease progression was worse for the patients treated with tamoxifen (P=0.03). Toxicity was similar in the two groups, with no episodes of deep venous thrombosis. CONCLUSIONS: The addition of tamoxifen did not improve the response rate, time to progression, or survival compared with chemotherapy with dacarbazine and carboplatin in unselected patients with metastatic melanoma.
RCT Entities:
BACKGROUND:Metastatic melanoma is a disease associated with a poor prognosis, and dacarbazine is still the reference agent. The authors conducted a randomized trial to test the benefit of adding tamoxifen to dacarbazine and carboplatin chemotherapy for previously untreated patients with metastatic melanoma. METHODS: Eligible patients with histologically confirmed, measurable metastatic melanoma were randomized to carboplatin 300 mg/m2 and dacarbazine 1 g/m2 administered intravenously on Day 1 with or without tamoxifen 20 mg/day administered orally throughout the treatment period (C + D +/- T). Chemotherapy was repeated in 28-day treatment cycles for a minimum of 2 cycles or until disease progression. The study was designed to be stopped after accrual of 28 patients per treatment arm based on 80% power to detect an improvement in response from 20% to 40% among patients treated with tamoxifen. RESULTS: A total of 56 patients were randomized; all were evaluable for response and survival. The 2 treatment groups were well balanced for various prognostic factors; 75% of patients had predominant visceral disease. Complete and partial responses combined were 10.7% in the C + D arm and 14.3% in the C + D + T arm (P=1.0). Median survival was 7 months for C + D and 4.6 months for C + D + T (the difference was not significant). The median time to disease progression was worse for the patients treated with tamoxifen (P=0.03). Toxicity was similar in the two groups, with no episodes of deep venous thrombosis. CONCLUSIONS: The addition of tamoxifen did not improve the response rate, time to progression, or survival compared with chemotherapy with dacarbazine and carboplatin in unselected patients with metastatic melanoma.
Authors: Charles R Scoggins; Merrick I Ross; Douglas S Reintgen; R Dirk Noyes; James S Goydos; Peter D Beitsch; Marshall M Urist; Stephan Ariyan; Jeffrey J Sussman; Michael J Edwards; Anees B Chagpar; Robert C G Martin; Arnold J Stromberg; Lee Hagendoorn; Kelly M McMasters Journal: Ann Surg Date: 2006-05 Impact factor: 12.969
Authors: Takuji Mori; Steve R Martinez; Steven J O'Day; Donald L Morton; Naoyuki Umetani; Minoru Kitago; Atsushi Tanemura; Sandy L Nguyen; Andy N Tran; He-Jing Wang; Dave S B Hoon Journal: Cancer Res Date: 2006-07-01 Impact factor: 12.701
Authors: Pascale Dequen; Paul Lorigan; Jeroen P Jansen; Marc van Baardewijk; Mario J N M Ouwens; Srividya Kotapati Journal: Oncologist Date: 2012-09-28
Authors: R Scott Braithwaite; Rowan T Chlebowski; Joseph Lau; Suzanne George; Rachel Hess; Nananda F Col Journal: J Gen Intern Med Date: 2003-11 Impact factor: 5.128
Authors: R Plummer; P Lorigan; E Brown; R Zaucha; V Moiseyenko; L Demidov; V Soriano; E Chmielowska; R Andrés; G Kudryavtseva; C Kahatt; S Szyldergemajn; S Extremera; B de Miguel; M Cullell-Young; H Calvert Journal: Br J Cancer Date: 2013-08-29 Impact factor: 7.640