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A phase III randomized trial of dacarbazine and carboplatin with and without tamoxifen in the treatment of patients with metastatic melanoma
Author(s) -
Agarwala Sanjiv S.,
Ferri William,
Gooding William,
Kirkwood John M.
Publication year - 1999
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(19990501)85:9<1979::aid-cncr15>3.0.co;2-g
Subject(s) - medicine , dacarbazine , carboplatin , tamoxifen , oncology , melanoma , randomized controlled trial , antiestrogen , chemotherapy , cancer , breast cancer , cancer research , cisplatin
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/m 2 and dacarbazine 1 g/m 2 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. Cancer 1999;85:1979–84. © 1999 American Cancer Society.