Agarwala S S, Ferri W, Gooding W, Kirkwood J M
The University of Pittsburgh Cancer Institute, Pennsylvania 15213, USA.
Cancer. 1999 May 1;85(9):1979-84.
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.
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.
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.
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.
转移性黑色素瘤是一种预后较差的疾病，达卡巴嗪仍是参照药物。作者进行了一项随机试验，以测试在达卡巴嗪和卡铂化疗基础上加用他莫昔芬对既往未接受治疗的转移性黑色素瘤患者的益处。
符合条件的经组织学确诊、可测量的转移性黑色素瘤患者被随机分为两组，一组在第1天静脉注射卡铂300mg/m²和达卡巴嗪1g/m²，整个治疗期间口服他莫昔芬20mg/天（C+D±T）；另一组仅接受卡铂和达卡巴嗪治疗。化疗以28天为一个周期重复进行，至少2个周期或直至疾病进展。该研究设计为每个治疗组招募28名患者后停止，基于80%的检验效能来检测他莫昔芬治疗患者的缓解率从20%提高到40%。
共有56名患者被随机分组；所有患者均可评估缓解情况和生存情况。两个治疗组在各种预后因素方面平衡良好；75%的患者以内脏疾病为主。C+D组的完全缓解和部分缓解合并率为10.7%，C+D+T组为14.3%（P=1.0）。C+D组的中位生存期为7个月，C+D+T组为4.6个月（差异无统计学意义）。接受他莫昔芬治疗的患者疾病进展的中位时间更差（P=0.03）。两组毒性相似，均无深静脉血栓形成事件。
对于未选择的转移性黑色素瘤患者，与达卡巴嗪和卡铂化疗相比，加用他莫昔芬并未提高缓解率、疾病进展时间或生存率。
