TREATMENT OF METASTATIC MALIGNANT-MELANOMA WITH DACARBAZINE PLUS TAMOXIFEN
TREATMENT OF METASTATIC MALIGNANT-MELANOMA WITH DACARBAZINE PLUS TAMOXIFEN
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DOI：
10.1056/nejm199208203270803
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发表时间：
1992-08-20
影响因子：
158.5
通讯作者：
BACCHI, M
中科院分区：
文献类型：
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作者：
COCCONI, G;BELLA, M;BACCHI, M
背景内分泌因素可能会影响恶性黑色素瘤的临床进程和对这种疾病的治疗反应。在黑色素瘤中存在雌激素受体的建议，偶尔反应抗雌激素治疗已被报道。我们将117例转移性恶性黑色素瘤患者随机分为单用达卡巴嗪或达卡巴嗪联合他莫昔芬治疗组。客观地测量，接受达卡巴嗪联合他莫昔芬治疗的患者的总体反应率高于单独接受达卡巴嗪治疗的患者（28% vs. 12%，P = 0.03），生存期长于接受达卡巴嗪联合他莫昔芬治疗的患者（中位数，48 vs. 29周，P = 0.02）。在女性中，达卡巴嗪联合他莫昔芬治疗的反应率（38%对10%，P = 0.04）和中位生存期（69对30周，P = 0.008）均优于单用达卡巴嗪，而在男性中，差异较小，无统计学意义。在单用达卡巴嗪的患者中，女性和男性的应答率没有显著差异（10%对13%）或生存率（30周对27周），而在达卡巴嗪加他莫昔芬的患者中，女性的结局更好，这两种反应率都表明了这一点。（38%对19%，P = 0.15）和生存率（69 vs. 31周，P = 0.02）。当我们分析克托莱体重指数时，（体重（公斤）除以身高（米）的平方）作为绝经后妇女和男性内源性雌激素水平的间接指标，在单独给予达卡巴嗪的组中，存活率不受体重指数的影响，而在给予达卡巴嗪加他莫昔芬的组中，克托莱指数高于中位值的患者的生存期长于克托莱指数低于中位值的患者（60 vs. 26周，P
Background. Endocrine factors may affect the clinical course of malignant melanoma and the response to the treatment of this disease. The presence of estrogen receptors in melanomas has been suggested, and occasional responses to antiestrogen therapy have been reported.Methods and Results. We randomly assigned 117 patients with metastatic malignant melanoma to treatment with dacarbazine alone or dacarbazine in combination with tamoxifen. The overall rate of response, measured objectively, was higher (28 percent vs. 12 percent, P = 0.03) and survival was longer (median, 48 vs. 29 weeks, P = 0.02) among the patients who received dacarbazine plus tamoxifen than among those who received dacarbazine alone. Among women, both the response rate (38 percent vs. 10 percent, P = 0.04) and the median survival (69 vs. 30 weeks, P = 0.008) were better with dacarbazine plus tamoxifen than with dacarbazine alone, whereas among men the differences were smaller and not statistically significant. Among the patients given dacarbazine alone, there were no significant differences between women and men in response rate (10 percent vs. 13 percent) or survival (30 vs. 27 weeks), whereas among those given dacarbazine plus tamoxifen, women had better outcomes, as indicated by both response rate (38 percent vs. 19 percent, P = 0.15) and survival (69 vs. 31 weeks, P = 0.02).When we analyzed the Quetelet body-mass index (the weight in kilograms divided by the square of the height in meters) as an indirect indicator of the levels of endogenous estrogens in postmenopausal women and in men, survival was not affected by the body-mass index in the group given dacarbazine alone, whereas in the group given dacarbazine plus tamoxifen, survival was longer among patients whose Quetelet index was above the median value than among those with a Quetelet index lower than the median value (60 vs. 26 weeks, P