Phase III trial of dacarbazine versus dacarbazine with interferon α-2b versus dacarbazine with tamoxifen versus dacarbazine with interferon α-2b and tamoxifen in patients with metastatic malignant melanoma:: An Eastern Cooperative Oncology Group study
Phase III trial of dacarbazine versus dacarbazine with interferon α-2b versus dacarbazine with tamoxifen versus dacarbazine with interferon α-2b and tamoxifen in patients with metastatic malignant melanoma:: An Eastern Cooperative Oncology Group study
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DOI：
10.1200/jco.1998.16.5.1743
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发表时间：
1998-05-01
影响因子：
45.3
通讯作者：
Blum, RH
中科院分区：
文献类型：
--
作者：
Falkson, CI;Ibrahim, J;Blum, RH
目的：研究单用达卡巴嗪、达卡巴嗪加干扰素（IFN）、达卡巴嗪加他莫昔芬（TMX）或达卡巴嗪加IFN加TMX治疗转移性黑色素瘤患者的反应率、治疗失败时间（TTF）、总生存期和毒性。271名患者（258名符合资格）以2 x 2析因设计随机接受上述治疗之一。该试验湿设计检测一个50%的改善生存与83%power.Results：9个完全（CR）和18个部分反应（PR），观察到在接受治疗的患者，其中包含IFN相比，4个CR和18个PR的患者接受治疗，不包含IFN。TMX治疗组发生5例CR和20例PR，而未接受TMX治疗组发生8例CR和16例PR。反应差异不显著。总的中位TTF为2.6个月，总的中位生存期为8.9个月。在任何不同的治疗中，TTF或存活率均无显著差异。体力状态差、肝转移和体重减轻是显著的不良预后因素。23例患者的TTF大于20个月，这些持久的反应均匀分布在治疗臂，更严重和危及生命的毒性事件发生与治疗，包含IFN.Conclusion：无论是IFN，TMX，也没有组合显着提高反应率，TTF，或生存时，加入达卡巴嗪，但IFN显着增加毒性。(C)1998年，美国临床肿瘤学会。
Purpose: To investigate the response rate, time to treatment failure (TTF), overall survival, and toxicity in patients with metastatic melanoma treated with dacarbazine alone, dacarbazine plus interferon (IFN), dacarbazine plus tamoxifen (TMX), or dacarbazine plus IFN plus TMX.Materials and Methods: Two hundred seventy-one patients (258 were eligible) were randomized in a 2 x 2 factorial design to receive one of the above treatments. The trial wets designed to detect a 50% improvement in survival with 83% power.Results: Nine complete (CRs) and 18 partial responses (PRs) were observed in the patients who received treatments that contained IFN compared with four CRs and 18 PRs in the patients who received treatments that did not contain IFN. Five CRs and 20 PRs occurred in patients treated with TMX compared with eight CRs and 16 PRs in those treated without TMX. Response differences were nonsignificant. The overall median TTF was 2.6 months, and the overall median survival wets 8.9 months. There was no significant difference in TTF or survival among any of the different treatments. Poor performance status (PS), hepatic metastases, and weight loss were significant adverse prognostic factors. Twenty-three patients had a TTF greater than 20 months, and these durable responses were evenly distributed among the treatment arms, Significantly more severe and life-threatening toxic events occurred with treatments that contained IFN.Conclusion: Neither IFN, TMX, nor the combination significantly improved the response rate, TTF, or survival when added to dacarbazine, but IFN significantly increased toxicity. (C) 1998 by American Society of Clinical Oncology.