Docetaxel (Taxotere) and estramustine versus mitoxantrone and prednisone for hormone-refractory prostate cancer: scientific basis and design of Southwest Oncology Group Study 9916.
Docetaxel (Taxotere) and estramustine versus mitoxantrone and prednisone for hormone-refractory prostate cancer: scientific basis and design of Southwest Oncology Group Study 9916.
复制标题
多西他赛（泰索帝）和雌莫司汀与米托蒽醌和泼尼松治疗激素难治性前列腺癌：西南肿瘤小组研究 9916 的科学基础和设计。
作者：
M. Hussain;D. Petrylak;E. Fisher;C. Tangen;D. crawford
激素难治性前列腺癌是前列腺癌自然史的终点。到目前为止，没有化疗药物已被证明会影响在这个阶段的临床结果。最近，美国食品和药物管理局在2项随机试验中批准了米托蒽醌和泼尼松的联合用药，仅基于其与单独使用类固醇相比具有更好的上级姑息作用。生物驱动的药物开发的进展导致了几种基于雌莫司汀的方案的鉴定，尽管这些方案基于单一机构的经验，但似乎在难治性前列腺癌患者中至少具有可比但非常有希望的活性水平。一种这样的组合，雌莫司汀加多西他赛（泰索帝; Rhône-Poulenc Régent，科尔奇维尔，PA），由于其方便的时间表和副作用特征而特别有吸引力。为了客观地评估这种组合的治疗效果，西南肿瘤组正在启动一项随机III期试验，比较雌莫司汀和多西他赛与米托蒽醌和泼尼松的标准组，使用进展时间和生存作为主要终点。次要终点将包括毒性特征、生活质量参数评估和两个治疗组之间前列腺特异性抗原水平下降的幅度。
Hormone-refractory prostate cancer is the terminal step in the natural history of prostate cancer. To date, no chemotherapeutic agents have been shown to impact clinical outcome at this stage. Recently, the Food and Drug Administration approved the combination of mitoxantrone and prednisone based solely on its superior palliative effects as compared to steroids alone in 2 randomized trials. Progress in biologically driven drug development has led to the identification of several estramustine-based regimens that, although based on single institution experience, appear to have at least a comparable but very promising level of activity in hormone-refractory prostate cancer patients. One such combination, estramustine plus docetaxel (Taxotere; Rhône-Poulenc Rorer, Collegeville, PA), is particularly attractive because of its convenient schedule and side effect profile. To objectively assess the therapeutic benefit of this combination, the Southwest Oncology Group is initiating a randomized phase III trial comparing estramustine and docetaxel with the standard arm of mitoxantrone and prednisone using time to progression and survival as the primary end points. Secondary end points will include toxicity profiles, assessments of quality of life parameters, and magnitude of decline of prostate-specific antigen levels between the two treatment arms.