Bicalutamide and Flutamide, Each in Combination with Luteinizing Hormone-Releasing Hormone Analogs, in Advanced Prostate Cancer: Exploratory Analysis of Impact of Extent of Disease by Bone Scan on Outcome

M. Soloway, P. Schellhammer, R. Sharifi, N. Block, P. Venner, A. Patterson, M. Sarosdy, N. Vogelzang, Julie Jones Schellenger, G. Kolvenbag
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引用次数: 8

Abstract

Objectives: We performed an exploratory analysis to determine whether there was a difference between two antiandrogen-plus-luteinizing hormone-releasing hormone analogs (LHRHas) combinations in patients with minimal or extensive disease. Materials and Methods: Data from a prospective, randomized, double-blind study with a median follow-up of 160 weeks were used to perform an exploratory analysis of outcome with 2 combined androgen blockade regimens in 813 advanced prostate cancer patients based on disease status at entry (minimal or extensive disease). A total of 404 patients received bicalutamide plus LHRHa, and 409 patients received flutamide plus LHRHa. Patients were grouped prospectively by “extent of disease” as determined by bone scan: minimal disease was defined as zero to five lesions, while extensive disease was defined as greater than or equal to six lesions. Patients with no lesions on bone scan (0 lesions) had to have at least one measurable nonskeletal metastasis. Results: Patients with minimal disease receiving bicalutamide plus LHRHa demonstrated a trend to longer survival as reflected by a hazard ratio (HR) of 0.79 (95% confidence interval 0.59–1.07), but this was not statistically significant. In the extensive disease group, the effects of bicalutamide plus LHRHa and flutamide plus LHRHa on disease progression and survival were similar (HR 0.96 and 0.90, respectively). Conclusions: Our results are consistent with previously published data demonstrating that patients with stage D2 prostate cancer and minimal disease have a better outcome than patients with extensive disease. In the patients with minimal disease per bone scan, there was a trend toward a benefit for bicalutamide plus LHRHa compared with flutamide plus LHRHa in terms of survival, but not in terms of disease progression.
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比卡鲁胺和氟他胺联合黄体生成素释放激素类似物治疗晚期前列腺癌:骨扫描疾病程度对预后影响的探索性分析
目的:我们进行了一项探索性分析,以确定两种抗雄激素+促黄体生成素释放激素类似物(LHRHas)组合在轻度或广泛疾病患者中是否存在差异。材料和方法:来自一项前瞻性、随机、双盲研究的数据,中位随访时间为160周,用于对813例晚期前列腺癌患者根据入院时疾病状态(轻微或广泛疾病)使用两种联合雄激素阻断方案的结果进行探索性分析。404例患者接受比卡鲁胺加LHRHa治疗,409例患者接受氟他胺加LHRHa治疗。根据骨扫描确定的“疾病程度”对患者进行前瞻性分组:最小疾病定义为0至5个病变,而广泛疾病定义为大于或等于6个病变。骨扫描无病变(0个病变)的患者必须至少有一个可测量的非骨骼转移。结果:最小疾病患者接受比卡鲁胺加LHRHa治疗的风险比(HR)为0.79(95%可信区间0.59-1.07),显示出生存期延长的趋势,但这没有统计学意义。在广泛疾病组,比卡鲁胺加LHRHa和氟他胺加LHRHa对疾病进展和生存的影响相似(HR分别为0.96和0.90)。结论:我们的研究结果与先前发表的数据一致,表明D2期前列腺癌和小病变患者的预后优于广泛病变患者。在每次骨扫描疾病最小的患者中,与氟他胺加LHRHa相比,比卡鲁胺加LHRHa在生存方面有优势,但在疾病进展方面没有优势。
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