Unger Joseph M, Griffin Katherine, Donaldson Gary W, Baranowski Karen M, Good Margorie J, Reburiano Eunicia, Hussain Maha, Monk Paul J, Van Veldhuizen Peter J, Carducci Michael A, Higano Celestia S, Lara Primo N, Tangen Catherine M, Quinn David I, Wade James L, Vogelzang Nicholas J, Thompson Ian M, Moinpour Carol M
1SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA USA.
17Fred Hutchinson Cancer Research Center, M3-C102/P.O. Box 19024, 1100 Fairview Avenue North, Seattle, WA 98109-1024 USA.
J Patient Rep Outcomes. 2018 Jun 13;2:27. doi: 10.1186/s41687-018-0054-5. eCollection 2017.
SWOG S0421 was a large randomized trial comparing docetaxel/prednisone plus placebo (DPP) to docetaxel/prednisone plus atrasentan over 12 cycles for patients with metastatic castration-resistant prostate cancer (mCRPC). The current report presents the PRO results for this trial, an important secondary endpoint.
The trial specified two primary PRO endpoints. Palliation of worst pain was based on the Brief Pain Inventory (BPI), where a 2 point difference is defined as clinically meaningful. Improvement of functional status was based on the Functional Assessment of Cancer Therapy - Prostate Cancer Trial Outcome Index (FACT-P TOI); a 5-point difference has been defined as clinically meaningful. We compared rates by arm using chi-square tests. Longitudinal analyses using linear mixed models addressed changes by arm over time.
Four-hundred eighty-nine patients on each arm were evaluable for PRO endpoint data. There were no differences by arm in clinically meaningful pain palliation (41.7% for DPP vs. 44.0% for DPA, = .70) or functional status (24.2% for DPP vs. 28.7% for DPA, = .13). Longitudinal comparisons indicated no differences over time by arm for BPI Worst Pain scores (0.13 points, = .23). Patients on the DPA arm had improved functional status of 1.78 points on average, a statistically significant ( = .02) but not clinically meaningful difference.
The SWOG S0421 PRO data showed little evidence of clinically meaningful differences by arm in either pain palliation or functional status.
SWOG S0421是一项大型随机试验，比较多西他赛/泼尼松加安慰剂（DPP）与多西他赛/泼尼松加阿曲生坦用于转移性去势抵抗性前列腺癌（mCRPC）患者12个周期的疗效。本报告展示了该试验的PRO结果，这是一个重要的次要终点。
该试验指定了两个主要的PRO终点。最严重疼痛的缓解基于简明疼痛量表（BPI），其中2分的差异被定义为具有临床意义。功能状态的改善基于癌症治疗功能评估-前列腺癌试验结果指数（FACT-P TOI）；5分的差异被定义为具有临床意义。我们使用卡方检验比较了两组的发生率。使用线性混合模型的纵向分析探讨了两组随时间的变化。
每组489例患者可评估PRO终点数据。两组在具有临床意义的疼痛缓解（DPP组为41.7%，DPA组为44.0%，P = 0.70）或功能状态（DPP组为24.2%，DPA组为28.7%，P = 0.13）方面无差异。纵向比较表明，两组的BPI最严重疼痛评分随时间无差异（0.13分，P = 0.23）。DPA组患者的功能状态平均改善了1.78分，差异具有统计学意义（P = 0.02），但无临床意义。
SWOG S0421的PRO数据显示，两组在疼痛缓解或功能状态方面几乎没有具有临床意义的差异。
