Patient-reported outcomes for patients with metastatic castration-resistant prostate cancer receiving docetaxel and Atrasentan versus docetaxel and placebo in a randomized phase III clinical trial (SWOG S0421)

Journal of Patient-Reported Outcomes

Ian M. Thompson¹  James L. Wade¹  Jr²  Carol M. Moinpour³  III⁴  Eunicia Reburiano⁵  Michael A. Carducci⁶  Karen M. Baranowski⁷  Margorie J. Good⁸  Celestia S. Higano⁹  Maha Hussain^1,10  Katherine Griffin^1,11  Catherine M. Tangen^1,11  Joseph M. Unger^1,11  Peter J. Van Veldhuizen^1,12  Paul J. Monk^1,13  Nicholas J. Vogelzang^1,14  Primo N. Lara^1,15  David I. Quinn^1,16  Gary W. Donaldson^1,17 

[1] ;CHRISTUS Santa Rosa Hospital Medical Center;Fred Hutchinson Cancer Research Center;Heartland NCORP;ICON PLCC;Johns Hopkins University School of Medicine;Karmanos Cancer Center;National Cancer Institute;Pacific Cancer Research Consortium NCORP, Seattle Cancer Care Alliance, University of Washington;Robert H. Lurie Comprehensive Cancer Center of Northwestern University;SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center;Sarah Cannon Cancer Center;The Ohio State University James Cancer Hospital;US Oncology Research Comprehensive Cancer Centers;University of California at Davis;University of Southern California Norris Comprehensive Cancer Center;University of Utah;

关键词: Patient-reported outcomes;    Health-related quality of life (HRQL);    Pain;    Functional status;    Cancer clinical trial;    Metastatic castration-resistant prostate Cancer (mCRPC);   

DOI  :  10.1186/s41687-018-0054-5

来源: DOAJ

【 摘 要 】

Abstract Background 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. Methods 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. Results 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, p = .70) or functional status (24.2% for DPP vs. 28.7% for DPA, p = .13). Longitudinal comparisons indicated no differences over time by arm for BPI Worst Pain scores (0.13 points, p = .23). Patients on the DPA arm had improved functional status of 1.78 points on average, a statistically significant (p = .02) but not clinically meaningful difference. Conclusions The SWOG S0421 PRO data showed little evidence of clinically meaningful differences by arm in either pain palliation or functional status.

【 授权许可】

Unknown