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).

Autor: Unger JM; 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., Griffin K; 1SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA USA., Donaldson GW; 2University of Utah, Salt Lake City, UT USA., Baranowski KM; 3Karmanos Cancer Center, Farmington Hills, MI USA., Good MJ; 4National Cancer Institute, Washington, DC USA., Reburiano E; ICON PLCC, Philadelphia, PA USA., Hussain M; 6Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL USA., Monk PJ; 7The Ohio State University James Cancer Hospital, Columbus, OH USA., Van Veldhuizen PJ; Sarah Cannon Cancer Center, Kansas City, KS USA., Carducci MA; 9Johns Hopkins University School of Medicine, Baltimore, MD USA., Higano CS; 10Pacific Cancer Research Consortium NCORP, Seattle Cancer Care Alliance, University of Washington, Seattle, WA USA., Lara PN; 11University of California at Davis, Sacramento, CA USA., Tangen CM; 1SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA USA., Quinn DI; 12University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA USA., Wade JL III; 1SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA USA.; 2University of Utah, Salt Lake City, UT USA.; 3Karmanos Cancer Center, Farmington Hills, MI USA.; 4National Cancer Institute, Washington, DC USA.; ICON PLCC, Philadelphia, PA USA.; 6Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL USA.; 7The Ohio State University James Cancer Hospital, Columbus, OH USA.; Sarah Cannon Cancer Center, Kansas City, KS USA.; 9Johns Hopkins University School of Medicine, Baltimore, MD USA.; 10Pacific Cancer Research Consortium NCORP, Seattle Cancer Care Alliance, University of Washington, Seattle, WA USA.; 11University of California at Davis, Sacramento, CA USA.; 12University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA USA.; Heartland NCORP, Decatur, IL USA.; US Oncology Research Comprehensive Cancer Centers, Las Vegas, NV USA.; 15CHRISTUS Santa Rosa Hospital Medical Center, San Antonio, TX USA.; 16Fred 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., Vogelzang NJ; US Oncology Research Comprehensive Cancer Centers, Las Vegas, NV USA., Thompson IM Jr; 1SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA USA.; 2University of Utah, Salt Lake City, UT USA.; 3Karmanos Cancer Center, Farmington Hills, MI USA.; 4National Cancer Institute, Washington, DC USA.; ICON PLCC, Philadelphia, PA USA.; 6Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL USA.; 7The Ohio State University James Cancer Hospital, Columbus, OH USA.; Sarah Cannon Cancer Center, Kansas City, KS USA.; 9Johns Hopkins University School of Medicine, Baltimore, MD USA.; 10Pacific Cancer Research Consortium NCORP, Seattle Cancer Care Alliance, University of Washington, Seattle, WA USA.; 11University of California at Davis, Sacramento, CA USA.; 12University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA USA.; Heartland NCORP, Decatur, IL USA.; US Oncology Research Comprehensive Cancer Centers, Las Vegas, NV USA.; 15CHRISTUS Santa Rosa Hospital Medical Center, San Antonio, TX USA.; 16Fred 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., Moinpour CM; 16Fred Hutchinson Cancer Research Center, Seattle, WA USA.
Jazyk: angličtina
Zdroj: Journal of patient-reported outcomes [J Patient Rep Outcomes] 2018 Jun 13; Vol. 2, pp. 27. Date of Electronic Publication: 2018 Jun 13 (Print Publication: 2017).
DOI: 10.1186/s41687-018-0054-5
Abstrakt: 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.
Competing Interests: The study protocol was approved by Institutional Review Boards at the participating institutions enrolling cancer patients on the trial. All patients who participated in the trial and who could complete PRO forms signed detailed consent forms for the PRO component of the trial.CMM received support from Abbott to fund the quality of life component for S0421 but no competing interests within the last 36 months. In the last 36 months, CSH has had a spouse in leadership role for CTI Biopharma. Under Other, CSH reports serving on Advisory Boards for Aptevo, Asana, Astellas, Bayer, Blue Earth Diagnostics, Churchill, Clovis, Dendreon, Endocyte, Ferring, Medivation, MorphoSys, Orion, and Pfizer. CSH has received sponsored research from Aptevo, Bayer, Aragon, AstraZeneca, Dendreon, Exelixis, Genentech, Medivation, Millenium, Sanofi, Teva, and Pfizer. During the last 36 months, DIQ reported grant funding from Sanofi and personal fees from Sanofi, Bayer, Astellas, Dendreon, and AstraZeneca. The other authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Databáze: MEDLINE
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