CONTEXT: Comorbidities may increase the negative effects of specific anticancer treatments such as androgen suppression therapy (AST). OBJECTIVES: To compare 6 months of AST and radiation therapy (RT) to RT alone and to assess the interaction between level of comorbidity and all-cause mortality. DESIGN, SETTING, AND PATIENTS: At academic and community-based medical centers in Massachusetts, between December 1, 1995, and April 15, 2001, 206 men with localized but unfavorable-risk prostate cancer were randomized to receive RT alone or RT and AST combined. All-cause mortality estimates stratified by randomized treatment group and further stratified in a postrandomization analysis by the Adult Comorbidity Evaluation 27 comorbidity score were compared using a log-rank test. MAIN OUTCOME MEASURE: Time to all-cause mortality. RESULTS: As of January 15, 2007, with a median follow-up of 7.6 (range, 0.5-11.0) years, 74 deaths have occurred. A significant increase in the risk of all-cause mortality (44 vs 30 deaths; hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.1-2.9; P = .01) was observed in men randomized to RT compared with RT and AST. However, the increased risk in all-cause mortality appeared to apply only to men randomized to RT with no or minimal comorbidity (31 vs 11 deaths; HR, 4.2; 95% CI, 2.1-8.5; P < .001). Among men with moderate or severe comorbidity, those randomized to RT alone vs RT and AST did not have an increased risk of all-cause mortality (13 vs 19 deaths; HR, 0.54; 95% CI, 0.27-1.10; P = .08). CONCLUSIONS: The addition of 6 months of AST to RT resulted in increased overall survival in men with localized but unfavorable-risk prostate cancer. This result may pertain only to men without moderate or severe comorbidity, but this requires further assessment in a clinical trial specifically designed to assess this interaction. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00116220.
RCT Entities:
CONTEXT: Comorbidities may increase the negative effects of specific anticancer treatments such as androgen suppression therapy (AST). OBJECTIVES: To compare 6 months of AST and radiation therapy (RT) to RT alone and to assess the interaction between level of comorbidity and all-cause mortality. DESIGN, SETTING, AND PATIENTS: At academic and community-based medical centers in Massachusetts, between December 1, 1995, and April 15, 2001, 206 men with localized but unfavorable-risk prostate cancer were randomized to receive RT alone or RT and AST combined. All-cause mortality estimates stratified by randomized treatment group and further stratified in a postrandomization analysis by the Adult Comorbidity Evaluation 27 comorbidity score were compared using a log-rank test. MAIN OUTCOME MEASURE: Time to all-cause mortality. RESULTS: As of January 15, 2007, with a median follow-up of 7.6 (range, 0.5-11.0) years, 74 deaths have occurred. A significant increase in the risk of all-cause mortality (44 vs 30 deaths; hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.1-2.9; P = .01) was observed in men randomized to RT compared with RT and AST. However, the increased risk in all-cause mortality appeared to apply only to men randomized to RT with no or minimal comorbidity (31 vs 11 deaths; HR, 4.2; 95% CI, 2.1-8.5; P < .001). Among men with moderate or severe comorbidity, those randomized to RT alone vs RT and AST did not have an increased risk of all-cause mortality (13 vs 19 deaths; HR, 0.54; 95% CI, 0.27-1.10; P = .08). CONCLUSIONS: The addition of 6 months of AST to RT resulted in increased overall survival in men with localized but unfavorable-risk prostate cancer. This result may pertain only to men without moderate or severe comorbidity, but this requires further assessment in a clinical trial specifically designed to assess this interaction. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00116220.
Authors: Behfar Ehdaie; Coral L Atoria; Amit Gupta; Andrew Feifer; William T Lowrance; Michael J Morris; Peter T Scardino; James A Eastham; Elena B Elkin Journal: Cancer Date: 2011-11-09 Impact factor: 6.860
Authors: Samuel Swisher-McClure; Craig E Pollack; John P Christodouleas; Thomas J Guzzo; Naomi B Haas; Neha Vapiwala; Justin E Bekelman Journal: Int J Radiat Oncol Biol Phys Date: 2011-11-11 Impact factor: 7.038
Authors: Wanling Xie; Meredith M Regan; Marc Buyse; Susan Halabi; Philip W Kantoff; Oliver Sartor; Howard Soule; Donald Berry; Noel Clarke; Laurence Collette; Anthony D'Amico; Richard De Abreu Lourenco; James Dignam; Mario Eisenberger; Nicholas James; Karim Fizazi; Silke Gillessen; Yohann Loriot; Nicolas Mottet; Wendy Parulekar; Howard Sandler; Daniel E Spratt; Matthew R Sydes; Bertrand Tombal; Scott Williams; Christopher J Sweeney Journal: J Clin Oncol Date: 2020-06-18 Impact factor: 44.544
Authors: Anup Kumar; Srinivas Samavedi; Anthony S Bates; Vladimir Mouraviev; Rafael F Coelho; Bernardo Rocco; Vipul R Patel Journal: J Robot Surg Date: 2016-07-19
Authors: Mehmet Asim Bilen; Marcella M Johnson; Paul Mathew; Lance C Pagliaro; John C Araujo; Ana Aparicio; Paul G Corn; Nizar M Tannir; Franklin C Wong; Michael J Fisch; Christopher J Logothetis; Shi-Ming Tu Journal: Cancer Date: 2014-08-22 Impact factor: 6.860
Authors: Jeff M Michalski; Jennifer Moughan; James Purdy; Walter Bosch; Deborah W Bruner; Jean-Paul Bahary; Harold Lau; Marie Duclos; Matthew Parliament; Gerard Morton; Daniel Hamstra; Michael Seider; Michael I Lock; Malti Patel; Hiram Gay; Eric Vigneault; Kathryn Winter; Howard Sandler Journal: JAMA Oncol Date: 2018-06-14 Impact factor: 31.777