title: A Randomized, Open-Label, Multicenter, Phase III Study of Epoetin Alfa Versus Best Standard of Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy.
abstract: An open-label, noninferiority study to evaluate the impact of epoetin alfa (EPO) on tumor outcomes when used to treat anemia in patients receiving chemotherapy for metastatic breast cancer.
  
  
  
  Women with hemoglobin ≤ 11.0 g/dL, receiving first- or second-line chemotherapy for metastatic breast cancer, were randomly assigned to EPO 40,000 IU subcutaneously once a week or best standard of care. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, time to tumor progression, overall response rate, RBC transfusions, and thrombotic vascular events.
  
  
  
  In 2,098 patients randomly assigned, median PFS (based on investigator-determined disease progression [PD]) was 7.4 months in both groups (hazard ratio [HR], 1.089; 95% CI, 0.988 to 1.200); upper bound exceeded prespecified noninferiority margin of 1.15. Median PFS per independent review committee-determined PD was 7.6 months in both groups (HR, 1.028; 95% CI, 0.922 to 1.146); upper bound did not exceed prespecified noninferiority margin. Median overall survival at clinical cutoff (1,337 deaths) was 17.2 months in the EPO and 17.4 months in the best standard of care group (HR, 1.057; 95% CI, 0.949 to 1.177), median time to tumor progression was 7.5 months in both groups (HR, 1.094; 95% CI, 0.991 to 1.209), and overall response rate was 50% versus 51% (odds ratio, 0.950; 95% CI, 0.799 to 1.130). RBC transfusions were 5.8% versus 11.4% (P < .001), and thrombotic vascular events were 2.8% versus 1.4% (P = .038), respectively.
  
  
  
  The primary end point, PFS based on investigator-determined PD, did not meet noninferiority criteria. As a consistency assessment with the primary finding, PFS based on independent review committee-determined PD met noninferiority criteria. Overall, this study did not achieve noninferiority objective in ruling out a 15% increased risk in PD/death. RBC transfusion should be the preferred approach for the management of anemia in this population.
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ. bleylandj@aol.com.
authors: Brian
authors: B
authors: Leyland-Jones
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Igor
authors: I
authors: Bondarenko
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Gia
authors: G
authors: Nemsadze
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Vitaliy
authors: V
authors: Smirnov
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Iryna
authors: I
authors: Litvin
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Irakli
authors: I
authors: Kokhreidze
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Lia
authors: L
authors: Abshilava
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Mikheil
authors: M
authors: Janjalia
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Rubi
authors: R
authors: Li
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Kuntegowda C
authors: KC
authors: Lakshmaiah
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Beka
authors: B
authors: Samkharadze
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Oksana
authors: O
authors: Tarasova
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Ranjan Kumar
authors: RK
authors: Mohapatra
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Yaroslav
authors: Y
authors: Sparyk
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Sergey
authors: S
authors: Polenkov
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Vladimir
authors: V
authors: Vladimirov
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Liang
authors: L
authors: Xiu
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Eugene
authors: E
authors: Zhu
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Bruce
authors: B
authors: Kimelblatt
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Kris
authors: K
authors: Deprince
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Ilya
authors: I
authors: Safonov
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Peter
authors: P
authors: Bowers
authors: Brian Leyland-Jones, Avera Cancer Institute, Sioux Falls, SD; Igor Bondarenko, Dnepropetrovsk Medical Academy; and Iryna Litvin, Dnepropetrovsk Regional Oncological Dispensary, Dnepropetrovsk; Vitaliy Smirnov, Donetsk Regional Anticancer Center, Donetsk; Oksana Tarasova, Institute of Medical Radiology, Kharkiv; Yaroslav Sparyk, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv; and Sergey Polenkov, Chernigov Regional Oncology Center, Chernigov, Ukraine; Gia Nemsadze, Institute of Clinical Oncology (LTD. K. Madichi Mammological Center); Irakli Kokhreidze, Martin D. Abeloff Laboratory Cancer Research Center; Lia Abshilava, Chemotherapy and Immunotherapy Clinic Medulla; Mikheil Janjalia, Tbilisi Cancer Center; and Beka Samkharadze, Research Institute of Clinical Medicine, Tbilisi, Georgia; Rubi Li, St. Luke's Medical Center, Quezon City, Philippines; Kuntegowda C. Lakshmaiah, Kidwai Memorial Institute of Oncology, Bangalore; and Ranjan Kumar Mohapatra, Apollo Specialty Hospital, Chennai, India; Vladimir Vladimirov, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russian Federation; and Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, and Els Vercammen, Janssen Research & Development, Raritan, NJ.
authors: Els
authors: E
authors: Vercammen
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D018450:Disease Progression; D004334:Drug Administration Schedule; D000068817:Epoetin Alfa / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D016017:Odds Ratio; D011788:Quality of Life; D059039:Standard of Care; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D000068817:Epoetin Alfa