Table C33

KQ1 Outcome V. Tumor Response: Epoetin versus Control

Study IDOutcomeResponse definitionIntervention (Events/sample size)Control (Events/sample size)Intervention: other reported measurementsControl: other reported measurements (EPO)Relative Risk or Hazard Ratio (95% CI)P-ValueComments
EPO-GBR-7Complete response at week 12NR108/114 (95%)106/111 (95%)NRNRNRNRJ&J report
EPO-GBR-7Overall response (complete and partial response) at week 12NR113/114 (99%)110/111 (99%)NRNRNRNRJ&J report
N93 004 limited and extensive diseaseComplete response after 3 cycles of chemotherapy (primary endpoint)Complete response: absence of detectable tumor18/109 (17%)16/115 (14%)NRNRNRNSJ&J report
N93 004 limited and extensive diseaseOverall response (CR plus PR) 3 cycles of chemotherapyCR plus PR79/109 (72%)77/115 (67%)Tumor response rate 73% (64%; 81%)Tumor response rate 67% (58%; 76%)NRNSJ&J report
N93 004 limited and extensive SCLCComplete response after last cycle of chemotherapy (secondary endpoint)CR20/109 (18%)21/115 (18%)NRNRNRNRJ&J report
N93 004 limited and extensive SCLCOverall response after last cycle of chemotherapy (secondary endpoint)CR plus PR65/109 (60%)64/115 (56%)NRNRNRDifference (Epo minus placebo) 4 (−9; 17)J&J report
N93 004 extensive SCLCOverall response (CR plus PR) 3 cycles of chemotherapyCR plus PR53/7241/68NRDifference (Epo minus placebo) 13 (−2; 29)J&J report
N93 004 limited SCLCOverall response (CR plus PR) 3 cycles of chemotherapyCR plus PR26/3736/47NRDifference (Epo minus placebo) − 6 (−25; 13)J&J report
N93 004 extensive SCLCOverall response after last cycle of chemotherapy (secondary endpoint)CR plus PR38/7235/68Tumor response rate 53% (41%; 64%)Tumor response rate 51% (40%; 63%)NRDifference (Epo minus placebo) 1 (−15; 18)J&J report
N93 004 limited SCLCOverall response after last cycle of chemotherapy (secondary endpoint)CR plus PR27/3729/47Tumor response rate 73% (59%; 87%)Tumor response rate 62% (48%; 76%)NRDifference (Epo minus placebo) 11 (−9; 31)J&J report
Vadhan-Raj 2004 Tumor responseno definition given14/2214/22NRNRNRP=0.777Machtay 2004, “The tumour response for rectal cancer at MDACC site was similar between both treatment groups with 14/22 (63.6%) in each treatment group (p=0.777)”; Abstract, no definition for tumour response given, analysis not based on ITT population.
Throuvalas 2000 Complete responseWHO criteria22/2818/26NRNRNRNRThrouvalas 2000 and personal communication
Machtay 2004 Complete responseno definition given73% (52/71)74% (52/70)NRNRNRp=0.99Abstract slides, no definition given

From: Appendix C, Evidence Tables

Cover of Comparative Effectiveness of Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment
Comparative Effectiveness of Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment [Internet].
Comparative Effectiveness Reviews, No. 3.
Seidenfeld J, Piper M, Bohlius J, et al.

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