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Adding epoetin alfa to intense dose-dense adjuvant chemotherapy for breast cancer: randomized clinical trial.

Moebus V, Jackisch C, Schneeweiss A, Huober J, Lueck HJ, du Bois A, Thomssen C, Kurbacher C, Kuhn W, Nitz U, Runnebaum IB, Hinke A, Kreienberg R, Untch M, AGO Breast Study Gro - J. Natl. Cancer Inst. (2013)

Bottom Line: Except for the primary hypothesis, all statistical tests were two-sided.After a median follow-up of 62 months, epoetin alfa treatment did not affect overall survival, relapse-free survival, or intramammary relapse.However, epoetin alfa had an adverse effect, resulting in increased thrombosis.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynecology and Obstetrics, Klinikum Frankfurt Höchst, Frankfurt, Germany. volker.moebus@klinikumfrankfurt.de

ABSTRACT

Background: The AGO-ETC trial compared 5-year relapse-free survival of intense dose-dense (IDD) sequential chemotherapy with epirubicin (E), paclitaxel (T), and cyclophosphamide (C) (IDD-ETC) every 2 weeks vs conventional scheduled epirubicin/cyclophosphamide followed by paclitaxel (EC→T) (every 3 weeks) as adjuvant treatment in high-risk breast cancer patients. The objective of this study was to evaluate the safety and efficacy of epoetin alfa in a second randomization of the intense dose-dense arm.

Methods: One thousand two hundred eighty-four patients were enrolled; 658 patients were randomly assigned to the IDD-ETC treatment group. Within the IDD-ETC group, 324 patients were further randomly assigned to the epoetin alfa group, and 319 were randomly assigned to the non-erythropoiesis-stimulating agent (ESA) control group. Primary efficacy endpoints included change in hemoglobin level from baseline to Cycle 9 and the percentage of subjects requiring red blood cell transfusion. Relapse-free survival, overall survival, and intramammary relapse were secondary endpoints estimated with Kaplan-Meier and Cox regression methods. Except for the primary hypothesis, all statistical tests were two-sided.

Results: Epoetin alfa avoided the decrease in hemoglobin level (no decrease in the epoetin alfa group vs -2.20g/dL change for the control group; P < .001) and statistically significantly reduced the percentage of subjects requiring red blood cell transfusion (12.8% vs 28.1%; P < .0001). The incidence of thrombotic events was 7% in the epoetin alfa arm vs 3% in the control arm. After a median follow-up of 62 months, epoetin alfa treatment did not affect overall survival, relapse-free survival, or intramammary relapse.

Conclusions: Epoetin alfa resulted in improved hemoglobin levels and decreased transfusions without an impact on relapse-free or overall survival. However, epoetin alfa had an adverse effect, resulting in increased thrombosis.

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Related in: MedlinePlus

Kaplan–Meier curve of overall survival (intent-to-treat population). Log-rank test. All statistical tests were two-sided. CI = confidence interval; EPO = epoetin alfa; ETC = epirubicin, paclitaxel, and cyclophosphamide; HR = hazard ratio; OS = overall survival.
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Figure 5: Kaplan–Meier curve of overall survival (intent-to-treat population). Log-rank test. All statistical tests were two-sided. CI = confidence interval; EPO = epoetin alfa; ETC = epirubicin, paclitaxel, and cyclophosphamide; HR = hazard ratio; OS = overall survival.

Mentions: The Kaplan–Meier estimates of overall survival for the intent-to-treat population are shown in Figure 5. The hazard ratio was 0.97 (95% CI = 0.67 to 1.41), and the difference between groups was not statistically significant (P = .89).


Adding epoetin alfa to intense dose-dense adjuvant chemotherapy for breast cancer: randomized clinical trial.

Moebus V, Jackisch C, Schneeweiss A, Huober J, Lueck HJ, du Bois A, Thomssen C, Kurbacher C, Kuhn W, Nitz U, Runnebaum IB, Hinke A, Kreienberg R, Untch M, AGO Breast Study Gro - J. Natl. Cancer Inst. (2013)

Kaplan–Meier curve of overall survival (intent-to-treat population). Log-rank test. All statistical tests were two-sided. CI = confidence interval; EPO = epoetin alfa; ETC = epirubicin, paclitaxel, and cyclophosphamide; HR = hazard ratio; OS = overall survival.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3714019&req=5

Figure 5: Kaplan–Meier curve of overall survival (intent-to-treat population). Log-rank test. All statistical tests were two-sided. CI = confidence interval; EPO = epoetin alfa; ETC = epirubicin, paclitaxel, and cyclophosphamide; HR = hazard ratio; OS = overall survival.
Mentions: The Kaplan–Meier estimates of overall survival for the intent-to-treat population are shown in Figure 5. The hazard ratio was 0.97 (95% CI = 0.67 to 1.41), and the difference between groups was not statistically significant (P = .89).

Bottom Line: Except for the primary hypothesis, all statistical tests were two-sided.After a median follow-up of 62 months, epoetin alfa treatment did not affect overall survival, relapse-free survival, or intramammary relapse.However, epoetin alfa had an adverse effect, resulting in increased thrombosis.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynecology and Obstetrics, Klinikum Frankfurt Höchst, Frankfurt, Germany. volker.moebus@klinikumfrankfurt.de

ABSTRACT

Background: The AGO-ETC trial compared 5-year relapse-free survival of intense dose-dense (IDD) sequential chemotherapy with epirubicin (E), paclitaxel (T), and cyclophosphamide (C) (IDD-ETC) every 2 weeks vs conventional scheduled epirubicin/cyclophosphamide followed by paclitaxel (EC→T) (every 3 weeks) as adjuvant treatment in high-risk breast cancer patients. The objective of this study was to evaluate the safety and efficacy of epoetin alfa in a second randomization of the intense dose-dense arm.

Methods: One thousand two hundred eighty-four patients were enrolled; 658 patients were randomly assigned to the IDD-ETC treatment group. Within the IDD-ETC group, 324 patients were further randomly assigned to the epoetin alfa group, and 319 were randomly assigned to the non-erythropoiesis-stimulating agent (ESA) control group. Primary efficacy endpoints included change in hemoglobin level from baseline to Cycle 9 and the percentage of subjects requiring red blood cell transfusion. Relapse-free survival, overall survival, and intramammary relapse were secondary endpoints estimated with Kaplan-Meier and Cox regression methods. Except for the primary hypothesis, all statistical tests were two-sided.

Results: Epoetin alfa avoided the decrease in hemoglobin level (no decrease in the epoetin alfa group vs -2.20g/dL change for the control group; P < .001) and statistically significantly reduced the percentage of subjects requiring red blood cell transfusion (12.8% vs 28.1%; P < .0001). The incidence of thrombotic events was 7% in the epoetin alfa arm vs 3% in the control arm. After a median follow-up of 62 months, epoetin alfa treatment did not affect overall survival, relapse-free survival, or intramammary relapse.

Conclusions: Epoetin alfa resulted in improved hemoglobin levels and decreased transfusions without an impact on relapse-free or overall survival. However, epoetin alfa had an adverse effect, resulting in increased thrombosis.

Show MeSH
Related in: MedlinePlus