Effects of anemia correction with epoetin beta in patients receiving radiochemotherapy for advanced cervical cancer

Authors

  • H.-G. STRAUSS,

    1. Departments of *Gynecology and †Radiotherapy, Martin Luther University Halle-Wittenberg, Halle, Germany; ‡Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; §Medical Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland; ‖I. Medical Clinic, University of Heidelberg, Mannheim and Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and ¶Department of Obstetrics and Gynaecology, Johannes Gutenberg University, Mainz, Germany
    Search for more papers by this author
  • G. HAENSGEN,

    1. Departments of *Gynecology and †Radiotherapy, Martin Luther University Halle-Wittenberg, Halle, Germany; ‡Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; §Medical Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland; ‖I. Medical Clinic, University of Heidelberg, Mannheim and Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and ¶Department of Obstetrics and Gynaecology, Johannes Gutenberg University, Mainz, Germany
    Search for more papers by this author
  • J. DUNST,

    1. Departments of *Gynecology and †Radiotherapy, Martin Luther University Halle-Wittenberg, Halle, Germany; ‡Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; §Medical Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland; ‖I. Medical Clinic, University of Heidelberg, Mannheim and Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and ¶Department of Obstetrics and Gynaecology, Johannes Gutenberg University, Mainz, Germany
    Search for more papers by this author
  • C.R.W. HAYWARD,

    1. Departments of *Gynecology and †Radiotherapy, Martin Luther University Halle-Wittenberg, Halle, Germany; ‡Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; §Medical Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland; ‖I. Medical Clinic, University of Heidelberg, Mannheim and Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and ¶Department of Obstetrics and Gynaecology, Johannes Gutenberg University, Mainz, Germany
    Search for more papers by this author
  • H.-U. BURGER,

    1. Departments of *Gynecology and †Radiotherapy, Martin Luther University Halle-Wittenberg, Halle, Germany; ‡Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; §Medical Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland; ‖I. Medical Clinic, University of Heidelberg, Mannheim and Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and ¶Department of Obstetrics and Gynaecology, Johannes Gutenberg University, Mainz, Germany
    Search for more papers by this author
  • A. SCHERHAG,

    1. Departments of *Gynecology and †Radiotherapy, Martin Luther University Halle-Wittenberg, Halle, Germany; ‡Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; §Medical Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland; ‖I. Medical Clinic, University of Heidelberg, Mannheim and Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and ¶Department of Obstetrics and Gynaecology, Johannes Gutenberg University, Mainz, Germany
    Search for more papers by this author
  • H. KOELBL

    Corresponding author
    1. Departments of *Gynecology and †Radiotherapy, Martin Luther University Halle-Wittenberg, Halle, Germany; ‡Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; §Medical Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland; ‖I. Medical Clinic, University of Heidelberg, Mannheim and Medical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and ¶Department of Obstetrics and Gynaecology, Johannes Gutenberg University, Mainz, Germany
      Heinz Koelbl, MD, Department of Obstetrics and Gynaecology, Johannes Gutenberg University Mainz, Langenbeckstrasse, Mainz 55131, Germany. Email: koelbl@frauen.klinik.uni-mainz.de
    Search for more papers by this author

Heinz Koelbl, MD, Department of Obstetrics and Gynaecology, Johannes Gutenberg University Mainz, Langenbeckstrasse, Mainz 55131, Germany. Email: koelbl@frauen.klinik.uni-mainz.de

Abstract

Patients with cervical cancer frequently suffer from anemia. This two-stage, adaptive-design study investigated the effect of anemia correction with epoetin beta on treatment outcomes. Patients with stage IIB–IVA cervical cancer received radiochemotherapy (RCT) and were randomized to epoetin 150 IU/kg three times weekly (n = 34) or standard care (control; n = 40) for up to 12 weeks. Primary end point for stage 1 aimed to establish a correlation between anemia correction and treatment failure (no complete response or relapsing within 6 months after RCT initiation) as a proof of concept before moving into stage 2. Secondary end points included progression/relapse-free survival, overall survival, response to RCT, hemoglobin (Hb) response, and safety. Median baseline Hb was 11.4 and 11.6 g/dL in epoetin and control groups, respectively. At treatment end point, median Hb increased by 1.3 g/dL with epoetin, but decreased by 0.7 g/dL in the control group (P < 0.0001). No significant correlation between Hb increase and treatment failure was demonstrated. There were no significant differences between epoetin and control groups in progression/relapse-free survival (29.4% vs 32.5% patients with events; P = 0.96), overall survival (23.5% vs 12.5% patients with events; P = 0.22) or overall complete response (53% vs 58%; P = 0.86). Adverse events were well matched between groups. This study shows that epoetin beta rapidly, effectively, and safely increases Hb levels in patients with cervical cancer receiving RCT. No positive correlation of Hb increase and improvement in clinical outcomes could be demonstrated.

Ancillary