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Darbepoetin alfa in lung cancer patients on chemotherapy: a retrospective comparison of outcomes in patients with mild versus moderate-to-severe anaemia at baseline

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Abstract

Goals

Currently, there is some debate concerning the haemoglobin level at which treatment of anaemia with erythropoiesis-stimulating agents should be initiated in cancer patients on chemotherapy. We report several analyses of data from a phase III trial of darbepoetin alfa versus placebo, comparing outcomes for patients with mild and moderate-to-severe anaemia.

Patients and methods

Data were obtained from a phase III trial of darbepoetin alfa versus placebo in anaemic patients with lung cancer receiving chemotherapy (n=314). Outcomes were compared for patients with baseline haemoglobin ≥10–11 g/dl and <10 g/dl.

Results

Darbepoetin alfa significantly reduced transfusions compared with placebo, irrespective of haemoglobin level at treatment initiation. For patients with baseline haemoglobin <10 g/dl, 31% and 59% of those receiving darbepoetin alfa and placebo, respectively, required a transfusion from week 5 to the end of the treatment phase (P<0.038). For patients with baseline haemoglobin ≥10 g/dl, the proportions were 15% and 41%, respectively (P<0.001). Darbepoetin alfa also improved fatigue compared with placebo in both haemoglobin categories.

Conclusions

These findings show that initiating treatment at haemoglobin levels both <10 g/dl and ≥10–11 g/dl results in substantial clinical benefits, supporting the use of erythropoietic therapy also in patients with mild anaemia.

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Acknowledgements

The authors would like to thank the Aranesp 980297 Study Group: Dr. Ehtesham Abdi, Bendigo Base Hospital, Bendigo, Australia; Dr. Stephen Ackland, Newcastle Mater Misericordiae Hospital, Newcastle, Australia; Dr. Andrea Ardizzoni, Istituto Nationale per la Ricerca sul Cancro, Genova, Italy; Prof. Dr. med Walter Aulitzky, Robert-Bosch Krankenhaus, Stuttgart, Germany; Dr. F Barata, Centro Hospitalar de Ciombra, Coimbra, Portugal; Dr. Bonne Biesma, Bosch Medicentrum, Hertogenbosch, The Netherlands; Dr. Alexander Berč, Louis Pasteur Hospital, Kosice, Slovak Republic; Dr. Peter Beržinec, Institute of Tuberculosis and Respiratory Diseases, Nitra, Slovak Republic; Dr. Corrado Boni, Ospedale Spallanzani, Reggio Emilia, Italy; Dr. Jean-Luc Canon, Centre Hospitalier Notre-Dame et Reine Fabiola, Charleroi, Belgium; Dr. José Chang, Lakeridge Health Centre, Oshawa, Canada; Prof. Ivan Chernozemsky, National Oncology Centre, Sofia, Bulgaria; Dr. Petio Chilingirov, District Oncology Dispensary, Stara Zagora, Bulgaria; Associate Prof. Dr. Ladislav Chovan, Institute of Tuberculosis and Respiratory Diseases, Bratislava, Slovak Republic; Dr. Lucio Crinò, University Hospital, Bologna, Italy; Dr. Eduardo Diaz-Rubio, Hospital Clinico San Carlos, Madrid, Spain; Dr. med. Wilfried Eberhardt, Universitätsklinikum, Essen, Germany; Dr. Enriqueta Felip, Hospital Vall d’Hebron, Barcelona, Spain; Dr. A Font, Hospital Germans Trias I Pujol, Badalona, Spain; Dr. M. Fiegl, Innsbruck University Hospital, Innsbruck, Austria; Prof. Dr. med. Norbert Frickhofen, Dr-Horst-Schmidt-Kliniken GmbH, Wiesbaden, Germany; Prof. August M. Garin, Russian Cancer Research Center, Moscow, Russia; Dr. med. Ulrich Gatzemeier, Krankenhaus Großhansdorf, Großhansdorf, Germany; Prof. Vera Andreevna Gorbunova, Russian Cancer Research Center, Moscow, Russia; Dr. Terezia Janásková, Nemocnice Vitkovice, Ostrava, Czech Republic; Prof. Patrick Johnston, The Queen’s University, Belfast, UK; Dr. Vítezlav Kolek, University Hospital, Olomouc, Czech Republic; Dr. Andrev V. Konev, Burdenko Main Military Clinical Hospital, Moscow, Russia; Dr. Katerina Kosatová, Pneumologiká Klinika, Praha, Czech Republic; Dr. Harvey Kreisman, Jewish General Hospital, Montreal, Canada; Dr. Iveta Kulíšková, University Hospital, Martin, Slovak Republic; Dr. Bernard Lesperance, Hôpital du Sacré-Coeur, Montreal, Canada; Dr. Mikhail R. Lichinitser, Russian Cancer Research Center, Moscow, Russia; Dr. Vladimír Malec, Nemocnicas poliklinikou FD Roosevelta Hospital, Banská Bystrica, Slovak Republic; Prof. Dr. med. Christian Manegold, Thoraxklinik der LV Baden, Heidelberg, Germany; Prof. Goergy M. Manikhas, City Oncology Dispensary, St Petersburg, Russia; Dr. B. Massuti, Hospital General de Alicante, Alicante, Spain; Dr. Maurizio Marangolo, Ospedale Civile, Ravenna, Italy; Dr. Renato Sotto Mayor, Hospital Santa Maria, Lisboa, Portugal; Dr. Maria José Melo, Hospital de Puido Valente, Lisboa, Portugal; Dr. J. Musil, University Hospital Bulkova, Prague, Czech Republic; Dr. Srisaladevi Navaratnam, Manitoba Cancer Foundation, Winnipeg, Canada; Prof. Dr. med. Andreas Neubauer, Universitätsklinikum Marburg, Marburg, Germany; Prof. Serguei V. Odinstov, Medical Center, Moscow, Russia; Prof. Dr. med. Christian Peschel, Klinikum Rechts der Isar, München, Germany; Dr. Miloš Pešek, University Hospital, Plzen-Bory, Czech Republic; Prof. Henrique Queiroga, Hospital de São João, Porto, Portugal; Dr. Pavel Reiterer, Masarykova Nemocnice, Ustí nad Labem, Czech Republic; Dr. Jaromír Roubec, Ostrava Poruba, Ostrava, Czech Republic; Dr. Giorgio Scagliotti, Azienda Ospedaliera San Luigi Gonzaga, Torino, Italy; Dr. med. Wolfgang Schütte, Städtisches Krankenhaus Martha Maria, Halle, Germany; Prof. S. Siena, Ospedale Niguarda Cá Granda, Milan, Italy; Dr. Egbert F. Smit, Free University Hospital, Amsterdam, The Netherlands; Prof. Nicholas Thatcher, Christie CRC Research Centre, Manchester, UK; Prof. Dr. med. Michael Thomas, Westfälische Wilhelms Universität, Muenster, Germany; Dr. Antoaneta Tomova, District Oncology Dispensary, Plovdiv, Bulgaria; Prof. Christo Tsekov, Varna University Medical Hospital, Varna, Bulgaria; Associate Prof. Valentina Tzekova, University Hospital, Sofia, Bulgaria; Dr. Craig Underhill, Murray Valley Private Hospital, Wodonga, Australia; Dr. Mark Vincent, London Regional Cancer Centre, London, Canada; Dr. med. Joachim von Pawel, Asklepios Frachkliniken München-Gauting, Gauting, Germany; Prof. Eduward K. Voznyi, Russian Scientific Center for Radiology, Moscow, Russia.

Michiel Hagendoorn performed the statistical programming, and Claire Wilson assisted in drafting the manuscript.

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Authors and Affiliations

  1. Respiratory Oncology Unit (Pulmonology), University Hospital Gasthuisberg, Herestraat 49, B-3000, Leuven, Belgium

    J. Vansteenkiste

  2. Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799, USA

    D. Tomita & G. Rossi

  3. Department of Internal Medicine I, University of Vienna, Währinger Gürtel 18-20, Vienna, Austria

    R. Pirker

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  1. J. Vansteenkiste
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  2. D. Tomita
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  3. G. Rossi
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  4. R. Pirker
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Corresponding author

Correspondence to J. Vansteenkiste.

Additional information

J. Vansteenkiste is the beneficiary of the Amgen Fund in Supportive Cancer Care at the Catholic University, Leuven, Belgium.

This work was supported by Amgen Inc., Thousand Oaks, California, USA

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Vansteenkiste, J., Tomita, D., Rossi, G. et al. Darbepoetin alfa in lung cancer patients on chemotherapy: a retrospective comparison of outcomes in patients with mild versus moderate-to-severe anaemia at baseline. Support Care Cancer 12, 253–262 (2004). https://doi.org/10.1007/s00520-003-0583-0

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