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Correlation between variation in quality of life and change in hemoglobin level after treatment with epoetin alfa 40,000 IU administered once-weekly

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Abstract

Introduction

Anemia is frequently associated with cancer due to the disease itself and antineoplastic treatments. This open-label, uncontrolled, multi-center study evaluated the effects of once-weekly (qw) epoetin alfa 40,000 IU on hemoglobin (Hb) levels and quality of life (QoL) in anemic patients receiving chemotherapy for solid tumors.

Materials and methods

A total of 522 patients with Hb level ≤12 g/dL received epoetin alfa 40,000 IU qw subcutaneously for 9–20 weeks to reach and maintain Hb range of 12–14 g/dL. QoL was assessed with the Functional Assessment of Cancer Therapy-Anemia (FACT-An [anemia sub-scale]) and Cancer Linear Analogue Scale (CLAS) at study entry, after two chemotherapy cycles, and at study end.

Results

Mean baseline Hb was 10.43 g/dL. Hb increases (g/dL) from baseline after 4, 8, 12 weeks and at study end were 1.07, 1.77, 1.92 and 1.71 g/dL, respectively. Response rates (Hb increase ≥1 and ≥2 g/dL during trial) were 81% and 61%, respectively. Mean increases in the FACT-An score from baseline (mean 55.4) were 3.1 after two chemotherapy cycles and 3.3 at study end; mean increases in the CLAS score from baseline (58.4 mm) were 5.9 mm after two chemotherapy cycles and 6.5 mm at study end.

Discussion

The greatest QoL increase was recorded when patients approached Hb level of 12 g/dL, independent of the baseline Hb level. Hb changes from baseline to trial end were related to corresponding changes in the FACT-An score. A positive correlation was also observed in patients with progressive disease. Adverse events were essentially those associated with chemotherapy. Incidence of thrombovascular events (6.7%) did not differ from the expected standard treatment in cancer patients. Epoetin alfa 40,000 IU qw increased Hb levels and improved or preserved QoL.

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Acknowledgements

The following investigators participated in this study: Adamo V. (Messina), Aglietta M. (Candiolo-TO), Alabiso O. (Novara), Altavilla G. (Messina), Amadori D. (Forlì), Amunni G. (Firenze), Bajetta E. (Milano), Bobbio Pallavicini E. (Crema), Bonsignori M. (Ancona), Bordonaro R. (Catania), Bottini A. (Cremona), Catalano G. (Napoli), Chiavacci A. (Pistoia), Cigolari S. (Napoli), Ciotti R. (Lecco), Conte P. /Ricci S. (Pisa), Contillo A. (Foggia), Contu A. (Sassari), Cortesi E. (Roma), Crispino S. (Siena), D’Aprile M. (Latina), De Chiara A. (Napoli), De Signoribus G. (S.Benedetto del Tronto), Del Prete S. (Frattamaggiore-NA), Donghi M./Antonelli P. (Como), Falcone A. (Livorno), Fioretto L. (Bagno a Ripoli-FI), Fornasiero A. (Piove di Sacco-PD), Gamucci T. (Frosinone), Ghezzi P. (Arezzo), Giusto M. (Belluno), Iacono C. (Ragusa), Lombardo M. (Pescara), Manente P. (Castelfranco Veneto-TV), Mantovani G. (Monserrato-CA), Marchetti P. (L’Aquila), Masina A. (Imola-BO), Mattioli R. (Fano-PU), Menichetti E. (Senigallia-AN), Minisini A. (Udine), Neri B. (Firenze), Nettuno R. (S. Felice a Cancello-CE), Palazzo S. (Cosenza), Palmeri S. (Palermo), Palmiotti G. (Carbonara-BA), Patrone F. (Genova), Pezzella G. (Taranto), Pinotti G. (Varese), Pizza C. (Nola-NA), Pollera F. (Viterbo), Savarese A. (Roma), Savarino A. (Agrigento), Sbalzarini G. (Casalpusterlengo-LO), Serravezza G. (Casarano-LE), Siena S. (Milano), Sobrero A. (Genova), Surace G. (Ostuni-BR), Vecchione A. (Roma), Vietti Ramus G. (Torino), Vinante O. (Noale-VE), Zagonel V. (Roma).

Epoetin alfa was supplied by Ortho Biotech, a division of Janssen-Cilag.

Disclosure of potential conflicts of interest

Giacomo Cartenì, Laura Giannetta, Giovanni Ucci, Giorgio De Signoribus, Aldo Vecchione, Graziella Pinotti, Fabio Puglisi, Antonio Contillo and Giuseppe Pezzella declare they have no competing interests.

Simona Orecchia and Patrizia Beccaglia are employees of the Medical Department of Janssen-Cilag SpA (Italy).

Author information

Authors and Affiliations

  1. Department of Medical Oncology, Cardarelli Hospital, Via Cardarelli, 9, 80131, Napoli, Italy

    Giacomo Cartenì

  2. Oncologia Falck, Ospedale Niguarda Ca’ Granda, Milan, Italy

    Laura Giannetta

  3. Medical Oncology, “A. Manzoni” H., Lecco, Italy

    Giovanni Ucci

  4. Oncology Unit, “Madonna del Soccorso” H., San Benedetto del Tronto, Italy

    Giorgio De Signoribus

  5. Oncology Department, II University of Rome “La Sapienza”, S. Andrea H., Rome, Italy

    Aldo Vecchione

  6. Medical Oncology, Circolo H., Varese, Italy

    Graziella Pinotti

  7. Clinical Oncology, University of Udine, Udine, Italy

    Fabio Puglisi

  8. Oncology Unit, Ospedali Riuniti, Foggia, Italy

    Antonio Contillo

  9. Medical Oncology, “SS: Annunziata” H., Taranto, Italy

    Giuseppe Pezzella

  10. Medical Department, Janssen-Cilag, Milan, Italy

    Simona Orecchia & Patrizia Beccaglia

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  1. Giacomo Cartenì
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OBI/EPO-ITA-01/1 study group

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Correspondence to Giacomo Cartenì.

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Cartenì, G., Giannetta, L., Ucci, G. et al. Correlation between variation in quality of life and change in hemoglobin level after treatment with epoetin alfa 40,000 IU administered once-weekly. Support Care Cancer 15, 1057–1066 (2007). https://doi.org/10.1007/s00520-007-0220-4

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  • DOI: https://doi.org/10.1007/s00520-007-0220-4

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