Evaluation of clinical use and effectiveness of darbepoetin alfa in cancer patients with chemotherapy-induced anemia

Abstract

Purpose:

To investigate the patterns of use of darbepoetin alfa in Spanish centers, and to evaluate its effectiveness in the treatment of chemotherapy-induced anemia under clinical practice conditions.

Methods:

This was an observational, retrospective, multicenter study in adult patients with non-myeloid malignancies who initiated chemotherapy and darbepoetin alfa. Data was collected for up to 16 weeks or until treatment discontinuation.

Results:

A total of 685 patients (72.7% with solid tumors and 27.3% with hematologic malignancies) were included in the study. Median age was 64.7 years (range 18.5–88.9 years), 50.7% were women, 82.4% had ECOG status 0–1 and 80.5% had stage III/IV cancer. At darbepoetin initiation, mean hemoglobin (Hb) was 100 g/L (SD 10), with 11.0% and 23.1% of patients below 90 g/L in solid and hematologic malignancies, respectively. A decrease in transfusion requirements was observed between weeks 5–16 with respect to weeks 0–16 (13.3% [95% CI: 10.7 to 15.9] versus 19.0% [95% CI: 16.0 to 22.0]). Hb levels were significantly increased during the treatment (mean change of 10.4 g/L for solid tumors [p < 0.001], and 16.6 g/L for hematologic malignancies [p < 0.001]). The percentage of patients with baseline Hb level <110 g/L who achieved an Hb level ≥110 g/L during the study was 66.5% (95% CI: 62.5% to 70.5%). Six serious adverse reactions were considered related to darbepoetin alfa (thromboembolic events, 1.0%).

Conclusions:

With the limitation of a retrospective design, our results suggest that darbepoetin alfa is a well tolerated treatment that increases hemoglobin levels and reduces the need for transfusion in cancer patients receiving chemotherapy in clinical practice.

Key words::

• Anemia
• Chemotherapy
• Darbepoetin alfa
• Hematologic malignancies
• Solid tumors
• Transfusion

Transparency

Declaration of funding

This study was financially supported by Amgen S.A.

Declaration of financial/other relationships

J.A.G. is an employee of Amgen S.A. A.A. and F.C. have received consulting fees or other remuneration from Amgen. A.B., R.A., P.M.A., N.D., J.F., M.L., and J.M.M.S. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

Author contributions: A.A. designed the study, coordinated the group, and reviewed the analysis and the manuscript. J.A.G. reviewed the analysis and the manuscript. The other authors contributed to clinical data collection and reviewed the manuscript.

CMRO peer reviewers have disclosed any relevant financial relationships.

Acknowledgments

Medical writing support was funded by Amgen S.A. Writing assistance was provided by Neus Valveny from Trial Form Support.

Previous presentation: presented in abstract form at the American Society of Hematology Annual Meeting (Orlando, FL, USA, May 29 – June 2, 2009): A. Bustos, M. A. Cruz, P. Aramburo et al. Evaluation of clinical use of darbepoetin alfa in patients with chemotherapy-induced anemia. J Clin Oncol 2009;27(Suppl; abstr e20585).

The following investigators are members of the RADAR Spanish Study Group and also participated in this study: Dr. M^a José Allegue, Hospital de Montecelo; Dr. Salomón Menjón, Hospital Virgen de las Nieves; Dr. Pedro Sánchez-Rovira, Hospital de Jaén; Dr. Vicente Alberola, Arnau Vilanova; Dr. Begoña Martin, ICO Girona; Dr. Juan Bayo, Clínica los Naranjos (Huelva); Dr. Antonio Fernández, Hospital de Albacete; Dr. Marta Martín, Hospital Sant Pau; Dr. Alberto Fernández, ICO, Hospital Duran i Reynals de Bellvitge; Dr. Santiago Escrivá, Hospital de Granollers; Dr. Laura Salgado, Centro Hospitalario de Pontevedra; Dr. Jesús García, Complejo Hospitalario Ourense; Dr. Urbano Anido, Hospital Clínico Universitario de Santiago; Dr. José Luis Bello, Hospital Clínico Universitario de Santiago; Dr. Gaspar Esquerdo, Hospital de Elda; Dr.Raquel de Paz, Hospital La Paz; Dr. Albert Font, Hospital Germans Trias i Pujol; Dr. Manuel Cobo, Hospital Carlos Haya; Dr. Joaquín Casal, Hospital Meixoeiro; Dr. José Ramón Mayans, Arnau Vilanova; Dr. Ángel Artal, Hospital Miguel Servet; Dr. M^a José Romero, Hospital Rafael Méndez (Lorca); Dr. Elena Ramila, Hospital Parc Taulí; Dr. Kenny Villadiego, Hospital Sagrat Cor; Dr. Àngels Arcusa, Hospital Terrassa; Dr. Marta Rodríguez, Complejo Hospitalario Ourense; Dr. Uriel Bohn, Hospital Dr. Negrin; Dr. Jesús Odriozola, Ramón y Cajal; Dr. Norberto Batista, Hospital Clínico Universitario; Dr. Miguel Hernández, Dr. Bernardo González, Hospital Clínico Universitario; Dr. M^a Esperanza Real, Dr. Fernando Hernández, Hospital Játiva (Lluís Alcanyis); Dr. Isabel Krsnik, Hospital Puerta del Hierro; Dr. Guillermo Cañigral, Hospital General de Castellón; Dr. M^a Dolores López, Hospital Santa María del Rosell; Dr. Juan de la Haba, Clínica San Juan de Dios (Córdoba); Dr. Sonia del Barco, Hospital de Figueres; Dr. Christian Rolfo, Clínica Rotger; Dr. José A. Arranz, Hospital Gregorio Marañón; Dr. Encarnación Jiménez, Hospital Jérez de la Frontera; Dr. Esperanza Romero, Hospital Arquitecto Marcide; Dr. Isidro Barneto, Dr. M^a Jesús Rubio, Hospital de la Cruz Roja; Dr. Manuel Ramos, Centro Oncológico Piñeiro; Dr. Adolfo Murias, Hospital Insular de Canarias; Dr. Pilar López, Dr. Pilar Navarro, Hospital Virgen de las Nieves; Dr. Pablo Iglesias, Hospital San Cecilio; Dr. Juan R. Delgado, Hospital Virgen de las Nieves; Dr. Javier Cassinello, Hospital de Guadalajara; Dr. Javier Dorta, Hospital de la Candelaria.