Addition of Erythropoetin to Radiotherapy Does Not Improve Outcomes

Addition of Erythropoetin to Radiotherapy Does Not Improve Outcomes Among Anemic Patients with Head and Neck Cancers

Preliminary results from the Radiation Therapy Oncology Group (RTOG) indicate that erythropoietin improved hemoglobin levels in anemic patients with head and neck cancers, but did not improve survival, cancer-free survival, or control of cancer.[1] This study was closed early when an unplanned interim analysis revealed that it would be extremely unlikely (<5% chance) that erythropoietin would improve cancer-control or survival. These results were reported in the plenary session of the 46th annual meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO) held in Atlanta GA, Oct 3-7, 2004.

Anemia is a condition characterized by low levels of red blood cells and/or hemoglobin. Red blood cells are blood cells that start as immature cells in the bone marrow (spongy material inside bones) and ultimately become mature cells in circulating blood. Red blood cells contain a substance called hemoglobin that is responsible for carrying oxygen to all tissues in the body. Anemia can be a result of a chronic disease, such as cancer, or a side effect of treatment, such as chemotherapy and/or radiation. Anemia may significantly decrease the quality of life of a patient, with common symptoms including severe fatigue, shortness of breath, diminished activity level, reduced overall feeling of well-being, and possible mental dysfunction. Anemia may also exacerbate existing medical conditions. Furthermore, if anemia becomes severe, treatment may be delayed or doses reduced, possibly compromising optimal outcomes for the patient. Some recent research has also indicated that anemia may reduce the anti-cancer effects of radiation and/or some chemotherapy agents in some types of cancer.

Anemia has been associated with poor outcomes in cancer patients. Recombinant human erythropoietin elevates hemoglobin levels in anemic patients and has been shown to improve outcomes in patients with cancer.[2], [3]

The trial presented at ASTRO included 148 patients with non-metestatic, non-operable squamous cell carcinoma of the head and neck who were also anemic. Anemia was defined as hemoglobin levels between 9 g/dl and 13.5 g/dl for men and 9 g/dl and 12.5 g/dl for women. Patients were randomly assigned to receive radiotherapy alone or radiotherapy plus erythropoietin. Erythropoietin was administered until hemoglobin levels reached 16 g/dl for men and 14 g/dl for women and restarted if hemoglobin levels fell below 13.5 g/dl and 12 g/dl. Patients with stage III or IV disease also received concurrent high-dose Platinol® or moderate dose Platinol®/Taxol®.

The results presented at ASTRO were following 14 months of follow-up overall and 19 months of follow-up for survivors. While erythropoietin did significantly improve hemoglobin levels, erythropoietin treatment did not produce an improvement in failure-free survival, overall survival, or time to treatment failure compared to radiotherapy alone (see table).

There was no significant difference in the overall rate of grade 3+ side effects between the two arms.

These results indicate that the addition of treatment with erythropoietin in patients being treated with radiation for head and neck cancer does not appear to improve overall survival or cancer-free survival. Hemoglobin levels were improved with erythropoietin; however, further research is necessary to determine the long-term effects of erythropoietin in this patient population.

References:

[1]. Machtay M, Pajak T, Suntharalingam M, et al. Definitive Radiotherapy Erythropoietin for Squamous Cell Carcinoma of the Head and Neck: Preliminary Report of RTOG 99-03. Proceedings from the 46th annual meeting of the American Society for Therapeutic Radiology and Oncology, Atlanta GA, Oct 2-5 2004, Abstract #5.

[2]. Pronzato P, Cortesi E, van der Rijt C, et al. Early intervention with epoetin alfa in breast cancer (BC) patients (pts) undergoing chemotherapy (CT): Results of a randomized, multicenter, phase IIIb study (EPO-INT-47 Study Group). Annals of Oncology. 2002; 13 (Suppl. 5):168. Abstract 6200. Proceedings from the twenty-seventh annual meeting of the European Society of Medical Oncology, October 2002.

[3]. OShaughnessy J, Vukelja S, Savin M, et al. Impact of epoetin alfa on cognitive function, asthenia, and quality of life in women with breast cancer receiving adjuvant or neoadjuvant chemotherapy: analysis of 6-month follow-up data. Proceedings from the 25th Annual Breast Cancer Symposium. December 2002. Abstract 550.

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