Influence of erythropoietin on transfusion requirements in patients receiving preoperative chemoradiotherapy for rectal cancer

PURPOSE: Perioperative homologous blood transfusion has been suggested to h ave an adverse effect on survival in patients undergoing resection of color ectal cancers. Preoperative therapy is being increasingly used for rectal c ancer patients and has an adverse effect on erythropoietic capacity. The ob jectives of this study were to evaluate the feasibility and safety of admin istration of recombinant human erythropoietin to patients receiving preoper ative therapy for rectal cancer and to assess the impact of such treatment on blood transfusion requirements. METHODS: The study was an open-label, Ph ase I and II, nonrandomized, two-center trial. All patients received 50.4 G y of irradiation with 5-fluorouracil infusions. Ten patients diagnosed with rectal cancer received 250 U/kg of recombinant human erythropoietin subcut aneously three times per week during preoperative radiation and chemotherap y. Oral iron was given to patients receiving erythropoietin. Ten contempora neously treated patients who received both radiation and chemotherapy were used as controls. RESULTS: Of the 20 patients 13 were males; mean age was 6 4 years. Surgical procedures that patients underwent were abdominoperineal resection (14 patients), low anterior resection (4 patients), coloanal anas tomosis (1 patient), or none (1 patient). There were no significant differe nces between groups in age, gender, stage or hemoglobin levels before thera py. No adverse reactions to erythropoietin were encountered. Hemoglobin lev els were significantly higher in the treatment group during Weeks 1,3, and 5 (P < 0.02 for each). Transfusion requirements were significantly decrease d in patients who received erythropoietin (0.4 vs. 3.7 units; P < 0.0003). CONCLUSIONS: The data showed that use of erythropoietin during preoperative therapy can prevent the decline in hemoglobin that commonly occurs during therapy. Further, this was not associated with adverse events and significa ntly decreased the need for perioperative blood transfusions. This suggests that the use of erythropoietin in support of a preoperative chemoradiother apy regimen for patients with rectal cancer is safe and should be considere d. Whether such transfusion avoidance will translate into a survival benefi t in this setting will require a large, prospective, clinical trial.