PURPOSE: Perioperative homologous blood transfusion has been suggested to have an adverse effect on survival in patients undergoing resection of colorectal cancers. Preoperative therapy is being increasingly used for rectal cancer patients and has an adverse effect on erythropoietic capacity. The objectives of this study were to evaluate the feasibility and safety of administration of recombinant human erythropoietin to patients receiving preoperative therapy for rectal cancer and to assess the impact of such treatment on blood transfusion requirements. METHODS: The study was an open-label, Phase I and II, nonrandomized, two-center trial. All patients received 50.4 Gy of irradiation with 5-fluorouracil infusions. Ten patients diagnosed with rectal cancer received 250 U/kg of recombinant human erythropoietin subcutaneously three times per week during preoperative radiation and chemotherapy. Oral iron was given to patients receiving erythropoietin. Ten contemporaneously treated patients who received both radiation and chemotherapy were used as controls. RESULTS: Of the 20 patients 13 were males; mean age was 64 years. Surgical procedures that patients underwent were abdominoperineal resection (14 patients), low anterior resection (4 patients), coloanal anastomosis (1 patient), or none (1 patient). There were no significant differences between groups in age, gender, stage or hemoglobin levels before therapy. No adverse reactions to erythropoietin were encountered. Hemoglobin levels were significantly higher in the treatment group during Weeks 1, 3, and 5 (P < 0.02 for each). Transfusion requirements were significantly decreased 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 significantly decreased the need for perioperative blood transfusions. This suggests that the use of erythropoietin in support of a preoperative chemoradiotherapy regimen for patients with rectal cancer is safe and should be considered. Whether such transfusion avoidance will translate into a survival benefit in this setting will require a large, prospective, clinical trial.
PURPOSE: Perioperative homologous blood transfusion has been suggested to have an adverse effect on survival in patients undergoing resection of colorectal cancers. Preoperative therapy is being increasingly used for rectal cancerpatients and has an adverse effect on erythropoietic capacity. The objectives of this study were to evaluate the feasibility and safety of administration of recombinant humanerythropoietin to patients receiving preoperative therapy for rectal cancer and to assess the impact of such treatment on blood transfusion requirements. METHODS: The study was an open-label, Phase I and II, nonrandomized, two-center trial. All patients received 50.4 Gy of irradiation with 5-fluorouracil infusions. Ten patients diagnosed with rectal cancer received 250 U/kg of recombinant humanerythropoietin subcutaneously three times per week during preoperative radiation and chemotherapy. Oral iron was given to patients receiving erythropoietin. Ten contemporaneously treated patients who received both radiation and chemotherapy were used as controls. RESULTS: Of the 20 patients 13 were males; mean age was 64 years. Surgical procedures that patients underwent were abdominoperineal resection (14 patients), low anterior resection (4 patients), coloanal anastomosis (1 patient), or none (1 patient). There were no significant differences between groups in age, gender, stage or hemoglobin levels before therapy. No adverse reactions to erythropoietin were encountered. Hemoglobin levels were significantly higher in the treatment group during Weeks 1, 3, and 5 (P < 0.02 for each). Transfusion requirements were significantly decreased 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 significantly decreased the need for perioperative blood transfusions. This suggests that the use of erythropoietin in support of a preoperative chemoradiotherapy regimen for patients with rectal cancer is safe and should be considered. Whether such transfusion avoidance will translate into a survival benefit in this setting will require a large, prospective, clinical trial.