the use of erythropoietin instead of transfusions to correct anemia in hyperfractionated...

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chemotherapy was viewed as the least desirable outcome. While there was significant intersubject variability in subjects’ utilities, it was not explained by the sociodemographic factors examined. We intend to use these utilities to more fully evaluate the cost-effectiveness of RT in this setting. Health State A RT3NR B RT3R3CT C NRT3NR D NRT3R3RT E NRT3R3CT Mean 0.90 0.83 0.89 0.89 0.86 Interquartile Range (0.89-0.97) (0.75-0.95) (0.88-0.97) (0.87-0.97) (0.84-0.95) Table Key: RT radiation therapy, NR no recurrence, R recurrence, CT chemotherapy, NRT no radiation therapy 2273 The Use of Erythropoietin Instead of Transfusions to Correct Anemia in Hyperfractionated Chemoradiation of Advanced Head and Neck Cancer A. Villar, J. Martinez, C. Fuentes, M. Cabezon, M. Perez, M. Espin ˜eira, R. Hernandez, C. Borque, J. Martin Radiation Oncology, Hospital NS Candelaria, Santa Cruz de Tenerife, Spain Purpose: To investigate the use of erythropoietin therapy as a substitute for transfusions in a highly efficient hyperfractionated chemoradiation schedule for advanced head and neck cancer. Materials and Methods: From March 1996 to November 2000 56 patients with advanced head and neck cancer (8 stage III and 48 stage IV) were treated with a chemoradiation regimen composed of 2 fractions per day separated by 6 hours. Each fraction consisted of 5 mg/m2 of carboplatin 115 cGy. Carbogen breathing was added to each fraction so that patients breathed carbogen (6 l/m) 4 minutes before and during radiotherapy administration. Treatment was given 5 days a week up to total doses of 350 mg/m2 of carboplatin 8050 cGy in 7 weeks. Hemoglobin levels were recorded prior to treatment and at least once a week during treatment and one month postreatment. Thereafter hemoglobin levels were recorded monthly up to one year postreatment. The rate of complete responses (CR), Local Control (LC), Cause-specific survival (CSS) and overall survival (OS) at 2 and 4 years (41 patients) have been reported ( IJROBP 2001. 50/1: 47-53). Briefly 100% of CR, 85% LC, 69% CSS and 68% OS were obtained. Presently 56 consecutive patients have been treated. Initially, anemia was corrected with transfusion if Hb level reached the value of 11 g/dl. After treating 20 patients, and due to the high rate of transfusions needed (see results) erythropoietin therapy (10.000 U, 3 times a week) was given if Hb level reached the value of 13 g/dl. Results: Mean diminution of Hb level between initiation and end of treatment was 1,2 g/dl for the whole group of patients, 1,8 g/dl for the group whose anemia was corrected with transfusions and 0,48 g/dl for the group whose anemia was corrected with erythropoietin. Five transfusions (25%) were needed in the first group whereas no transfusion was required in the erythropoietin group with 37% of patients of this group requiring erythropoietin therapy.Differences in CR, LC, CSS and OS were not significant when compared according to the method of anemia correction. Conclusion: The method of anemia correction did not influence the results. However it greatly improved the tolerance to the regimen because it completely eliminated the need of transfusions. We believe that this is relevant taking into account not only the side effects but also the social concern generated by transfusions, and encourages the use of erythropoietin therapy to correct anemia in efficient chemoradiation protocols. 2274 Does Recombinant Human Erythropoietin Improve the Outcome of Radiation Therapy in Head and Neck Cancer Patients K. Aziz 1 , T. Hashem 1 , N. Mobarek 1 , N. Bary 1 , I. Ghoneimy 2 , S. Haddad 2 1 Clinical Oncology, Menoufeya University, Shebin El Kom, Egypt, 2 Clinical Oncology, Cairo University, Cairo, Egypt Objectives: The purpose of the present study is to evaluate the impact of Recombinant Human Erythropoietin (rhEPO) on Hemoglobin (Hgb) level, loco regional control and acute radiotherapy complications in Head and Neck Carcinoma. Patients and Methods: Between January 1999 and February 2000, 60 patients with histologically proven Squamous Cell Carcinoma (SCC) of Head and Neck, with Hgb 11g/dl, planned to receive a course of irradiation, were randomly divided into two groups: Group A 30 patients received oral iron supplementation in a dose of 300 mg ferrous sulphate tds after meals 10 days prior to and during the course of irradiation. Group B 30 patients received oral iron supplementation (dose as in group A) plus rhEPO – started 10 days prior to irradiation – in a dose of 300 IU/Kg subcutaneously 3 times weekly for 3 weeks, decreased to 150 IU/Kg there after till the end of irradiation. Hgb and clinical response were assessed 10 days prior to and every week during the irradiation. Clinical, radiological and histopathological assessments were carried out 1 month after the end of irradiation. Results: Of the 60 patients included, 50 were eligible for evaluation. 22 patients in Group A and 28 patients in Group B. The pretreatment mean Hgb levels were comparable 8.06 /- 1.36 for Group A and 7.96 /- 1.34 for Group B (p value 0.05). At the end of treatment, the mean Hgb levels for Group A and B were 8.18 /- 2.04 and 12.89 /- 1.63 respectively (p value 0.05). Of the 50 patients eligible for evaluation, 28 (56%) achieved Complete Response (CR), 8/22 (36.36%) in Group A and 20/28 (71.43%) in Group B (p value 0.05). The frequency of Grade 3 and 4 mucosal and skin reactions were 4/22 (18.18%) & 2/22 (9.09%) in Group A, and 6/28 (21.42%) & 4/28 (14.28%) in Group B respectively, and the differences were not statistically significant. Conclusion: Low Hgb levels have an adverse effect on loco regional control in patients with Head and Neck Cancer. rhEPO plays a major role in improving anemia in patients undergoing radiotherapy in this group of patients . 367 Proceedings of the 43rd Annual ASTRO Meeting

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Page 1: The use of erythropoietin instead of transfusions to correct anemia in hyperfractionated chemoradiation of advanced head and neck cancer

chemotherapy was viewed as the least desirable outcome. While there was significant intersubject variability in subjects’utilities, it was not explained by the sociodemographic factors examined. We intend to use these utilities to more fully evaluatethe cost-effectiveness of RT in this setting.

Health StateA

RT3NRB

RT3R3CTC

NRT3NRD

NRT3R3RTE

NRT3R3CT

Mean 0.90 0.83 0.89 0.89 0.86Interquartile Range (0.89-0.97) (0.75-0.95) (0.88-0.97) (0.87-0.97) (0.84-0.95)

Table Key: RT � radiation therapy, NR � no recurrence, R � recurrence, CT � chemotherapy, NRT � no radiation therapy

2273 The Use of Erythropoietin Instead of Transfusions to Correct Anemia in HyperfractionatedChemoradiation of Advanced Head and Neck Cancer

A. Villar, J. Martinez, C. Fuentes, M. Cabezon, M. Perez, M. Espineira, R. Hernandez, C. Borque, J. Martin

Radiation Oncology, Hospital NS Candelaria, Santa Cruz de Tenerife, Spain

Purpose: To investigate the use of erythropoietin therapy as a substitute for transfusions in a highly efficient hyperfractionatedchemoradiation schedule for advanced head and neck cancer.

Materials and Methods: From March 1996 to November 2000 56 patients with advanced head and neck cancer (8 stage IIIand 48 stage IV) were treated with a chemoradiation regimen composed of 2 fractions per day separated by 6 hours. Eachfraction consisted of 5 mg/m2 of carboplatin � 115 cGy. Carbogen breathing was added to each fraction so that patientsbreathed carbogen (6 l/m) 4 minutes before and during radiotherapy administration. Treatment was given 5 days a week up tototal doses of 350 mg/m2 of carboplatin � 8050 cGy in 7 weeks. Hemoglobin levels were recorded prior to treatment and atleast once a week during treatment and one month postreatment. Thereafter hemoglobin levels were recorded monthly up toone year postreatment. The rate of complete responses (CR), Local Control (LC), Cause-specific survival (CSS) and overallsurvival (OS) at 2 and 4 years (41 patients) have been reported ( IJROBP 2001. 50/1: 47-53). Briefly 100% of CR, 85% LC,69% CSS and 68% OS were obtained. Presently 56 consecutive patients have been treated. Initially, anemia was corrected withtransfusion if Hb level reached the value of 11 g/dl. After treating 20 patients, and due to the high rate of transfusions needed(see results) erythropoietin therapy (10.000 U, 3 times a week) was given if Hb level reached the value of 13 g/dl.

Results: Mean diminution of Hb level between initiation and end of treatment was 1,2 g/dl for the whole group of patients, 1,8g/dl for the group whose anemia was corrected with transfusions and 0,48 g/dl for the group whose anemia was corrected witherythropoietin. Five transfusions (25%) were needed in the first group whereas no transfusion was required in the erythropoietingroup with 37% of patients of this group requiring erythropoietin therapy.Differences in CR, LC, CSS and OS were notsignificant when compared according to the method of anemia correction.

Conclusion: The method of anemia correction did not influence the results. However it greatly improved the tolerance to theregimen because it completely eliminated the need of transfusions. We believe that this is relevant taking into account not onlythe side effects but also the social concern generated by transfusions, and encourages the use of erythropoietin therapy to correctanemia in efficient chemoradiation protocols.

2274 Does Recombinant Human Erythropoietin Improve the Outcome of Radiation Therapy in Head and NeckCancer Patients

K. Aziz1, T. Hashem1, N. Mobarek1, N. Bary1, I. Ghoneimy2, S. Haddad2

1Clinical Oncology, Menoufeya University, Shebin El Kom, Egypt, 2Clinical Oncology, Cairo University, Cairo, Egypt

Objectives: The purpose of the present study is to evaluate the impact of Recombinant Human Erythropoietin (rhEPO) onHemoglobin (Hgb) level, loco regional control and acute radiotherapy complications in Head and Neck Carcinoma.

Patients and Methods: Between January 1999 and February 2000, 60 patients with histologically proven Squamous Cell Carcinoma(SCC) of Head and Neck, with Hgb �11g/dl, planned to receive a course of irradiation, were randomly divided into two groups:Group A � 30 patients received oral iron supplementation in a dose of 300 mg ferrous sulphate tds after meals 10 days prior to andduring the course of irradiation. Group B � 30 patients received oral iron supplementation (dose as in group A) plus rhEPO – started10 days prior to irradiation – in a dose of 300 IU/Kg subcutaneously 3 times weekly for 3 weeks, decreased to 150 IU/Kg there aftertill the end of irradiation. Hgb and clinical response were assessed 10 days prior to and every week during the irradiation. Clinical,radiological and histopathological assessments were carried out 1 month after the end of irradiation.

Results: Of the 60 patients included, 50 were eligible for evaluation. 22 patients in Group A and 28 patients in Group B. Thepretreatment mean Hgb levels were comparable 8.06 �/- 1.36 for Group A and 7.96 �/- 1.34 for Group B (p value �0.05).At the end of treatment, the mean Hgb levels for Group A and B were 8.18 �/- 2.04 and 12.89 �/- 1.63 respectively (p value�0.05). Of the 50 patients eligible for evaluation, 28 (56%) achieved Complete Response (CR), 8/22 (36.36%) in Group A and20/28 (71.43%) in Group B (p value� 0.05). The frequency of Grade 3 and 4 mucosal and skin reactions were 4/22 (18.18%)& 2/22 (9.09%) in Group A, and 6/28 (21.42%) & 4/28 (14.28%) in Group B respectively, and the differences were notstatistically significant.

Conclusion: Low Hgb levels have an adverse effect on loco regional control in patients with Head and Neck Cancer. rhEPOplays a major role in improving anemia in patients undergoing radiotherapy in this group of patients .

367Proceedings of the 43rd Annual ASTRO Meeting