TY - JOUR
T1 - Phase I-II trial of erythropoietin in the treatment of cisplatin-associated anemia
AU - Miller, Carole B.
AU - Platanias, Leonidas C.
AU - Mills, Sharon R.
AU - Zahurak, Marianna L.
AU - Ratain, Mark J.
AU - Ettinger, David S.
AU - Jones, Richard J.
N1 - Funding Information:
Received July 8, 1991; revised November 7. 1991: accepted November 15. 1991. Supported in part by Chugai-Upjohn; by Public Health Service grants CA-14599 and CA-06973 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services; and by an American Cancer Society Clinical Oncology Cancer Development Award to M. J. Ratain. C. B. Miller, S. R. Mills, M. L. Zahurak, D. S. Ettinger, R. J. Jones, The Johns Hopkins Oncology Center, Baltimore, Md. L. C. Platanias, M. J. Ratain, The University of Chicago. The Pritzker School of Medicine, Chicago, III. *Correspondence to: Carole B. Miller, M.D., The Johns Hopkins Oncology Center, 600 N. Wolfe St., Rm. 167, Baltimore, MD 21205.
PY - 1992/1/15
Y1 - 1992/1/15
N2 - Background: Cancer Patients undergoing Chemotherapy with cisplatin-containing regimens often develop anemia. Al-though the cause is multifactorial, erythropoietin deficiency appears to play an important role. recombinant human erythropoietin (epoetin)has been trported to be effective in reversing cisplatin-associated anemia in animal studies but not in clinical trials. Purpose: This phase I-II clinical trial with epotin for anemia associted with cisplatin chemo therapy. Methods: Twenty-one cancer partients treated with cisplatin and manifesting anemia (hemogolbin level < 110 g/ L) received eopetin at escalating dose (25, 50, 100, Or 200 U/ kg boby weight) intravenously five tomes a week for 4 weeks. Results: Epoetin was well tolerated, and a maximal tolerated dose was not reached. Two patients experienced hypertension, which reponded to strandard antihypertensive therapy. No dose-dependent severe toxic effects were seen. The increase in hemoglobin levels from baseline on day 1 or the stuy was statistically significant after 4 weeks of eopetin therapy in the groups receiving 100 U/ kg; (mean change=±17 g/ L; p=. 007). A clinical reponse - an increase in hwmoglobin level grater than 10 g/ l was achieved in 12 patients after 4 weeks of treatment. For these responder, the mean increase in hemoglobin level was 25 ± 3.3 g/ L over the level nor hemoglobin level predicated a patient's response to epoetin. Conclusions: These preliminary findings suggest that epoetin is effective and well tolerated for the reversal of cisplatin-associated anemia, with the 100- U/ kg and 200-U/ kg dose levels offering optiaml clinical reponse. Implications: We are conducting a phase III trial to determine the effect of epoetin on transfusion requirements in patients undergoing chemotherapy. [j Nati cancer inst 84: 98-103,1992]
AB - Background: Cancer Patients undergoing Chemotherapy with cisplatin-containing regimens often develop anemia. Al-though the cause is multifactorial, erythropoietin deficiency appears to play an important role. recombinant human erythropoietin (epoetin)has been trported to be effective in reversing cisplatin-associated anemia in animal studies but not in clinical trials. Purpose: This phase I-II clinical trial with epotin for anemia associted with cisplatin chemo therapy. Methods: Twenty-one cancer partients treated with cisplatin and manifesting anemia (hemogolbin level < 110 g/ L) received eopetin at escalating dose (25, 50, 100, Or 200 U/ kg boby weight) intravenously five tomes a week for 4 weeks. Results: Epoetin was well tolerated, and a maximal tolerated dose was not reached. Two patients experienced hypertension, which reponded to strandard antihypertensive therapy. No dose-dependent severe toxic effects were seen. The increase in hemoglobin levels from baseline on day 1 or the stuy was statistically significant after 4 weeks of eopetin therapy in the groups receiving 100 U/ kg; (mean change=±17 g/ L; p=. 007). A clinical reponse - an increase in hwmoglobin level grater than 10 g/ l was achieved in 12 patients after 4 weeks of treatment. For these responder, the mean increase in hemoglobin level was 25 ± 3.3 g/ L over the level nor hemoglobin level predicated a patient's response to epoetin. Conclusions: These preliminary findings suggest that epoetin is effective and well tolerated for the reversal of cisplatin-associated anemia, with the 100- U/ kg and 200-U/ kg dose levels offering optiaml clinical reponse. Implications: We are conducting a phase III trial to determine the effect of epoetin on transfusion requirements in patients undergoing chemotherapy. [j Nati cancer inst 84: 98-103,1992]
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U2 - 10.1093/jnci/84.2.98
DO - 10.1093/jnci/84.2.98
M3 - Article
C2 - 1735886
AN - SCOPUS:0026565866
SN - 0027-8874
VL - 84
SP - 98
EP - 103
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 2
ER -