Early intervention with epoetin alfa during platinum-based chemotherapy: an analysis of the results of a multicenter, randomized, controlled trial based on initial hemoglobin level.
OBJECTIVE
This analysis of the results of a randomized, controlled trial evaluating the effects of epoetin alfa (EPO) therapy on transfusion requirements, hemoglobin (Hb), and quality of life (QOL) in patients with cancer receiving platinum-based chemotherapy was conducted to evaluate the effect of initial Hb level on study outcomes.


METHODS
Patients with Hb levels < or =12.1 g/dl were randomized 2:1 to receive EPO, 10,000 U three times weekly s.c. or best supportive care (BSC) until 4 weeks after their last chemotherapy cycle. For this analysis, patients were stratified by baseline Hb level (< or =9.7 g/dl, >9.7 g/dl to < or =10.5 g/dl, >10.5 g/dl to < or =11.3 g/dl, and >11.3 g/dl to < or =12.1 g/dl), and study results were reanalyzed.


RESULTS
Significantly fewer EPO patients than BSC patients with initial Hb levels >9.7 g/dl to < or =12.1 g/dl required transfusions. EPO maintained Hb levels throughout the study for patients with Hb levels >11.3 g/dl to < or =12.1 g/dl, compared with a decrease with BSC. For patients with baseline Hb levels >10.5 g/dl, for whom the mean changes from baseline to last assessment were measured by the Cancer Linear Analogue Scale assessments of energy and overall QOL as well as by the Functional Assessment of Cancer Therapy (FACT)-Fatigue and FACT-An Anemia subscale, QOL scores were significantly greater with EPO than with BSC. QOL declined in patients receiving BSC, and the mean decreases in QOL scores were greater for BSC patients with baseline Hb levels >10.5 g/dl, compared with the overall BSC group.


CONCLUSIONS
In patients with cancer receiving platinum-based chemotherapy and with baseline Hb levels >10.5 g/dl, early intervention with EPO reduces transfusions, maintains Hb level, and maintains or improves QOL. This study supports the positive effects of early intervention when analyzed according to initial Hb value.
Savonije
Jorine H
JH
VU Medisch Centrum, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.
van Groeningen
Cees J
CJ
Wormhoudt
Lars W
LW
Giaccone
Guiseppe
G
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy* / Q000503:physiopathology; D000970:Antineoplastic Agents / Q000009:adverse effects; D001803:Blood Transfusion / Q000706:statistics & numerical data*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage* / Q000627:therapeutic use; D005221:Fatigue / Q000209:etiology; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000627:therapeutic use; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D017671:Platinum Compounds / Q000009:adverse effects; D011788:Quality of Life; D011994:Recombinant Proteins; D018434:Sickness Impact Profile; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D006397:Hematinics; D006454:Hemoglobins; D017671:Platinum Compounds; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa