Early Intervention with epoetin alfa during platinum-based chemotherapy: an analysis of quality-of-life results of a multicenter, randomized, controlled trial compared with population normative data.
OBJECTIVE
To evaluate the effect of epoetin alfa on quality of life (QOL) in patients with solid tumors and mild-to-moderate anemia receiving platinum-based chemotherapy relative to population norms.


METHODS
In the original study, patients (n = 316) with hemoglobin (Hb) levels < or =12.1 g/dl were randomized 2:1 to receive either epoetin alfa at a dose of 10,000 U thrice weekly s.c. or best supportive care (BSC) to compare the effects on transfusion use, hematologic response, and QOL (measured by the Functional Assessment of Cancer Therapy-Anemia [FACT-An]and Cancer Linear Analogue Scale [CLAS]). The QOL data from this previously reported trial were reanalyzed here relative to population norms.


RESULTS
Mean baseline QOL scores were similar between groups. At study completion, mean CLAS, FACT-An, FACT-An Anemia subscale, and FACT-An Fatigue subscale scores were significantly higher for patients given epoetin alfa than for those treated with BSC. Compared with population norms, both groups had impaired QOL at baseline. Differences in mean QOL change scores from baseline to study end for epoetin alfa versus BSC were 3.17 points for the FACT-General Total, 9.90 for the FACT-An Fatigue subscale, and 7.30 for the FACT-An Anemia subscale. This was equivalent to corrections in QOL deficits attributable to epoetin alfa of 97.3%, 40.7%, and 38.0% for the FACT-General Total, FACT-An Fatigue, and FACT-An Anemia subscale scores, respectively, versus BSC. A somewhat greater QOL benefit was observed for the FACT-An Fatigue and FACT-An Anemia subscales in the subset of patients with baseline Hb levels >10.5 g/dl.


CONCLUSIONS
Patients in this study had impaired QOL compared with population norms. Early treatment with epoetin alfa to correct anemia improved QOL in a statistically significant and clinically meaningful way, and improvements were greater in patients with baseline Hb levels >10.5 g/dl.
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; 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; D012016:Reference Values; 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