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PURPOSE:
This randomized, double-blind, placebo-controlled trial (N93-004) evaluated
the effects of epoetin alfa on tumor response to chemotherapy and survival
in patients with small-cell lung cancer (SCLC).
PATIENTS AND METHODS:
Adult patients with hemoglobin < or = 14.5 g/dL starting chemotherapy
received epoetin alfa 150 U/kg or placebo subcutaneously 3 times weekly
until 3 weeks after completion of chemotherapy. Survival was assessed for 3
years. The primary end point was the proportion of patients with complete or
partial response after three chemotherapy cycles.
RESULTS:
The trial was terminated prematurely after 224 of a projected 400 patients
were accrued. Baseline characteristics were similar between groups. Epoetin
alfa and placebo patients (n = 109 and n = 115, respectively) had mean
baseline hemoglobin of 12.8 g/dL and 13.0 g/dL, respectively. Overall tumor
response was similar between the epoetin alfa and placebo groups after three
chemotherapy cycles (72% and 67%, respectively; 95% CI of difference, -6% to
18%) and after completion of chemotherapy (60% and 56%, respectively; 95% CI
of difference, -9% to 17%). Epoetin alfa and placebo groups had similar
median overall survival (10.5 and 10.4 months, respectively) and overall
mortality (91.7% and 87.8%, respectively; hazard ratio, 1.172; 95% CI, 0.887
to 1.549; P = .264). Hemoglobin was maintained in the prechemotherapy range
in epoetin alfa patients, but decreased substantially in placebo patients.
Fewer epoetin alfa patients than placebo patients required transfusion.
CONCLUSION:
These results suggest that in newly diagnosed patients with SCLC epoetin
alfa does not affect tumor response to chemotherapy or survival. However,
the early trial closure makes these conclusions preliminary.
Reference:
J Clin Oncol. 2005 Dec 20;23(36):9377-86. |