Carcinoma Clinical Trial
Official title:
Randomized Trial of Epoetin Alfa in Men With Hormone-refractory Prostate Cancer and Anemia.
The purpose of this study was to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) or placebo on anemia related quality-of-life and anemia in hormone-refractory (not responding to hormone therapy) prostate cancer patients.
Anemia is a common problem experienced by patients with malignancy. Although cancer
treatment such as systemic chemotherapy is an obvious cause, many cancer patients are anemic
at presentation. Estimates in prostate cancer patients suggest that nearly 40% present with
hemoglobin levels less than 120 g/L. The most common clinical manifestation of anemia is
fatigue, although vertigo, loss of appetite, poor concentration and dyspnea (shortness of
breath) can also occur. Anemia often leads to impairment of physical capacity, lowers
patients' subjective sense of well-being, and diminishes their overall quality-of-life
(QoL). The use of recombinant erythropoietin for patients with chronic anemia of end stage
renal disease, acquired immune deficiency syndrome, or anemia of chronic disease in the
setting of malignancy (cancer) is well established to provide benefit in reducing
transfusion requirements. There exists a number of published data on QoL in cancer patients.
Abels et al. published in 1991 initial results of clinical reports that specifically
reported on QoL outcomes. The study actually consisted of a series of three concurrent
randomized, double blind, placebo controlled trials conducted on groups of patients with a
variety of underlying malignancies. The three studies included 124 patients not previously
treated with systemic therapy, 132 patients treated systemically with cisplatinum containing
chemotherapy regimens and 157 patients treated with non-cisplatinum containing regimens
respectively. All patients had pre-treatment hemoglobins of less than 105 g/L or hematocrits
(percentage of red blood cells in blood) of less than 32%. In each trial, patients
randomized to receive recombinant erythropoietin had significantly greater increases in
hematocrit than placebo patients. QoL parameters (as measured on a visual analog scale) were
significantly improved in patients receiving erythropoietin who demonstrated an increase in
hematocrit throughout the three studies. Overall QoL improved significantly over baseline,
although individual studies only demonstrated a trend towards improvement. Littlewood et al.
published in 2001 the results of a double-blind, placebo controlled multi-center study of
375 cancer patients receiving non-platinum containing chemotherapy. A baseline hemoglobin of
less than or equal to 105 g/L, or a drop of 20 g/L with chemotherapy was required for
eligibility. Patients were randomized 1:2 to either placebo or epoetin alfa, for up to 4
weeks following chemotherapy. Active treatment demonstrated significant effectiveness in
increasing hemoglobin levels and reducing transfusion requirements. Significant improvement
in all primary cancer- and anemia-specific QoL domains favoured epoetin alfa. Although
clinical evidence suggests benefit beyond reduced transfusion requirements, many studies
looking at impact on QoL have been uncontrolled by design, with variable quality and
collection of QoL data. Since they have also involved patients with a myriad of primary
malignancies, and previous therapies, the translation of results to site and situation
specific clinical practice has been difficult. As erythropoiesis is a complex process that
depends on inhibiting or stimulating cytokines, which may be regulated differently among
various neoplastic diseases (i.e. different tumour types), studies in more homogenous groups
of patients were deemed necessary to evaluate impact on QoL. Prostate cancer is the most
common serious cancer in men. Despite advances in screening and treatment, progression to
the incurable metastatic phase of the disease remains common. Androgen ablation therapy
using surgery or drugs remains the standard of treatment, but inevitably, androgen
resistance develops. Hormone refractory prostate cancer represents a spectrum of disease
ranging from asymptomatic patients with only biochemical evidence of androgen resistance to
end-stage disease characterized by extensive bone metastases, pain, wasting, reduced QoL,
and a median survival of less than one year. Treatment of hormone refractory prostate cancer
does not prolong survival, but may improve symptoms and QoL. Anemia is common in this group
of patients, with hemoglobin levels of less than 120 g/L often seen (in up to 40% patients).
Patients are also genrally older, often have co-morbid conditions, and transfusions for
palliation are frequently given. A randomized, placebo-controlled study evaluating an
intervention with epoetin alfa that could significantly improve QoL was thus carried out in
hormone refractory prostate cancer patients. It was deemed that such an intervention, if
successful, could have the potential to change current clinical practice. Moreover, improved
QoL, in response to increased Hb levels, could also lead to a reduction in hospital
admissions and to fewer transfusions in this patient population.
Patients were to receive either 40,000 IU epoetin alfa weekly or matching placebo
subcutaneously for 16 weeks.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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