Presenter: Peter T Silberstein Presenter's Affiliation: The North Central Cancer Treatment Group RTOG Type of Session: Scientific
Anemia occurs in a significant number of patients with cancer, and is
associated with symptoms of fatigue, dizziness, headache and decreased
health-related quality of life (QoL). Clinical trials have demonstrated the ability of epoetin alfa (EPO) delivered 3 times per week to increase hemoglobin concentrations and reduce transfusion requirements in patients with cancer. This study asks if weekly EPO administration produce similar results.
Materials and Methods
This was a randomized placebo-controlled trial of weekly EPO for 16 weeks
344 patients were accrued and randomized to placebo or EPO
Patients with advanced cancer requiring myelosuppressive chemotherapy were eligible if they had anemia (males <11.5 g/dL; females <10 g/dL)
All patients had a performance status 0, 1, and a life expectancy >6 months
Patients were randomized to placebo or EPO 40,000 units SQ weekly for 16 weeks.
If after 4 weeks of therapy, the hemoglobin had not increased by >1 g/dL, the dose was increased to 60,000 units
All patients received oral ferrous sulfate 324 mg/day.
All patients completed QOL measures
(UNISCALE, the symptom distress scale, and FACT-An) at the start of the study and monthly throughout the study for 16 weeks.
EPO significantly increased the time to transfusion compared to placebo p= .010
EPO also significantly increased the mean hemoglobin compared to placebo p= .001
There were trends towards reduced incidence rates of toxicity for EPO versus placebo for creatinine (2% vs 6%, p=0.04) and infection (5% vs 10%, p=0.05) but higher for myalgia (10% vs 4%, p=0.06)
Completion rates for the QOL endpoints were in 96% of evaluable patients
Despite the significant change in hemoglobin levels there was no significant difference in QoL data
EPO has a comparable toxicity profile to placebo in patients with advanced cancer.
QoL data can be collected in such a setting with a high rate of compliance.
QoL scores were different between the groups possibly due to increased transfusion in the placebo group.
Maintaining optimal quality of life, while achieving tumor stabilization or regression, is essential to the successful management of patients with cancer. Weekly EPO has been shown to increase hemoglobin concentration and decrease transfusion requirements. Regardless of a lack of noted difference in QoL scores between the two groups, given the frequency of adverse sequelae associated with anemia, its aggressive management should become an integral and routine part of cancer treatment.
Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.
Nov 2, 2010 - Most recent oncology randomized controlled trials evaluate drugs that are available "off-protocol therapy" in the United States, and this can adversely impact trial enrollment, according to a study published online Oct. 25 in the Journal of Clinical Oncology.