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A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study Of Novel Erythropoiesis Stimulating Protein (NESP) In Patients Undergoing Platinum Treatment For Lung Cancer
Heather Jones, MD
University of Pennsylvania Cancer
Last Modified: May 13, 2001
Presenter: Robert Pirker
Affiliation: NESP 980297 Study Group
Studies indicate that the carbohydrate content of erythropoietin influences serum half-life. The novel erythropoiesis stimulating protein darbepoetin alfa (NESP) is a glycoprotein with 2 more N linked carbohydrate side chains than Recombinant human erythropoietin (rHuEPO). NESP has a serum half-life 2- to 3-times longer than that of rHuEPO in patients with renal failure. The half-life of NESP in patients with cancer who are receiving chemotherapy is over 40 hours. Phase I/II studies demonstrated NESP increases hemoglobin concentrations in patients with solid tumors and lymphoproliferative malignancies who were or were not receiving chemotherapy. This phase III study was designed to evaluate if NSEP administration would lead to a clinical meaningful reduction in transfusion requirements.
Materials and Methods:
- 320 anemic patients (hemoglobin [less than or equal to] 11 g/dL) with lung cancer, receiving platinum-containing chemotherapy, who had an ECOG performance status of 0 to 2, were evaluated.
- The patients could not be iron deficient, and could not have received rHuEPO therapy within 8 weeks or 2 red blood cell (RBC) transfusions within 4 weeks.
- Primary study end point was need for red blood cell transfusion after the first month of therapy - week 5 to the end of the treatment phase.
- Patients were randomized to receive NESP 2.25 ug/kg/week or placebo. Study drug was administered subcutaneously once weekly for a maximum of 12 weeks. Study drug was withheld if hemoglobin concentrations were 14 g/dL (for women) or 15 g/dL (for men) and was doubled if at week 6 the hemoglobin had increased [less than or equal to] 1.0 g/dL
- NESP significantly reduced the portion of patients requiring a blood transfusion. Placebo groups vs NESP at week 5 to end of treatment phase (51% vs 21% p < 0.001). NESP improved the hemoglobin profile over time compared with placebo.
- NESP was found to decrease patient self- reported fatigue
- NESP patients had higher FACT-fatigue scores. With 32% of the NESP patients vs 19 % of the placebo patients reporting a 25 % or more improvement in fatigue (p= 0.019).
- NESP was well tolerated by patients and no antiNESP antibodies were detected at the end of treatment.
This phase III trial demonstrates that NESP administration is able to increase the hemoglobin concentration in patients with lung cancer; and a meaningful reduction in transfusion requirements was also demonstrated. This study also demonstrated an improvement in patient's quality of life with an increase in the FACT-Fatigue scores.
Cancer related anemia and its associated fatigue is a daunting cancer associated symptom. It is associated with loss of function and emotional distress. This study demonstrates that this long acting novel erythropoietin-stimulating agent (NSEP) would be and excellent tool in an oncologist's armamentarium in the fight against anemia and fatigue. The duration of the agent is an excellent bonus to the added benefit to the improved quality of life this drug affords its patients.
OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen