Once‐weekly dosing of epoetin‐α increases hemoglobin and improves quality of life in anemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy

Abstract

BACKGROUND The current study was performed to prospectively evaluate the effectiveness, clinical outcomes, and safety of once‐weekly (QW) recombinant human erythropoietin (r‐HuEPO [epoetin‐α]) in anemic cancer patients with nonmyeloid malignancies who were receiving radiation therapy (RT) concomitantly or sequentially with chemotherapy (CT). METHODS A total of 777 anemic patients (hemoglobin [Hb] ≤ 11 g/dL) were enrolled in this multicenter, open‐label, nonrandomized, 16‐week study. Patients initially received epoetin‐α at a dose of 40,000 units (U) subcutaneously QW, escalating to a dose of 60,000 U QW if the Hb increased to ≤ 1 g/dL after 4 weeks. Endpoints were changes in hematologic and quality of life (QOL) parameters. RESULTS Among the 442 patients evaluable for hematologic response, the mean increase in Hb from baseline to the time of final evaluation was 1.9 ± 1.8 g/dL (P < 0.05). An increase in Hb of ≥ 2 g/dL, in the absence of blood transfusions, occurred in 68.3% of patients (278 of 407 patients) who were on the study for ≥ 30 days. The overall response rate (Hb increase ≥ 2 g/dL or Hb ≥ 12 g/dL in the absence of blood transfusions) was 74.0% (301 of 407 patients). In 359 patients who were evaluable for QOL assessment, epoetin‐α therapy was found to significantly (P < 0.05) improve mean Linear Analog Scale Assessment (LASA) scores for energy level, ability to perform daily activities, and overall QOL from baseline to the time of final evaluation. QW epoetin‐α therapy was found to be well tolerated. CONCLUSIONS Treatment with QW epoetin‐α was found to increase Hb levels, decrease transfusion requirements, and improve functional status and QOL in anemic patients with nonmyeloid malignancies who were receiving RT concomitantly or sequentially with CT. Clinical benefits and the safety profile of QW epoetin‐α in this setting appear to be similar to those observed in anemic cancer patients receiving CT. Cancer 2003;98:1072–9. © 2003 American Cancer Society. DOI 10.1002/cncr.11616

Validation of Single-Item Linear Analog Scale Assessment of Quality of Life in Neuro-Oncology Patients

“…Also, though no formal validation trial of the LASA with other cancer patients has been published, the LASA has been used in other trials, with concurrent validation data published alongside the individual trial results. [36][37][38][39][40][41][42][43][44] Further work also has been done using the LASA across a wide spectrum of patient populations [45][46][47][48][49] and healthy populations. 50 Secondly, we assessed QOL at three time points across four months, which is appropriate for patients, such as high-grade glioma patients, with a relatively short median survival.…”

New Insights Into Erythropoietin and Epoetin Alfa: Mechanisms of Action, Target Tissues, and Clinical Applications

“…In the community-based studies and the randomized, placebocontrolled clinical trial discussed above, TIW [41][42][43] or QW [44,46] epoetin alfa therapy significantly improved QOL. Moreover, in studies that assessed the impact of disease progression as a confounder of QOL, functional improvements with epoetin alfa therapy occurred independently of tumor response [41,42].…”

“…In both community-based studies and randomized, placebo-controlled clinical trials, epoetin alfa, 150-300 U/kg or 10,000-20,000 U administered three times weekly (TIW) [41][42][43] or 40,000-60,000 U once weekly (QW) [44][45][46], has been shown to significantly increase Hb levels and reduce transfusion requirements in anemic patients (generally, Hb ≤11 g/dl) with various solid and hematologic malignancies who are undergoing chemotherapy and/or radiation therapy.…”

Patients Previously Transfused or Treated with Epoetin Alfa at Low Baseline Hemoglobin Are at Higher Risk for Subsequent Transfusion: An Integrated Analysis of the Canadian Experience

“…It was the development of a human recombinant erythropoietin in 1983 [8] that allowed for the first innovative and effective treatment alternative for cancer-related anemia. A consistent body of evidence has since emerged, confirmed in numerous clinical trials, that treatment with erythropoietic agents in patients with anemia related to cancer and/or cancer treatment significantly decreases RBC transfusion requirements and increases hemoglobin (Hb) levels [9][10][11][12][13][14][15][16][17][18][19][20][21][22]. More recently, improved quality of life (QOL) associated with the use of erythropoietic agents has also been confirmed in cancer patients [10-15, 23, 24].…”