Hb Response Rate Research Articles

C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis

This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis. In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb +/-1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation. Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated. Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-naïve patients who are not on dialysis.

Epoetin Beta (Neorecormon®) Treatment for Anemia of Patients with Non-Myeloid Hematological Malignancy under Chemotherapy: Results of a Large Prospective Cohort Study.

Background: The efficacy of epoetin beta (E) is well documented in clinical trials in anemic cancer patients (pts). This study was conducted to assess E use, efficacy, safety and effect on quality of life in cancer pts, in usual practice.Methods: This prospective, multicenter, longitudinal, observational French study assessed a 4-month follow-up of informed consent cancer pts (including both solid tumors (ST) and non-myeloid hematological malignancies (H)) treated with E for chemotherapy-related anemia. Data were collected between January 2005 and March 2006. We only present here the results of the H subgroup.Results: Among 2809 pts, 675 had an H including 325 non-Hodgkin lymphoma (NHL), 181 multiple myeloma (MM) and 80 chronic lymphocytic leukemia (CLL). 52% of pts received their first line of chemotherapy, 24% their second one. At inclusion, Hb levels were distributed as follows: < 9 g/dl: 32%, [9–11[ g/dl, 56%, [11–13[ g/dl, 11%. At inclusion, endogenous erythropoietin rate was monitored for only 8% of pts, ferritin was available for 32%, transferrin saturation for 17% and reticulocytes for 24%. At initiation, pts received a median dose of 30000 U/week of E on a once weekly regimen schedule for 98% of pts. E was associated with iron supplementation in 20% of pts (1% IV). The mean Hb level increased from 10 g/dl [5 – 14] at baseline to 13 g/dl [7 – 17] in the entire cohort of H pts, from 10 g/dl [5 – 14] to 12 g/dl [7 – 16] in NHL pts, from 10 g/dl [6 – 13] to 13 g/dl [8 – 17] in MM pts and from 10 g/dl [6 – 13] to 13 g/dl [7 – 17] in CLL pts. Hb response rate (RR) was 56% (CI95: 51 – 61) in H pts, 53% (CI95: 46 – 60) in NHL pts, 57% (CI95: 48 – 66) in MM pts and 56% (CI95: 41 – 70) in CLL pts. 41% of patients were transfused at inclusion or during the study. Good performance status (PS≤1) (OR=1.6, CI95: 1.1–2.5), non platinum-based regimen (OR=2.4, CI95: 1.2–4.9) and iron supplementation (OR=2.6, CI95: 1.4–5.1) are identified both in univariate and multivariate analysis as predictive factors of Hb response. The mean of FACT score improved from 29 (CI95: 26–31) at initiation to 36 (CI95: 34–38) at the end of study (p<0.0001). Thromboembolic events were reported in 2% of patients.Conclusion: These results confirm the efficacy and safety of epoetin beta in routine practice for anemic patients with a non-myeloid hematological malignancy receiving chemotherapy. Epoetin beta improves the quality of life measured by FACT score.

Epoetin Beta with Intravenous Iron Results in Overall Cost Savings in a Population of Anemic Patients with Lymphoid Malignancies Not Receiving Chemotherapy.

Erythropoiesis-stimulating agents (ESAs) provide effective treatment for anemia in patients with cancer, but studies suggest that response rates can vary from 50 to 80%. One major reason why a patient may fail to respond to an ESA is functional iron deficiency (FID), defined as a failure to provide iron rapidly enough to meet the needs of erythropoiesis, despite the presence of sufficient iron stores. Consequently, concomitant intravenous (IV) iron supplementation has the potential to improve response to ESAs, thereby, allowing a decrease in dose requirements. A recent study of 67 anemic (hemoglobin [Hb] 9–11 g/dL) patients with lymphoid malignancies not receiving chemotherapy evaluated the Hb response (defined as an increase in Hb of ≥2 g/dL without transfusion up to Week 15) to epoetin beta 30 000 IU Once Weekly with or without IV iron sucrose (Hedenus et al. Leukemia. 2007; 21:627–632). Patients were iron replete at baseline, as shown by the presence of stainable iron in the bone marrow. This analysis aimed to investigate whether use of epoetin beta and IV iron is cost-effective compared with epoetin beta without IV iron, based on the results of this study. The analysis was performed from a Swedish societal perspective based on differences in overall costs (drug costs, laboratory tests and resource use) and differences in effect (Hb increase) during 16 weeks' treatment with epoetin beta with or without IV iron. All costs are presented in 2006 Swedish Kronor (SEK). In normal practice in Sweden, IV iron is administered by a nurse in an outpatient setting. Therefore, resource costs in this analysis included an estimate of costs of nurse time and all materials required for administration of IV iron, as well as the cost of travel to the clinic for the patient. Since 20% of patients attend with a companion, an estimate of the cost of loss of companion work time for 20% of visits was also included. In contrast, epoetin beta is usually self-administered in Sweden; thus, no resource costs for epoetin beta administration were included. In the intention-to-treat population (n=67), the Hb increase (mean 2.76 g/dL versus 1.56 g/dL, respectively; p=0.0002) and Hb response rate (87% versus 53%, respectively; p=0.0014) were significantly greater in patients receiving epoetin beta with IV iron compared with patients receiving epoetin beta without IV iron. Total cumulative dose of epoetin beta over the course of the study was lower in the epoetin beta with IV iron group (532 000 IU) than in the epoetin beta without IV iron group (629 000 IU; p=0.059). Overall mean cost per patient in the epoetin beta with IV iron group was SEK 56 411 and in the epoetin beta without IV iron group was SEK 60 666. Despite the additional costs of iron administration, epoetin beta treatment with IV iron resulted in overall cost savings of ∼7% compared with epoetin beta without IV iron, mainly due to reduced ESA dosages. Treatment of anemic patients with lymphoid malignancies not receiving chemotherapy with epoetin beta and IV iron resulted in better outcomes at lower cost compared with epoetin beta without IV iron. This suggests that epoetin beta with IV iron is a dominant (or superior) therapy at least from a Swedish perspective.

Effectiveness of epoetin beta 30,000 UI once weekly (QW) for treatment of anemia in solid tumor patients under chemotherapy

19588 Background: Anemia is the most frequent hematological complication of cancer. Epoetin beta (E), an effective treatment of anemia in patients with solid tumors (ST) was administered three-times weekly. However, the QW regimen used in patients with hematological malignancies would be more convenient and may improve patient compliance. The aim of our study was to evaluate efficacy and safety of E 30 000 IU QW in patients with ST. Methods: This study was an open-label, single-arm, multicenter trial carried out in 87 French centers between December 2003 and August 2005. Eligibility criteria were: informed consent, age =18 yrs, WHO performance status 0–2, malignant ST or non-myeloid hematological malignancy, on-going chemotherapy and anemia: hemoglobin (Hb) &lt;12 g/dl. E 30 000 IU QW was administered SC for up to 16 weeks. Follow-up visits were scheduled after each chemotherapy cycle. Primary endpoint was Hb response defined as an Hb increase of =2 g/dl (whatever the baseline Hb level) and/or an achievement of Hb level of =12 g/dl or 13 g/dl (patients with Hb levels &lt;11 g/dl or &gt;11 g/dl at baseline respectively). Delay of Hb response, transfusion requirement, mood and cognitive functions were also assessed. Here we focus specifically on the subgroup of patients with ST. Results: In total, 365 patients with ST were included. The most frequent cancer sites were: lung (102 pts) and breast (86 pts). Median Hb level at baseline was 10.4 g/dl [7.9–12.3]. At endpoint, median Hb level increased to 12.5 g/dl [8.4–15.0]. Hb response rate (RR) was: 61% (IC95: 55–66%), 50% (IC95: 38–55%) in patients treated with platinum based regimen and 72% (IC95 : 62–76%) in patients treated without platinum. RR was 54% in lung (IC95: 44–64%), 76% in breast (IC95: 67- 85%). E treatment was well tolerated. Thromboembolic events occurred in 7% of patients, a rate consistent with information provided in the current label for E. Conclusion: Epoetin beta 30 000 IU once weekly is effective and well tolerated in anemic patients with solid tumor treated with chemotherapy. Once weekly treatment offers a convenient therapy which will improve patient compliance. [Table: see text]

Addition of intravenous iron to epoetin beta increases hemoglobin response and decreases epoetin dose requirement in anemic patients with lymphoproliferative malignancies: a randomized multicenter study

This randomized study assessed if intravenous iron improves hemoglobin (Hb) response and permits decreased epoetin dose in anemic (Hb 9-11 g/dl), transfusion-independent patients with stainable iron in the bone marrow and lymphoproliferative malignancies not receiving chemotherapy. Patients (n=67) were randomized to subcutaneous epoetin beta 30 000 IU once weekly for 16 weeks with or without concomitant intravenous iron supplementation. There was a significantly (P<0.05) greater increase in mean Hb from week 8 onwards in the iron group and the percentage of patients with Hb increase >or=2 g/dl was significantly higher in the iron group (93%) than in the no-iron group (53%) (per-protocol population; P=0.001). Higher serum ferritin and transferrin saturation in the iron group indicated that iron availability accounted for the Hb response difference. The mean weekly patient epoetin dose was significantly lower after 13 weeks of therapy (P=0.029) and after 15 weeks approximately 10 000 IU (>25%) lower in the iron group, as was the total epoetin dose (P=0.051). In conclusion, the Hb increase and response rate were significantly greater with the addition of intravenous iron to epoetin treatment in iron-replete patients and a lower dose of epoetin was required.

Functional Iron Deficiency Effectively Overcome by Adjuvant IV Iron during Epoetin Treatment.

Background: 30–40% of anemic cancer patients don’t respond to epoetin treatment. New insights in iron regulation have indicated that one reason for lack of response may be functional iron deficiency (FID), in which an upregulation of hepcidin by imflammatory cytokines impairs the ferroportin-mediated iron export from macrophages. Aims: To assess whether adjuvant IV iron therapy would overcome the iron restriction of FID as well as that of exhaustion of iron stores during epoetin treatment of anemia in patients with lymphoproliferative disorders (LPD) and proven iron presence in the bone marrow. Methods: 67 patients with indolent lymphoid malignancy (19 NHL, 23 CLL and 25 MM), Hb ≥9 to ≤11 g/dl and a positive bone marrow iron staining were randomized to receive epoetin-beta, (NeoRecormon®) 30 000 IU QW or this treatment plus IV iron sucrose, (Venofer®) 100 mg QW, during week 0–6, 100 mg Q2W week 7–16 with dose modifications of epoetin according to the label. 60 patients completed the study. Three patients received transfusion and/or chemotherapy and thus 57 were evaluable. Results: The Hb response rate was superior in the iron-treated group, 91% vs 54%, the time to response (&gt;2 g/dL) half as long, 6 w vs 12 w and the Hb level was 1.2 g/dL higher at the end of study(1). In both groups, the mean transferrin saturation (Tsat) was low at baseline, 22%, and the mean S-ferritin was around 200 ug/L. During treatment, several indicators showed that iron availability was superior in the iron-treated group. In the non-iron group Tsat declined from baseline to &lt;20% in 26 out of 30 patients for the duration of the study, and S-ferritin fell rapidly during the first week and then steadily declined from a baseline value of 191 to 112 ug/L at the end of study. (EOS). The mean soluble transferrin receptor (sTfR) level increased from normal to a maximum of 3.7 mg/L in week 8. In the iron-treated group (n=27) Tsat increased from baseline and stabilized at 30%. S-Ferritin showed no initial fall and continued to increase from 210 at baseline to 398 ug/L at EOS. Discussion. Iron restriction may be present in epoetin treatment of cancer anaemia by two different mechanisms. Iron deposits may be small and become depleted, and secondly iron may be trapped in the macrophages due to FID. In these patients, FID was common, as indicated by the presence of bone marrow iron and the low mean Tsat at baseline. In some patients, small iron deposits were exhausted by the increased erythropoiesis in the non-iron group, as shown by subnormal S-ferritin levels. The fact that the mean Tsat and S-ferritin increased in the iron-treated group indicated that iron availability was constantly better in this group and the reason for the superior Hb response. Conclusions - Functional iron deficiency (low Tsat and iron-restricted erytropoiesis in spite of proven iron stores) is common in patients with anaemia of haematological malignancies. - FID is a common and important reason for lack fo response to epoetin treatment - IV iron treatment improves epoetin response both by overcoming FID and by avoiding iron depletion casued by increased erythropoiesis.

Final hematologic results: Epoetin alfa (EPO) 40,000 U QW vs darbepoetin alfa (DARB) 200 μg Q2W in anemic cancer patients (pts) receiving chemotherapy (CT)

8030 Background: We report final results of a trial comparing hematologic outcomes, QOL, & safety for EPO & DARB using dosing regimens commonly prescribed in anemic pts with cancer receiving CT. Methods: Randomized, open-label trial enrolled pts ≥18 y with solid tumors, baseline (BL) hemoglobin (Hb) ≤11 g/dL, scheduled for ≥12 weeks (wks) of CT. Pts were stratified by +/− platinum CT, then randomized to EPO 40,000 U SC QW or DARB 200 μg SC Q2W for 12–16 wks; dose adjustments per NCCN guidelines. 150 pts per arm ensured 90% power to detect ≥20% difference in primary endpoint, Hb response rate (HRR; proportion of pts with Hb increase ≥1 g/dL within first 4 wks). Interim analysis of primary endpoint was planned after first 300 pts completed 4 wks. If HRR was statistically greater (P<.0125, 1-sided) for EPO compared with DARB, the null hypothesis would be refuted & enrollment would be terminated. Results: 358 pts were randomized to EPO (178) or DARB (180). Primary endpoint achieved based on interim analysis o...

Head-to-Head Comparison of Epoetin Alfa (EPO) 40,000 U QW vs Darbepoetin Alfa (DARB) 200 μg Q2W in Anemic Cancer Patients Receiving Chemotherapy (CT): Final Results of a Planned Interim Analysis (IA).

Although pharmacokinetic differences between EPO and DARB are known, clinical comparisons are best determined through randomized clinical trials. This randomized, open-label, multicenter study was designed to compare the efficacy of EPO and DARB for the treatment of CT-induced anemia using dosing consistent with the 2004 NCCN Cancer and Treatment-Related Anemia Guidelines. Hb response, transfusions (TFNs), and safety were assessed in patients (pts): ≥18 y with solid tumors; with baseline (BL) Hb ≤11 g/dL; scheduled to receive CT for ≥12 wks; and no prior erythropoietin therapy within 3 months. Pts were stratified by CT type (platinum/nonplatinum) then randomized 1:1 to EPO 40,000 U SC QW or DARB 200 μg SC Q2W for up to 16 wks. Dose increases were required for nonresponders (<1 g/dL Hb increase) after 4 wks for EPO (40,000 U to 60,000 U) or 6 wks for DARB (200 μg to 300 μg). If Hb increased to >13 g/dL, study drug was held and then reduced, and if Hb increased >1.3 g/dL (EPO) or >1.0 g/dL (DARB) in a 2-wk period, dose was reduced. Pts were withdrawn if CT was discontinued or CT type changed from platinum to nonplatinum or vice versa. Primary efficacy endpoint is Hb response rate (HRR; proportion of pts achieving an Hb increase of ≥1 g/dL from BL during the first 4 weeks) excluding Hb values within 28 days following a TFN. Primary analysis is a logistic regression model (treatment group and CT type as factors) comparing HRRs between the 2 treatment groups. A maximum of 400 pts could have been randomized; however, a prespecified IA of the primary endpoint using logistic regression was to be performed after the first 300 pts completed 4 wks of therapy. If the IA demonstrated that P≤.0125 (1-sided), then the treatment difference between EPO and DARB was considered statistically significant in favor of EPO and enrollment would be terminated. 339 pts (170 EPO, 169 DARB) comprised a modified intent-to-treat (MITT) population (pts with ≥1 dose of study drug and ≥1 postbaseline Hb or TFN value). 305 (151 EPO, 154 DARB) of these pts had completed 4 wks of therapy by the same date and were included in the IA. The IA demonstrated a statistically significantly higher HRR for EPO pts, 47%, compared with DARB pts, 33%, P=.0078 (1-sided). Enrollment was terminated; some patients remain on study. Demographics for all randomized patients were similar for EPO/DARB (mean age: 62/63 y; men: 38/31%; ECOG PS 0–1: 86/82%; and nonplatinum CT: 62/58%). Most common tumor types were breast, lung, and colorectal. In the MITT population, mean BL Hb was 10.1 g/dL in each group and Hb increases for EPO and DARB, respectively, were 0.7 and 0.3 g/dL after 4 wks, 1.0 and 0.5 g/dL after 8 wks, 1.3 and 0.7 g/dL after 12 wks, and 1.3 and 0.7 g/dL after 16 wks; last-value-carried-forward method used to impute missing Hb values and Hb values within 28 days following RBC TFN. After study day 28, 22/170 (13%) EPO pts and 28/169 (17%) DARB pts received RBC or whole blood TFN. Available data suggest a similar safety profile for the 2 agents. This study demonstrated that pts treated with EPO 40,000 U SC QW had a significantly greater HRR during the first 4 wks of therapy compared with DARB 200 μg SC Q2W. In addition, EPO-treated pts had greater Hb increases throughout the study compared with DARB.

Benefits of Early Hemoglobin Response to Epoetin Alfa in Elderly Patients with Chemotherapy-Related Anemia.

Background: Previous research has shown early hemoglobin (Hb) response to epoetin alfa (EPO) therapy is associated with reduced transfusion requirements, higher Hb response rates, quality of life score improvements, and decreased EPO drug utilization. This subgroup analysis of elderly (age >/=65) patients (pts) with chemotherapy-related anemia (CRA) assesses the benefit of an early Hb response in this distinct population.Methods: Data from three large multicenter EPO clinical trials were evaluated. In EPO 1, pts received 10,000 Units TIW with potential escalation to 20,000 Units TIW. In EPO 2 and EPO 3, pts received 40,000 Units QW with escalation to 60,000 Units QW. Pts eligible for this analysis were >/=65 years of age with a non-myeloid malignancy, had a baseline Hb </=11g/dL, and received chemotherapy with or without radiotherapy (EPO 1: N=935: EPO 2: N=1,270; EPO 3: N=269). Early Hb response was defined as >/=1g/dL Hb rise following four weeks of EPO therapy, independent of transfusion in the prior 28 days. Three outcomes of pts who exhibited early Hb response were compared to those of pts who did not: proportion of pts requiring transfusion, subsequent Hb response (Hb rise >/=2 g/dL independent of transfusion), and average weekly EPO dose.Results: Early Hb response was observed in 54.1%, 47.5%, and 47.2% of pts from EPO 1, 2 and 3, respectively. In all trials, early responders had markedly lower transfusion use (EPO 1: 7.6% v 22.5%, p<.0001; EPO 2: 5.4% v 18.7%, p<.0001; EPO 3: 8.8% v 17.2%, p=.0525), higher subsequent Hb response (EPO 1: 78.7% v, 47.6%; EPO 2: 84.0% v 46.2%, EPO 3: 72.8% v. 47.8%, all studies p<.0001), and lower average weekly EPO dose (EPO 1: 30,467 vs. 40,594 Units, EPO 2: 39,286 vs. 47,310 Units; EPO 3: 38,043 v. 45,835 Units; all studies p<.0001).Conclusions: Elderly cancer pts achieving an early Hb response to EPO QW or TIW experienced greater clinical benefits (lower proportion of pts transfused, higher subsequent Hb response rates, and less EPO utilization) compared to pts who did not. These findings are consistent with analyses involving pts with younger age groups. As early Hb response is associated with clinical benefits, it should be an important goal of erythropoietic therapy for chemotherapy-induced anemia, especially in the elderly population, as demonstrated here.

Epoetin alfa 60,000 U QW followed by 80,000 U Q3W maintenance in patients with anemia and cancer receiving chemotherapy

8215 Background: Epoetin alfa (EPO) at a starting dose of 40,000 U SC once weekly (QW) has been shown to be effective in the treatment of chemotherapy-induced anemia in cancer patients (pts). It is hypothesized that higher starting doses followed by less frequent maintenance dosing may shorten time to Hb response and increase response rates. Methods: In this ongoing open-label, multicenter, pilot study in 130 anemic pts with cancer receiving CT, EPO 60,000 U SC was administered QW for up to 12 weeks (wks) until a target Hb ≥12 g/dL was reached (initiation phase [IP]). Pts then received EPO 80,000 U SC every 3 weeks (Q3W; maintenance phase [MP]) to maintain Hb 11.5 g/dL to 12.5 g/dL. Primary end point was proportion of pts with Hb ≥12 g/dL or Hb increase ≥2 g/dL from baseline in the IP. Eligible pts were ≥18 y with nonmyeloid malignancy, baseline Hb ≤11 g/dL, and scheduled to receive CT Q3W for ≥15 wks. Pts were followed for up to 24 wks and received 1 dose of EPO after last CT cycle. Pts with Hb ≥12 g/dL during IP continued QW dosing until the start of next CT cycle, then began Q3W MP. Pts were withdrawn for missed doses or Hb <11 g/dL during MP. Results: Thirty-six pts are evaluable for analysis (mean baseline Hb 10.2 ± 0.9 g/dL). Nineteen pts entered the MP after a median of 5 wks; mean Hb was 12.0 ± 0.9 g/dL at start of MP therapy and has been maintained for a median of 7 wks. The proportion of pts with Hb ≥12 g/dL or Hb increase ≥2 g/dL from baseline in the IP was 61%. Seventeen (55%) of 31 pts had Hb increase ≥1 g/dL after 4 wks. EPO dose was reduced to 40,000 U QW in 9 (25%) pts in IP and 60,000 U Q3W in 7 (37%) pts in MP due to Hb>13 g/dL or Hb increase >1.3-g/dL in 2 wks. Seventeen pts were withdrawn (8 in IP, 9 in MP) due to MP Hb <11 g/dL (n = 4), loss to follow-up (n = 3), not reaching target Hb ≥12 g/dL in the IP (n = 2), death (n = 1), AE (n = 1), and other/missing (n = 6). Conclusions: These preliminary data suggest that EPO 60,000 U QW increases Hb and that 60,000–80,000 U Q3W can maintain Hb in the majority of pts entering maintenance. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho Biotech Products, L.P. Aventis; Johnson & Johnson; Ortho Biotech Products, L.P. Johnson & Johnson Novartis

Epoetin alfa 60,000 U QW followed by 80,000 U Q3W maintenance in patients with anemia and cancer receiving chemotherapy

8215 Background: Epoetin alfa (EPO) at a starting dose of 40,000 U SC once weekly (QW) has been shown to be effective in the treatment of chemotherapy-induced anemia in cancer patients (pts). It is hypothesized that higher starting doses followed by less frequent maintenance dosing may shorten time to Hb response and increase response rates. Methods: In this ongoing open-label, multicenter, pilot study in 130 anemic pts with cancer receiving CT, EPO 60,000 U SC was administered QW for up to 12 weeks (wks) until a target Hb ≥12 g/dL was reached (initiation phase [IP]). Pts then received EPO 80,000 U SC every 3 weeks (Q3W; maintenance phase [MP]) to maintain Hb 11.5 g/dL to 12.5 g/dL. Primary end point was proportion of pts with Hb ≥12 g/dL or Hb increase ≥2 g/dL from baseline in the IP. Eligible pts were ≥18 y with nonmyeloid malignancy, baseline Hb ≤11 g/dL, and scheduled to receive CT Q3W for ≥15 wks. Pts were followed for up to 24 wks and received 1 dose of EPO after last CT cycle. Pts with Hb ≥12 g/dL during IP continued QW dosing until the start of next CT cycle, then began Q3W MP. Pts were withdrawn for missed doses or Hb <11 g/dL during MP. Results: Thirty-six pts are evaluable for analysis (mean baseline Hb 10.2 ± 0.9 g/dL). Nineteen pts entered the MP after a median of 5 wks; mean Hb was 12.0 ± 0.9 g/dL at start of MP therapy and has been maintained for a median of 7 wks. The proportion of pts with Hb ≥12 g/dL or Hb increase ≥2 g/dL from baseline in the IP was 61%. Seventeen (55%) of 31 pts had Hb increase ≥1 g/dL after 4 wks. EPO dose was reduced to 40,000 U QW in 9 (25%) pts in IP and 60,000 U Q3W in 7 (37%) pts in MP due to Hb>13 g/dL or Hb increase >1.3-g/dL in 2 wks. Seventeen pts were withdrawn (8 in IP, 9 in MP) due to MP Hb <11 g/dL (n = 4), loss to follow-up (n = 3), not reaching target Hb ≥12 g/dL in the IP (n = 2), death (n = 1), AE (n = 1), and other/missing (n = 6). Conclusions: These preliminary data suggest that EPO 60,000 U QW increases Hb and that 60,000–80,000 U Q3W can maintain Hb in the majority of pts entering maintenance. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho Biotech Products, L.P. Aventis; Johnson & Johnson; Ortho Biotech Products, L.P. Johnson & Johnson Novartis