Chemotherapy-induced Anemia In Patients Research Articles

Efficacy of ferric carboxymaltose or darbepoetin alfa for chemotherapy-induced anemia in patients with esophagogastric or pancreaticobiliary cancer: a retrospective comparative study.

Esophagogastric and pancreaticobiliary cancers are associated with chronic blood loss, poor nutrition, and surgical interventions that interfere with iron absorption. Patients with these cancers often have a higher incidence of chemotherapy-induced anemia (CIA) than patients with other malignancies. To investigate the efficacy of intravenous iron or erythropoietin-stimulating agents (ESA) for CIA treatment in patients with esophagogastric or pancreaticobiliary cancer. Retrospective, comparative chart review of patients with esophagogastric or pancreaticobiliary cancer who received ferric carboxymaltose (FCM), or darbepoetin alfa (DA), and myelosuppressive chemotherapy at Chungbuk National University Hospital between June 2018 and December 2022. To assess the efficacy of FCM or DA over time, data on hemoglobin (Hb) levels were collected from the time of administration of FCM or DA (baseline) until 6 months post-baseline, when available. In total, 214 patients (124 in the FCM and 90 in the DA group) were included in the analysis. The FCM group had a higher maximum Hb level and Hb changes for 3 months (mean ± standard deviation) following FCM or DA administration from baseline than the DA group (11.3 ± 1.5 versus 10.9 ± 1.2 g/dL, p = 0.02 and 2.0 ± 1.4 versus 1.5 ± 1.1 g/dL, p = 0.004, respectively). The FCM group had a higher proportion of Hb responders than the DA group (83.9% versus 68.9%, p = 0.013). Based on multivariable analysis, only the CIA treatment group was a significant factor for Hb response (odds ratio = 2.06, 95% confidence interval = 1.05-4.06, p = 0.036). Both FCM and DA are effective, and FCM showed a higher Hb response than DA for CIA treatment in patients with esophagogastric or pancreaticobiliary cancer. Therefore, further randomized controlled trials should determine the optimal treatment for CIA in patients with these cancers undergoing myelosuppressive chemotherapy.

LBA96 Roxadustat for chemotherapy-induced anemia in patients with non-myeloid malignancies: A randomized, open-label, active-controlled, phase III study

LBA96 Roxadustat for chemotherapy-induced anemia in patients with non-myeloid malignancies: A randomized, open-label, active-controlled, phase III study

The addition of oral iron improves chemotherapy-induced anemia in patients receiving erythropoiesis-stimulating agents.

Although many studies have shown that supplementation with iron and erythropoiesis-stimulating agents (ESA) is frequently used for managing chemotherapy-induced anemia (CIA), optimal combination therapy using these agents together to ameliorate anemia is not well characterized. To assess the effects of ESA combined with oral or intravenous (IV) iron on relieving CIA, PubMed, Cochrane Library, Embase and China National Knowledge Infrastructure (CNKI) were searched for articles. Data collected in the articles were meta-analyzed using RevMan 5.3 software with a random-effects model. Our comprehensive search yielded 1666 potentially relevant trials. A total of 41 trials randomizing 4200 patients with CIA fulfilled inclusion criteria, including 34 Chinese articles and 7 English articles. Meta-analysis showed that treatment with both ESA and iron more effectively improved CIA relative to iron supplementation alone, with increased hemoglobin, hematocrit, red blood cell count and hematopoietic response rate. Subgroup analyses revealed iron administration, both oral and IV iron, improved anemia in ESA-treated cancer patients with CIA. Our analysis demonstrates that iron supplementation combined with ESA more effectively ameliorates CIA relative to iron supplementation alone, without regard to whether IV or oral iron was used. Together, our findings may contribute to the clinical treatment of CIA using iron therapy with or without ESA.

Erythropoietin combined with traditional Chinese medicine for chemotherapy-induced anemias: A protocol of systematic review and meta-analysis.

Background:As far as we know, several systematic review and meta-analysis have assessed the safety and efficacy of erythropoiesis-stimulating agents (ESAs) in the patients with chemotherapy-induced anemia (CIA). But no study assesses the safety and efficacy of ESAs combined with traditional Chinese medicine (TCM). The aim of our study is to assess the efficacy and safety of ESAs combination with TCM for patients with CIA and will provide a higher level of evidence for clinical applications.Methods:This protocol adheres to the preferred reporting items for systematic reviews and meta-analysis protocol statement. The source of literature will be a structured search of the following 7 electronic databases: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Database. Records will be independently evaluated by 2 reviewers. Disagreements will be resolved through consensus or third-party adjudication. Review Manager 5.3 software (Cochrane Collaboration, Copenhagen Denmark) will be used to perform meta-analysis. For dichotomous variables, odds ratio with 95% confidence intervals will be obtained by the Mantel–Haenszel method. For continuous data, mean difference with 95% confidence intervals will be used. P < 0.05 will be considered to be statistically significant.Results:This study will be performed to test the efficacy and safety of ESAs combined with TCM for CIA in patients with cancer.Conclusions:The result of this study will be promoted mainly in 2 ways: publish in peer-reviewed journals in the fastest way; and promotion in domestic and foreign conferences.INPLASY registration number:INPLASY202080041.

Epidemiology of Chemotherapy-Induced Anemia in Patients with Non-Hodgkin Lymphoma.

Anemia is a common adverse effect of myelosuppressive chemotherapy, and the development of chemotherapy-induced anemia (CIA) is more common in patients with hematologic malignant tumors. To assess the incidence and treatment pattern of CIA in patients diagnosed with non-Hodgkin lymphoma (NHL) from a large managed care organization in California. Patients diagnosed with NHL between 2010 and 2012 were studied to provide an updated picture of CIA in current hematology-oncology practice. Trends in anemia treatment patterns were examined from 2000 to 2013. All data were collected from Kaiser Permanente Southern California electronic health records. Of 699 chemotherapy-treated patients with NHL diagnosed between 2010 and 2012, 36.9% and 11.6% developed moderate (hemoglobin < 10 g/dL) and severe (hemoglobin < 8 g/dL) CIA during chemotherapy, respectively. Proportions of moderate CIA events treated with erythropoiesis-stimulating agents (ESAs) decreased from 2000 to 2013: 34% in phase 1 (January 1, 2000, to December 31, 2006), 22% in phase 2 (January 1, 2007, to March 24, 2010), and 6% in phase 3 (March 25, 2010, to June 30, 2013). An increasing trend of red blood cell transfusion was observed: 12% in phase 1, 22% in phase 2, and 27% in phase 3. Similar calendar trends were observed for management of severe CIA events. In contrast to previous European reports, we note a higher incidence of CIA in patients with NHL in this US community practice setting. Moderate to severe CIA is common in patients with NHL receiving chemotherapy. Multiple ESA-related policy changes occurred from 2000 to 2013. A large proportion of CIA episodes were currently not treated with ESA, and transfusions have become more common. Further studies are needed to determine associations between CIA symptom burden and CIA treatment as they relate to patient outcomes and quality of life.

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10Years' Experience Gained.

High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin biosimilars. The now extensive European experience with biosimilar epoetins should reassure regulators from other territories.

Development and 10-year history of a biosimilar: the example of Binocrit®.

Patent expirations for several biological products have prompted the development of alternative versions, termed ‘biosimilars’, which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the ‘reference’ medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit® (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit® as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa. This was followed by a clinical development program comprising phase I pharmacokinetic/pharmacodynamic studies to show bioequivalence to the reference medicine and a confirmatory phase III study to confirm therapeutic effectiveness in CIA. Since its approval, Binocrit® has been extensively used and studied in real-world clinical practice. The accumulated data confirm that Binocrit® is an effective and well-tolerated option for the treatment of CIA in patients with cancer.

A retrospective open-label uncontrolled study of Epoetin zeta on the treatment of chemotherapy-induced anemia in solid tumors.

This is a single-center uncontrolled retrospective study to evaluate the efficacy and safety of the biosimilar epoetin zeta after approval in chemotherapy-induced anemia (CIA). Patients screened were >18years old suffering from solid malignancies and CIA with Hg ≤10 or <11g/dl if symptomatic anemia. Patients had measurable disease by TNM and Eastern Cooperative Oncology Group (ECOG). Patients were treated for at least 12weeks and the primary endpoint was to determine the incidence of blood transfusions, and secondarily, the overall safety and efficacy defined as ≥1g/dl rise in Hb concentration or ≥40,000cells/μl rise in reticulocyte count. Quality of life was assessed with ECOG performance status (PS) and functional assessment of cancer therapy-anemia (FACT-An) score. 1287 patients with median Hb 9.3g/dl (range 8.3-10.6) were enrolled and included in the evaluation. Median age was 63years (range 33-78). 74% of patients were stage III/IV. Patients received epoetin zeta subcutaneously at fixed 40,000-IU once weekly. Blood transfusions were given in 178 patients (13.8%; 95% CI 11.9-15.6%). Appropriate response was observed in 79% patients by week 4, 87% by week 8, and 91% by week 12. A mean Hb increase of 2.5g/dl was observed by week 12 which correlated with an improvement in PS and Fact-An score. Thrombotic events occurred in 5.2% (95% CI 3.4-7.1%) of patients. Epoetin zeta is effective in palliation and treatment of CIA in patients with solid tumors. Overall, it is well tolerated and safe even in patients with increased disease burden.

A Study of Symptom Burdens Related to Chemotherapy-Induced Anemia in Patients Diagnosed with Breast Cancer, Lung Cancer and Non-Hodgkin Lymphoma

Background: Chemotherapy-induced anemia (CIA) is associated with a number of symptoms that negatively impact patients' quality of life. Management of these symptoms is essential for comprehensive patient care. However, with the exception of fatigue, a systematic examination of symptoms in patients with CIA is lacking. In order to better inform patient care, here we described the occurrence of a comprehensive list of CIA-related symptoms in patients with stage IV malignancies undergoing chemotherapy.Methods: Patients diagnosed with incident non-Hodgkin lymphoma, breast and lung cancer at age 18 or older at Kaiser Permanente Southern California (KPSC) between 2010-2012 and initiated myelosuppressive chemotherapy prior to June 2013 were initially eligible for the study. Of these patients, those who did not have any hemoglobin measurement during the course of chemotherapy were excluded. Those who had the following conditions prior to chemotherapy were also excluded: less than 12 months KPSC membership, anemia, transfusion, radiation therapy or bone marrow transplant. CIA in this study was defined as hemoglobin <10 g/dl after the initiation of chemotherapy. Data on chemotherapy administration, hemoglobin measurements and other clinical characteristics were collected from KPSC’s electronic medical records. Standardized chart review was performed to collect data on occurrence (based on physician documentation) of 24 pre-selected symptoms/signs for all patients with stage IV malignancies who developed CIA during the course of chemotherapy, and a random sample of patients with stage IV malignancies who did not develop CIA. The 24 symptoms/signs assessed are shown in Table 1. The prevalence of pre-existing symptoms (i.e., before chemotherapy), incident symptoms (those occurred only after chemotherapy) or prevalent symptoms (any symptoms during chemotherapy, whether they occurred prior to chemotherapy or not) across the study samples was described. The prevalence of each symptom and the distribution of number of symptoms per patient were also described by chemotherapy cycle and anemia grade. Anemia grade was defined following the Common Terminology Criteria for Adverse Events as grade 1: 10 g/dL to lower limit of normal (14 g/dL for men and 12 g/dL for women) ; grade 2: 8.0-9.9 g/dL; grade 3: 6.5-7.9 g/dL; and grade 4: <6.5 g/dL.Results: A total of 402 patients who developed CIA and 98 patients without CIA were included. Among patients who developed CIA, fatigue was the most prevalent symptom during the course of chemotherapy, noted in 90% of the study sample. Dyspnea/shortness of breath (58%), nausea/vomiting (56%) and loss of appetite (56%) were documented in 50% or more of these patients (Table 1). Abdominal pain (35%), depression/anxiety (43%), dizziness/lightheadedness (30%), edema (39%), palpitations/tachycardia (34%), and pectoral angina/chest pain (34%) were documented in 30% or more of these patients. In patients without CIA, fatigue remained the most prevalent symptom (77% of the patients). However, only dyspnea/shortness of breath (41%), nausea/vomiting (43%) and paralysis/ataxia/tingling in extremities (33%) were noted in 30% or more of this study sample. There was not a clear increasing trend of the mean number of symptoms per patient across chemotherapy cycle. However, the mean number of symptoms per patient drastically increased as CIA grade increased (3 and 6 for grade 2 and 4 CIA, respectively, Table 2).Conclusions: Our study provides greater insights into the burden of symptoms in patients with Stage IV malignancies who develop CIA. High grade CIA correlates with an increased symptom burden. These data support early treatment of CIA, before symptom burden rises steeply. [Display omitted] [Display omitted] DisclosuresChao:Amgen Inc.: Research Funding. Family:Amgen Inc.: Research Funding. Cannavale:Amgen Inc.: Research Funding. Pourmoussa:Amgen Inc.: Research Funding. Xu:Amgen Inc.: Research Funding. Bhakti:Amgen Inc.: Research Funding. Xu:Amgen Inc.: Research Funding.

Biosimilar epoetin for the management of chemotherapy-induced anemia in elderly patients.

IntroductionChemotherapy-induced anemia (CIA) is a frequent complication among cancer patients, with elderly patients more likely to suffer severe effects. Biosimilar erythropoiesis-stimulating agents lower costs of supportive cancer treatment, and thus are particularly relevant in the elderly cancer population, which is growing rapidly worldwide. The goal of this subanalysis was to compare the tolerability and effectiveness of an epoetin biosimilar for treating CIA in patients <70 years old vs patients ≥70 years old.Materials and methodsThe ORHEO observational trial enrolled patients with CIA (hemoglobin [Hb] <11 g/dL) in association with chemotherapy for solid tumors, lymphoma, or myeloma. Patients received an epoetin biosimilar and were evaluated at 3 and 6 months for response, defined as achieving target Hb without blood transfusions during the 3 weeks preceding measurement, Hb ≥10 g/dL, or Hb increase ≥1 g/dL since study enrollment. Secondary end points included changes in Hb level, treatment interruptions, transfusion rates, and adverse events.ResultsAmong the 2,310 original patients, 1,301 <70 years old were compared to 1,009 ≥70 years old. Almost all patients (99.9%) received the biosimilar epoetin zeta (Retacrit). Patients in both groups responded well to treatment with biosimilar epoetin, with 79.8% and 84% responding at 3 months and 86.3% and 86.8% at 6 months among younger and elderly cohorts, respectively. Biosimilar epoetin therapy was well tolerated, with adverse events reported in only 17.6% and 16.4% of younger and elderly patients, respectively. A greater number of thromboembolic events and a lesser rate of infections were reported in the elderly, but were still lower than reported in clinical registration trials. No treatment fatalities occurred in either group.ConclusionBiosimilar epoetin was an effective and well-tolerated treatment for managing CIA in elderly cancer patients.

Real-world efficacy of epoetin zeta for chemotherapy-induced anemia in patients with solid tumors: A sub-analysis of the SYNERGY study.

e21614Background: The management of chemotherapy-induced anemia (CIA) by erythropoiesis-stimulating agents is well established, with EU and US guidelines advising their use to reduce red blood cell...

Abstract P1-10-02: Usage of epoetin alfa biosimilars in the management of chemotherapy-induced anemia in patients with breast cancer: A subanalysis of the ORHEO study

Abstract Introduction Chemotherapy-induced anemia (CIA) is a frequent complication of breast cancer patients that is associated with fatigue and impaired quality of life. Biosimilars of erythropoietin-stimulating agents have now been approved to treat CIA in Europe. The ORHEO (biOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an observational study conducted in France to evaluate the efficacy and safety of a biosimilar epoetin alfa in an oncology setting. The large number of patients who enrolled in the study permitted indication-specific subanalyses to be undertaken. Herein we report the results of the subanalysis that focuses on the subpopulation of breast cancer patients. Methods The ORHEO study was a prospective, observational, longitudinal, multicenter postmarketing study. Patients ≥18 years with CIA (hemoglobin [Hb] &amp;lt;11 g/dL)-associated solid tumors, lymphomas, or myelomas who were eligible for treatment with an epoetin alfa biosimilar were enrolled. The primary endpoint was Hb response (defined as Hb reaching ≥10 g/dL, an increase of Hb ≥1 g/dL since inclusion, or reaching target Hb) measured at 3 and 6 months (M3 and M6, respectively). Secondary endpoints included safety and tolerability. Only breast cancer patients with CIA were included in this subanalysis. Results The ORHEO study enrolled 2333 patients; of these, 266 patients presented with CIA associated with breast cancer and were included in this subanalysis. The mean age was 61 years, the majority had ECOG PS 1 (51.5%) and metastatic disease (56.0%), and 99.6% received an epoetin alfa biosimilar. At baseline, the mean Hb level was 9.9 g/dL. At the M3 and M6 time points, an Hb response was observed in 86.8% and 91.7% of patients, respectively; average Hb levels increased by 1.3 g/dL (M3) and 1.8 g/dL (M6). By M3, 44% of patients reached their target Hb level; this increased to 53.7% at M6. At M3 and M6, of those patients who definitively or temporarily discontinued treatment, over half did so because the target Hb had been reached (M3: 55.6% [n = 74/133]; M6: 53.2% [n = 81/152]). Clinically significant adverse events (AEs) were observed in 9.9% of patients; the most common AE was infection (7.9%), while thrombotic events were only reported in 0.8% of patients. High baseline systolic blood pressure, high hematocrit levels at M3, and clinical improvement by M3 were identified as potential indicators of a positive response to an epoetin alfa biosimilar. Conclusion This subanalysis of the large ORHEO observational study has demonstrated the utility of biosimilar epoetin alfa in a real-world setting. Biosimilar epoetin alfa was seen to be efficacious and well tolerated in patients with breast cancer who presented with CIA, and no new safety signals were identified in this subpopulation. These data support the results observed in the parent ORHEO study, and confirm that biosimilar epoetin alfa (Hospira) is a therapeutic alternative for treating CIA in patients with breast cancer. Several potential prognostic indicators were identified that may warrant further study. Citation Format: Albrand H, Luporsi E, Michallet M, Soubeyran P. Usage of epoetin alfa biosimilars in the management of chemotherapy-induced anemia in patients with breast cancer: A subanalysis of the ORHEO study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-10-02.

Lessons from the past: Long-term safety and survival outcomes of a prematurely terminated randomized controlled trial on prophylactic vs. hemoglobin-based administration of erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia.

Prophylactic erythropoiesis-stimulating agent (ESA) administration for chemotherapy-induced anemia (CIA) is not supported by current guidelines. Long-term follow-up of patients WHO had been treated with ESA for CIA in the past may provide useful information. In 2002, we undertook a prospective, randomized phase III trial of prophylactic vs. hemoglobin (Hb)-based (threshold: 11 mg/dl) ESA administration in patients with solid tumors and CIA. ESA administration FOR CIA was permanently suspended in 2007 in view of published data at that time, while patient surveillance continued. Among 630 evaluable patients, 38.6% were male, 50.9% had advanced cancer at diagnosis, 40.6% had Hb levels <12 mg/dl at baseline and 47.9% received ESA prophylactically (1:1 randomization). The major tumor types included colorectal (36.0%), breast (20.6%), non-prostate genitourinary (11.0%) and lung CANCER (8.4%). After a median follow-up of 85.4 months, 358 patients had relapsed and 380 had succumbed to the disease. Patients in the prophylactic ESA group (GROUP A; experimental arm), as compared with those in the Hb-based group (GROUP B; iron supplementation alone), exhibited A significantly more prominent increase in median Hb levels, particularly in the subset of patients with non-metastatic disease (two-sided P<0.01) among patients receiving chemotherapy for advanced cancer, those who received ESAs prophylactically exhibited a lower incidence of CIA (all grades: P=0.014, grades 3-4: P=0.034) and fatigue (all grades: P<0.001, grades 3-4: P=0.055), but a higher rate of a composite outcome encompassing all thrombosis-related events (all grades: P=0.043, grades 3-4: P=0.099). These differences were less prominent in the group of patients who received adjuvant treatment. There were no significant differences in overall mortality and relapse/progression rates between the two groups. therefore, prophylactic, compared with Hb-based, administration of ESAs for CIA in patients with solid tumors, was found to be associated with a significantly lower incidence of anemia and fatigue, but with a marginally higher rate of thrombosis-related adverse events, particularly in patients receiving first-line chemotherapy for advanced cancer.

KIAA0101 is associated with human renal cell carcinoma proliferation and migration induced by erythropoietin.

Erythropoietin (EPO) is a frequently prescribed anti-anemic drug for patients with advanced renal carcinoma. However, recent evidence from clinical studies suggested that EPO accelerated tumor progression and jeopardized the 5-year survival. Herein, we show, starting from the in silico microarray bioinformatics analysis, that activation of Erythropoietin signaling pathway enhanced renal clear carcinoma (RCC) progression. EPO accelerated the proliferative and migratory ability in 786-O and Caki-2 cells. Moreover, comparative proteomics expression profiling suggested that exogenous EPO stimulated RCC progression via up-regulation of KIAA0101 expression. Loss of KIAA0101 impeded the undesirable propensity of EPO in RCC. Finally, low expression of KIAA0101 was associated with the excellent prognosis and prognosticated a higher 5-year survival in human patients with renal carcinoma. Overall, KIAA0101 appears to be a key promoter of RCC malignancy induced by EPO, which provide mechanistic insights into KIAA0101 functions, and pave the road to develop new therapeutics for treatment of cancer-related and chemotherapy-induced anemia in patients with RCC.

Management of chemotherapy‐induced anemia (CIA) with biosimilar epoetin alfa (Binocrit) in patients with pancreatic cancer (PC): An interim analysis of an ongoing French national observational study (The OncoBOS study).

479 Background: OncoBOS is a prospective, non-interventional study describing Binocrit use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma or myeloma. This interim sub-analysis focuses on patients with PC. Methods: Patients ≥18 years with PC, CIA and eligible for treatment with Binocrit were included in this analysis. Patients characteristics, data on CIA and its management and predominant factors considered by the physician in prescribing Binocrit were recorded at baseline (BL), 3-4 weeks and 12 (± 1) weeks later. Hemoglobin (Hb) outcomes assessed included the proportion of patients achieving a Hb increase ≥1 and ≥2 g/dL, and the mean Hb change from BL. Results: 59 patients with PC (32 females (54.2%), mean age 68.3 years) from 22 sites were recruited from September 2011 to April 2014. Mean and median BL Hb levels were both 10 g/dL. The mean increase in Hb level was 1.1 g/dL after 1 month and 1.2 g/dL after 3 months (p&lt;0.001 vs BL) of Binocrit treatment. A Hb increase ≥1 g/dL was achieved by 48.3% of patients at week 3-4 and 54.2% at week 12; a Hb increase ≥2 g/dL was achieved by 25.9% and 35.4% of patients at the same time points. Patients received a median dose of 30,000 IU Binocrit once weekly. Three of the 59 patients (5.1%) required a dose increase. Transfusion rates remained stable at 11.9% and 15.1% at week 3-4 and week 12, respectively. Oral and intravenous (IV) iron supplementation rates were low: oral iron was received by 1.7% and 0% of patients at week 3-4 and week 12, respectively; 20.3% and 13.2% of patients received IV supplementation at the same time points. Of note, iron status was assessed in only 11.9% of subjects at BL. Physicians considered quality of life (37.3%), fatigue (25.4%) and avoidance of blood transfusion (10.2%) as predominant factors in the rationale for CIA management. Over the treatment period, three treatment-related adverse reactions (non-serious) were recorded. Conclusions: This sub-analysis indicates that Binocrit, used in routine practice, is effective and well tolerated for the treatment of CIA in patients with PC.

Management of chemotherapy‐induced anemia (CIA) with biosimilar epoetin alfa (Binocrit) in patients with colorectal cancer (CC): An interim analysis of an ongoing French national observational study (The OncoBOS study).

742 Background: OncoBOS is a prospective, non-interventional study describing Binocrit use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma, or myeloma. This interim sub-analysis focuses on patients with CC, receiving usual chemotherapeutic agents. Methods: Patients ≥18 years with CC, CIA, and eligible for treatment with Binocrit were included in this analysis. Patients characteristics, data on CIA and its management, and predominant factors considered by the physician in prescribing Binocrit were recorded at baseline (BL), 3-4 weeks and 12 (±1) weeks later. Hemoglobin (Hb) outcomes assessed included the proportion of patients achieving a Hb increase ≥1 and ≥2 g/dL, and the mean Hb change from BL. Results: 96 patients with CC (51 males [53.1%], mean age 68.5 years) from 28 sites were recruited from September 2011 to April 2014. Mean and median BL Hb levels were 9.9 g/dL and 10 g/dL, respectively. The mean increase in Hb level was 1.2 g/dL after 1 month and 1.7 g/dL after 3 months (p&lt;0.001 vs. BL) of Binocrit treatment. A Hb increase ≥1 g/dL was achieved by 56.8% of patients at week 3-4 and 77.6% at week 12; a Hb increase ≥2 g/dL was achieved by 17.9% and 47.4% of patients at the same time points. Patients received a median dose of 30,000 IU Binocrit once weekly. Four of the 96 patients (4.2%) required a dose increase. Transfusion rates remained low at 2.1% and 1.1% at week 3-4 and week 12, respectively. Oral and intravenous (IV) iron supplementation rates were low: oral iron was received by 4.2% and 4.7% of patients at week 3-4 and week 12, respectively; 15.6% and 9.3% of patients received IV supplementation at the same time points. Physicians considered quality of life (49%), fatigue (24%), and avoidance of blood transfusion (15.6%) as predominant factors in the rationale for CIA management. Over the treatment period, no treatment-related adverse reaction was recorded. Conclusions: This sub-analysis indicates that Binocrit, used in routine practice, is effective and well tolerated for the treatment of CIA in patients with CC, whatever CT received.

Management of Chemotherapy‐induced Anemia (CIA) with Biosimilar Epoetin Alfa (Binocrit®) in Patients with Multiple Myeloma (MM): An Interim Analysis of an Ongoing French National Observational Study (The OncoBOS study)

Background: OncoBOS is a national, prospective, non-interventional, longitudinal, observational study describing biosimilar epoetin alfa (Binocrit®) use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma or myeloma. This sub-analysis focuses on the management of CIA in patients with MM.Patients and methods: Patients ≥18 years with MM, CIA and eligible for treatment with Binocrit® were included in this analysis. Patients characteristics, data on CIA and its management and predominant factors considered by the physician in prescribing Binocrit® were recorded at baseline, 3-4 weeks and 12 (± 1) weeks later. Hemoglobin (Hb) outcomes assessed included the proportion of patients achieving a Hb increase ≥1 and ≥2 g/dL, and the mean Hb change from baseline.Results: 99 patients with MM (mean age 71.1 years) from 20 sites were recruited from September 2011 to April 2014. 54.5% of subjects were male. Mean and median baseline Hb levels were 9.4 g/dL and 10 g/dL, respectively. The mean increase in Hb level was 1.1 g/dL after 1 month and 2.2 g/dL after 3 months (p<0.001 vs baseline) of Binocrit® treatment. A Hb increase ≥1 g/dL was achieved by 57.6% of patients at week 3-4 and 78.0% at week 12; a Hb increase ≥2 g/dL was achieved by 22.2% and 60.4% of patients at the same time points. Patients received a median dose of 30,000 IU Binocrit® once weekly. Four of the 99 patients (4.0%) required a dose increase; 3 of these patients had their dose doubled during the treatment period. Transfusion rates remained stable at 12.1% and 9.6% at week 3-4 and week 12, respectively. Oral and intravenous (IV) iron supplementation rates were low: oral iron was received by 1.0% and 2.2% of patients at week 3-4 and week 12, respectively; 1.0% and 1.1% of patients received IV supplementation at the same time points. Of note, these low rates could be explained by the fact that iron status (serum ferritin and transferrin saturation coefficient) was assessed in only 32.3% of subjects at baseline. Physicians considered quality of life (59.6%), fatigue (20.2%) and avoidance of blood transfusion (13.1%) as predominant factors in the rationale for anemia management and treatment. Over the treatment period, one treatment-related adverse reaction was recorded, which was not considered serious.Conclusion: This sub-analysis indicates that Binocrit®, used in routine practice, is effective and well tolerated for the treatment of CIA in patients with MM receiving CT. DisclosuresVoronina:Sandoz: Investigator Other. Ojeda-Urib:Sandoz: Honoraria. Dauriac:Sandoz: Investigator Other. Voillat:Sandoz: Investigator Other. Aubron-Olivier:Sandoz: Employment. Fernet:Sandoz: Employment. Karlin:Celgene: Honoraria, Membership on an entity’s Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity’s Board of Directors or advisory committees; Sandoz: Honoraria, Membership on an entity’s Board of Directors or advisory committees. Fitoussi:Sandoz: Honoraria.

Lessons from the Past: Long-Term Safety and Efficacy Outcomes of a Prematurely Terminated, Randomized Phase III Trial of Precautionary Versus Hemoglobin-Based Erythropoietin Administration for Chemotherapy-Associated Anemia in Patients with Solid Tumors

ABSTRACT Aim: Prophylactic erythropoiesis-stimulating agent (ESA) administration for chemotherapy-induced anemia (CIA) is not supported by current guidelines. Long-term follow-up of patients that had been treated with EPO for CIA in the past may provide useful information. Methods: In 2002 we undertook a prospective, randomized phase III trial of prophylactic versus hemoglobin (Hgb)-based (threshold: 12 mg/dl) ESA administration in patients with solid tumors and CIA, which was permanently suspended in 2005 in the view of published data at that time, while patient surveillance continued. Herein we present safety and efficacy outcomes after more than a decade of follow-up. Results: Among 630 evaluable patients, 40.1% were male, 50.9% had advanced cancer at diagnosis, 39.2% had Hgb levels Conclusions: Prophylactic administration of ESA for CIA in patients with solid tumors was associated with increased incidence of a composite of thrombosis-related adverse events, especially in patients receiving adjuvant treatment, but did not have a detrimental impact on relapse/progression and survival rates. Disclosure: All authors have declared no conflicts of interest.

Effectiveness Of Biosimilar Epoetin Alfa For The Treatment Of Chemotherapy-Induced Anemia In Patients With Hematological Malignancies

BackgroundEpoetin and intravenous iron are used at St. Bartholomew's Hospital (Barts Health NHS Trust) for the treatment of patients with non-myeloid malignancy and chemotherapy-induced anemia. Modified American Society of Hematology/American Society of Clinical Oncology guidelines are used to guide epoetin use. This is combined with a systematic approach to iron supplementation based on iron status markers, including zinc protoporphyrin (ZPP). Using this approach, we have previously reported very high hemoglobin response rates of up to 92% with epoetin beta (Agrawal et al. Blood 2005; 106: Abs 588). Biosimilar versions of epoetin alfa are now approved in Europe to treat chemotherapy-induced anemia in patients with cancer. These agents offer potentially substantial cost savings to healthcare payers, and their greater affordability may increase patient access to treatments. We performed a pilot study of the effectiveness of biosimilar epoetin alfa (Sandoz, Germany) in our protocol for the management of chemotherapy-induced anemia in patients with hematological malignancies. MethodsPatients with chronic lymphocytic leukemia (CLL), myeloma or lymphoma, receiving chemotherapy and with Hb<10 g/dL, were treated with biosimilar epoetin alfa (30,000 IU subcutaneously once weekly, increased to 60,000 IU at 4 weeks if no response [Hb increase<1 g/dL over baseline]). Minor and major responses to epoetin were defined as a Hb increase of 1–2 g/dL and >2 g/dL, respectively. Iron support was given in the form of intravenous (i.v.) iron sucrose 200 mg weekly if indicated based on iron status markers (serum ferritin, transferring saturation [TSAT], mean corpuscular Hb [MCH] and ZPP). ResultsNineteen patients treated with biosimilar epoetin alfa were included in this analysis (9 with CLL, 7 with myeloma, 3 with lymphoma). Ages ranged from 25 to 84 years. 18 patients had a response to biosimilar epoetin alfa (95%); of these, 12 had a major response and 6 a minor response. Only one patient required an epoetin dose increase. Four patients were transfusion-dependent at baseline, 3 of whom became transfusion-independent on epoetin therapy. Seven of the 19 patients were ineligible for iron supplementation because of a serum ferritin >1000 μg/L. Of the remaining 12 patients, five (43%) received i.v. iron support based on their iron status markers at baseline and during epoetin therapy. In all five, the trigger for iron support was a raised ZPP in combination with a low/normal serum ferritin; TSAT was low in only 2/5and the MCH was normal in 5/5. All five patients achieved a response to epoetin. In contrast, five other patients who had a raised ZPP did not receive iron support because of markedly raised serum ferritin (>750 μg/L) with raised TSAT. ConclusionsThis pilot study indicates that biosimilar epoetin alfa is effective for the treatment of chemotherapy-induced anemia in patients with hematological malignancies. Although this is a small data set, response rates using biosimilar epoetin alfa in our epoetin/iron supplementation protocol (95%) are very high and similar to historical data using epoetin beta (92%). While ZPP appears to be a useful parameter to guide iron support in patients with hematological malignancies, it cannot be used in isolation and must be correlated with serum ferritin. Appropriate use of iron support, based on assessment of readily available laboratory parameters, may increase response rates to epoetin therapy. Disclosures:Agrawal:Sandoz Biopharmaceuticals: Consultancy, Honoraria, Research Funding. Turner:Sandoz Biopharmaceuticals: Employment.

Costes de los agentes estimulantes de la eritropoyesis en el tratamiento de la anemia inducida por quimioterapia en España: resultados preliminares procedentes de la adaptación de un estudio belga

ObjectivesSpaepen et al. (The Oncologist 13:596–607, [2008]) compared the management cost of chemotherapy-induced anaemia in patients treated with darbepoetin-alfa (DARB), epoetin-alfa (EPO-A), and epoetin-beta (EPO-B) in Belgium based on a database analysis, and concluded that the cost in patients treated with DARB was significantly lower than in patients treated with EPO-A or EPO-B. The objectives of present study were to determine the applicability of the Belgian analysis to Spain, and to estimate the differences in costs between erythropoiesis-stimulating agents (ESAs) in Spain.MethodsDifferences in epidemiology and treatment patterns between Belgium and Spain were adjusted using data from Eurostat, national cancer registries, IMS sales data, and reimbursement and treatment guidelines. Belgian unit costs were replaced with Spanish-specific costs. Costs were analyzed using a mixed-effects model stratifying for propensity score quintiles.ResultsThe two populations were comparable in terms of age; gender; and ESA, iron, and blood transfusions use. After adjusting for Spanish-specific chemotherapy use and cancer incidence, total management costs per patient (Euro, 2010) for DARB were €6,815, 21% lower than for EPO-A (€8,583; p<0.0001) and 19% lower than for EPO-B (€8,420; p=0.0019). The duration of treatment was 40.63±2.39 days for DARB, 53.59±1.25 days for EPO-A and 52.39±2.54 days for EPO-B.ConclusionThe findings of this study are in line with the Belgian analysis: total costs and anaemia-related costs were lowest in patients receiving DARB compared with EPO-A or EPO-B. This study demonstrates the feasibility of adapting real-life country-specific data to other settings, adjusting for differences in patients’ characteristics and treatment strategies.