{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T11:07:17Z","timestamp":1763809637006},"reference-count":25,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2016,11,23]],"date-time":"2016-11-23T00:00:00Z","timestamp":1479859200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Data on efficacy and safety of darbepoetin alfa (DA) administered at hemoglobin (Hb) \u226410\u00a0g\/dL are limited. In this analysis, we examined DA's efficacy and safety in patients with Stage IV cancers and chemotherapy\u2010induced anemia (CIA) initiated on DA at Hb \u226410\u00a0g\/dL. Data for patients with Stage IV cancers and CIA and who initiated DA at Hb \u226410\u00a0g\/dL were extracted from three phase 3 trials identified in a central database of Amgen\u2010sponsored DA studies in CIA. Efficacy outcomes were assessed by achievement of Hb increases of \u22651\u00a0g\/dL and \u22652\u00a0g\/dL and red blood cell (RBC) or whole blood transfusion requirements. Data were analyzed for all patients with baseline Hb \u226410\u00a0g\/dL, and by the subgroups of patients with baseline Hb \u22659 to \u226410 g\/dL versus &lt;9\u00a0g\/dL. Crude and Kaplan\u2013Meier proportions of patients who experienced each outcome and time (days) to each outcome were summarized by treatment. Meta\u2010analysis (fixed\u2010effects inverse\u2010variance model) was performed to compare outcomes for DA versus placebo. Safety was assessed by occurrence of adverse events. Data from 213 patients were analyzed: DA, <jats:italic>n\u00a0<\/jats:italic>=\u00a0115; placebo, <jats:italic>n\u00a0<\/jats:italic>=\u00a098. More patients in the DA versus the placebo subgroup achieved Hb increase of \u22651\u00a0g\/dL (72% vs. 36%; HR: 2.92, 95% CI: 1.95, 4.39) and \u22652\u00a0g\/dL (44% vs. 18%; HR: 2.98, 95% CI: 1.71, 5.21) during the first 12\u00a0treatment weeks. Median times to Hb increase of \u22651\u00a0g\/dL and \u22652\u00a0g\/dL were 36 days and 78\u00a0days for DA, respectively. RBC or whole blood transfusions were less common in patients in the DA versus the placebo subgroup (24% vs. 45%; HR: 0.44, 95% CI: 0.27, 0.73). No new safety issues were reported. Our results confirm that DA use in patients with Stage IV cancer and CIA is more effective than placebo at increasing Hb levels and at reducing transfusion needs when DA treatment is initiated at Hb\u00a0\u226410\u00a0g\/dL.<\/jats:p>","DOI":"10.1002\/cam4.958","type":"journal-article","created":{"date-parts":[[2016,11,24]],"date-time":"2016-11-24T04:53:09Z","timestamp":1479963189000},"page":"3445-3453","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy and safety of darbepoetin alfa initiated at hemoglobin \u226410\u00a0g\/dL in patients with stage IV cancer and chemotherapy\u2010induced anemia"],"prefix":"10.1002","volume":"5","author":[{"given":"Ralph V.","family":"Boccia","sequence":"first","affiliation":[{"name":"Center for Cancer and Blood Disorders  Bethesda Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David H.","family":"Henry","sequence":"additional","affiliation":[{"name":"University of Pennsylvania  Philadelphia Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Belton","sequence":"additional","affiliation":[{"name":"LB Biostatistics  London United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chet","family":"Bohac","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hassan H.","family":"Ghazal","sequence":"additional","affiliation":[{"name":"Kentucky Cancer Clinic  Hazard Kentucky"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,11,23]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2146\/ajhp060601"},{"key":"e_1_2_7_3_1","unstructured":"National Comprehensive Cancer Network.2016.NCCN\u00aeClinical Practice Guidelines in Oncology. Cancer\u2010 and Chemotherapy\u2010Induced Anemia version 2. Avaliable athttps:\/\/www.nccn.org\/store\/login\/login.aspx?ReturnURL=http:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/anemia.pdf(Accessed 7 October 2016)"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.13-S3-33"},{"key":"e_1_2_7_5_1","unstructured":"Aranesp\u00ae(darbepoetin alfa) prescribing information: Thousand Oaks CA: Amgen Inc."},{"key":"e_1_2_7_6_1","unstructured":"Aranesp\u00ae(darbepoetin alfa) summary of product characteristics: Breda: Amgen Europe BV."},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2141.2003.04448.x"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/94.16.1211"},{"key":"e_1_2_7_9_1","first-page":"CD007303","article-title":"Erythropoietin or darbepoetin for patients with cancer\u2013meta\u2010analysis based on individual patient data","author":"Bohlius J.","year":"2009","journal-title":"Cochrane Database Syst. 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