{"entity":{"id":"paper-xm22-03-bondarenko-bmc-cancer-2013","kind":"paper","name":"Efficacy and safety of lipegfilgrastim versus pegfilgrastim in breast cancer patients receiving doxorubicin and docetaxel (XM22-03)","aka":[],"tldr":"In women having chemotherapy for breast cancer, a single dose of the new white-cell booster lipegfilgrastim kept the dangerous dip in white cells as short as the standard booster pegfilgrastim, with no cases of infection-related fever on the new drug.","summary":"Primary publication of XM22-03 (EudraCT 2009-015999-10), a phase 3, double-blind, randomised, active-controlled, non-inferiority trial. Patients with high-risk stage II, III or IV breast cancer and an absolute neutrophil count of at least 1.5 x 10^9 cells per litre were randomised to a single 6 mg subcutaneous injection of lipegfilgrastim (n = 101) or pegfilgrastim (n = 101) on day 2 of each 21-day doxorubicin and docetaxel cycle, for up to four cycles. The primary efficacy endpoint was the duration of severe neutropenia during cycle 1.\n\nMean duration of severe neutropenia in cycle 1 was 0.7 days with lipegfilgrastim and 0.8 days with pegfilgrastim (lambda -0.218, 95 percent CI -0.498 to 0.062; p = 0.126); no severe neutropenia was seen in 56 percent and 49 percent of patients. Across all cycles, febrile neutropenia occurred in three pegfilgrastim-treated patients (all in cycle 1) and none on lipegfilgrastim. Drug-related adverse events were reported in 28 percent and 26 percent.","asOf":"2026-09-24","links":[{"label":"BMC Cancer 2013","url":"https://doi.org/10.1186/1471-2407-13-386"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/23945072/"},{"label":"Lonquex EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonquex"}],"tags":[],"related":[],"cancers":["breast-cancer"],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["lipegfilgrastim","pegfilgrastim"],"companies":["teva"],"institutions":[],"pathways":[],"terms":[],"trials":["xm22-03"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["bmc-cancer"],"dependsOn":[],"notes":[],"journal":"BMC Cancer","year":2013,"doi":"10.1186/1471-2407-13-386","pmid":"23945072","authors":"Bondarenko I, Gladkov OA, Elsaesser R, et al.","paperType":"rct","findings":["Mean duration of severe neutropenia in cycle 1: 0.7 days with lipegfilgrastim vs 0.8 days with pegfilgrastim (p = 0.126); non-inferiority shown.","No severe neutropenia in cycle 1 in 56 percent vs 49 percent of patients.","Febrile neutropenia in 0 vs 3 patients (efficacy population); drug-related adverse events in 28 percent vs 26 percent."],"whatItMeans":"This is the breast-cancer pivotal behind the 2013 EU authorisation of Lonquex, establishing lipegfilgrastim as an alternative once-per-cycle growth factor to pegfilgrastim. The confidence interval for lambda belongs to a Poisson-model effect estimate and is not a hazard ratio.","caveats":["Non-inferiority design; the p value of 0.126 is the between-arm comparison, not evidence of superiority.","The confidence interval bounds are printed with percent signs in the abstract but are on the same scale as lambda.","Three co-authors were employees of the sponsor."],"changedPractice":true,"participants":202},"route":"/key-papers/paper-xm22-03-bondarenko-bmc-cancer-2013/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"section":[{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"drug":[{"id":"lipegfilgrastim","kind":"drug","name":"Lipegfilgrastim","route":"/drugs/lipegfilgrastim/"},{"id":"pegfilgrastim","kind":"drug","name":"Pegfilgrastim","route":"/drugs/pegfilgrastim/"}],"company":[{"id":"teva","kind":"company","name":"Teva Pharmaceuticals","route":"/companies/teva/"}],"trial":[{"id":"xm22-03","kind":"trial","name":"XM22-03","route":"/trials/xm22-03/"}],"journal":[{"id":"bmc-cancer","kind":"journal","name":"BMC cancer","route":"/journals/bmc-cancer/"}]}}