# Efficacy and safety of lipegfilgrastim versus pegfilgrastim in breast cancer patients receiving doxorubicin and docetaxel (XM22-03)

Source: https://onco.cc/key-papers/paper-xm22-03-bondarenko-bmc-cancer-2013/  
OnCo record `paper-xm22-03-bondarenko-bmc-cancer-2013` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Mean 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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: BMC Cancer
- Year: 2013
- DOI: 10.1186/1471-2407-13-386
- Authors: Bondarenko I, Gladkov OA, Elsaesser R, et al.
- 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.
- What it means: 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.

## Sources

- BMC Cancer 2013: https://doi.org/10.1186/1471-2407-13-386
- PubMed: https://pubmed.ncbi.nlm.nih.gov/23945072/
- Lonquex EPAR (EMA): https://www.ema.europa.eu/en/medicines/human/EPAR/lonquex

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- fronts: [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- drugs: [Lipegfilgrastim](https://onco.cc/drugs/lipegfilgrastim/), [Pegfilgrastim](https://onco.cc/drugs/pegfilgrastim/)
- companies: [Teva Pharmaceuticals](https://onco.cc/companies/teva/)
- trials: [XM22-03](https://onco.cc/trials/xm22-03/)
- journals: [BMC cancer](https://onco.cc/journals/bmc-cancer/)

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