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