Abstract 3482
Background
Lipegfilgrastim (LONQUEX®) has proven to be non-inferior to pegfilgrastim (NEULASTA®) in the reduction of the duration of severe neutropenia (DSN) in breast cancer patients. The efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with B-NHL at high risk for R-CHOP-21-induced neutropenia was investigated. The primary efficacy endpoint was the DSN in cycle 1.
Methods
One hundred and one patients with NHL, median age of 74 years, were randomized to receive either 6 mg of lipegfilgrastim or pegfilgrastim per cycle during 6 cycles of R-CHOP-21.
Results
Lipegfilgrastim was non-inferior to pegfilgrastim in the DSN in cycle 1: the mean DSN (days) in cycle 1 was 0.8±.96 and 0.9±1.08 in the per-protocol population, respectively with an adjusted mean difference (95% confidence interval) between groups of -0.3 (-0.70, 0.19). The upper boundary was below the predefined non-inferiority margin of 1. Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of febrile neutropenia (FN) in cycle 1 was 2% (1/41) in the lipegfilgrastim and 0% (0/44) in the pegfilgrastim group. The incidence of severe neutropenia in cycle 1 was similar in the lipegfilgrastim (21/41; 51%) and pegfilgrastim (23/44; 52%) groups. The mean time to absolute neutrophil count recovery to a threshold of ≥ 2.0 × 109/L was similar in lipegfilgrastim (8.3 days) and pegfilgrastim (8.7 days) groups. Adverse events (AEs) occurred in 98% of patients; in 45/46 of lipegfilgrastim and 49/50 of the pegfilgrastim group. Serious AEs occurred in 46% of patients; 21/46 in the lipegfilgrastim and 23/50 in pegfilgrastim group; none were assessed as treatment-related by the investigator. Fatal AEs occurred in 4% (2/46) of lipegfilgrastim and 10% (5/50) of the pegfilgrastim group. Study withdrawal due to AEs occurred in 2% (1/46) of the lipegfilgrastim and 18% (9/50) of the pegfilgrastim group.
Conclusions
Lipegfilgrastim was non-inferior to pegfilgrastim in the reduction of the DSN in elderly patients with B-NHL. The safety of lipegfilgrastim was comparable to pegfilgrastim.
Clinical trial identification
EudraCT: 2013-001284-23.
Legal entity responsible for the study
Merckle GmbH (part of Teva Pharmaceuticals group).
Funding
Merckle GmbH (part of Teva Pharmaceuticals group).
Editorial Acknowledgement
Disclosure
H. Link: Advisory boards, investigator in sponsored trial: Teva. G. Illerhaus, U.M. Martens, A. Salar, R. Depenbusch, A. Kohler, M.M. Engelhardt, S. Mahlmann, M. Zaiss: Investigator in Teva sponsored trial. A. Lammerich, P. Bias, A. Buchner: Employee and stock options: Teva.
Resources from the same session
2595 - Real-Life Utilization of Genomic testing for invasive Breast Cancer patients in Italy and France reduces Chemotherapy Recommendations
Presenter: Sandro Barni
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2343 - Benefit of adjuvant chemotherapy in hormone receptor-positive, HER2-negative, invasive lobular carcinoma of the breast
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2990 - Baseline lymphocyte counts predict distant recurrence in early breast cancer
Presenter: Gun Min Kim
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4532 - A propensity score analysis exploring the impact of the addition of adjuvant chemotherapy (aCT) to hormone therapy (aHT) in a multi-center series of resected luminal early stage pure Invasive Lobular Breast Carcinoma (ILC).
Presenter: Luisa Carbognin
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2344 - Benefit of Adjuvant Systemic Therapies in HR+ HER2- pT1ab Node-Negative Breast Carcinomas
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3525 - Anti-proliferative effect of oral metronomic vinorelbine in PAM50 Luminal/HER2-negative early breast cancer (SOLTI-1501 VENTANA): an open-label, randomized, three-arm, multicenter, window-of-opportunity study
Presenter: Aleix Prat
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3908 - Clinicopathologic significance of androgen receptor expression and discordant receptor status during progression in breast cancer
Presenter: Chan Heun Park
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4075 - The outcomes of early breast cancers utilizing the Oncotype Dx Recurrence score (RS) instead of Clinico-pathological (CP) factors for prognostic risk assessment: A Single Institution Experience
Presenter: Adhar Alsayed
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
738 - Circulating tumor cells as a prognostic marker in non metastatic breast cancer patients.
Presenter: Summar Elmorshidy
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3151 - Molecular subtyping of breast cancer by dedicated breast PET
Presenter: Satoshi Sueoka
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract