88 Eflapegrastim, a Long-Acting Granulocyte Colony–Stimulating Factor, Administered the Same Day as Chemotherapy in Patients With Early-Stage Breast Cancer: Results From a Multicenter, Open-Label Study

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Article
Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 37-38

88 Eflapegrastim, a Long-Acting Granulocyte Colony–Stimulating Factor, Administered the Same Day as Chemotherapy in Patients With Early-Stage Breast Cancer: Results From a Multicenter, Open-Label Study

88 Eflapegrastim, a Long-Acting Granulocyte Colony–Stimulating Factor, Administered the Same Day as Chemotherapy in Patients With Early-Stage Breast Cancer: Results From a Multicenter, Open-Label Study

Background

Patients with early-stage breast cancer receiving docetaxel and cyclophosphamide chemotherapy have a risk of severe neutropenia and febrile neutropenia. The National Comprehensive Cancer Network recommends GCSF to reduce the risk of febrile neutropenia. Eflapegrastim—a novel, long-acting, recombinant human GCSF linked to human IgG4 Fc fragment—showed improved bone marrow residence vs pegfilgrastim that may allow for same-day dosing. In the phase 3 trials ADVANCE (NCT02643420) and RECOVER (NCT02953340), eflapegrastim administered about 24 hours post docetaxel and cyclophosphamide was noninferior to pegfilgrastim in reducing the duration and incidence of severe neutropenia. This study evaluated the safety of a same-day dose of eflapegrastim.

Materials and Methods

This multicenter, open-label phase 1 study (NCT04187898) enrolled patients with confirmed early-stage breast cancer (stage I-IIIA), aged 18 years or older who were candidates for docetaxel and cyclophosphamide. Patients received subcutaneous eflapegrastim (single, fixed dose of 13.2 mg [3.6 mg GCSF]) 0.5 hours ± 5 minutes post docetaxel and cyclophosphamide (docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2). Primary end point: time to recovery of absolute neutrophil counts (ANC) from nadir to ≥1.5×109/L in cycle 1. Secondary end points: incidence of severe neutropenia (ANC <0.5×109/L) and febrile neutropenia (ANC <0.5×109/L and temperature >38.3oC or 2 consecutive readings ≥38.0oC over 2 hours), duration of severe neutropenia, and incidence of neutropenic complications (anti-infective use/hospitalization). Treatment-emergent adverse effects (TEAEs) of interest are reported here.

Results

Fifty-three patients (mean [SD] age: 62.7 [11.9] years; female: 100%) from 13 US sites, were enrolled (White: 62.3%; Black: 9.4%; others: 28.3%). Patients were relatively healthy (ECOG 0, 52.8% [n = 28]; ECOG 1, 47.2% [n = 25]). Efficacy in cycle 1 was evaluable in 49 patients, with mean (SD) time to ANC recovery: 1.8 (1.1) days; incidence of severe neutropenia: 42.9% (n = 21); mean (SD) duration of severe neutropenia; 0.7 (0.9) days; and incidence of febrile neutropenia: 2% (n = 1). No neutropenic complications occurred during the study. Safety was assessed in all 53 patients who received 1 or more doses. Overall, 43 patients (81.1%) experienced any TEAEs of musculoskeletal pain. Common musculoskeletal TEAEs in 10% or more of patients: bone pain (52.8%; n = 28); back pain (26.4%; n = 14), pain in extremity (20.8%; n = 11); arthralgia (17.0%; n = 9), and myalgia (13.2%; n = 7). No deaths occurred during the study.

Conclusion

Eflapegrastim given on the same day as docetaxel and cyclophosphamide chemotherapy may reduce the time to ANC recovery and related complications in early-stage breast cancer. The AEs observed were consistent with those observed with other GCSF products.

Articles in this issue

39 Development and Validation of a Questionnaire to Assess Motivation and Satisfaction in Mastectomy Patients With or Without Reconstruction
39 Development and Validation of a Questionnaire to Assess Motivation and Satisfaction in Mastectomy Patients With or Without Reconstruction
40 Frequency of Documented IHC Score in Patients With HER2-Negative Breast Cancer in the US: An Observational Study Using Guardian Research Network Data
40 Frequency of Documented IHC Score in Patients With HER2-Negative Breast Cancer in the US: An Observational Study Using Guardian Research Network Data
41 Provider Preferences and Practices in Testing and Reporting HER2 Immunohistochemistry in Patients With Breast Cancer: A Survey and Interview Study Among US Pathologists and Oncologists
41 Provider Preferences and Practices in Testing and Reporting HER2 Immunohistochemistry in Patients With Breast Cancer: A Survey and Interview Study Among US Pathologists and Oncologists
42 Exploring the Treatment Gap in High-Risk HR+, HER2– Early Breast Cancer: Eligible Patients Not Receiving Abemaciclib in the US
42 Exploring the Treatment Gap in High-Risk HR+, HER2– Early Breast Cancer: Eligible Patients Not Receiving Abemaciclib in the US
TPS 43 ADELA: A Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial of Elacestrant + Everolimus vs Elacestrant + Placebo in ER+/HER2– Advanced Breast Cancer Patients With ESR1-Mutated Tumors Progressing on Endocrine Therapy
TPS 43 ADELA: A Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial of Elacestrant + Everolimus vs Elacestrant + Placebo in ER+/HER2– Advanced Breast Cancer Patients With ESR1-Mutated Tumors Progressing on Endocrine Therapy
45 A Phase 3 Randomized Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response at Surgery
45 A Phase 3 Randomized Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response at Surgery
46 Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for High-Risk, Early-Stage Triple-Negative Breast Cancer: Overall Survival and Subgroup Results From the Phase 3 KEYNOTE-522 Study
46 Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for High-Risk, Early-Stage Triple-Negative Breast Cancer: Overall Survival and Subgroup Results From the Phase 3 KEYNOTE-522 Study
48 Prevalence of “HER2 Ultra-Low” Among Advanced Breast Cancer Patients With Historical IHC0 Status
48 Prevalence of “HER2 Ultra-Low” Among Advanced Breast Cancer Patients With Historical IHC0 Status
49 Clinical Characteristics and Treatment Persistence in US Patients With HR+/HER2–, Node-Positive Early Breast Cancer Treated With Abemaciclib: Real-World Study From First Year After Approval
49 Clinical Characteristics and Treatment Persistence in US Patients With HR+/HER2–, Node-Positive Early Breast Cancer Treated With Abemaciclib: Real-World Study From First Year After Approval
52 Correlation and Prediction of Complete Pathologic Response Rates and Ki-67 in Patients Receiving Neoadjuvant Immunotherapy for Triple-Negative Breast Cancer
52 Correlation and Prediction of Complete Pathologic Response Rates and Ki-67 in Patients Receiving Neoadjuvant Immunotherapy for Triple-Negative Breast Cancer
53 Comparison of Surgical Complications With Direct-to-Implant vs Tissue Expander Reconstruction After Wise Pattern Skin-Sparing Mastectomy
53 Comparison of Surgical Complications With Direct-to-Implant vs Tissue Expander Reconstruction After Wise Pattern Skin-Sparing Mastectomy
54 The Treatment of Breast Cancer With Percutaneous Thermal Ablation: Results of the THERMAC Trial
54 The Treatment of Breast Cancer With Percutaneous Thermal Ablation: Results of the THERMAC Trial
55 Do Genetic Counseling and Testing Affect Rates of Contralateral Prophylactic Mastectomy in Patients Without Clinically Actionable Mutations?
55 Do Genetic Counseling and Testing Affect Rates of Contralateral Prophylactic Mastectomy in Patients Without Clinically Actionable Mutations?
56 Paternal vs Maternal Inheritance of a BRCA Mutation: Is There a Difference in Presentation and Stage of Breast Cancer at Diagnosis?
56 Paternal vs Maternal Inheritance of a BRCA Mutation: Is There a Difference in Presentation and Stage of Breast Cancer at Diagnosis?
57 Tumor Morphology Concordance in Multifocal/Multicentric Triple- Negative and HER2+ Breast Cancers
57 Tumor Morphology Concordance in Multifocal/Multicentric Triple- Negative and HER2+ Breast Cancers
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