Efficacy and Safety of Lipegfilgrastim for the Prophylaxis of Chemotherapy-induced Neutropenia in Breast Cancer Patients in Poland

IntroductionLipegfilgrastim is a long-acting glycopegylated granulocyte-colony stimulating factor (G-CSF) used to prevent chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). The aim of the current study was to obtain data on the drug efficacy and safety in real-world clinical practice.Material and methodsThis is an exploratory analysis of Polish breast cancer patients participating in a pan-European study of lipegfilgrastim in primary and secondary prophylaxis for patients receiving cytotoxic chemotherapy (Lonquex ObsErvational Cohort Study, LEOS). Patients were followed since the start of neutropenia prophylaxis until 6 to 8 weeks after the last dose of the lipegfilgrastim . The efficacy measures were chemotherapy dose reductions, omissions, delays and the proportion of the planned cumulative dose actually delivered.ResultsA total of 45 mostly high risk of FN patients were included in the analysis. Overall, 31 of 212 chemotherapy cycles (14.6%) were delayed in 19 patients (42.2%). Cumulative dose of chemotherapy was reduced in 1.4% of the cycles in 4.4% of the patients. The mean percentage of cumulative dose planned actually administrated was 99.95% across all cycles. Only one patient had FN. There were 15 episodes of neutropenia in 3 patients (6.7%), A total of 69 adverse events were reported, which 65% were drug-related. The most common were musculoskeletal pain (17.8%) and myalgia (11.1%) Four adverse events were serious and two of them were related to lipegfilgrastim.ConclusionsLipegfilgrastim proved to be effective and well-tolerated for CIN prophylaxis in patients with breast cancer receiving myelosuppressive chemotherapy in a real-life setting.

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Toxicities Associated with Docetaxel-Based Regimens in the Adjuvant Treatment of Early-Stage Breast Cancer: A Multicenter Prospective Real-Life Experience

Breast Care ◽

10.1159/000481339 ◽

2018 ◽

Vol 13 (2) ◽

pp. 119-123

Author(s):

Elie El Rassy ◽

Marwan Ghosn ◽

Fadi Farhat ◽

Ziad Bakouny ◽

Tarek Assi ◽

...

Keyword(s):

Breast Cancer ◽

Adverse Events ◽

Cancer Patients ◽

Life Experience ◽

Early Stage ◽

Real Life ◽

Early Stage Breast Cancer ◽

Efficacy And Safety ◽

Breast Cancer Patients ◽

Skin Reactions

Background: The present study reports on the efficacy and safety of adjuvant docetaxel in real-life patients with early-stage breast cancer. Methods: This is a prospective, multicenter, post-marketing study that evaluates the efficacy and safety of docetaxel-based regimens in patients with early breast cancer treated between 2007 and 2012. Results: A total of 698 female breast cancer patients receiving adjuvant docetaxel-based regimens were included in this study. Docetaxel monotherapy was administered in 4.2%, whilst most patients received polychemotherapy. Non-hematological adverse events included skin reactions in 32.7% of the subjects. Multiple adverse events were reported and most commonly included asthenia (66.5%), alopecia (43.4%), and diarrhea (24.2%). It is noteworthy that no fatal toxicities occurred. Several hematological adverse events were reported during treatment, with anemia being the most common. Conclusion: The results of this real-life experience, characterized by a relatively large sample size and long follow-up, confirm that docetaxel is effective and well tolerated in early-stage breast cancer patients.

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Efficacy and safety of pegfilgrastim in prophylaxis of chemotherapy-induced neutropenia in breast cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e12511 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e12511-e12511

Author(s):

Wen Xia ◽

Fei Xu ◽

Zhongyu Yuan ◽

Ruilian Xu ◽

Yi Jiang ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Secondary Prophylaxis ◽

Fixed Dose ◽

Efficacy And Safety ◽

Breast Cancer Patients ◽

Open Label ◽

End Point ◽

Chemotherapy Induced Neutropenia ◽

Grade 3

e12511 Background: The role of secondary prophylaxis with pegfilgrastim (brand name: Jinyouli) in Chinese breast cancer patients has not been fully evaluated. We assessed the efficacy and safety of pegfilgrastim in secondary prophylaxis of chemotherapy-induced neutropenia in breast cancer patients. Methods: In the open-label, single-arm, multicenter trail, 319 patients were enrolled. Breast cancer patients who developed grades 3/4 neutropenia in the previous chemotherapy cycle were given a fixed dose of subcutaneous pegfilgrastim, 24-48 hours after receiving the same chemotherapy regimen in the subsequent cycle. A dose of 6mg/cycle was given to patients weighed ≥45kg, and a dose of 3mg/cycle was given to patients weighed <45kg. The primary end point was the incidence of grade 3/4 neutropenia and secondary end point was the incidence of febrile neutropenia (FN). Results: In patients who received prophylactic pegfilgrastim, the incidence of grade 3/4 neutropenia was reduced to 12.53% (95% CI, 9.1 to 16.7) and the incidence of FN was reduced from 6.58% (95% CI, 4.1 to 9.9) in the screening cycle to 0.94% (95% CI, 0.2 to 2.7)(Table). Among the 40 patients who still developed grades 3/4 neutropenia after receiving pegfilgrastim, the absolute neutrophil count (ANC) was not significantly different between patients with (n=10) or without (n=30) additional filgrastim treatment. The most common adverse events (AEs) associated with pegfilgrastim were bone pain and myalgia, which were prevalent in 10% to 15% of the patients. However, both AEs were mild or moderate (grades 1/2). Conclusions: Prophylactic administration of pegfilgrastim is effective and safe in reducing the risk of grades 3/4 neutropenia and FN in breast cancer patients after receiving chemotherapy. [Table: see text]

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Efficacy and safety of eribulin in combination with trastuzumab in HER2-positive metastatic breast cancer patients: Real life experience

European Journal of Cancer ◽

10.1016/s0959-8049(20)30684-5 ◽

2020 ◽

Vol 138 ◽

pp. S59

Author(s):

E. Kovalenko ◽

L. Manzyuk ◽

V. Gorbunova ◽

I. Kolyadina ◽

L. Bolotina ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Cancer Patients ◽

Life Experience ◽

Real Life ◽

Metastatic Breast ◽

Efficacy And Safety ◽

Breast Cancer Patients ◽

Her2 Positive

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Efficacy and Safety of Capecitabine Alone or in Combination in Advanced Metastatic Breast Cancer Patients Previously Treated with Anthracycline and Taxane: A Systematic Review and Meta-Analysis

Oncology Research and Treatment ◽

10.1159/000510356 ◽

2020 ◽

Vol 43 (12) ◽

pp. 694-702

Author(s):

Louai Alsaloumi ◽

Shaima Shawagfeh ◽

Abdikarim Abdi ◽

Bilgen Basgut

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Adverse Events ◽

Cancer Patients ◽

Meta Analysis ◽

Metastatic Breast ◽

Efficacy And Safety ◽

Breast Cancer Patients ◽

Significant Difference ◽

Hand Foot Syndrome

Background: Capecitabine is frequently used alone or combined with other chemotherapy agents for the treatment of metastatic breast cancer in relapsed patients. Objective: The objective of this meta-analysis is to evaluate the effectiveness and safety of capecitabine monotherapy versus combination in the treatment of metastatic breast cancer patients pretreated with anthracycline and taxane. Methods: Eligible randomized controlled trials examining the efficacy and safety of capecitabine alone compared to capecitabine combination were systematically searched. Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and grades 3–4 drug-related adverse events were the outcomes assessed. Results: A total of 6,714 patients of 9 trials were involved in the pooled analysis. Our findings demonstrated that capecitabine combination is significantly superior to capecitabine monotherapy in improving PFS (hazard ratio [HR] 1.32, 95% CI 1.13–1.54, p < 0.0001) and ORR (risk ratio [RR] 0.67, 95% CI 0.54–0.83, p < 0.001), but it was insignificant in OS (HR 1.09, 95% CI 0.98–1.22, p = 0.12). On the other hand, the incidence of non-hematological adverse events such as hand-foot syndrome and diarrhea was lower in capecitabine combination compared to capecitabine monotherapy. Conclusion: Capecitabine-based combination chemotherapy showed superiority over capecitabine monotherapy in terms of PFS and ORR, with no significant difference in OS. Non-hematological adverse effects such as hand-foot syndrome were fewer with a combination regimen. However, hematological adverse events were fewer with capecitabine monotherapy regimen.

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