Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: a multicenter retrospective study

Background: Eribulin is a nontaxane microtubule inhibitor approved in China for patients with advanced breast cancer who show progression after ⩾2 lines of chemotherapy. The aim of this study was to determine the efficacy and safety profile of eribulin and explore potential predictive factors for the efficacy of eribulin among Chinese women with metastatic breast cancer (MBC) in real-world practice. Patients and Methods: A total of 272 consecutive MBC patients who were treated with eribulin between November 2019 and October 2020 in 9 institutions nationwide were included in this study. Eribulin was administered intravenously at a dose of 1.4 mg/m2 on days 1 and 8 of a 21-day cycle. Efficacy outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Adverse events (AEs) were graded according to The National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.0. Results: Eribulin showed a median PFS of 4.1 months (95% confidence interval [CI] 3.6–4.6); however, the OS data were immature. The ORR was 17.6% and the CBR was 24.6%. A total of 51.8% of patients received eribulin monotherapy, while 48.2% of patients were treated with eribulin plus targeted therapy or other chemotherapy. The number of metastatic sites, duration of previous taxane treatment for MBC, and combination with bevacizumab were significant in Cox multivariate analysis ( p = 0.023, p = 0.048, and p = 0.046, respectively) and were significantly associated with PFS of eribulin. The most common AEs with eribulin treatment were hematological toxicities, including neutropenia, leukopenia, and anemia. Conclusion: Eribulin was effective with a manageable toxicity profile in clinical practice. Furthermore, when prescribed in combination with other agents, eribulin did not increase the toxic effects of each agent. Eribulin monotherapy or plus other agents is an alternative for the heavily pretreated patients with MBC.

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Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: A multicenter retrospective study.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e13057 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e13057-e13057

Author(s):

Yannan Zhao ◽

Ning Xie ◽

Wei Li ◽

Wenyan Chen ◽

Zheng Lv ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Real World ◽

Objective Response ◽

Locally Advanced ◽

Metastatic Breast ◽

Combination Regimen ◽

Real World Data ◽

Heavily Pretreated ◽

Pretreated Patients

e13057 Background: Eribulin is a nontaxane microtubule inhibitor approved in China for patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxane. The aim of this study was to evaluate the efficacy and safety profile of eribulin and explore potential predictive factors for the efficacy of eribulin among Chinese women with metastatic breast cancer (MBC) in real-world practice. Methods: A total of 272 consecutive MBC patients who were treated with eribulin from November 2019 to October 2020 in 9 institutions nationwide were included in this study. Eribulin was administered intravenously at a dose of 1.4 mg/m2 on days 1 and 8 of a 21-day cycle. Efficacy outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Adverse events (AEs) were graded according to The National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.0. Results: Eribulin showed a median PFS of 3.9 months (95% confidence interval [CI] 3.3–4.3); however, the OS data were immature. The ORR was 16.2%, and the CBR was 21.7%. A total of 51.8% of patients received eribulin monotherapy, and 48.2% of patients were treated with eribulin combine with targeted therapy or other chemotherapy. The number of metastatic sites, duration of previous taxane treatment for MBC, and combination regimen with bevacizumab were significant in Cox multivariate analysis (p=0.048, p=0.039, and p=0.045, respectively) and were significantly associated with PFS of eribulin. The most common AEs with eribulin treatment were hematological toxicities, including neutropenia, leukopenia, and anemia. Conclusions: This is the first cohort of eribulin real-world data base on retrieval currently after eribulin launched in China. Eribulin was effective with a manageable toxicity profile in clinical practice. Furthermore, when prescribed in combination with other agents, eribulin did not increase the toxic effects of each agents. Eribulin monotherapy or combine with other agents is alternative for the heavily pretreated patients with MBC. [Table: see text]

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Abstract P6-18-19: Real-world survival of heavily pretreated patients with refractory HR+, HER2- metastatic breast cancer receiving single-agent chemotherapy - A comparison with MONARCH 1

10.1158/1538-7445.sabcs18-p6-18-19 ◽

2019 ◽

Author(s):

H Rugo ◽

V Dieras ◽

J Cortes ◽

D Patt ◽

H Wildiers ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Real World ◽

Single Agent ◽

Metastatic Breast ◽

Heavily Pretreated ◽

Pretreated Patients ◽

Single Agent Chemotherapy

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Prospective Analysis of Patients with Metastatic Breast Cancer receiving Eribulin Mesylate as Second or More Lines of Chemotherapy: An Indian Experience

Clinical Medicine Insights Oncology ◽

10.1177/1179554918782475 ◽

2018 ◽

Vol 12 ◽

pp. 117955491878247 ◽

Cited By ~ 1

Author(s):

BJ Srinivasa ◽

Bhanu Prakash Lalkota ◽

Girish Badarke ◽

Diganta Hazarika ◽

Nasiruddin Mohammad ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Treatment Options ◽

Metastatic Breast ◽

Progression Free Survival ◽

Microtubule Inhibitor ◽

Eribulin Mesylate ◽

Primary Tumors ◽

Free Survival ◽

Heavily Pretreated

Background: Eribulin mesylate is a non-taxane microtubule inhibitor which can be used after anthracycline and taxane treatment in patients with metastatic breast cancer (MBC). The purpose of this study was to investigate the efficacy and safety of eribulin monotherapy in heavily pretreated patients with MBC. Methods: In this study, a total of 45 eligible patients with MBC who received eribulin in HCG Cancer Speciality Center from November 2014 to March 2016 were prospectively analyzed. Breslow (generalized Wilcoxon) survival analysis was carried out for progression-free survival and for overall survival. Patients were excluded if they had not taken treatment for 3 cycles and defaulted/expired during the treatment. Results: In this study, median age of patients was 52 years. A total of 27 (60%) patients had estrogen receptor and progesterone receptor (PR) positive primary tumors, whereas HER2 was overexpressed or amplified in 7 (15.6%); a triple negative subtype was recorded in 13 patients (28.9%). Regarding toxicity, 30 patients (66.67%) tolerated treatment well and 3 patients (6.67%) got anemia, 6 patients (13.3%) experienced neutropenia, and 7 (15.62%) patients had neurological toxicity. About 14 (31.1%) patients showed PR, 12 (26.7%) patients had stable disease (SD), whereas 19 (42.25%) patients showed progression disease (PD). Response evaluation at 6 cycles was possible in 18 patients and revealed that 4 (22.5%) patients showed PR, 10 (55.5%) patients had SD, whereas 4 (22.2%) patients had PD. Progression-free survival of the overall study population was 3.95 months. Conclusions: Eribulin mesylate is efficacious and tolerable chemotherapy as second- and third-line treatment options for MBC.

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Eribulin and carboplatin in heavily pretreated patients with metastatic breast cancer: A single institution experience.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.28_suppl.122 ◽

2015 ◽

Vol 33 (28_suppl) ◽

pp. 122-122

Author(s):

Patricia Martin Romano ◽

Iosune Baraibar ◽

Oscar Fernández-Hidalgo ◽

Marta Santisteban ◽

Jaime Espinós ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Survival Rates ◽

Metastatic Breast ◽

Progression Free Survival ◽

Complete Response ◽

Clinical Activity ◽

Heavily Pretreated ◽

Radiological Response ◽

Pretreated Patients

122 Background: In recent years many drug combinations have demonstrated clinical activity in heavily pretreated patients (pts) with metastatic breast cancer (MBC). Eribulin (E) in monotherapy has shown a beneficial effect in overall survival (OS) with slight rate of objective responses (OR) and poor effect in progression free survival (PFS). The Eribulin – Carboplatin (Cb) combination has been studied in other types of tumors in a phase Ib with promising results. We initiated an exploratory program with an off-label combination of E – Cb in pts with visceral disease and ECOG < 2. Methods: We retrospectively analyzed pts with MBC previously treated with anthracyclines, taxanes, and Capecitabine. Chemotherapy regimen consisted of E 1.1mg/m2 on days 1 and 8 and Cb AUC: 5 on day 1 every 21 days. Toxicity was assessed according to CTC criteria v 4.0. OR, PFS and OS rates were also evaluated. RECIST criteria were used to appraise radiological response. Results: Treatment was delivered in 10 pts. Median (M) age was 56 (range, 39-65). Pts characteristics were defined as follows: ECOG 0 (1 pt), 1 (6 pts) and 2 (3 pts); histological subtypes: luminal 9 pts and Her-2, 1 pt. M of previous lines was 7 (3-11). M of metastatic localizations were 3 (1-4). M of administered cycles was 6’5 (1-10). Grade 2 toxicity was asthenia 40%, peripheral neuropathy 10% and nausea - vomiting 10%. G 3 anemia and thrombopenia were noted in 20%. G 3-4 neutropenia was observed in 5 pts. Two pts required hospital admission due to febrile neutropenia. OR rate: complete response 10%, partial response 50% and stable disease 40%. Biochemical response rate was 80%. M of follow-up was 11 months, with M PFS and OS of 8 (4-11) and 18 months (4-18) respectively. Conclusions: Eribulin and Carboplatin is feasible, achieving remarkable response and survival rates with an acceptable toxicity profile in heavily pretreated patients with metastatic breast cancer. Preliminary results are promising and encourage us to continue recruiting patients.

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Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study

Therapeutic Advances in Medical Oncology ◽

10.1177/1758835920987651 ◽

2021 ◽

Vol 13 ◽

pp. 175883592098765

Author(s):

Raffaella Palumbo ◽

Rosalba Torrisi ◽

Federico Sottotetti ◽

Daniele Presti ◽

Anna Rita Gambaro ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Endocrine Therapy ◽

Real World ◽

Hormone Receptor ◽

Metastatic Breast ◽

Progression Free Survival ◽

Her2 Receptor ◽

Treatment Line ◽

Hormone Receptor Positive

Background: The CDK4/6 inhibitor palbociclib combined with endocrine therapy (ET) has proven to prolong progression-free survival (PFS) in women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC). Few data are available regarding the efficacy of such a regimen outside the clinical trials. Patients and methods: This is a multicentre prospective real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary aim was the clinical benefit rate (CBR); secondary aims were the median PFS, overall survival (OS) and safety. Patients received palbociclib plus letrozole 2.5 mg (cohort A) or fulvestrant 500 mg (cohort B). Results: In total, 191 patients (92 in cohort A, 99 in cohort B) were enrolled and treated, and 182 were evaluable for the analysis. Median age was 62 years (range 47–79); 54% had visceral involvement; 28% of patients had previously performed one treatment line (including chemotherapy and ET), 22.6% two lines and 15.9% three. An overall response rate of 34.6% was observed with 11 (6.0%) complete responses and 52 (28.6%) partial responses. Stable disease was achieved by 78 patients (42.9%) with an overall CBR of 59.8%. At a median follow-up of 24 months (range 6–32), median PFS was 13 months without significant differences between the cohorts. When analysed according to treatment line, PFS values were significantly prolonged when palbociclib-based therapy was administered as first-line treatment (14.0 months), to decrease progressively in second and subsequent lines (11.7 and 6.7 months, respectively). Median OS was 25 months, ranging from 28.0 months in 1st line to 18.0 and 13.0 months in 2nd and subsequent lines, respectively. Conclusions: Our data indicate that palbociclib plus ET is active and safe in HR+/HER2− MBC, also suggesting a better performance of the combinations in earlier treatment lines.

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Paclitaxel activity in heavily pretreated breast cancer: a National Cancer Institute Treatment Referral Center trial.

Journal of Clinical Oncology ◽

10.1200/jco.1995.13.8.2056 ◽

1995 ◽

Vol 13 (8) ◽

pp. 2056-2065 ◽

Cited By ~ 85

Author(s):

J S Abrams ◽

D A Vena ◽

J Baltz ◽

J Adams ◽

M Montello ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Progressive Disease ◽

Overall Response Rate ◽

Metastatic Breast ◽

Investigational Drug ◽

Single Institution ◽

Doxorubicin Treatment ◽

Heavily Pretreated ◽

Pretreated Patients

PURPOSE To provide paclitaxel, an investigational drug at the inception of this study, to women with chemotherapy-refractory metastatic breast cancer and to evaluate response and toxicity in these patients. PATIENTS AND METHODS Two hundred sixty-seven patients with progressive disease (PD) following at least two chemotherapy regimens for metastatic breast cancer and a contraindication to further doxorubicin treatment received paclitaxel either at 175 mg/m2 intravenously (IV) over 24 hours or at 135 mg/m2 if they had prior irradiation to 30% of marrow-bearing bone or a cumulative dose of mitomycin > or = 20 mg/m2. RESULTS In a subgroup of patients (n = 172) with measurable disease, four complete responses (CRs) and 36 partial responses (PRs) occurred, for an overall response rate of 23% (95% confidence interval [CI], 17% to 30%). No differences in response rates were noted according either to the number of prior chemotherapy regimens received or to whether patients were considered refractory to doxorubicin. The dose and schedule used in this trial resulted in febrile neutropenia in 45% of patients and a hospitalization rate of 49%. CONCLUSION Paclitaxel's activity in this multiinstitutional trial in heavily pretreated patients confirms the encouraging results attained in single-institution trials. Although at this dose and schedule paclitaxel may be considered too myelosuppressive for palliative care, supportive measures such as colony-stimulating factors and antibiotics were not used prophylactically. Current research efforts are focusing on whether paclitaxel's activity against breast cancer is dose- and/or schedule-dependent, and on what role it has in patients with less advanced disease.

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Phase II Study of Temsirolimus (CCI-779), a Novel Inhibitor of mTOR, in Heavily Pretreated Patients With Locally Advanced or Metastatic Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2005.66.130 ◽

2005 ◽

Vol 23 (23) ◽

pp. 5314-5322 ◽

Cited By ~ 347

Author(s):

Stephen Chan ◽

Max E. Scheulen ◽

Stephen Johnston ◽

Klaus Mross ◽

Fatima Cardoso ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Adverse Events ◽

Dose Level ◽

Locally Advanced ◽

Metastatic Breast ◽

Heavily Pretreated ◽

Pretreated Patients ◽

Grade 3 ◽

Time To Tumor Progression

Purpose In this study, two doses of temsirolimus (CCI-779), a novel inhibitor of the mammalian target of rapamycin, were evaluated for efficacy, safety, and pharmacokinetics in patients with locally advanced or metastatic breast cancer who had been heavily pretreated. Patients and Methods Patients (n = 109) were randomly assigned to receive 75 or 250 mg of temsirolimus weekly as a 30-minute intravenous infusion. Patients were evaluated for tumor response, time to tumor progression, adverse events, and pharmacokinetics of temsirolimus. Results Temsirolimus produced an objective response rate of 9.2% (10 partial responses) in the intent-to-treat population. Median time to tumor progression was 12.0 weeks. Efficacy was similar for both dose levels but toxicity was more common with the higher dose level, especially grade 3 or 4 depression (10% of patients at the 250-mg dose level, 0% at the 75-mg dose level). The most common temsirolimus-related adverse events of all grades were mucositis (70%), maculopapular rash (51%), and nausea (43%). The most common, clinically important grade 3 or 4 adverse events were mucositis (9%), leukopenia (7%), hyperglycemia (7%), somnolence (6%), thrombocytopenia (5%), and depression (5%). Conclusion In heavily pretreated patients with locally advanced or metastatic breast cancer, 75 and 250 mg temsirolimus showed antitumor activity and 75 mg temsirolimus showed a generally tolerable safety profile.

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