Eribulin for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry


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Hartmut Kristeleit1, Ian Brown2, Vivek Misra3, Natasha Mithal4, Laura Kenny5

1Guy’s and St Thomas’ NHS Foundation Trust, London, UK,2Eisai Ltd, Hatfield, UK,3Christie NHS Foundation Trust, Manchester, UK,4Kent Oncology Centre, Canterbury, UK,5Imperial College Healthcare NHS Trust, London, UK

Abstract

Background

Eribulin is indicated for locally advanced/metastatic breast cancer that has progressed after ≥1 chemotherapeutic regimens for advanced disease. This study evaluated the safety and effectiveness of eribulin in routine clinical practice.

Method

76 Patients who had ≤2 prior chemotherapeutic regimens for advanced disease were enrolled from 13 sites in UK/Ireland/Denmark. Eribulin was administered at a dose of 1.23 mg/m2 on days 1 and 8 of every 21-day cycle. All patients received ≥1 cycle of eribulin. Toxicities were graded by CTCAEv4.0, and efficacy assessed using imaging as per local practice.

Results

Mean age was 59y (range 34-78y). Hormone-receptor positive patients: 75%; HER2-positive: 13%; triple-negative: 22%. Median sites of disease=2 (range: 1-6). Visceral disease: 81%; 1 patient had bone-only disease. Prior hormone therapy for advanced disease: 40%. Eribulin was first-line chemotherapy in 2% of patients, second-line in 20%, and third-line in 78%.

Adverse events (AEs) occurred in 99% of patients. By investigator assessment, 88% of patients had eribulin-related AEs. The most common AEs (all grades) were fatigue (65%), alopecia (37%), nausea (36%), constipation (30%), and peripheral neuropathy (28%). Serious AEs occurred in 42% of patients; 24% had eribulin-related SAEs. The most common Grade 3/4 AEs were neutropenia (11%), febrile neutropenia (9%, all Grade 3, all resolved), dyspnea and pleural effusion (5% each). There were no fatal AEs. Dose reductions occurred in 32% of patients, 42% experienced dose delays, and 9% discontinued due to toxicity. Median number of eribulin cycles=5 (range: 1-26). Response rates in evaluable patients were 3% complete response, 20% partial response, and 36% stable disease. The median time to progression was 4.0 months.

Conclusion

Eribulin treatment was well tolerated with a manageable AE profile. Clinical activity was high given the large proportion of patients receiving third-line treatment, with approximately two-thirds of evaluable patients showing clinical benefit.

Background

Eribulin is indicated for locally advanced/metastatic breast cancer that has progressed after at least one prior chemotherapy for advanced disease. The aim of this study was to evaluate the safety-profile and effectiveness in routine clinical practice.

 

Method

77 patients who had ≤2 prior chemotherapeutic regimens for advanced disease were enrolled from 13 sites in UK/Ireland/Denmark. This analysis looks at 67 patients who had received ≥1 cycle of eribulin. Toxicities were graded according to NCI CTCAEv4.0, efficacy assessed using imaging as per local practice.

 

Results

Median age was 59 (range 34-78). 15% were HER2 positive, 72% ER/PR positive and 18% triple-negative.

 

Median sites of disease was 2 (range 1-5), 79% of patients had visceral disease.

 

Eribulin was 1st line chemotherapy for advanced disease in 3% of patients, 2nd line in 19% and 3rd line in 78%.

 

AEs were recorded in 96% of patients. 84% of patients had eribulin related AEs judged by investigator assessment. The most common AEs (all grades) were fatigue (58%), alopecia (34%), constipation (33%) and nausea (31%). SAEs occurred in 42% of patients, 25% of patients had SAEs that were investigator assessed as eribulin related. Grade 3/4 events occurred in 36% of patients, most common were neutropenia (11%) and febrile neutropenia (10%, all G3 and resolved). There were no deaths assessed by investigators as treatment related.

 

At least 1 dose reduction occurred in 30% of patients and dose delay(s) in 39% of patients, haematological toxicity was the most common reason. Treatment was discontinued due to toxicity in 13% of patients.

 

Mean number of eribulin cycles received was 5 (range 1-16). Response rates were 2% CR, 22% PR, 36% SD and 40% PD.

 

Conclusion

Use of eribulin in routine clinical practice was well tolerated with a manageable side effect profile. Efficacy rates were high, 60% of patients exhibited a clinical benefit.