September 12, 2024

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Eribulin Shows Superior Survival Benefit for HER2-Negative Metastatic Breast Cancer

Eribulin Shows Superior Survival Benefit for HER2-Negative Metastatic Breast Cancer



Eribulin Shows Superior Survival Benefit for HER2-Negative Metastatic Breast Cancer

Approximately 80% of all breast cancers are HER2-negative, and chemotherapy is one of the cornerstone treatments for patients with this subtype.

Given that metastatic breast cancer remains incurable, extending survival while maintaining quality of life is crucial for these patients.

Among various chemotherapy regimens, eribulin has shown comparable survival benefits and potentially better quality of life improvements in second-line treatment of metastatic breast cancer compared to other chemotherapeutic agents.

To further evaluate the efficacy of eribulin as a frontline treatment, a research team led by scholars from Hokkaido University conducted a phase 3 clinical trial.

The results indicate that in first- and second-line treatment of HER2-negative metastatic breast cancer, eribulin provides superior overall survival benefits compared to another effective chemotherapeutic drug, S-1, while maintaining similar health-related quality of life for patients.

The findings were recently published in eClinicalMedicine, a journal under The Lancet. Eribulin is already approved in multiple regions, including China, for use in later-line chemotherapy for locally advanced or metastatic breast cancer. This study supports eribulin as a potential treatment option for more patients with HER2-negative metastatic breast cancer.

Eribulin Shows Superior Survival Benefit for HER2-Negative Metastatic Breast Cancer

This was a non-inferiority, randomized, controlled, open-label phase 3 trial conducted across 50 hospitals in Japan. Between June 2016 and October 2019, 300 patients with HER2-negative metastatic breast cancer were enrolled and randomly assigned in a 1:1 ratio to receive either eribulin (152 patients) or the active control drug S-1 (148 patients). Eribulin is a macrocyclic ketone analog of halichondrin B, which inhibits cancer cell growth by disrupting microtubule dynamics. S-1 is an oral fluoropyrimidine with advantages in survival and quality of life and is considered a frontline treatment option for HER2-negative metastatic breast cancer in some regions.

Notably, the proportions of patients who had not received previous chemotherapy for advanced breast cancer were 70.2% in the eribulin group and 70.1% in the control group, meaning that the majority of participants received first-line treatment in this study.

The primary endpoint focused on quality of life, assessing the time from treatment initiation to deterioration in overall health status. Quality of life analysis was performed on 270 patients with valid questionnaire data. The results showed that the risk of overall health deterioration within one year was similar between the two groups:

  • The median time to first deterioration in overall health status was 5.64 months (95% CI: 3.51-8.00 months) in the eribulin group and 5.28 months (95% CI: 3.28-7.80 months) in the control group.
  • The proportion of patients without deterioration in overall health status within one year was 33.8% in the eribulin group and 33.0% in the control group.

However, the non-inferiority of the overall health deterioration risk did not meet the pre-specified statistical target. One significant factor was that the actual number of enrolled and effectively surveyed patients was slightly lower than expected.

Quality of life was assessed using the widely accepted European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), with evaluations conducted every six weeks for the first 24 weeks (four assessments) and every nine weeks thereafter (two assessments) until week 42. Deterioration was defined as a decrease of more than 10 points in the overall health status score of the EORTC QLQ-C30 or death within one year of randomization. The overall response rate to the questionnaire was 85.6%.

The secondary endpoint focused on survival improvement, with patients in the eribulin group showing significantly longer survival. The median overall survival was 34.7 months in the eribulin group and 27.8 months in the control group (HR 0.72, 95% CI: 0.54-0.96; P=0.026). The median progression-free survival was 7.57 months in the eribulin group and 6.75 months in the control group (HR 0.88, 95% CI: 0.67-1.16; P=0.35).

Regarding safety, no new adverse events were observed during treatment.

Overall, this study suggests that eribulin, when used primarily as a first-line treatment, can significantly improve overall survival compared to the currently preferred chemotherapy drug, with a similar time to overall health deterioration. Continued validation of this therapy’s advantages in first-line treatment is anticipated, offering more options for breast cancer treatment.

Eribulin Shows Superior Survival Benefit for HER2-Negative Metastatic Breast Cancer


References:

[1] Ties Boerma, et al., (2024). Global epidemiology of use of and disparities in caesarean sections. The N Engl J Med, DOI: 10.1016/S0140-6736(18)31928-7

[2] Cancer Stat Facts: Female Breast Cancer Subtypes. Retrieved July 22, 2024 from https://seer.cancer.gov/statfacts/html/breast-subtypes.html

(source:internet, reference only)

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