New agent improves survival in previously treated metastatic breast cancer

[kkmalaysia]

A new chemotherapy agent, eribulin, improves overall survival (OS) by about two-and-a-half months among women with heavily pre-treated metastatic breast cancer (MBC), according to a global, phase III trial.

“Until now, there hasn’t been a standard treatment for women with such advanced breast cancer. For those who have already received all of the recognized treatments, these are promising results,” said Dr. Christopher Twelves, the lead author of the study and head of the Clinical Cancer Research Groups at the Leeds Institute of Molecular Medicine and St. James’s Institute of Oncology in Leeds, UK

“The study has also favoured eribulin over conventional therapies in terms of overall response rate and progression free survival (PFS), with a manageable safety profile. The most frequent side effects with eribulin, as witnessed in the trial, were tiredness, low white blood cell count, hair loss, nausea and peripheral neuropathy,” added Twelves, while reporting the results of the Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus Eribulin (EMBRACE).

The participants included 762 women with MBC who had received two-to-five prior chemotherapies (CTs), including an anthracycline and a taxane, unless contraindicated. They were randomized to eribulin, or treatment of physician’s choice (TPC). TPC was any cytotoxic, hormonal or biologic monotherapy, or supportive care only. The primary endpoint was OS, while the secondary endpoints incuded PFS, objective response rate (ORR), duration of response (DOR) and safety.

Participants had a median age of 55.2 years and had received a median of four prior CTs. Sixteen percent of patients were HER2-positive, while 19 percent were triple-negative and 73 percent received prior capecitabine.

Patients in the eribulin group had a median overall survival of 13.1 months, significantly higher than the 10.7 months achieved in the TPC group.

Median PFS was 3.7 months for eribulin and 2.3 months for TPC (P=0.09; HR 0.85; 95% CI 0.70, 1.03). The ORR was 12 percent (0.4 percent complete response [CR], 11.5 percent partial response [PR]) for eribulin and 5 percent (0 percent CR; 5 percent PR) for TPC (P=0.005).

Median DOR was 4.1 months for eribulin and 6.7 months for TPC. Adverse effects of interest associated with eribulin included asthenia/fatigue (7.6 percent), neutropenia (44 percent) and peripheral neuropathy (8.4 percent).

“The EMBRACE findings are significant as approximately 50 percent of women with breast cancer go on to develop MBC, for which there is no cure currently. But now eribulin – a microtubule dynamics inhibitor, a synthetic analog of halichondrin B – may emerge as a new, effective option,” concluded Twelves.

Source: mims.com