Phase III Open-Label Randomized Study of Eribulin Mesylate Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

Abstract

PurposeThis phase III randomized trial (ClinicalTrials.gov identifier: NCT00337103) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer (MBC).Patients and MethodsWomen with MBC who had received prior anthracycline- and taxane-based therapy were randomly assigned to receive eribulin or capecitabine as their first-, second-, or third-line chemotherapy for advanced/metastatic disease. Stratification factors were human epidermal growth factor receptor-2 (HER2) status and geographic region. Coprimary end points were overall survival (OS) and progression-free survival (PFS).ResultsMedian OS times for eribulin (n = 554) and capecitabine (n = 548) were 15.9 and 14.5 months, respectively (hazard ratio [HR], 0.88; 95% CI, 0.77 to 1.00; P = .056). Median PFS times for eribulin and capecitabine were 4.1 and 4.2 months, respectively (HR, 1.08; 95% CI, 0.93 to 1.25; P = .30). Objective response rates were 11.0% for eribulin and 11.5% for capecitabine. Global health status and overall quality-of-life scores over time were similar in the treatment arms. Both treatments had manageable safety profiles consistent with their known adverse effects; most adverse events were grade 1 or 2.ConclusionIn this phase III study, eribulin was not shown to be superior to capecitabine with regard to OS or PFS.

Sustainability of Eribulin Treatment for Patients with Metastatic Breast Cancer: is the Cost of the Drug Related to the Benefit Produced (Effectiveness and Safety)? a Single Center Experience

“…While PFS is comparable to western data, the ORR, and DCR in our analysis was lower than other studies evaluating eribulin (8,9,10,11). The costs associated with eribulin therapy have proved acceptable if we consider eribulin a lifeextending, end-of-life treatment.…”

“…Despite the multiple options available, there is no consensus as to which drug is to be preferred in pretreated MBC (9,13,14). Innovative and expensive drugs often appear to be the main cost drivers in cancer treatment, particularly for MBC.…”

A phase II study of capecitabine plus cisplatin in metastatic triple-negative breast cancer patients pretreated with anthracyclines and taxanes

“…38,39 Eribulin had been suggested to be more effective in metastatic TNBC patients than in hormone receptor-positive patients in the EMBRACE study, 40 which recruited extensively pretreated MBC patients. On the other hand, a recently published phase III study had compared eribulin and capecitabine in MBC patients pretreated with anthracyclines and taxanes in an earlier line setting, 41 and shown that median OS of TNBC patients treated in eribulin group was 14.4 months, which was longer than in control group (14.4 vs 9.4 months; HR 0.70 [95% CI 0.55-0.91]). Meanwhile, another phase III study had evaluated the combination of cisplatin and gemcitabine as firstline therapy for TNBC patients, and reported a PFS of 7.73 months in this setting of patients, which was superior than the paclitaxel plus gemcitabine group (7.73 vs. 6.47 months, p D 0.009).…”

Eribulin Mesylate: Our Experience in a Real-Life Clinical Setting

“…Исходя из полученных данных, можно отметить высокую эффективность эрибулина в проведенном нами анализе. Для сравнения, ЧОО в исследовании EMBRACE составила 13 % и 12 % (оценка исследователя и независимая оцен-ка) соответственно [9]; в исследовании 301 объективный ответ по оценке исследователей составил 16,1 %, а по не-зависимой оценке -11,0 % [10][11]. Высокая ЧОО в на-шей работе, с одной стороны, говорит об эффективности препарата.…”

“…Далее компания инициировала открытое рандомизиро-ванное исследование III фазы (301 исследование) по изуче-нию эффективности эрибулина в сравнении с капецитаби-ном при местнораспространенном или мРМЖ у пациентов, получавших ранее антрациклины и таксаны [10].…”