59pdfinal analysis of serum biomarkers in patients pts from the phase iii study of lenvatinib len vs sorafenib sor in unresectable hepatocellular carcinoma uhcc reflect

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Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer

Purpose. Following the demonstrated efficacy and safety of eribulin mesylate in heavily pretreated patients with metastatic breast cancer, an exploratory analysis was performed to investigate the effect of age in these patients. Methods. Data were pooled from two single-arm phase II studiesandoneopen-label randomizedphase III study inwhich patients received eribulin mesylate at 1.4 mg/m2 as 2- to 5- minute intravenous infusions on days 1 and 8 of a 21-day cycle. The effect of age on median overall survival (OS), progressionfree survival (PFS), overall response rate (ORR), clinical benefit rate (CBR), and incidence of adverse events (AEs) was calculated for four age groups (<50 years, 50-59 years, 60-69 years,70 years). Results. Overall, 827 patients were included in the analysis (<50 years, n 5 253; 50-59 years, n 5 289; 60-69 years, n5206;70 years, n579). Age had no significant impact on OS (11.8 months, 12.3 months, 11.7 months, and 12.5 months, respectively;p5.82),PFS (3.5months, 2.9months, 3.8months, and 4.0 months, respectively; p 5.42), ORR (12.7%, 12.5%, 6.3%, and 10.1%, respectively), or CBR (20.2%, 20.8%, 20.4%, and 21.5%, respectively). Although some AEs had higher incidence in either the youngest or the oldest subgroup, there was no overall effect of age on the incidence of AEs (including neuropathy, neutropenia, and leukopenia). Conclusion. Eribulin monotherapy in these selected older patients with good baseline performance status led to OS, PFS, ORR, CBR, and tolerability similar to those of younger patients with metastatic breast cancer.The benefits and risks of eribulin appear to be similar across age groups. AlphaMed Press 2014.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Correction: Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma (British Journal of Cancer, (2019), 121, 3, (218-221), 10.1038/s41416-019-0506-6)

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Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): A phase 3 open-label randomised study

Background: Treatments with survival benefit are greatly needed for women with heavily pretreated metastatic breast cancer. Eribulin mesilate is a non-taxane microtubule dynamics inhibitor with a novel mode of action. We aimed to compare overall survival of heavily pretreated patients receiving eribulin versus currently available treatments. Methods: In this phase 3 open-label study, women with locally recurrent or metastatic breast cancer were randomly allocated (2:1) to eribulin mesilate (1.4 mg/m 2 administered intravenously during 2-5 min on days 1 and 8 of a 21-day cycle) or treatment of physician's choice (TPC). Patients had received between two and five previous chemotherapy regimens (two or more for advanced disease), including an anthracycline and a taxane, unless contraindicated. Randomisation was stratified by geographical region, previous capecitabine treatment, and human epidermal growth factor receptor 2 status. Patients and investigators were not masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00388726. Findings: 762 women were randomly allocated to treatment groups (508 eribulin, 254 TPC). Overall survival was significantly improved in women assigned to eribulin (median 13.1 months, 95% CI 11.8-14.3) compared with TPC (10.6 months, 9.3-12.5; hazard ratio 0.81, 95% CI 0.66-0.99; p=0.041). The most common adverse events in both groups were asthenia or fatigue (270 [54%] of 503 patients on eribulin and 98 [40%] of 247 patients on TPC at all grades) and neutropenia (260 [52%] patients receiving eribulin and 73 [30%] of those on TPC at all grades). Peripheral neuropathy was the most common adverse event leading to discontinuation from eribulin, occurring in 24 (5%) of 503 patients. Interpretation: Eribulin showed a significant and clinically meaningful improvement in overall survival compared with TPC in women with heavily pretreated metastatic breast cancer. This finding challenges the notion that improved overall survival is an unrealistic expectation during evaluation of new anticancer therapies in the refractory setting. Funding: Eisai. © 2011 Elsevier Ltd.SCOPUS: ar.jinfo:eu-repo/semantics/publishe