EFFICACY AND SAFETY OF ERIBULIN COMPARED WITH CONTROL THERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER- A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS
Author(s)
Pagada A1, Mishra RK2, Bolshete P2, Rai MK1
1IQVIA Consulting and Information Services India Private Limited, Mumbai, India, 2Tata Consultancy Services, Thane, India
OBJECTIVES: To evaluate the efficacy and safety of eribulin (mono or combined therapy) compared with control therapy in patients with locally advanced or metastatic breast cancer (MBC). METHODS: Literature search was conducted using Embase, PubMed and the Cochrane Library databases up to January 2018. Randomized controlled trials (RCTs) comparing eribulin (mono or combined therapy) to control therapy in patients with locally advanced or metastatic breast cancer were included. Interventions included in the comparator arms were ixabepilone, capecitabine, gemcitabine, paclitaxel, doxorubicin and cyclophosphamide. Main outcomes assessed were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). The pooled hazard ratio (HR), odds ratio (OR) and risk ratio (RR) were estimated, with associated 95% confidence interval (CI) using random-effects model in case of substantial heterogeneity (I >50%) performed in Review Manager (version 5.3.). RESULTS: Of the 425 studies identified in the initial search, five trials involving 2136 patients were analyzed. Eribulin therapy resulted in a statistically significant OS compared with control therapy (HR, 0.85; 95% CI, 0.76 to 0.95; 3 studies). However, no significant difference was observed in PFS (HR, 0.99; 95% CI, 0.88 to 1.11; 3 studies) and in ORR (OR, 1.66; 95% CI, 0.95 to 2.89; 5 studies) with eribulin therapy. Patients in the eribulin group had a non-significant risk for grade 3/4 neutropenia (RR: 1.82; 95% CI, 0.69 to 4.84), peripheral neuropathy (RR: 2.50; 95% CI, 0.51 to 12.13), fatigue (RR: 0.29; 95% CI, 0.06 to 1.49), and anemia (RR: 1.07; 95% CI, 0.61 to 1.89). CONCLUSIONS: Eribulin therapy demonstrated improved OS compared to control therapy with tolerable safety profile in advanced MBC. However, this benefit was not observed in terms of PFS and ORR.
Conference/Value in Health Info
2018-09, ISPOR Asia Pacific 2018, Tokyo, Japan
Value in Health, Vol. 21, S2 (September 2018)
Code
PCN2
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes, Safety & Pharmacoepidemiology
Disease
Oncology