Abstract 318P
Background
This study aimed to capture treatment paradigms regarding the administration of EVE in early lines of HR+/HER2- aBC and to identify factors linked to EVE utilization in the first (L1) or second (L2) line in the routine care in Greece.
Methods
Multicenter, single-visit, observational drug utilization study that consecutively enrolled female outpatients with HR+/HER2- aBC treated with EVE in L1 (EVE1) or L2 (EVE2).
Results
Between July 2016 and March 2018, 88 eligible patients were enrolled at 12 hospital sites. Of the patients, 46.6% (N=41) were initiated on EVE1 and 53.4% (N=47) on EVE2. Of patients in EVE1 and EVE2, 75.6% and 59.6%, respectively, had been diagnosed at an earlier BC stage, with a median DFI of 3.8 and 7.9 years, respectively. Management of early BC stages included surgery and adjuvant chemotherapy (CT) and/or endocrine therapy (ET) in all patients, while adjuvant radiotherapy was given to 77.4% and 67.9% of patients in EVE1 and EVE2, respectively. Specifically, CT plus ET was given to 74.2% and 71.4%, ET only to 22.6% and 21.4%, and CT only to 3.2% and 7.1% of patients in EVE1 and EVE2, respectively. Main physician-reported reasons for not including an mTOR inhibitor in L1 were ‘tumor biology/aggressiveness’ (36.2%), ‘patient’s age’ (31.9%), and ‘patient’s preference’ (21.3%). In multivariable analysis, physician-classified high tumor volume (OR: 5.42; 95%CI: 1.18-24.83); >5 metastatic lesions (OR: 7.64; 95%CI: 2.03-28.79), medical/surgical history and/or >1 comorbidity (OR: 6.16; 95%CI: 1.74-21.87); and endocrine resistance (OR: 12.74; 95%CI: 2.80-58.01) at L1, were positively associated with EVE administration in L1.
Table: 318P
| Patient characteristics | At the start of 1st Line | At the start of 2nd Line | |
| EVE1 (N=41) | EVE (N=47) | EVE2 (N=47) | |
| Age (years), mean ± standard deviation | 64.7±10.6 | 64.8±13.3 | 66.8±13.4 |
| PS0 | 65.9% | 59.6% | 53.2% |
| High tumor volume | 24.4% | 14.9% | 26.1% |
| Endocrine resistance | 65.9% | 29.8% | 87.2% |
| Distant metastases | 100% | 100% | 100% |
| >5 lesions | 73.2% | 48.9% | 70.2% |
| Visceral | 56.1% | 40.4% | 48.9% |
| Bone only | 29.3% | 38.3% | 34.0% |
| Bone + other non visceral | 7.3% | 19.1% | 14.9% |
| Other non-visceral only | 7.3% | 2.1% | 2.1% |
| Medical/Surgical history, Comorbidity | 43.9% | 19.1% | 23.4% |
| EVE starting dose | |||
| 10mg EVE + 25mg exemestane once daily | 92.7% | NA | 83% |
Conclusions
In routine care in Greece, endocrine resistance, high tumor volume, comorbidity burden, and number of metastases, are main contributors to EVE usage in L1.
Clinical trial identification
trial protocol number NA
release date: 5 July 2017
Editorial acknowledgement
Legal entity responsible for the study
Novartis Hellas.
Funding
Novartis Hellas.
Disclosure
The author has declared no conflicts of interest.