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DOI: 10.1055/s-0039-1688074
Real-world effectiveness of ribociclib + aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line treatment: baseline data from the RIBANNA study
Publication History
Publication Date:
28 May 2019 (online)
Background:
Ribociclib, a selective CDK4/6 inhibitor, in combination with an aromatase inhibitor (AI) is approved for the treatment of HR+/HER2- advanced breast cancer (aBC). Real-world evidence for the effectiveness, safety and tolerability of ribociclib + AI in routine clinical practice is needed to support its use.
Methods:
RIBANNA (CLEE011ADE03) is a non-interventional study running in Germany since October 2017 involving up to 3020 postmenopausal patients receiving ribociclib + AI, endocrine monotherapy (ET), or chemotherapy (CT) as first-line treatment for HR+/HER2- aBC. Further lines of treatment are documented to examine outcomes of sequential therapy.
Results:
461 patients were enrolled to October 9, 2018 (Table 1). The first-line mean daily ribociclib dose was 382 mg including and 540 mg excluding dose interruptions; mean exposure to ribociclib was 128 days. Ribociclib was given in combination with anastrozole (8%), exemestane (7%), and letrozole (83%); ET comprised a selective estrogen receptor degrader (25%), nonsteroidal AI (64%), steroidal AI (5%), and a selective estrogen receptor modulator (7%).
Ribociclib + AI (N = 350) |
Endocrine therapy (N = 48) |
Chemotherapy (N = 63) |
|
Mean age, years (SD) |
67 (10) |
71 (12) |
62 (10) |
Median time since initial diagnosis, years |
5.5 |
6.5 |
3.9 |
Median time since diagnosis of metastases/relapse, days |
22 |
20.5 |
21 |
T Stage at start of study TX/T0/T1/T2/T3/T4, % |
20/8/12/24/7/15* |
23/8/15/23/8/8* |
18/0/10/28/10/23* |
N Stage at start of study NX/N0/N1/N2/N3, % |
24/20/25/11/5* |
27/31/12/15/0* |
23/18/35/5/10* |
M Stage at start of study |
1/88* |
0/92* |
0/90* |
Conclusions:
Population characteristics from the RIBANNA study show a diverse group of patients from a real-world Setting.