Real-world effectiveness of ribociclib + aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line treatment: baseline data from the RIBANNA study

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%).

Tab. 1:

Baseline demographics and characteristics; *Remaining cases unknown/unavailable.

	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 M1/M2, %	1/88*	0/92*	0/90*

Conclusions:

Population characteristics from the RIBANNA study show a diverse group of patients from a real-world Setting.