Abstract 326P
Background
Real-world evidence is playing an increasingly important role in healthcare with the data being utilized by healthcare professionals as well as regulatory bodies to monitor post-market safety, adverse events and even label updates. TreatER+ight is the first prospective observational study collecting real-world evidence on Canadian HR+ HER2– advanced breast cancer patients currently receiving endocrine therapy (ET) alone or in combination with targeted therapy (TT) (NCT02753686).
Methods
This exploratory analysis focuses more specifically on treatment sequencing around the CDK4/6 class at various lines of treatment given the adoption of the CDK4/6 class within the treatment paradigm. At data cut-off of December 16th 2019, 400 patients were enrolled from 24 sites since March 2016 with 193 patients receiving CDK4/6is at baseline. Data from 396 patients were evaluable for this analysis and will be shared.
Results
Table: 326P
| Baseline Characteristics | Overall (n=396) | CDK4/6 + ET (n=193) | |
| Median age, years (range) | 67 (23 – 92) | 65 (23-87) | |
| ECOG 0,1,2* | 67, 107, 22 | 26, 46, 7 | |
| Post-menopausal* | 284 (71.7%) | 125 (64.7%) | |
| Pre/peri-menopausal* | 110 (27.7%) | 66 (34.1%) | |
| Treatment by line of therapy | First line (N = 257) | Second line (N = 150) | Third line (N = 100) |
| CDK4/6 + ET | 157 (61.8%) 81 (31.5%) 15 (5.8%) 4 (1.5%) | 67 (44.6%) 39 (26%) 16 (10.6%) 28 (18.6%) | 25 (25%) 18 (18%) 36 (36%) 21 (21%) |
| ET | |||
| Chemo | |||
| mTOR + ET | |||
| Most Commonly Observed Sequencing Trends from first to third-line of therapy (Data Available for 88 patients) | |||
| CDK -> mTOR -> Chemo n = 12 CDK -> ET -> mTOR n = 4 CDK -> ET -> Chemo n = 2 | ET -> CDK -> Chemo n = 9 ET -> CDK -> mTOR n = 7 ET -> mTOR -> CDK n = 4 |
* Data missing for some patients at the time of this analysis
Conclusions
The majority of patients in the database have received a combination of targeted plus endocrine therapy as their first treatment for metastatic disease with the most common treatment being a CDK4/6-based therapy. Of the patients treated with a CDK4/6i (N = 249) a majority received this therapy in the 1L (63%) or 2L (27%) with a median duration on therapy of 19.3 [95% CI, 13.3 to 21.8] and 14.7 [95% CI, 8.5 to 22.8] months; respectively. For patients receiving CDK4/6 therapy in 1L, the most common 2L treatment was either an endocrine therapy single agent or everolimus + exemestane which was accessed by compassionate means or unique provincial coverage. In addition, baseline demographics, duration on therapy kaplan-meier curves, biomarker information and method of access to therapy will be displayed and compared to outcomes from phase III registration clinical trials.
Clinical trial identification
NCT02753686.
Editorial acknowledgement
Legal entity responsible for the study
Novartis Pharmaceuticals Canada.
Funding
Novartis Pharmaceuticals Canada.
Disclosure
C. Doyle: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis Pharmaceuticals Canada. T.A. Vandenberg: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche Pharmaceuticals Canada. C. Ferrario: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis Pharmaceuticals Canada; Honoraria (self), Research grant/Funding (institution): Pfizer Pharmaceuticals Canada; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche Pharmaceuticals Canada; Honoraria (self), Research grant/Funding (institution): Merck Pharmaceuticals Canada; Research grant/Funding (institution): Eli Lilly Pharmaceuticals Canada; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bayer Pharmaceuticals Canada; Research grant/Funding (institution): Astellas Pharmaceuticals Canada; Research grant/Funding (institution): Celldex. N. Califaretti: Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada. N.N. Iqbal: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada; Honoraria (self): Janssen; Honoraria (self), Advisory/Consultancy: Pfizer Pharmaceuticals Canada; Advisory/Consultancy: Lilly Pharmaceuticals Canada; Honoraria (self): Merck Pharmaceuticals Canada. S. Kulkarni: Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada. M. Mates: Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada. J. Hilton: Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada; Advisory/Consultancy: Pfizer Pharmaceuticals Canada; Advisory/Consultancy: Puma Pharmaceuticals Canada; Advisory/Consultancy: BMS Pharmaceuticals Canada; Advisory/Consultancy: Merck Pharmaceuticals Canada; Advisory/Consultancy: Lilly Pharmaceuticals Canada. N. Bouganim: Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada. J-W. Henning: Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada. S. Haftchenary: Full/Part-time employment: Novartis Pharmaceuticals Canada. S.R. Perri: Full/Part-time employment: Novartis Pharmaceuticals Canada. S.K.L. Chia: Advisory/Consultancy, Research grant/Funding (institution): Novartis Pharmaceuticals Canada; Advisory/Consultancy, Research grant/Funding (institution): Genomic health; Advisory/Consultancy: Pfizer Pharmaceuticals Canada; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca Pharmaceuticals Canada.