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Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis
abstracts
Annals of Oncology
Table: 326P
v114 | Breast Cancer, Metastatic
327P
Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis
M. Torres1, X. Liu2, J. Mardekian3, L. McRoy4 1 Department of Radiation Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA, 2US Medical Affairs, Pfizer Inc, Peapack, NJ, USA, 3Statistics, Pfizer Inc, New York, NY, USA, 4Global Medical Affairs, Pfizer Inc, New York, NY, USA Background: CDK4/6 inhibitor in combination with an aromatase inhibitor (AI) as initial endocrine therapy has become standard of care for patients with HRþ/HER2– advanced/metastatic breast cancer (mBC). Large representative studies are needed to understand effectiveness of CDK4/6 inhibitor þ AI in the real-world clinical setting. This study describes patient characteristics and real-world progression-free survival (rwPFS) in mBC patients treated with Palbociclib þ AI in the first line setting. Methods: The Flatiron longitudinal database contains information from 2 million cancer patients treated in the US from 275 cancer clinics. From this database, 878 HRþ/ HER2– mBC women treated with Palbociclib þ AI as first-line therapy between February 2015 and August 2018 with at least 3 months of follow-up available were identified. Patients were followed from start of Palbociclib þ AI therapy to November 2018, death, or last visit, whichever came first. rwPFS was defined as months from start of Palbociclib þ AI to death or disease progression based on clinical assessment or radiographic progression with or without biopsy confirmation. Kaplan-Meier methods were used to estimate survival proportions in rwPFS. Results: In our cohort of 878 eligible patients with a median follow-up of 19.4 months, 66.9% were white, mean age was 65.2 years, 50.8% had visceral disease (liver and/or lung involvement). Among these patients, 92.7% received Letrozole along with Palbociclib. Median rwPFS was 21.9 months (95%CI ¼ 20.1 – 28.2). Table presents median rwPFS by subgroups. Conclusions: These findings from a large cohort of patients in US routine clinical practices support first-line Palbociclib þ AI therapy as standard of care for HRþ/HER2advanced/metastatic breast cancer.
Volume 30 | Supplement 5 | October 2019
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Disclosure: M. Martın: Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Eli Lilly and Company; Honoraria (self): Taiho Oncology; Honoraria (self): Pharmamar; Honoraria (self): Roche/Genentech. S. Johnston: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy: Eli Lilly and Company; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Research grant / Funding (self): Puma Biotechnology; Speaker Bureau / Expert testimony: Eisai. J. Huober: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eli Lilly and Company; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy: Abbvie. A. Di Leo: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai; Honoraria (self), Advisory / Consultancy: Genomic Health; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eli Lilly and Company; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Daiichi Sankyo; Advisory / Consultancy: Genentech; Advisory / Consultancy: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Puma Biotechnology. V.A. Andre: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. H.R. Martin: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. M.C. Hardebeck: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. M.P. Goetz: Honoraria (self): Genomic Health; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly and Company; Advisory / Consultancy: Biovica; Advisory / Consultancy: Novartis; Advisory / Consultancy: Sermonix; Advisory / Consultancy: Context Pharm; Research grant / Funding (institution): Pfizer. All other authors have declared no conflicts of interest.
abstracts
Annals of Oncology
Table: 327P Real-world progression-free survival (rwPFS) by subgroups Median rwPFS (months)
95%CI
878
21.9
20.1 – 28.2
407 294 177
21.8 21.4 28.6
18.8—26.4 16.1—29.9 20.1—NE
587 62 18 28 183
22.6 NE 13.8 NE 19.9
20.3—28.6 11.3—NE 7.8—NE 5.9—NE 16.1—NE
67 811
19.5 22.4
14.3—25.9 20.2—28.7
311 119 359 89
21.9 21.0 22.2 26.5
17.6—33.1 13.1—28.6 19.5—32.7 15.5—NE
322 225 623 255 446 432
22.4 21.0 17.3 NE 14.8 33.1
18.9—NE 16.5—28.3 14.6—20.2 NE 12.7—18.3 28.3—NE
352 266 256
NE 20.2 11.3
NE 17.1—33.0 9.8—13.7
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz242.022/5576979 by guest on 24 October 2019
All patients Age, year 18-64 65-74 75 Ethnicity White Black Asian Hispanic Other/unknown Menopausal status Premenopausal (Age50) Postmenopausal (Age>50) Disease stage at initial diagnosis 1 or 2 3 4 (De novo) Unknown ECOG Score 0 1þ No bone-only disease Bone-only disease Visceral disease Nonvisceral disease No# of metastic sites 1 2 3þ
N
NE ¼ not estimable Legal entity responsible for the study: Pfizer Inc. Funding: Pfizer Inc. Disclosure: M. Torres: Full / Part-time employment: Emory University; Research grant / Funding (self): Pfizer Inc. X. Liu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. J. Mardekian: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. L. McRoy: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc.
Volume 30 | Supplement 5 | October 2019
doi:10.1093/annonc/mdz242 | v115
Annals of Oncology
Table: 326P
v114 | Breast Cancer, Metastatic
327P
Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis
M. Torres1, X. Liu2, J. Mardekian3, L. McRoy4 1 Department of Radiation Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA, 2US Medical Affairs, Pfizer Inc, Peapack, NJ, USA, 3Statistics, Pfizer Inc, New York, NY, USA, 4Global Medical Affairs, Pfizer Inc, New York, NY, USA Background: CDK4/6 inhibitor in combination with an aromatase inhibitor (AI) as initial endocrine therapy has become standard of care for patients with HRþ/HER2– advanced/metastatic breast cancer (mBC). Large representative studies are needed to understand effectiveness of CDK4/6 inhibitor þ AI in the real-world clinical setting. This study describes patient characteristics and real-world progression-free survival (rwPFS) in mBC patients treated with Palbociclib þ AI in the first line setting. Methods: The Flatiron longitudinal database contains information from 2 million cancer patients treated in the US from 275 cancer clinics. From this database, 878 HRþ/ HER2– mBC women treated with Palbociclib þ AI as first-line therapy between February 2015 and August 2018 with at least 3 months of follow-up available were identified. Patients were followed from start of Palbociclib þ AI therapy to November 2018, death, or last visit, whichever came first. rwPFS was defined as months from start of Palbociclib þ AI to death or disease progression based on clinical assessment or radiographic progression with or without biopsy confirmation. Kaplan-Meier methods were used to estimate survival proportions in rwPFS. Results: In our cohort of 878 eligible patients with a median follow-up of 19.4 months, 66.9% were white, mean age was 65.2 years, 50.8% had visceral disease (liver and/or lung involvement). Among these patients, 92.7% received Letrozole along with Palbociclib. Median rwPFS was 21.9 months (95%CI ¼ 20.1 – 28.2). Table presents median rwPFS by subgroups. Conclusions: These findings from a large cohort of patients in US routine clinical practices support first-line Palbociclib þ AI therapy as standard of care for HRþ/HER2advanced/metastatic breast cancer.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz242.022/5576979 by guest on 24 October 2019
Disclosure: M. Martın: Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Eli Lilly and Company; Honoraria (self): Taiho Oncology; Honoraria (self): Pharmamar; Honoraria (self): Roche/Genentech. S. Johnston: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy: Eli Lilly and Company; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Research grant / Funding (self): Puma Biotechnology; Speaker Bureau / Expert testimony: Eisai. J. Huober: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eli Lilly and Company; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy: Abbvie. A. Di Leo: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai; Honoraria (self), Advisory / Consultancy: Genomic Health; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eli Lilly and Company; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Daiichi Sankyo; Advisory / Consultancy: Genentech; Advisory / Consultancy: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Puma Biotechnology. V.A. Andre: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. H.R. Martin: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. M.C. Hardebeck: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. M.P. Goetz: Honoraria (self): Genomic Health; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly and Company; Advisory / Consultancy: Biovica; Advisory / Consultancy: Novartis; Advisory / Consultancy: Sermonix; Advisory / Consultancy: Context Pharm; Research grant / Funding (institution): Pfizer. All other authors have declared no conflicts of interest.
abstracts
Annals of Oncology
Table: 327P Real-world progression-free survival (rwPFS) by subgroups Median rwPFS (months)
95%CI
878
21.9
20.1 – 28.2
407 294 177
21.8 21.4 28.6
18.8—26.4 16.1—29.9 20.1—NE
587 62 18 28 183
22.6 NE 13.8 NE 19.9
20.3—28.6 11.3—NE 7.8—NE 5.9—NE 16.1—NE
67 811
19.5 22.4
14.3—25.9 20.2—28.7
311 119 359 89
21.9 21.0 22.2 26.5
17.6—33.1 13.1—28.6 19.5—32.7 15.5—NE
322 225 623 255 446 432
22.4 21.0 17.3 NE 14.8 33.1
18.9—NE 16.5—28.3 14.6—20.2 NE 12.7—18.3 28.3—NE
352 266 256
NE 20.2 11.3
NE 17.1—33.0 9.8—13.7
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz242.022/5576979 by guest on 24 October 2019
All patients Age, year 18-64 65-74 75 Ethnicity White Black Asian Hispanic Other/unknown Menopausal status Premenopausal (Age50) Postmenopausal (Age>50) Disease stage at initial diagnosis 1 or 2 3 4 (De novo) Unknown ECOG Score 0 1þ No bone-only disease Bone-only disease Visceral disease Nonvisceral disease No# of metastic sites 1 2 3þ
N
NE ¼ not estimable Legal entity responsible for the study: Pfizer Inc. Funding: Pfizer Inc. Disclosure: M. Torres: Full / Part-time employment: Emory University; Research grant / Funding (self): Pfizer Inc. X. Liu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. J. Mardekian: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. L. McRoy: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc.
Volume 30 | Supplement 5 | October 2019
doi:10.1093/annonc/mdz242 | v115