Found 2 Presentations For Request "329P"

Poster Display session 2 Poster Display session

329P - Comparative effectiveness of palbociclib plus letrozole vs letrozole for metastatic breast cancer in US real-world clinical practices (ID 3599)

Presentation Number
329P
Lecture Time
12:00 - 12:00
Speakers
  • Rachel M. Layman (Houston, TX, United States of America)
Session Name
Poster Display session 2
Location
Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
12:00 - 13:00

Abstract

Background

Palbociclib, the first clinically available oral CDK4/6 inhibitor, in combination with endocrine therapy has become standard of care for HR+/HER2- advanced/metastatic breast cancer (MBC). No real-world studies have examined relative effectiveness of palbociclib plus endocrine therapy compared with endocrine therapy alone. This study compared real-world progression free survival (rwPFS) of palbociclib plus letrozole (PB+LE) vs letrozole alone (LE) for MBC in US routine clinical practices.

Methods

We conducted a retrospective analysis of MBC patients from the Flatiron Health longitudinal database, which contains electronic health records from 275 cancer clinics representing more than 2 million actively treated cancer patients in the US. Between February 2015 and August 2018, 1416 HR+/HER2– MBC women started PB+LE (n = 798) or LE (n = 618) as first-line therapy. Patients were evaluated from start of PB+LE or LE to November 2018, death, or last visit, whichever came first. rwPFS was defined as months from start of PB+LE or LE to death or disease progression based on clinical assessment or evidence by radiographic scan/tissue biopsy. 1:1 propensity score (PS) matching was used to balance patient characteristics.

Results

Of 1416 eligible patients, 906 were 1:1 PS matched (453 for each cohort). Median follow-up was 16.8 months, median age was 68.0 years, 70% were white, and 49.7% had visceral disease. Median rwPFS was 24.5 months (95%CI = 20.7 – 32.7) in PB+LE cohort and 17.1 months (95%CI=13.7—19.8) in LE cohort (HR = 0.68, 95%CI=0.56—0.84, p =.0003). Table presents key patient characteristics and landmark rwPFS rates.

329P Patient characteristics and real-world progressionfree survival (rwPFS)

VariablePB+LE (N = 453)LE alone (N = 453)
 Median age (years)68.068.0
 White (%)69.870.6
 Median number of metastatic sites (n)2.02.0
 Bone only disease (%)26.932.2
 Visceral disease (%)49.749.7
 Median rwPFS, months (95%CI)24.5 (20.7—32.7)17.1 (13.7—19.8)
 rwPFS rate at 6 months (%)82.874.5
 rwPFS rate at 12 months (%)72.158.9
 rwPFS rate at 18 months (%)60.148.4
 rwPFS rate at 24 months (%)50.239.1
 Median follow-up, months (IQR)16.8(8.1—27.1)16.8(6.9—26.9)

PB+LE = Palbociclib plus letrozole; LE = Letrozole alone; IQR = Interquartile Range

Conclusions

The first comparative analysis of a CDK4/6 inhibitor in combination with endocrine therapy compared to endocrine therapy alone provides real-world evidence confirming the findings of PFS benefit demonstrated in clinical trial data for palbociclib in diverse clinical practices.

Legal entity responsible for the study

Pfizer Inc.

Funding

Pfizer Inc.

Disclosure

R.M. Layman: Research grant / Funding (institution): 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.

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Poster Display session 3 Poster Display session

1329P - Comparable responses of melanoma at primary site and synchronous lymph node metastases upon neoadjuvant ipilimumab (IPI) and nivolumab (NIVO) (ID 3230)

Presentation Number
1329P
Lecture Time
12:00 - 12:00
Speakers
  • Judith M. Versluis (Amsterdam, Netherlands)
Session Name
Poster Display session 3
Location
Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
12:00 - 13:00

Abstract

Background

In stage III melanoma patients, adjuvant immune checkpoint inhibition (ICI) has shown to improve relapse free survival. However, preclinical and translational data suggest that neoadjuvant (neoadj) ICI might be more beneficial due to broader immune activation. In the OpACIN and OpACIN-neo trials with neoadj IPI+NIVO, high pathologic (path) response rates (pRR) were observed (78% and 77%, respectively). Furthermore, neoadj ICI could reduce tumor burden, making surgery less mutilating. In patients presenting with synchronous lymph node (LN) metastases, neoadj ICI might improve surgical resectability of both sites. To date, response of these primary melanoma lesions upon neoadj IPI+NIVO is not reported.

Methods

Here we report on four stage III melanoma patients with melanoma at the primary site and synchronous LN metastases that were treated with neoadj IP+NIVO.

Results

Four stage III melanoma patients were identified. In the OpACIN-neo trial, one patient treated with 2 courses IPI 1 mg/kg + NIVO 3 mg/kg showed a path partial response (33% viable tumor cells) in the in-scar recurrence and a complete response (CR) in the LN metastasis, and one patient treated with 2 courses IPI 3 mg/kg followed by 2 courses NIVO 3 mg/kg showed no pathological response in both the in-scar recurrence (60% viable tumor cells) and LN metastasis (59% vital tumor). In the PRADO extension cohort, one patient treated with 2 courses IPI 1 mg/kg + NIVO 3 mg/kg demonstrated a path CR in both the axillar LN metastases and the primary melanoma on digit 4 of his right hand, preventing finger amputation. The results of another PRADO patient with a large primary on the shoulder and axillar LN metastases are pending (expected June 2019).

Conclusions

Neoadjuvant IPI+NIVO induces comparable responses in LN metastases and at the primary melanoma location. In the light of the high LN response upon neoadj IPI+NIVO, postponing the resection of the primary or recurrent melanoma should be considered, improving surgical resectability and reducing morbidity.

Clinical trial identification

NCT02977052.

Legal entity responsible for the study

Netherlands Cancer Institute.

Funding

BMS.

Disclosure

E.A. Rozeman: Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: NanoString. A.C.J. van Akkooi: Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: MSD Merck; Advisory / Consultancy: Merck-Pfizer; Advisory / Consultancy: 4SC. G.V. Long: Advisory / Consultancy: Aduro; Advisory / Consultancy: Amgen; Advisory / Consultancy: BMS; Advisory / Consultancy: Merck MSD; Advisory / Consultancy: Mass-Array; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Roche. C.U. Blank: Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (self): BMS; Advisory / Consultancy: Roche; Advisory / Consultancy: GSK; Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: GenMab; Advisory / Consultancy: Lilly; Research grant / Funding (self): NanoString; Advisory / Consultancy: Pierre Fabre. All other authors have declared no conflicts of interest.

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