Abstract 4401
Background
In Feb 2015, palbociclib plus letrozole (P+L) became the first cyclin-dependent-kinase 4/6 inhibitor approved for mBC/aBC in the US. Until now, long-term outcomes studies have included a limited number of patients receiving P+L. The objective of this study is to describe real-world patient characteristics and clinical effectiveness associated with P+L as initial endocrine-based therapy use 4 years post approval.
Methods
Adult postmenopausal women diagnosed with metastatic HR+/HER2- breast cancer who initiated P+L as first-line therapy on or after 2/3/2015 were identified by providers in the Cardinal Health Oncology Provider Extended Network, including 1800 oncologists/hematologists in the US. A subset of providers abstracted data related to patient characteristics and clinical outcomes including disease response and disease progression into an electronic case report from (eCRF). Data were abstracted from the time of initiation of P+L through Feb 2019 (or end of follow up/death). Providers were shown response classification schema corresponding to RECIST v1.1 and asked to indicate the patient’s best response if recorded. The objective response rates (ORR – incl. complete response [CR] and partial response [PR]), clinical benefit rates (CBR – incl. CR+PR+stable disease [SD] >24 wks), and progression-free survival (PFS) rate at 12-month were reported. Each eCRF was reviewed by independent clinical staff; source data was verified on 10% of the patients.
Results
31 providers submitted 202 eCRFs, of which, 193 were eligible. Median follow-up from 1L P+L initiation was 15.4 months, 45.6% of patients had discontinued P+L at data cut-off. Table shows key patient characteristics and ORR, CBR, and PFS rate at 12-month, each showing benefit of 1L P+L in the real-world.Table:
338P
N = 193 | All |
---|---|
Mean age at diagnosis, yrs | 62.7 |
Non-Hispanic white, % | 74.6 |
Black/African-American, % | 17.1 |
ECOG-PS 0/1, % | 89.6 |
N0, % | 22.8 |
Visceral mets, % | 51.3 |
Bone only mets, % | 25.4 |
ORR, % | 65.8 |
CR | 9.8 |
PR | 56.0 |
CBR†, % | 88.0 |
CR | 12.7 |
PR | 61.3 |
SD† | 14.0 |
12-month PFS, % | 74.5 |
†Excluding 43 patients with duration of treatment <24 wks
Conclusions
These real-world data demonstrate the benefit of 1L P+L 4 years post approval in the US and support the clinical benefit of 1L P+L reported in randomized clinical trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Pfizer Inc.
Funding
Pfizer Inc.
Disclosure
J. Kish: Full / Part-time employment: Cardinal Health; Advisory / Consultancy, Paid consultant in connection with the development of this abstract: Pfizer Inc. J. Trocio: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. T. Miller: Full / Part-time employment: Cardinal Health; Advisory / Consultancy, Paid consultant in connection with the development of this abstract: Pfizer Inc. D. Nero: Full / Part-time employment: Cardinal Health; Advisory / Consultancy, Paid consultant in connection with the development of this abstract: Pfizer Inc. D. Liassou: Full / Part-time employment: Cardinal Health; Advisory / Consultancy, Paid consultant in connection with the development of this abstract: Pfizer Inc. X. Liu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. L. McRoy: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. B. Feinberg: Full / Part-time employment: Cardinal Health; Advisory / Consultancy, Paid consultant in connection with the development of this abstract: Pfizer Inc.
Resources from the same session
5124 - STAR_PAC: Phase I clinical trial repurposing all trans retinoic acid (ATRA) as stromal targeting agent in a novel drug combination for pancreatic cancer.
Presenter: Hemant Kocher
Session: Poster Display session 2
Resources:
Abstract
5257 - Outcomes of First Line FOLFIRINOX (FFX) Versus Gemcitabine and Nab-Paclitaxel (GN) in Patients with Advanced Pancreatic Cancer: Multi-Institutional Canadian Sites Experience
Presenter: Neha Papneja
Session: Poster Display session 2
Resources:
Abstract
1166 - Effect of prior cancer on survival outcomes for patients with pancreatic adenocarcinoma
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1169 - Association of combination of irreversible electroporation ablation and chemotherapy with outcomes of locally advanced pancreatic cancer: a large cohort study
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1222 - Results from phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) in combination with gemcitabine plus nab-paclitaxel as first-line treatment of unresectable pancreatic cancer
Presenter: Yusuke Hashimoto
Session: Poster Display session 2
Resources:
Abstract
1698 - Multicenter retrospective study of gemcitabine plus nab-paclitaxel for elderly patients with advanced pancreatic cancer
Presenter: Masato Ozaka
Session: Poster Display session 2
Resources:
Abstract
2424 - Irinotecan Combined with Oxaliplatin and S1 in Patients with Metastatic Pancreatic Adenocarcinoma
Presenter: Keke Nie
Session: Poster Display session 2
Resources:
Abstract
2885 - Cancer-associated thrombosis in patients with pancreatic cancer and its correlation with plasma tissue factor level: A Japanese prospective cohort study
Presenter: Satoshi Kobayashi
Session: Poster Display session 2
Resources:
Abstract
3702 - A Phase I/Ib, multi-center trial of ARQ-761 (Beta-Lapachone) with gemcitabine/nab-Paclitaxel in patients with advanced pancreatic cancer
Presenter: Muhammad Beg
Session: Poster Display session 2
Resources:
Abstract
5185 - Systemic administration of the hyaluronidase-expressing oncolytic adenovirus VCN-01 in patients with advanced or metastatic pancreatic cancer: first-in-human clinical trial
Presenter: Rocio Garcia-Carbonero
Session: Poster Display session 2
Resources:
Abstract