Tumori Journal Abstract Book - October 2020 - 114

114	

Tumori Journal 106(2S)

Cuyún Carter G.1, Stenger K.1, Mohanty M.2, Lee Chong A.1, Basa
P.2, Singuru S.2, Singh S.2, Tongbram V.2, Kümmel S.3, Guarneri V.4,
Tolaney S.M.5
1
Eli Lilly and Company, Indianapolis; 2Global Health Technology Assessment,
Health Economics, Reimbursement and Outcomes, Access, Commercialisation
& Communications, ICON plc., New York; 3Interdisciplinary Breast Unit, Kliniken
Essen-Mitte (KEM), Essen; 4Division of Medical Oncology 2, Veneto Oncological
Institute, University of Padua, Padova; 5Dana-Farber Cancer Institute, Brookline

Background: This systematic literature review identified
strength and consistency of evidence for prognostic factors
in HR+, HER2-, ABC patients.
Patients and methods: A search of major electronic databases (MEDLINE, EMBASE, Cochrane Controlled
Register of Trials) was conducted in Nov 2018 for clinical
studies published since 2010 in HR+, HER2- ABC patients
(pts). Endpoints of interest: tumor response, progressionfree survival (PFS), overall survival (OS) and BC specific
survival (BCSS).
Results: 79 studies with ABC pts (⩾50% HR+, HER2-)
were included; 67 assessed OS.
Negative progesterone receptor (PR) status, higher tumor
grade, higher CTC count, higher Ki67 level, number of metastatic sites (multiple vs single) and sites of metastases

(presence of liver metastases vs absence), relapsed BC vs de
novo metastatic BC, shorter time to recurrence/progression
to ABC, poor performance status, prior therapy attributes in
the early or metastatic setting therapy type and line, response
to prior therapy) and race (black vs white) were consistently
associated with worse OS; the relationship was inconsistent
for tumor size, histological type (lobular vs ductal), lymph
node involvement and age. Strength of association with OS
was moderate (HR between 1.5-2.9) for PR status, tumor
grade, CTC count, and Ki67 level, number and site of metastases, time to recurrence/progression to ABC, performance
status, prior therapy attributes, and weak (HR<1.5) for de
novo metastatic BC and race. Heterogeneity was observed
across studies in the composition of the pt population, definition and categorization for a few prognostic factors (number
and sites of metastases, prior therapy, age). Similar results
were seen for tumor response, PFS, BCSS.
Conclusions: Based on consistency and strength of the
data, PR status, tumor grade, CTC count, number and sites
of metastases, time to recurrence/progression to ABC, performance status and prior therapy attributes were identified as the prognostic factors. Reused with permission
2019 SABCS®.

Association between prognostic factors and OS.
Prognostic factor

Total no. of
studies assessing
association

Total no. of studies
reporting significant
association

No. studies
with significant
multivariate analysis

PR status
Tumor grade
CTC count
Ki67
No. of metastatic sites
Site of metastasis
De novo metastatic BC
Tumor size
Lymph node
Histological type
Time to disease recurrence/progression
Performance status
Prior therapy
Age
Race

10
21
10
5
26
33
5
12
11
5
18
14
35
37
13

8
14
9
4
23
21
4
5
4
1
13
11
27
17
7

5
11
7
2
13
17
3
5
1
1
8
8
20
13
6

E29
Correlations between
Neutropenia and Clinical Benefit
(CB) in women with estrogenreceptor (HR)-positive and (HER2)-
negative advanced breast cancer
treated with palbociclib: a "real
life" single institution experience
Sinjari M.1, Ceddia S.1, Cosimati A.1, Brandi M.1, Verrico M.1, Rossi
L.1, Cimino G.1, Tomao S.1
1

Oncologia Medica Universitaria, Sapienza Università di Roma, Aprilia (LT)

Background: Palbociclib is a selective CDK4/6 inhibitor
approved for locally advanced or metastatic (HR)-positive,
(HER2)-negative breast cancer treatment.
Most common AEs reported are hematologic, in particular
neutropenia, often not complicated and rapidly reversible;
dose modification occurs in a limited number of patients (pts).
Questions were raised regarding a possible correlation
between higher incidence of G3/4 AEs and better clinical
outcome. We present our "real life" results.
Material and methods: We retrospectively reviewed
records of all pts treated with palbociclib, from 2017-2020,
in first or second line of treatment.
Tumori Journal Abstract Book - October 2020

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