Tumori Journal Abstract Book - October 2020 - 101

E - Breast Cancer	

101

NLR and PLR were defined through the maximally
selected rank statistics. The impact of these parameters on
PFS was evaluated at univariate and multivariable analysis
by using Cox proportional hazard model.
Results: 308 pts were treated with palbociclib (n=256),
ribociclib (n=39) or abemaciclib (n=13) plus ETs. Of them,
168 (54.5%) pts received CDK 4/6i as first-line, 88 (28.6%)
as second-line, and 52 (16.9%) as third- or subsequent line
of treatment for advanced disease between January 2017
and March 2020. With a median follow-up of 16.8 months
(95% CI, 15.1-18.2), median PFS in the whole pt population
was 17.1 months (95% CI, 14.6-25.0). At multivariable
analysis, we found an independent association between high
NLR or PLR and lower PFS, both when these parameters
were evaluated at baseline (aHR 1.57, 95% CI 1.07-2.29,
p=0.02 and aHR 1.97, 95% CI 1.29-3.02, p=0.002, respectively) and after 3 treatment cycles (aHR 2.73, 95% CI 1.372.295.46, p=0.005 and aHR 2.13, 95% CI 1.21-3.77,
p=0.009, respectively). Previous treatment with taxanes and
the presence of liver metastases were independently associated with worse PFS, as well.
Conclusions: High baseline or on-treatment NLR or PLR
values were significantly associated with lower PFS in
HR+ HER2- aBC pts. Although our results need prospective validation, they suggest that NLR and PLR could be
used as precocious biomarkers of treatment efficacy.

E07
MONARCH 3: Updated time to
chemotherapy and disease
progression following
abemaciclib plus aromatase
inhibitor (AI) in HR+, HER2advanced breast cancer (ABC)
Martin M.1, Johnston S.2, Huober J.3, Di Leo A.4, Sohn J.5, Andre
V.A.6, Martin H.R.7, Hardebeck M.C.7, Goetz M.P.8, Biganzoli L.P.9

1
Instituto De Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam;
Universidad Complutense, Madrid; 2Breast Unit, The Royal Marsden
NHS Foundation Trust, London; 3University of Ulm, Ulm; 4Department
of Oncology, Hospital of Prato, Istituto Toscano Tumori, Prato; 5Yonsei
Cancer Center, Seoul; 6Eli Lilly and Company, Paris; 7Eli Lilly and
Company, Indianapolis; 8Department of Oncology, Mayo Clinic, Rochester;
9
Dipartimento di Oncologia Medica, Ospedale S. Stefano, Via Suor Niccolina
Infermiera, Prato

Background: MONARCH 3, a randomized, double-blind,
phase 3 trial of abemaciclib+AI (anastrozole/letrozole)
conferred significant clinical benefit in HR+, HER2- ABC.
We report data from additional 12-month (mo) follow-up
including analysis for clinically prognostic subgroups.
Patients and methods: From 31 Oct 2018 data cutoff,
exploratory intermediate efficacy parameters including time
to subsequent chemotherapy ([TCT] time from randomization to 1st chemotherapy [CT]) and time to 2nd disease progression ([PFS2] time from randomization to discontinuation
date of 1st post-discontinuation treatment [PDT] or start date
of 2nd PDT or death) were assessed. TCT and PFS2 were
analyzed by Kaplan-Meier method in intent to treat (ITT) and
subgroups previously identified as significantly prognostic.
Results: Updated PFS in ITT population: 28.2 vs 14.8 mo
(HR[95%CI]: .525[.415, .665]; p<.0001) in abemaciclib
vs placebo arms respectively. More patients discontinued
study in placebo vs abemaciclib arm thereby starting PDT.
Systemic PDT: 178 (54%; abemaciclib) and 123 (74.5%;
placebo) arm, of which 93(28.4%) and 82 (49.7%) received
CT respectively. Abemaciclib+AI deferred initiation of
CT in ITT (HR[95%CI] .513[.380, .691]; p<.0001) and
subgroups (Table). PFS2 was prolonged for abemaciclib
(HR .637[95%CI] .495, .819; p<.0004). Consistent with
ITT population, PFS2 favored abemaciclib in all subgroups of prognostic factors (Table).
Conclusions: Abemaciclib+AI prolonged PFS2 and TCT
in ITT and prognostic subgroups. Previously presented at
ESMO2019, FPN326P Martin M et al. Reused with
permission.

TCT
 

PFS2

Abemaciclib+AI
Events/N

Placebo+AI
Events/N

HR
(95%CI)

Abemaciclib+AI
Events/N

Placebo+AI
Events/N

ITT
 

93/328

82/165

152/328

106/165

ECOG PS
1

.513
(.380, .691)

34/136

36/61

64/136

45/61

0

59/192

46/104

88/192

61/104

Bone-only disease
Yes

.342
(.214, .548)
.639
(.435, .940)

13/69

16/40

21/69

23/40

No

80/259

66/125

.440
(.211, .914)
.495
(.357, .686)

131/259

83/125

HR
(95%CI)
 
.637
(.495, .819)
 
.504
(.344, .74)
.762
(.549, 1.059)
 
.523
(.289, .945)
.66
(.501, .871)
(Continued)



Tumori Journal Abstract Book - October 2020

Table of Contents for the Digital Edition of Tumori Journal Abstract Book - October 2020

Contents
Tumori Journal Abstract Book - October 2020 - Cover1
Tumori Journal Abstract Book - October 2020 - Cover2
Tumori Journal Abstract Book - October 2020 - I
Tumori Journal Abstract Book - October 2020 - II
Tumori Journal Abstract Book - October 2020 - Contents
Tumori Journal Abstract Book - October 2020 - IV
Tumori Journal Abstract Book - October 2020 - V
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Tumori Journal Abstract Book - October 2020 - Cover3
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