Tumori Journal Abstract Book - October 2020 - 106

106	
Goetz M.1, Okera M.2, Wildiers H.3, Campone M.4, Grischke E.5,
Manso L.6, Andre V.A.M.7, Lee Chong A.8, San Antonio B.9, Toi M.10,
Sledge Jr G.11, Biganzoli L.P.12
1
Department of Oncology, Mayo Clinic, Rochester; 2Adelaide Cancer Center,
Adelaide; 3Department of General Medical Oncology, University Hospitals
Leuven, Leuven; 4Institut de Cancerologie de l'Ouest-René Gauducheau, Saint
Herblain; 5Women's Hospital, University Hospital Tübingen, Tübingen; 612
de Octubre University Hospital, Madrid; 7Eli Lilly and Company, Paris; 8Eli
Lilly Canada Inc, Toronto; 9Eli Lilly and Company, Madrid; 10Department of
Breast Surgery, Kyoto University Hospital, Kyoto; 11Stanford University School
of Medicine, Stanford; 12Dipartimento di Oncologia Medica, Ospedale S.
Stefano, Via Suor Niccolina Infermiera, Prato

Background: Abemaciclib demonstrated clinically meaningful PFS improvement in combination with endocrine
therapy (ET) in HR+, HER2- advanced breast cancer
patients (pts) in MONARCH 2 and 3. Here we report exploratory subgroup analyses to provide age-specific outcomes.
Material (patients) and methods: In MONARCH 2, pts
progressing while on prior ET received abemaciclib/
placebo+fulvestrant; in MONARCH 3, postmenopausal
women (no prior systemic therapy for recurrent/metastatic
breast cancer) received abemaciclib/placebo+ letrozole/
anastrozole. Exploratory outcome analyses were performed for <65, 65-74 and ⩾75 years age groups. Using
pooled safety data, we performed age-specific subgroup
analyses of the most common TEAEs associated with
either ET or ET+abemaciclib. To assess the impact of age
on efficacy, a subgroup analysis of PFS was performed by
Cox model for each trial independently.
Results: Pooled safety data were available for 1152 pts,
including 59.7% pts <65 years, 28.7% pts between 65-74
years, and 11.5% pts ⩾75 years. Of those, 768 women
received abemaciclib+ET and 384 received placebo+ET.
Most frequent TEAE was diarrhea and most common
Grade⩾3 TEAE was neutropenia. Clinically relevant diarrhea (Grade2/3) was higher in abemaciclib-treated elderly
pts (<65, 39.5%; 65-74, 45.2%; ⩾75, 55.4%); however, in
the ⩾75 group, diarrhea (Grade2/3) incidence was also
higher for placebo+ET (<65, 6.8%; 65-74, 4.5%; ⩾75,
16%). Nausea and decreased appetite were moderately
higher (by 10-20%) in the 2 abemaciclib-treated elderly
subgroups. Fatigue (any grade) was higher in the 2 abemaciclib-treated elderly subgroups (<65, 34.8%; 65-74,
48.4%; ⩾75, 51.8%); no differences were found across the
3 placebo subgroups. The rates of Grade3/4 neutropenia
did not differ as a function of age for either abemaciclib+ET
(<65, 25.8%; 65-74, 27.4%; ⩾75, 18.1%) or placebo+ET.
For efficacy, consistent PFS benefit was observed with
abemaciclib+ET vs placebo+ET across all three subgroups in both studies (MONARCH 2 HR [95%CI]: <65,
.52 [.40, .68]; 65-74, .63 [.43, .94]; ⩾75, .62 [.34, 1.11];
p=.695 and MONARCH 3 HR [95%CI]: <65, .48 [.35,
.67]; 65-74, .64 [.40, 1.02]; ⩾75, .54 [.26, 1.13]; p=.634).
Conclusions: Abemaciclib+ET demonstrates tolerable
safety profile and consistent efficacy benefit across all

Tumori Journal 106(2S)
age subgroups, supporting use of this combination in
elderly pts.

E14
High Body mass index (BMI) is
associated with worse outcome
in patients with Human Epidermal
growth factor Receptor 2
(HER2)-positive early breast
cancer treated with adjuvant
trastuzumab
Ligorio F.1, Zambelli L.2, Bottiglieri A.2, Castagnoli L.2, Zattarin E.2,
Lobefaro R.2, Belfiore A.2, Vingiani A.2, Pruneri G.2, Bianchi G.2, Capri
G.2, Pupa S.2, De Braud F.2, Vernieri C.2
1

Istituto Nazionale dei Tumori, Milano; 2Istituto Nazionale dei Tumori di
Milano - Fondazione IRCCS, Milano

Background: Besides the established role of Body Mass
Index (BMI) as a risk factor for developing different
types of tumors, including breast cancer (BC), there is
increasing evidence of a positive association between
adiposity and worse BC outcomes. However, the impact
of excess weight on the prognosis of specific BC subtypes is still undefined.
Material (patients) and methods: We conducted a retrospective analysis to evaluate the impact of BMI on relapsefree survival (RFS) and overall survival (OS) in patients
with early-stage HER2-positive (HER2+) BC treated with
adjuvant trastuzumab-containing chemotherapy in our
Institution between January 2008 and September 2018. We
subsequently validated our results in a population of patients
with HER2+ BC receiving trastuzumab in the neoadjuvant
setting. Maximally selected rank statistics were used to estimate the best BMI and glycemia cut-points dividing our
population according to the risk of recurrence.
Results: Among 505 patients included in the study, 390
(77.2%) had a low (<27.77 kg/m2) BMI, while 115
(22.7%) had a high (=27.77 kg/m2) BMI. Both high BMI
and hyperglycemia were found to be associated with
worse RFS and OS at univariate analysis; however, only
high BMI was an independent predictor of worse RFS
(HR 2.26; 95% CI: 1.08 - 4.74, p=0.031) and OS (HR
2.25; 95% CI: 1.03-4.94, p=0.043) at multivariable analysis. A subgroup analysis showed that BMI effect on patient
prognosis was mainly driven by the HR-negative subtype.
Finally, in a validation cohort of 132 BC patients treated
with neoadjuvant trastuzumab we observed a trend
towards better progression free survival (PFS) in low vs
high BMI group (p=0.056, log rank test).
Conclusions: This is the first study to show the negative
impact of high BMI on both RFS and OS in HER2+
early BC patients treated with adjuvant trastuzumab in



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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