Tumori Journal Abstract Book - October 2020 - 98

98	
hormone receptor-positive (HR+), human epidermal growth
factor receptor-negative (HER2-) advanced breast cancer
(aBC). However, EVE-induced hyperglycemia and hyperinsulinemia could reduce EVE-EXE efficacy through the reactivation of the PI3K/AKT/mTORC1 pathway. Material
(patients) and methods: We conducted a retrospective, multicenter, Italian study to investigate the association between
glycemia, as evaluated at baseline and during the first 3
months (mos) of EVE-EXE therapy, on progression-free survival (PFS) of HR+ HER2- aBC pts. To exclude variables
not associated with clinical outcomes, we used a machinelearning approach through a Random Forest method. Then,
we fitted a Cox proportional hazard model to investigate the
independent impact of the selected variables on PFS.
Results: Out of 848 pts evaluated, 35 and 4 pts were
excluded because of the lack of sufficient information
about blood glucose levels and clinical outcomes, respectively. Of 809 pts finally included in the study, all pts had
previously received letrozole/anastrozole in the adjuvant or
advanced disease setting, while 54% of them had been
treated with anti-estrogens (i.e. fulvestrant and/or tamoxifen) in the advanced disease setting. With a median followup of 37.4 mos, median PFS and OS were 7.13 and 32.1
mos, respectively. During the first three mos of therapy,
EVE-EXE induced a significant increase of blood glucose
concentration (p<0.0001). At multivariable analysis, baseline and on-treatment glycemia were independently associated with PFS, with a significant interaction of these two
variables on clinical outcome (p<0.0001). In particular, pts
with low baseline glycemia (<95 mg/dl, 50th quantile)
who experienced on-treatment diabetes (>=126 mg/dl,
90th quantile) had significantly lower PFS (mPFS: 4.14
mos) when compared to both pts who were hyperglycemic
(>=95 mg/dl) at baseline but did not develop diabetes
(mPFS: 8.15 mos), and to pts who showed stably low or
stably high glycemia (mPFS: 7.13 mos) (p=0.0002).
Conclusions: EVE-induced diabetes is associated with
lower antitumor efficacy of EVE-EXE in HR+ HER2- aBC
pts with normal baseline glycemia. While these data need
prospective validation, experimental dietary or pharmacological strategies that prevent or reverse EVE-induced diabetes could improve the efficacy of EVE-EXE.

E02*
Survival analysis of the
prospective randomized Cher-Lob
study evaluating the dual antiHER2 treatment with trastuzumab
and lapatinib plus chemotherapy
as neoadjuvant therapy for HER2positive breast cancer
Guarneri V.1, Dieci M.V.1, Bisagni G.2, Generali D.G.3, Cagossi
K.4, Sarti S.5, Frassoldati A.6, Gianni L.7, Cavanna L.8, Pinotti G.9,

Tumori Journal 106(2S)
Musolino A.10, Piacentini F.11, Michelotti A.12, Cinieri S.13, Griguolo
G.1, Miglietta F.14, De Salvo G.L.15, Conte P.1
1

Università di Padova - Istituto Oncologico Veneto IOV-IRCCS, Padova;
Azienda USL-IRCCS, Reggio Emilia; 3University of Trieste - ASST Cremona,
Cremona; 4Ospedale Ramazzini, Carpi; 5IRST, Meldola; 6S Anna University
Hospital, Ferrara; 7Azienda USL Romagna, Rimini; 8G. da Saliceto Hospital,
Piacenza; 9ASST Sette Laghi, Varese; 10University Hospital, Parma;
11
University Hospital, Modena; 12Azienda Ospedaliera Universitaria Pisana,
Pisa; 13Antonio Perrino Hospital, Brindisi; 14Università di Padova, Padova;
15
Istituto Oncologico Veneto IOV-IRCCS, Padova
2

Background: The CHER-LOB randomized phase II study
showed that the combination of lapatinib and trastuzumab
plus chemotherapy increases the pathologic complete
response (pCR) rate compared with chemotherapy plus
either trastuzumab or lapatinib. Here we report the results
of survival analysis according to treatment arm and pCR.
Methods: The CherLOB study randomized 121 HER2positive, stage II-IIIA breast cancer patients to anthracyclines/taxane-based chemotherapy plus trastuzumab,
lapatinib, or both. Patients received adjuvant trastuzumab
for up to 1 year. The primary end point of the study was
met, with a relative increase of 80% in the pCR rate
achieved with chemotherapy plus trastuzumab and lapatinib compared with chemotherapy plus either trastuzumab or lapatinib (Guarneri, J Clin Oncol 2012).
Relapse-free survival (RFS) was calculated from randomization to breast cancer recurrence (locoregional or
distant) or death from any cause, whichever first. Overall
survival (OS) was calculated from randomization to
death from any cause.
Results: At a median follow up of 8.8 years, RFS rates at
5 years were: 85.8% in the trastuzumab + lapatinib arm,
77.8% in the trastuzumab arm, 78.1% in the lapatinib arm
(log-rank p=0.160). Patients treated with dual HER2
blockade (trastuzumab + lapatinib arm) experienced
numerically better RFS as compared to patients treated
with single HER2 blockade (trastuzumab arm and lapatinib arm combined): 5-yr RFS 85.8% vs 78.0%, log-rank
p=0.087; HR=0.51, 95% CI 0.23-1.12, p=0.093. The
achievement of pCR was a strong prognostic factor. 5-yr
RFS rate was 97.3% for pCR patients vs 72.9% for nonpCR patients (log-rank p<0.001, HR=0.12, 95% CI 0.030.49, p=0.003); similar significant results were observed
in both the estrogen receptor-negative and estrogen-receptor positive subgroups. OS was also improved in pCR
patients: 8-yr OS rates were 97.2% vs 80.0% (log-rank
p=0.028, HR=0.14, 95% CI 0.02-1.08, p=0.060).
Conclusions: In the Cher-LOB study, there was a not statistically significant signal for a better RFS for patients
who received dual HER2 blockade with trastuzumab and
lapatinib plus neoadjuvant chemotherapy experienced
improved RFS as compared to patients treated with single
anti-HER2 agent (trastuzumab or lapatinib) plus chemotherapy. Patients achieving a pCR had longer RFS and OS
as compared to non-pCR patients.



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
Tumori Journal Abstract Book - October 2020 - 1
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Tumori Journal Abstract Book - October 2020 - Cover3
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