Tumori Journal Abstract Book - October 2020 - 97

E - Breast Cancer	
** Hospital access was planned the day before surgery
for preoperative tests provided that nasopharingeal
swab for Covid-19 research had to be already done..
** The hospitalization was performed with the utmost
respect for preventive hygiene standards and physical distancing; the access to relatives was not allowed.
** Patients were discharged on the evening of the
operation if residing nearby the hospital.
** A multidisciplinary discussion was ensured through
videoconferencing with subsequent and timely
sharing of the treatment program with the patient.
** Access to systemic treatment was a priority for
patients with aggressive biological tumor characteristics (triple negative, HER-2 positive, high disease
volume).
Results: From the beginning of the pandemic today 56
breast tests and 22 surgical procedures (19 quadrantectomies
and 3 mastectomies) have been performed. Multidisciplinary
discussions were done every 2 weeks through multimedia
support. Hospital access has been maintained only for
patients with high priority features who needed to systemic
therapy, while the telephone management was performed for
those with low priority characteristics.
Conclusions: 5-year survival has been shown to reach
83.9% in high-volume facilities. The efficient work of a
multidisciplinary team produces appropriateness, consistency, and better use of human and economic resources.
The main purpose of each Breast Unit is trying to keep
these results even during the COVID-19 pandemic.

97
clinical trials but monitoring visit on site were suspended.
When possible remote monitoring visits have been performed. Start initiation visit for new trial, for which it is
essential the presence on site, were strongly postponed.
Ethics Committee evaluation of clinical trials or substantial amendments have suffered inevitable strong delays
nearly to 3 months because they had to adapt their activities also with organize their meetings by web-conferences.
Only access to compassionate use was ever granted.
Results: At site particular attention was needed in the
enrollment of new patients in the trials evaluating the risk/
benefits ratio. For each patient the possible postponement
of access to receive treatment has been assessed on the
basis of the relationship between the risks, for the patient
and the community related to access to the site, and the
expected benefits of the treatment itself. The closure of
several Hospital Units due to spread of contagion and limited availability of ancillary services caused the interruption of enrollment in clinical trials.
Conclusions: Our clinical research activity during the
pandemic has suffered negative repercussions but we think
that what happened could be an useful opportunity to
improve and transform clinical trial conduction system for
example by simplifying the study design, optimizing the
number of on-site monitoring visits and reducing patient's
access to the hospital.

E - Breast Cancer
E01*

D61
Oncology Clinical trials'
management in Italy during the
COVID-19 emergency: challenges
and improving opportunity
Menatti E.1, Pastorini A.1, Fusco O.1, Cantini S.1, Caponigro G.1,
Deligiannis P.1, Maiolani M.1, Cubeddu A.1, Doria A.1, Bertolini A.1
1

ASST della Valtellina e Alto Lario-Oncologia Medica, Sondrio

Background: The global COVID-19 pandemic has adversely
affected all aspects of clinical care and it has not spared even
clinical trials on cancer. Indeed the need to adopt precautionary measures for the containment of COVID-19 infection
have affected the access of cancer patients in clinical trials.
The devastating effects of this global crisis have also negatively impacted the work of our Oncology Unit which has so
far conducted more than 120 phase I-III studies.
Method: We faced numerous challenges with conducting
clinical trials due to COVID-19. In order to contain infection all the actor involved had to apply several precautions.
Pharmaceutical companies, no-profit Sponsors, CROs and
either our organization have applied or extended smartworking in order to continue their activities related to

Blood glucose levels are
associated with the efficacy of
everolimus-exemestane in patients
with advanced HR-positive/HER2
negative breast cancer: the
Italian EVERMET study
Vernieri C.1, Nichetti F.1, Guarneri V.2, Cortesi E.3, Moscetti L.4, Del
Mastro L.5, Fabbri A.6, Curigliano G.7, Montemurro F.8, Losurdo A.9,
Generali D.10, Fabi A.11, Pedersini R.12, Ciccarese M.13, Rocca A.14,
Arpino G.15, La Verde N.16, Puglisi F.17, Mariani L.1, De Braud F.1
1
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; 2Veneto Institute
of Oncology IOV, Padova; 3Policlinico Umberto I, Sapienza, Roma; 4University
Hospital of Modena, Modena; 5Ospedale Policlinico San Martino, Genova;
6
Belcolle Hospital, Viterbo; 7IEO, European Institute of Oncology IRCCS, Milano;
8
Candiolo Cancer Institute, FPO-IRCCS, Torino; 9IRCCS Humanitas Clinical and
Research Center, Milano; 10ASST Cremona, Cremona; 11IRCCS Regina Elena
National Cancer Institute, Roma; 12University of Brescia at ASST Spedali Civili,
Brescia; 13Vito Fazzi Hospital, Lecce; 14Istituto Scientifico Romagnolo per lo
Studio e la Cura dei Tumori (IRST) IRCCS, Meldola; 15University of Naples
Federico II, Napoli; 16ASST Fatebenefratelli Sacco - PO Luigi Sacco, Milano;
17
IRCCS Centro di Riferimento Oncologico di Aviano (CRO), Aviano

Background: The mTORC1 inhibitor everolimus (EVE) in
combination with the aromatase inhibitor exemestane (EXE)
is a standard-of-care treatment option for patients (pts) with



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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