Tumori Journal Abstract Book - October 2020 - 131

G - Neuroendocrine Tumours and Sarcomas	
to therapy. This heterogeneity depends of site of origin,
morphology and ki67. Temozolomide (TEM) seems to be
active in metastatic NEN but there are limited evidence in
gastrointestinal (GI) NENs. In this paper we analyzed the
"real-world" data on TEM alone or associated to capecitabine (CAPTEM) in patients (pts) with mNEN.
Patients and methods: One hundred consecutive
advanced NEN pts treated with TEM or CAPTEM between
2009 and 2019 were included. A pre-treatment Tumor
growth rate (TGR0) was calculated. Overall survival (OS),
Progression-free survival (PFS), tolerance, objective
response (ORR) and disease control rate (DCR)were analyzed. To balance baseline covariates for pts treated with
TEM and CAPTEM treatment a propensity score analysis
and Cox regression models were used.
Results: TEM-based therapy was administered to 95 pts
(26.3% CAPTEM and 83.7% TEM) with 59 (range:26-85)
years median age. ECOG performance status was 0-2.
About half of pts (49.5%) has more than 2 sites of metastasis. Twenty (21.1%) G3 neuroendocrine carcinoma and
9(9.4%) patients G3 neuroendocrine tumors (NET) were
included. On whole group mPFS was 10.4 (95%CI:6.011.5) months (m). In multivariate analysis, an higher risk of
progression was observed for NEC G3 pts
(HR:2.70,95%CI:1.25-5.84) and for a TGR ⩾19.55
(HR:2.53, 95%CI:1.45-4.40). Well differentiated morphology had a protective effect, although not statistically significant due to collinearity (HR: 0.62, 95%CI: 0.36-1.07).
Median OS was 23.4 m (95%CI: 17.0-29.0) and it was similar comparing TEM and CAPTEM (23.9 vs. 20.5 m,
p=0.585). In multivariate analysis, pts with TGR =19.55 had
an higher risk of death (HR:2.18, 95%CI:1.16-4.11) than
those with TGR<19.55, as well as NEC G3 (HR: 2.42,
95%CI:1.04-5.59) compared with NET pts. No differences
in terms of mPFS and mOS were seen according the primitive site. On 86 pts evaluable for response, ORR was 44.1%
with a DCR of 70.9%. Mild adverse events (grade I-II)
included anemia, neutropenia and headache. Rare cases of
grade 3 neutropenia and thrombocytopenia were recorded.
Conclusions: TEM-based regimens are associated with a
high DCR and a relatively tolerable toxicity profile in
NENs of Pancreatic, GI, Lung and other origins. Also pts
with NET G3 tumors have a benefit. This regimen warrants further exploration in a prospective clinical trial not
only in pancreatic but also intestinal and lung NETs.

G02
Activity and safety of Lanreotide
autogel (LAN) and temozolomide
(TMZ) combination in patients
with progressive thoracic
neuroendocrine tumours (TNETs):
the Italian ATLANT study results

131
BRIZZI M.P.1, Berruti A.2, Spada F.3, Ibrahim T.4, Colao A.5,
Faggiano A.6, Marconcini R.7, Vaccaro V.8, Giuffrida D.9, Rivaroli A.10,
Houchard A.11, Fazio N.12, Ferolla P.13
1
Oncologia Medica, A.O.U. San Luigi Gonzaga, Orbassano; 2ASST-Spedali
Civili di Brescia, Brescia; 3European Institute of Oncology, IRCCS, IEO, Milan;
4
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori,
Meldola (FC); 5Università Federico II di Napoli, Naples; 6Dipartimento di
Medicina Sperimentale, Università Sapienza di Roma, Rome; 7AOU Pisana,
Santa Chiara Hospital, Pisa; 8Regina Elena National Cancer Institute, IRCCS,
Rome; 9Istituto Oncologico del Mediterraneo, Viagrande (CT); 10Ipsen,
Assago, Milan; 11Ipsen, Boulogne-Billancourt, France; 12European Institute
of Oncology, IRCCS, IEO, Milan; 13Multidisciplinary NET Center, Umbria
Regional Cancer Network, Perugia

Background: LAN and TMZ are among the main therapies recommended for progressive TNETs but prospective
data are lacking. We present safety and efficacy outcomes
of this combination in progressive TNETs.
Patients and methods: ATLANT was a 12-month, phase
2, multicentre, single-arm, open-label study. Eligible
patients had unresectable, locally advanced or metastatic,
well-differentiated TNETs (bronchial or thymic, typical
or atypical carcinoid) with baseline radiological progression (RECIST v1.1) in the previous 12 months. Patients
received subcutaneous LAN 120 mg and oral TMZ 250
mg/day over 5 days, every 28 days. Primary endpoint:
disease control rate (DCR) at 9 months (RECIST v1.1
complete response, partial response or stable disease
[clinically relevant: ⩾30%, unacceptable: ⩽10%]). Data
were analysed using exact binomial proportion tests for
one-way tables.
Results: Patients (N=40; 60% male) had a mean (SD) age
of 64.9 (11.8) years. The primary tumour site was: lung,
90%; thymus, 10% (typical, 20.0%; atypical, 52.5%; carcinoid, 27.5%). Mitotic count (mitoses/2 mm²): <2: 30%;
⩾2-<10: 42.5%; ⩾10: 2.5%; not done: 25%. Ki-67
expression (N=20): <4%: 10%; 4-<25%: 80%; ⩾25%:
10%. TNM staging: primary tumour TX: 5.1%, T0:
46.2%, T1: 7.7%, T2: 12.8%, T3: 10.3%, T4: 17.9%;
regional lymph node N0: 56.4%, N1: 2.6%, N2: 23.1%,
N3: 17.9%; distant metastasis M0: 5.1%, M1: 94.9%.
Locally assessed DCR at 9 months (ITT population;
N=40) was 35.0% (95%CI: 20.63; 51.68) (significantly
higher than 10% p<0.0001 but not superior to 30%
p=0.297). Median progression-free survival was 37.1
(95%CI: 24.1; 52.9) weeks. In total, 97.5% of patients had
treatment-emergent adverse events (TEAEs; >90% of
TEAEs were Grade 1/2), 9 (22.5%) patients had serious
TEAEs (of which 2 were treatment related), 2 TEAEs led
to withdrawal of study treatment, and 2 led to death. The
observed TEAEs were in line with the known individual
drug profiles, and there were no new or unexpected AEs.
Most common TEAEs included nausea (52.5%), vomiting
(32.5%) and diarrhea (30.0%).
Conclusions: These results suggest that the LAN and
TMZ combination was generally well tolerated and could
Tumori Journal Abstract Book - October 2020

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