Tumori Journal Abstract Book - October 2020 - 47

C - Gastrointestinal (non-Colorectal) Cancers	

47

Ospedale del Mare, Naples, Italy; 2UCSF Helen Diller Family Comprehensive
Cancer Center, San Francisco, CA, USA; 3Ipsen Pharma, Boulogne-Billancourt,
France; 4Hôpital Haut-Lévêque, CHU de Bordeaux, Bordeaux, France;
5
University of Hong Kong, Hong Kong; 6National Taiwan University Hospital
and National Taiwan University Cancer Center, Taipei, Taiwan (Republic of
China); 7IQVIA Ltd, London, UK; 8Memorial Sloan Kettering Cancer Center,
New York, NY, USA

C05

Background: Cabozantinib and regorafenib are approved
for the second-line treatment of advanced hepatocellular
carcinoma (aHCC). As no trials have compared the drugs
directly, this matching-adjusted indirect comparison
(MAIC) evaluated the efficacy and safety of cabozantinib
and regorafenib in patients with progressive aHCC after
prior sorafenib.
Methods: The phase 3 CELESTIAL and RESORCE trials
were used for the analysis. Population-level data were
available for RESORCE, individual patient data (IPD) for
CELESTIAL. To align with RESORCE, the CELESTIAL
population was limited to patients who received first-line
sorafenib only. To minimize potential effect-modifying
population differences, the CELESTIAL IPD were
weighted to balance the distribution of clinically relevant
baseline characteristics with those of RESORCE. Overall
survival (OS) and progression-free survival (PFS) were
evaluated for the matching-adjusted second-line
CELESTIAL population and compared to those for
RESORCE using weighted Kaplan-Meier (KM) curves
and parametric modelling. Grade 3/4 treatment-emergent
adverse events affecting > 5% of patients in any trial arm
were compared.
Results: The MAIC included 573 RESORCE patients and
an effective sample size of 266 from CELESTIAL.
Weighted KM estimates for median (95% confidence
interval [CI]) OS were similar for the matching-adjusted
cabozantinib and regorafenib populations (11.4 [8.9-17.0]
vs. 10.6 [9.1-12.1] months; p = 0.3474, log-rank test).
Estimated median (95% CI) PFS was longer for cabozantinib than regorafenib (5.6 [4.9-7.3] vs. 3.1 [2.8-4.2]
months; p = 0.0005, log-rank test). As visual inspection of
the log-cumulative hazard plots for OS and PFS revealed
non-parallelism, and statistical tests confirmed that the
proportional hazards assumption was not satisfied,
anchored hazard ratios were not justified. Parametric models were therefore fitted, and generated survival estimates
mirroring those of the weighted KM analysis. Comparative
estimates for some grade 3/4 TEAEs were affected by low
incidence; only rates of grade 3/4 diarrhea were significantly different, favouring regorafenib (p ⩽ 0.001).
Conclusions: Cabozantinib may achieve similar OS and
prolonged PFS compared with regorafenib in patients
with progressive aHCC after prior sorafenib; grade 3/4
diarrhea rates maybe lower with regorafenib. MAIC
analyses cannot replace randomized clinical trials, but
may help to guide decision making in the absence of
direct trial evidence.

Rovesti G.1, Leone F.2, Brandi G.3, Cesario S.4, Scartozzi M.5, Niger
M.6, Yoo C.7, Caputo F.1, Filippi R.8, Casagrande M.9, Silvestris N.10,
Santini D.11, Faloppi L.12, Aglietta M.13, Cho H.7, Lai E.5, De Braud
F.6, Aprile G.14, Orsi G.15, Cascinu S.15, Casadei Gardini A.1

1

Prognostic role of PECS2 index in
advanced biliary tract cancer
(BTC) patients treated with first
line chemotherapy: Training and
Validation cohorts

1

Department of Oncology and Hematology, Division of Oncology, University
Hospital of Modena, Modena; 2Division of Medical Oncology, Nuovo Ospedale
degli Infermi, Ponderano (BI); 3Oncology Unit, Sant'Orsola Malpighi Hospital,
University of Bologna, Bologna; 4Medical Oncology Unit, Pisa University
Hospital, Pisa; 5Medical Oncology, University Hospital of Cagliari, Cagliari;
6
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale
dei Tumori di Milano, Milano; 7Department of Oncology, Asan Medical
Center, University of Ulsan College of Medicine, Seoul (Republic of Korea);
8
Department of Oncology, Centro Oncologico Ematologico Subalpino, Azienda
Universitaria Ospedaliera Citta` della Salute e della Scienza di Torino, Torino;
9
Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della
Misericordia, Udine; 10Medical Oncology Unit, IRCCS Istituto Tumori "Giovanni
Paolo II", Bari; 11Medical Oncology Department, Campus Biomedico University,
Roma; 12Oncology Unit, Macerata Hospital, Macerata; 13Department of
Oncology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo (TO); 14Department
of Clinical Oncology ULSS8 Berica, Vicenza; 15Department of Medical
Oncology, Universita` Vita- Salute, San Raffaele Hospital IRCCS, Milano

Background: Validated prognostic indexes are essential for
BTC. We previously set up the PECS index(PsECogSii),
made of PS ECOG and Systemic Inflammatory Index. To
improve its risk-stratification power, we created the PECS2
index made of PECS, Prognostic Nutritional Index (PNI)
and GOT. The aim of this study is to evaluate PECS2 index
as prognostic factor in unresectable locally advanced or metastatic BTC patients treated with first-line chemotherapy.
Material and methods: The study was retrospectively
conducted on a training cohort of 126 BTC patients from
Modena CancerCenter. A first validation cohort of 457
patients was recruited by 13 Italian CancerCenters, a second one of 76 patients by University of Cagliari and Istituto
Nazionale dei Tumori of Milan and a third one of 256
patients by ASAN medical Center in Republic of Korea.
The PECS2 index was calculated as PECS+PNI+GOT
(PECS:0=1point; PECS:1=1.4points; PECS:2=3.2points)
+ (PNI>36.7=1point; PNI<36.7=2points) + (GOT<100=
1point; GOT>100=2points). Patients were categorized into
three groups: PECS2-0 (value<3.5 points), PECS2-1
(value>3.5points; <5.4points), PECS2-2 (value>5.4points).
Event-time distributions were estimated using the KaplanMeier method and survival curves were compared using
the log-rank test.
Results: In the training cohort, median overall survival
(mOS) was 12.9 months,6.3 months and 2.8 months for
PECS2-0,PECS2-1 and PECS2-2, respectively (PECS20:HR=1; PECS2-1:HR 2.11,95% IC 1.34-3.31; PECS2-2:HR
4.93,95% IC 1.85-13.12; p<0.0001). The Harrell's C



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
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Tumori Journal Abstract Book - October 2020 - Cover3
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