Tumori Journal Abstract Book - October 2020 - 168

168	
Mauriziano, Torino; 4Istituto Nazionale per lo Studio e la Cura dei
Tumori, Napoli; 5FAVO, Roma; 6ECPC, AIMAC, Roma; 7FICOG, Milano;
8
Istituto Nazionale per lo Studio e la Cura dei Tumori Regina Elena,
Roma; 9Dipartimento di Economia, Università degli Studi di Messina,
Messina; 10SDA Bocconi School of Management, Milano; 11Azienda dei
Colli, Napoli; 12CENSIS, Roma; 13Istituto Nazionale per lo Studio e la
Cura dei Tumori, IRCCS Fondazione Pascale, Napoli; 14Università degli
Studi della Campania, Caserta

Background: Despite the worldwide growing interest in
evaluating the impact of costs in cancer care, and in the
development of measures that can capture the so called
financial toxicity (FT), no large scale initiative has yet
taken place in Italy. We aim to develop the first FT measure
fully developed in Italy, a country characterised by a public
healthcare system.
Methods: To develop the new Patient Reported Outcome
for Fighting Financial Toxicity (PROFFIT) questionnaire, potential items were developed by using goldstandard methods (literature search, patient involvement
with focus groups and expert involvement with ad-hoc
survey). Subsequently, item reduction was performed by
using a combined approach, applying importance analysis and cognitive interviews. The resulting PROFFIT prefinal questionnaire was then tested for its reliability
(explanatory factor analysis- EFA), internal consistency
(Cronbach's α test) and validity (Test-retest analysis).
Initial phases were supported by 3 oncological centres
(Napoli, Roma, Torino) and the final step included further 7 centres (Brindisi, Catania, Genova, Napoli2,
Padova, Pavia, Sassari).
Results: Guided by literature review analysis, 156 concepts were generated from focus groups and interviews.
After controlling for redundancy, 55 items were tested
through the importance analysis identifying 29 items that
scored at or above the median importance score plus one
more item added for clarity purpose. After cognitive
debriefing, 9 items (30%) were slightly changed due to
ambiguities or lack of specificity leaving a pre-final
30-items instrument. Such instrument entered reliability,
consistency and validity analyses. Factor analisys suggested a single factor structure of 7 items (Crombach's α
0.70) measuring the financial toxicity score (outcomes)
and an additional set of 9 items measuring the specific
determinants (causes) of such toxicity. Test-retest analysis
revealed a good validity of the instrument (ICC range=
.53-.79; k=.52-.79).
Conclusions: The PROFFIT instrument consists of 16
items and is the first patient-reported measure fully developed in Italy for assessing FT in Italian cancer patients. It
is a short, valid and reliable questionnaire that can be used
in future clinical studies as well as in routine practice settings. clinicaltrials.gov NCT03473379

Tumori Journal 106(2S)

S03
Is the dexamethasone (DEX)sparing strategy ready for
cisplatin? Results of a phase III,
controlled, non-inferiority trial
of two simplified DEX-sparing
regimens including NEPA for the
prevention of chemotherapyinduced nausea and vomiting
(CINV)
Celio L.1, Cortinovis D.2, Cogoni A.A.3, Cavanna L.4, Martelli O.5,
Carnio S.6, Collovà E.7, Bertolini F.8, Petrelli F.9, Cassano A.10, Chiari
R.11, Zanelli F.12, Vittimberga I.13, Letizia A.14, Misino A.15, Gernone
A.16, Bonizzoni E.17, Pilotto S.18, De Placido S.19, Bria E.10
1
Fondazione IRCCS "Istituto Nazionale dei Tumori", Milano; 2ASST Monza
- Ospedale San Gerardo, Monza; 3Azienda Ospedaliero-Universitaria di
Sassari, Sassari; 4Azienda Ospedaliera di Piacenza, Piacenza; 5A.O. San
Giovanni-Addolorata, Roma; 6A.O.U. San Luigi Gonzaga - Università di
Torino, Orbassano (TO); 7ASST Ovest Milanese - Ospedale di Legnano,
Legnano (MI); 8A.O.U. Policlinico di Modena, Modena; 9ASST Bergamo
Ovest - Ospedale di Treviglio, Treviglio (BG); 10Università Cattolica del Sacro
Cuore - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Roma;
11
AULSS 6 Euganea, Padova; 12AUSL Reggio di Emilia - IRCCS Santa Maria
Nuova, Reggio Emilia; 13ASST Lecco, Lecco; 14A.O.R.N. dei Colli - Ospedale
Monaldi, Napoli; 15Istituto Tumori "Giovanni Paolo II" - IRCCS, Bari; 16A.O.U.
Consorziale Policlinico di Bari, Bari; 17Università di Milano, Facoltà di
Medicina e Chirurgia, Milano; 18Azienda Ospedaliera Universitaria Integrata
di Verona, Verona; 19Università degli Studi di Napoli "Federico II", Napoli

Background: To reduce the overall exposure to DEX in
cisplatin-based chemotherapy, we evaluated the non-inferiority of DEX on day 1, with or without low-dose DEX on
days 2 and 3, combined with NEPA, a fixed combination
of the NK-1 receptor antagonist (RA), netupitant and the
pharmacologically distinct 5-HT3RA, palonosetron, compared with the guideline-recommended 4-day use of DEX.
Methods: In this open-label, multicenter study, chemonaïve lung cancer patients receiving cisplatin (⩾70 mg/
m2), were given a single oral dose of NEPA and DEX (12
mg i.v.) prior to chemotherapy and randomized (1:1:1) to
receive no further DEX (DEX1), oral DEX (4 mg once
daily) on days 2 and 3 (DEX3), or oral DEX (4 mg twice
daily) on days 2 to 4 (DEX4; reference arm). The primary
efficacy endpoint was complete response (CR: no emesis
and no use of rescue medication) during the overall (days
1-5) phase. Non-inferiority was defined as a lower 95%CI
greater than the non-inferiority margin threshold of -15%
difference (Arms DEX1 or DEX3 minus Arm DEX4).
Impact of CINV on daily life as assessed by the Functional
Living Index-Emesis (FLIE) questionnaire was also
evaluated.
Results: A total of 222 patients (76% male), 74 in each
arm, were evaluated. CR rates during the overall and
delayed phases were 77.0% in Arms DEX1 and DEX3 and


http://www.clinicaltrials.gov

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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