Tumori Journal Abstract Book - October 2020 - 181

T - Miscellanea
1

University Hospital of Parma, Parma; 2St. Salvatore Hospital, L'Aquila

Background: Immune checkpoints inhibitors (ICIs) alone
or in combination with chemotherapy are the new standard
of treatment in several solid tumors. The different impact
of single concomitant drugs administration on the outcome
of patients to immunotherapy is already known.
The aim of our study was to evaluate the prognostic value
of a "drug score" (DS), including three class of drugs able
to modulate the microbiota, in metastatic cancer patients
treated with ICIs.
Material and methods: We retrospectively enrolled
advanced cancer patients consecutively treated with ICI at
our center between October 2013 and October 2018, correlating the DS with overall survival (OS, primary endpoint)
and progression-free-survival (PFS, secondary endpoint).
Results: 219 patients were enrolled. Median age was 69
years (32-89). Primary tumors were: non-small cell lung
cancer (NSCLC, 69.9%), melanoma (15.1%), renal cell carcinoma (9.1%), other cancers (5.9%). Median follow-up
was 21.3 months. 12.3% and 33.8% of patients received
antibiotic and corticosteroid therapy within 30 days before
first ICI administration, respectively; 47.9% of patients
underwent treatment with pump protonic inhibitors (PPIs).
The use of PPIs, corticosteroids or antibiotics was individually associated to decreased OS and PFS at the univariate
analysis. Therefore, we developed a "drug score" including
these three drugs. 37.9% of patients did not receive any drug
(DS 0), 35.2% received only one drug (DS 1) and 26.9%
received two/three drugs (DS 2). Both OS and PFS were
significantly impacted by the DS: median OS was 19.4
months in DS 0 vs9.5 months in DS 1 vs2.7 months in DS 2
(p < 0.001), median PFS was 6.8 months in DS 0 vs3.7
months in DS 1 vs 1.6 in DS 2 (p < 0.001). The multivariate
analysis, including known prognostic factors as ECOG performance status, comorbidities and sites of disease, confirmed the independent prognostic role of the DS both for
OS [HR 1.48 (95%CI 1.17-1.88), p= 0.001] and PFS [HR
1.44 (95%CI 1.15-1.81), p= 0.001].
Conclusions: Our results confirmed the negative prognostic
role of PPIs, corticosteroids and antibiotics either as single
agents and included in the DS, probably due to the impact of
these drugs on gut and lung microbiota [Chalabi, Ann Oncol
2020; Arbour, J Clin Oncol 2018]. DS will be validated in
an extended multicenter retrospective cohort including
patients with metastatic NSCLC treated with ICI.

T11
The Royal Marsden Hospital (RMH)
Score and Princess Margaret
Hospital Index (PMHI) as prognostic
factor for patients (pts) with
advanced solid tumors enrolled
in phase I trials (PIT): the Modena
Cancer Center (MCC) Experience

181
Schipilliti F.1, Fontana A.1, Pettorelli E.2, Migali P.1, De Pierri Rizzello F.1,
Folloni S.1, Canino F.1, Isca C.1, Omarini C.1, Dominici M.3, Maur M.1
1
Oncology Unit, Oncology and Haematology Department, University Hospital
of Modena, Italy, Modena; 2Department of Medical and Surgical Sciences
for Children and Adults, Division of Oncology, University Hospital of Modena,
Modena; 3Department of Medical and Surgical Sciences for Children and
Adults, Division of Oncology, University Hospital of Modena, Italy, Modena

Background: The patient selection in PIT represent a significant challenge. The RMH and PMH were developed for
the purpose of a better selection for PIT. RMH is calculated
by serum albumin (ALB), lactate dehydrogenase (LDH),
and number of metastatic site at diagnosis. PMH instead
regard ALB, n° of metastatic site and PS ECOG. The OS
and PFS of good RMH / PMH score (0-1) group were significantly longer than those of poor score group (2-3).
Patients and methods: We conducted a retrospective analysis of 104 pts enrolled in PIT at MCC, divided into good and
poor score groups according to RMH and PMHI. Comparison
of overall survival (OS) and progression free survival (PFS)
was performed by Kaplan-Meier curves and log-rank tests.
Results: 104 pts enrolled: 68 with good and 36 with poor
RMH score; 71 with good and 33 with poor PMHI. Overall,
68 were female, 73 with ECOG 0, 60 with more than 2 metastatic sites, more than 96% with visceral disease. The primary cancer was: lung 24%, breast 23%, ovarian 12%, 41%
had de novo metastatic disease at diagnosis, 41% of pts
received more than 2 prior therapies. Phase I treatment was:
target and immunotherapy alone or in combination with
chemotherapy, cytokine-immunoconjugated mAb. Median
time of therapy duration was 20,8 weeks. All but 3 pts discontinued treatment: two-thirds for PD, only 17 for toxicity.
Analysis for RMH score: at 90-days from the beginning of
PIT-therapy 23 pts died: 39% in Good score group and 61%
in Poor score one. Good RMH score group had statistically
significant PFS and OS benefit compared to poor score one
(mPFS 3 vs 1 month, p = 0,0004, HR 2,68 95%CI 1.554.63, and mOS 17 vs 5 months, p= 0,0002, HR 2.72 95%CI
1.60-4.62 respectively). Analysis for PMHI score: among 23
pts died at 90-days from the beginning of PIT-therapy: 35%
in Good score group and 65% in Poor score one. Good RMH
score group had statistically significant PFS and OS benefit
compared to poor score one (mPFS 3 vs 1 month, p =
0,0310, HR 1,77 95%CI 1.05-2.98 and mOS 16 vs 3 months,
p= 0,0001, HR 3.05 95%CI 1.72-5,4 respectively).
Conclusions: RMH and PMH Scores clearly select a subgroup of patients who could not benefit from enrollment in
phase I clinical trials. Our data confirm those previous
published in literature.

T12
Do irinotecan (IRI) dose reductions
driven by UGT1A1*28 genotyping
prevent IRI-related severe
neutropenia? A real world study

Tumori Journal Abstract Book - October 2020

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