Tumori Journal Abstract Book - October 2020 - 127

F - Gynaecological Tumours	
Methods: We retrospectively collected and analyzed clinical data of patients(pts)treated in our institution with
Palbociclib plus ET between 2017 and 2019.We reported
pts characteristics, adverse events (AEs),dose reduction,
discontinuation rates.
Results: We treated 36 pts; median age was 62(range:
34-77);12 pts (33%) had newly diagnosed mBC;14 pts
(38,8%) were diagnosed during adjuvant therapy; one pts presented with locally advanced inoperable disease,17/36(47%)
had visceral disease and most of the pts 30/36(83%) had less
than 3 metastatic sites;16/36(44%) were previously exposed
to chemotherapy in neo/adjuvant setting.24/36 pts( 66.6%)
received adjuvant ET and 14/24(58%) progressed during
adjuvant ET. Most all of the pts received palbociclib associated with ET in first line metastatic setting, one pts received
palbociclib in 3rd line. Palbociclib was administred in combination with an aromatase inhibitor in 50% patients and with
fulvestrant in 50%. Hematological AEs were the most common toxicities reported: any grade neutropenia was observed
in 30/36 pts(85%),G3/G4 neutropenia in 20/36(55.5%).
Anemia G3 that required blood transfusion was recorded in
one case during the 1st cycle. Thrombocytopenia G3 was
observed in two pts (at 1st and 2nd cycle). Two pts experienced skin toxicity (G3 dermatititis at 3rd cycle and a G2 dermatitis at 8 cycle). The dose of palbociclib was reduced to
100 mg in 19 pts (52,7%) mostly for severe neutropenia and
one patient for dermatitis. Palbociclib was subsequently
reduced to 75 mg in 11 pts (in 10 pts for recurrent neutropenia
and 1 patient for headache and nausea). The main reason for
permanent discontinuation was progression; permanent discontinuation due to AEs occured in two pts (5.5%) for severe
hematological toxicity. Three pts developed distal thrombosis
during therapy (8%) and 2 of them (5.5%) were complicated
with pulmonary embolism. Only one of them was previously
exposed to chemotherapy. None of them had other risk
factors.
Conclusions: Incidence of hematological AEs and outcome were similar to clinical trials. Incidence of venous
thromboembolism rates seems much higher in clinical
practice compared with PALOMA trials.Larger studies are
required to confirm our preliminary findings.

F - Gynaecological Tumours
F01
Characterisation of patients
(pts) with long-term responses to
rucaparib in recurrent ovarian
cancer (OC)
Lorusso D.1, Oza A.M.2, Tinker A.V.3, Ray-Coquard I.4, Oaknin A.5,
Coleman R.L.6, Burris H.A.7, Aghajanian C.8, O'Malley D.M.9, Leary
A.10, Welch S.11, Provencher D.12, Shapiro G.I.13, Chen L.14, ShapiraFrommer R.15, Goble S.16, Lin K.K.16, McNeish I.A.17, Kristeleit R.S.18,
Swisher E.M.19

127
1
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome; 2Princess
Margaret Cancer Centre, University Health Network, Toronto, Ontario,
Canada; 3BC Cancer, Vancouver, British Columbia, Canada; 4Centre
Léon Bérard and University Claude Bernard and Groupe d'Investigateurs
Nationaux pour l'Etude des Cancers Ovariens (GINECO), Lyon, France;
5
Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology
(VHIO), Barcelona, Spain; 6US Oncology Research, The Woodlands, Texas,
USA; 7Sarah Cannon Research Institute at Tennessee Oncology, Nashville,
Tennessee, USA; 8Memorial Sloan Kettering Cancer Center, New York, New
York, USA; 9The Ohio State University, James Cancer Center, Columbus,
Ohio, USA; 10Gustave Roussy Cancer Center, INSERM U981, and Groupe
d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO),
Villejuif, France; 11London Regional Cancer Centre, London, Ontario, Canada;
12
Institut du Cancer de Montréal, CHUM Centre hospitalier de l'Université de
Montréal, Université de Montréal, Montreal, Quebec, Canada; 13Dana-Farber
Cancer Institute, Boston, Massachusetts, USA; 14University of California San
Francisco, San Francisco, California, USA; 15Oncology Institute, Sheba Medical
Center, Tel Hashomer, Israel; 16Clovis Oncology, Inc., Boulder, Colorado, USA;
17
Imperial College London, London, United Kingdom; 18UCL Cancer Institute,
University College London and UCL Hospitals, London, United Kingdom;
19
University of Washington, Seattle, Washington, USA

Background: Molecular interrogation of pts who derive
durable benefit from PARP inhibitor treatment would
allow insight into features associated with improved outcomes. We describe long-term responders from Study 10
(NCT01482715) and ARIEL2 (NCT01891344), studies of
the PARP inhibitor rucaparib for the treatment of highgrade recurrent OC.
Methods: This analysis included pts enrolled in Study 10
(BRCA1 or BRCA2 [BRCA]-mutant OC; Part 2A: platinum
sensitive, 2-4 prior chemotherapies; Part 2B: any platinum
status, 3-4 prior chemotherapies) and ARIEL2 (BRCAmutant or wild-type OC; Part 1: platinum sensitive; Part 2:
any platinum status, 3-4 prior chemotherapies). Final
results from Study 10 (n=54) and ARIEL2 (n=491) were
pooled. Long-term responders were defined as pts with
duration of response (DOR) ⩾1 y, and short-term responders as pts with a response followed by a short duration to
disease progression, resulting in a DOR ⩽20 weeks;
responses were evaluated using RECIST v1.1. Targeted
next-generation sequencing was used to detect deleterious
mutations and loss of heterozygosity (LOH) in tumours.
Results: Overall, 29% (159/545) of enrolled pts were
responders; 25% (138/545) had confirmed responses. 28%
(38/138) had confirmed long-term responses, including
16/138 (12%) with DOR ⩾2 y; 29 pts had a short-term
response, including 16 with confirmed responses. Both
long- and short-term responders received a median of 2
prior platinum-based therapies. Among pts with BRCA
mutations, BRCA homozygous deletion or rearrangement
was detected in 15% (4/27) of long-term responders vs 0%
(0/15) of short-term responders. In an expanded analysis
of the 95 pts with a BRCA mutation and a confirmed
response (regardless of DOR), pts with BRCA homozygous deletion or rearrangement had significantly longer
DOR to rucaparib than pts with other mutation types
(median not reached vs 0.6 y; HR=0.22; P=0.016). There



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
Tumori Journal Abstract Book - October 2020 - 1
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Tumori Journal Abstract Book - October 2020 - Cover3
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