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ePoster Display

1479P - Exploring second-line therapy outcome in pancreatic ductal adenocarcinoma (PDAC) patients with germlineBRCA1-2 pathogenic variants (gBRCA1-2pv)

Date

16 Sep 2021

Session

ePoster Display

Presenters

Giulia Orsi

Citation

Annals of Oncology (2021) 32 (suppl_5): S1084-S1095. 10.1016/annonc/annonc709

Authors

G. Orsi1, M. Milella2, F. Nappo3, M. Di Marco4, M. Niger5, S. Bozzarelli6, M.G. Rodriquenz7, S. Noventa8, G. Giordano9, I.G. Rapposelli10, I. Bernardini11, E. Vasile12, M. Macchini1, U. Peretti1, M.M. Valente1, C. Paratore13, A. Spallanzani14, M. Scartozzi15, S. Cascinu16, M. Reni1

Author affiliations

  • 1 Medical Oncology Department, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 2 Section Of Oncology, Department Of Medicine, University of Verona School of Medicine and Verona University Hospital Trust, 37134 - Verona/IT
  • 3 Medical Oncology Unit 1, Department Of Oncology - Department Of Surgery, Oncology And Gastroenterology, Veneto Institute of Oncology IOV IRCCS-University of Padua, Padova/IT
  • 4 Medical Oncology -department Of Experimental, Diagnostic And Specialty Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna - S. Orsola-Malpighi University Hospital, Bologna/IT
  • 5 Medical Oncology Department, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, 20133 - Milan/IT
  • 6 Department Of Medical Oncology And Hematology, Humanitas Cancer Center, Humanitas Clinical and Research Center – IRCCS, 20089 - Rozzano/IT
  • 7 Oncology Unit, Ospedale IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo (FG)/IT
  • 8 Department Of Medical Oncology, Fondazione Poliambulanza Istituto Ospedaliero, Brescia/IT
  • 9 Unit Of Medical Oncology And Biomolecular Therapy - Department Of Medical And Surgical Sciences, Policlinico Riuniti - University of Foggia, Foggia/IT
  • 10 Department Of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST, Meldola/IT
  • 11 Medical Oncology Unit, Ospedale Ramazzini, Carpi/IT
  • 12 Unit Of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Pisa/IT
  • 13 Department Of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin/IT
  • 14 Department Of Oncology And Hematology, University Hospital of Modena, Modena/IT
  • 15 Medical Oncology, University and University Hospital, Cagliari/IT
  • 16 Medical Oncology Department, IRCCS San Raffaele Scientific Institute- Università Vita-Salute, 20132 - Milan/IT
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Abstract 1479P

Background

Pancreatic Ductal Adenocarcinoma (PDAC) harboring germlineBRCA1-2 pathogenic variants (gBRCA1-2pv) is emerging as a distinct entity, benefitting from specific treatments (platinum agents, PARP-inhibitors). Information on second-line therapy (2LT) outcome in this setting is lacking.

Methods

Clinical data of stage IV PDAC patients (pts) carrying gBRCA1-2pv receiving a 2LT were retrospectively collected from 23 Italian Centers and descriptively analyzed, focusing on RECIST response and survival outcome. Progression-free and Overall survival2 (PFS2 and OS2) were calculated from 2LT start to 2nd progression or death, respectively.

Results

49 out of 63 pts treated with first-line therapy (1LT) between December 2008 and July 2020 had Progressive Disease (PD) at time of database lock: 7 pts (4 treated without platinum) did not receive subsequent therapies, while 42 (86%) started a 2LT, whose outcome was assessable in 40 pts (2 had immature follow-up). ECOG Performance Status at diagnosis was ≤1 in 38 (95%) pts, 32 (80%) had liver metastases, median age was 62 (39-84) years. RECIST responses of the 19 and 18 pts receiving platinum- and non-platinum-based multidrug 2L were 47% vs 28% partial responses, 21% vs 33% stable diseases and 32% vs 39% PD, respectively. Median PFS for 1LT (mPFS1), mPFS 2, mOS2 and total median OS (mOStot) are shown in the Table. Table: 1479P

Clinical characteristics and survival outcomes

Variable N mPFS2 (mo) mOS2 (mo) mPFS1 (mo) mOStot (mo)
All patients 40 5.3 9.8 7.5 19.9
Germline BRCA pathogenic variant 1 2 8 32 3.0 6.6 6.0 11.3 5.3 7.9 12.7 20.9
Gender male female 17 23 6.2 4.3 10.4 8.4 8.5 6.2 17.4 20.1
Age (years) ≤ 65 > 65 29 11 6.5 3.1 12.5 6.8 8.5 5.9 21.1 12.8
I line chemotherapy Nab-paclitaxel + Gemcitabine (m)FOLFIRINOX/PAXG/PEXG GEMOX/FOLFOX Gemcitabine 18 14 6 2 8.1 5.3 2.6 2.4 11.8 11.4 2.8 3.6 6.0 11.6 5.3 3.9 19.9 26.8 10.8 8.1
II line chemotherapy Platinum NO Platinum Gemcitabine or Capecitabine 19 18 3 8.7 5.3 2.4 12.0 7.4 4.9 5.9 9.5 3.5 21.1 18.7 9.7
Previous PFS1 (mo) ≤ 6 > 6 16 24 6.8 5.3 10.6 8.8 - - 14.7 21.5

mo: months

Conclusions

Keeping in mind the small sample size of our series, gBRCA1pv and > 65 years pts yielded limited benefit from 2LT. Platinum-based 2LT obtained longer PFS2 and OS2 as opposed to platinum-free 2LT. Pts with PFS1 ≤ 6 months had longer PFS2 and OS2, but shorter OStot if compared to pts with PFS1 > 6 months. Overall, 2L data confirm that platinum is the backbone of treatment for gBRCA1-2pv stage IV PDAC pts, but first-line use should be preferred.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

MyEverest ONLUS.

Disclosure

M. Milella: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: EUSA Pharma; Financial Interests, Personal, Invited Speaker: Merck-Serono; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Mylan. M. Niger: Financial Interests, Personal, Invited Speaker: Accademia della Medicina; Financial Interests, Personal, Other, Consultant: EMD Serono; Financial Interests, Personal, Other, Consultant: Basilea Pharmaceutica. S. Cascinu: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Baxter; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Other, Consultant: Amgen; Financial Interests, Personal, Other, Consultant: Baxter; Financial Interests, Personal, Other, Consultant: Eli Lilly; Financial Interests, Personal, Other, Consultant: Celgene; Financial Interests, Personal, Other, Consultant: Novartis; Financial Interests, Personal, Other, Consultant: MSD; Financial Interests, Personal, Research Grant: Celgene; Financial Interests, Personal, Research Grant: Eisai. M. Reni: Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Baxalta; Financial Interests, Personal, Advisory Board: Baxter; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Advisory Board: Shire; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Novocure; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Other, steering committee: AstraZeneca; Non-Financial Interests, Personal, Other, steering committee: Boston Pharmaceuticals. All other authors have declared no conflicts of interest.

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