Abstract 1668
Background
FOLFIRINOX has shown promising results in LA or BR pancreatic adenocarcinoma (PA) in non-randomized series. We report here an updated large cohort of pts treated with FOLFIRINOX for a LA or BR PA.
Methods
This French retro-prospective multicenter study included all consecutive patients (pts), PS 0/1/2, with non-metastatic, non-resectable, non-pretreated, LA or BR PA treated with FOLFIRINOX. Non-resectability was defined by each center’s multidisciplinary team meeting at diagnosis according to the ISGPS guidelines. FOLFIRINOX chemotherapy (CT) was performed as described in the PRODIGE 4 trial until progression, major toxicity or consolidation treatment radiotherapy (RT) or surgery.
Results
At the time of database lock, in December 2018, 293 pts were included (42% female, 33% > 65 years, 97% PS < 2). Disease was classified as BR (32%) or LA (68%). After a median of 7 (IQR: 5-11) CT cycles, objective response rate was 29% and stable disease 51%. Subsequent RT was performed in 42% and 24% had a curative intent surgery (R0: 72%; ypT0N0: 9%). Resection rates were 40% for BR and 17% for LA pts. Main G3/4 toxicities were: fatigue (14%), neutropenia (12%), nausea (8%) and diarrhea (7%). Oxaliplatin-induced peripheral neuropathy G2/3 was observed in 34%. 13% of pts has stopped chemotherapy for toxicity including 2 toxic deaths. After consolidation RT and/or surgery disease progression occurred in 52% and was mainly metastatic (56%). After a median follow-up of 24 months (mo), median OS (mOS) and PFS were 21 and 12 mo, respectively. mOS was 27 mo for BR and 19 mo for LA pts (p=.002). For pts treated by CT alone, or CT+RT, or CT+/-RT+surgery mOS were 14 mo, 22 mo and not reached, respectively (p<.0001). A trend to a better survival was seen when RT was performed before surgery (mOS 29 mo vs not reached, p=.08).
Conclusions
FOLFIRINOX for LA and BR PA seems to be effective with a manageable toxicity profile. However secondary surgery rate and OS were lower than what we previously reported, but similar to the meta-analysis we previously published. These promising results in “real life” pts have now to be confirmed in phase III randomized trial (PRODIGE 29 - NEOPAN). Updated results will be presented at the meeting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
AGEO.
Funding
Has not received any funding.
Disclosure
E. Francois: Advisory / Consultancy: Roche; Advisory / Consultancy: Servier; Advisory / Consultancy: Amgen; Advisory / Consultancy: MSD; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Novartis. J. Bachet: Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Serono; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Servier; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi. D. Tougeron: Advisory / Consultancy: Amgen; Advisory / Consultancy: Merck; Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Roche; Advisory / Consultancy: Bayer; Advisory / Consultancy: Servier. J. Forestier: Honoraria (self): Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Bayer; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self): Ipsen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck; Honoraria (self): Servier. R. Coriat: Advisory / Consultancy: Novartis; Advisory / Consultancy: Amgen; Advisory / Consultancy: Roche; Advisory / Consultancy: Merck; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Keocyt. J. Taieb: Advisory / Consultancy: Amgen; Advisory / Consultancy: Lily; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Roche; Advisory / Consultancy: Merck; Advisory / Consultancy: MSD; Advisory / Consultancy: Celgene; Advisory / Consultancy: Servier; Advisory / Consultancy: Sirtex; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Amgen; Advisory / Consultancy: Amgen. All other authors have declared no conflicts of interest.
Resources from the same session
3034 - Efficacy and safety of neoadjuvant chemotherapy plus trastuzumab and pertuzumab in non-metastatic HER2-positive breast cancer in real life: NEOPEARL STUDY
Presenter: Maria Agnese Fabbri
Session: Poster Display session 2
Resources:
Abstract
4772 - Real world comparison of the impact of adjuvant capecitabine in women with high-risk triple-negative breast cancer after neoadjuvant chemotherapy
Presenter: Maysa Vilbert
Session: Poster Display session 2
Resources:
Abstract
5627 - Influence of age on the indication of adjuvant chemotherapy in early breast cancer using Oncotype DX. An analysis of 240 patients treated in the Institut Catala d’Oncologia (ICO) hospitals
Presenter: Sabela Recalde
Session: Poster Display session 2
Resources:
Abstract
3917 - Impact of delayed neoadjuvant systemic chemotherapy on survival among breast cancer patients
Presenter: Mariana Chavez Mac Gregor
Session: Poster Display session 2
Resources:
Abstract
2246 - Clinical Confirmation of Higher Exposure to Niraparib in Tumor vs Plasma in Patients With Breast Cancer
Presenter: Laura Spring
Session: Poster Display session 2
Resources:
Abstract
581 - The rationale for the effectiveness of systemic treatment of breast cancer depending on the body weight index
Presenter: Mohammad Hojouj
Session: Poster Display session 2
Resources:
Abstract
5327 - Response to neoadjuvant chemotherapy in HER2 non-overexpressing breast cancer subtypes
Presenter: Silvia Mihaela Ilie
Session: Poster Display session 2
Resources:
Abstract
3613 - Pre-specified interim analysis of the SAFE trial (NCT2236806): a 4-arm randomized, double-blind, controlled study evaluating the efficacy and safety of cardiotoxicity prevention in non-metastatic breast cancer patients treated with anthracyclines with or without trastuzumab.
Presenter: Lorenzo Livi
Session: Poster Display session 2
Resources:
Abstract
3736 - Safety of hypofractionated whole breast irradiation after conservative surgery for patients aged less than 60 years: a multi-center comparative study.
Presenter: Icro Meattini
Session: Poster Display session 2
Resources:
Abstract
5085 - Usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab
Presenter: Isabel Blancas López-Barajas
Session: Poster Display session 2
Resources:
Abstract