FOLFIRINOX in locally advanced (LA) and borderline resectable (BR) pancreatic adenocarcinoma: Update of the AGEO cohort

abstracts

BioPharm Communications, Bristol-Myers Squibb, Celgene Corporation, Eisai, Inc., Ignyta, Inc., Pharmacyslics, LLC., Pharmcyte Biotech, Tocagen, Inc., Immunovia, CPRIT, AstraZeneca. M. Reni: Research grant / Funding (self): Celgene, Baxalta, Merck Serono, Helsinn; Non-remunerated activity/ ies: Celgene, Baxalta, Merck Serono, Lilly, Pfizer, AstraZeneca, Novocure, Halozyme, Novartis, Shire. H. Riess: Speaker Bureau / Expert testimony: Celgene, Roche, Shire; Advisory / Consultancy: Celgene, Shire. E.M. O’Reilly: Honoraria (self), Research grant / Funding (institution): Celgene Corporation; Research grant / Funding (self): ActaBiologica, Agios, Array, AstraZeneca, Bayer, Beigene, BMS, Casi, Exelixis, Genentech, Halozyme, Incyte, Lilly, Mabvax, Novartis, OncoQuest, Polaris Puma, QED, Roche. S. Krishnamurthi: Non-remunerated activity/ies, Research Funding: Taiho, CytomX, € Regeneron, Celgene, AbbVie. P. Osterlund: Advisory / Consultancy: Amgen; Bayer; Celgene; Eisai; Lilly; Merck Serono; Roche; Sanofi; Servier/Shire; Speaker Bureau / Expert testimony: Prime Oncology; Research grant / Funding (institution): Amgen (Inst); Bristol-Myers Squibb (Inst); Celgene (Inst); Lilly (Inst); Merck Serono (Inst); MSD (Inst); Nordic Drugs (Inst); Roche (Inst); Sanofi (Inst); Servier (Inst); Travel / Accommodation / Expenses: AbbVie, Pierre Fabre. M. Milella: Advisory / Consultancy: Pfizer; Speaker Bureau / Expert testimony: AstraZeneca, EUSA Pharma. S. Siena: Advisory / Consultancy: Amgen, Bayer, BMS, CheckmAb, Celgene, Daiichi-Sankyo, Incyte, Merck, Novartis, Roche-Genentech, and Seattle Genetics. J. Tabernero: Advisory / Consultancy, Personal Financial Interest: Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Part. E. Van Cutsem: Advisory / Consultancy: Bayer, Lilly, Roche, Servier, Bristol-Myers Squibb, Celgene, Merck Sharp & Dohme, Merck KGaA, Novartis, AstraZeneca; Research grant / Funding (self): Amgen, Bayer, Boehringer Ingelheim, Lilly, Novartis, Roche, Celgene, Ipsen, Merck, Merck KGaA, Servier, BristolMyers Squibb. P.A. Philip: Research grant / Funding (self): Celgene, Bayer, and Incyte; Speaker Bureau / Expert testimony: Roche, Sanofi, and Amgen; Advisory / Consultancy: Celgene Corporation. D. Goldstein: Advisory / Consultancy, Research grant / Funding (institution): Celgene Corporation, Pfizer. J.D. Berlin: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene Corporation. M. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. S. Ferrara: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. Y. Le Bruchec: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. D. McGovern: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. A. Biankin: Leadership role: Gene Forward Inc; Research grant / Funding (self): Celgene, AstraZeneca; Licensing / Royalties: Agilent; Honoraria (self): Celgene, AstraZeneca, Tusk, Astar; Travel / Accommodation / Expenses: Celegene, AstraZeneca, Roche; Speaker Bureau / Expert testimony: Celgene, AstraZeneca, Tusk, Astar, Roche. All other authors have declared no conflicts of interest.

683P

FOLFIRINOX in locally advanced (LA) and borderline resectable (BR) pancreatic adenocarcinoma: Update of the AGEO cohort

E. Auclin1, L. Marthey2, L. Mas3, E. Francois4, A. Sa Cunha5, J-B. Bachet6, D. Tougeron7, A. Vienot8, T. Lecomte9, V. Hautefeuille10, J. Forestier11, M. Collins2, R. Abdallah2, R. Coriat12, A-L. Pointet13, F. Leroy14, F. Ksontini3, N. Williet15, J. Taieb16 1 Gastrointestinal and Medical Oncology, Hopital European George Pompidou, Paris, France, 2Gastroenterology, CHU de Bic^etre, Le Kremlin Bicetre, France, 3 Gastroenterology, APHP Hoˆpital Pitie´ Salp^etrie`re, Paris, France, 4Oncology, Centre Anticancer Antoine Lacassagne, Nice, France, 5Centre Hepetobiliaire, Universite Paris Sud, Orsay, France, 6Gastroenterology, Groupe Hospitalier Pitie´ Salpetriere, Paris, France, 7 Gastroenterology and Oncology, CHU Poitiers, Jean Bernard Hoˆpital, Poitiers, France, 8 CHRU Besancon - Hopital Jean Minjoz, Besanc¸on, France, 9Hepato-Gastroenterology and Digestive Oncology, CHU de Tours, Hoˆpital Trousseau, Chambray-le`s-Tours, France, 10 Gastroenterology and Digestive Oncology, CHU Amiens-Picardie Site Nord, Amiens, France, 11Gastroenterology, Hopital Edouard Herriot Pav. E bis, Lyon, France, 12 Gastroenterology, Hoˆpital Cochin, Paris, France, 13Gastrointestinal Oncology, Hopital European George Pompidou, Paris, France, 14Medical Oncology, Institut Gustave Roussy, Villejuif, France, 15Gastroenterology, University Hospital of Saint-Etienne, Saint Priest En Jarez, France, 16Department of Gastroenterology and Digestive Oncology, Hopital European George Pompidou, Paris, France 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.

v260 | Gastrointestinal Tumours, Non-Colorectal

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 (p¼.002). For pts treated by CT alone, or CTþRT, or CTþ/-RTþsurgery 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, p¼.08). 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. 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.

684P

Impact of adjuvant treatment with nab-paclitaxel and gemcitabine (nab-P1GEM) vs gemcitabine alone (GEM) on health-related quality of life (QoL) in patients (pts) with surgically resected pancreatic adenocarcinoma (PA) in the adjuvant pancreatic adenocarcinoma clinical trial (APACT)

H. Riess1, J. Braverman2, M. Reni3, A.C. Dueck4, A. Hendifar5, D-Y. Oh6, C-P. Li7, T. Macarulla Mercade8, A. Shah9, N. Joshi10, M. Botterman11, E. Mantovani2, B. Lu2, M.A. Tempero12 1 Oncology, Charite´-Universit€ atsmedizin Berlin; Berlin; Germany; Freie Universit€ at Berlin, Humboldt-Universit€ at zu Berlin; Berlin; Germany; Berlin Institute of Health, Berlin, Germany, 2Clinical Research, Celgene Corporation, Summit, NJ, USA, 3Oncology, San Raffaele Scientific Institute, Milan, Italy, 4Hematology Department, Mayo Clinic, Phoenix, AZ, USA, 5Gastrointestinal Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA, 6Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea, 7Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, 8Medical Oncology Department, Vall d’Hebron Institute of Oncology (VHIO)-Cellex Center, Barcelona, Spain, 9 Real-World Evidence & Data Analytics, Pharmerit International, Bethesda, MD, USA, 10 Real-World Evidence & Data Analytics; Patient-Centered Outcomes, Pharmerit International, Bethesda, MD, USA, 11Health Economics Research, Pharmerit International, Bethesda, MD, USA, 12Division of Hematology and Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA Background: The APACT trial compared disease-free survival in pts with surgically resected PA randomized to nab-PþGEM or GEM as adjuvant regimens. We compared the QoL impact of both regimens in the biggest cohort of pts (n ¼ 379/arm) in which QoL was studied in this setting. Methods: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and pancreatic cancer module (PAN26) scores were assessed in 12-week intervals at screening (BL), middle and end of treatment (EOT), and up to 2.5 years of follow-up (FU). A mixed model for repeated measures analysis adjusting for BL score was conducted to predict scores by arm at each visit. Time until definite deterioration (TUDD) and improvement (TUDI) were compared between arms, separately during treatment and FU, using a minimal important difference (MID) threshold of 10-points for all QLQ-C30 scales and scale-specific thresholds for PAN26. Results: The proportion of pts with QoL data at EOT, year 1, and year 3 were 88%, 51%, and 17%, with similar attrition in both arms. The predicted differences between arms for global health (GH) and all but 1 subscale of the QLQ C-30 never reached the predefined MID threshold (Table). nab-PþGEM pts had meaningfully worse predicted scores than GEM pts on 6 of 17 PAN26 scales during treatment, but these differences persisted for only 2 scales at 2 FU visits. For TUDD and TUDI, nab-PþGEM pts deteriorated faster during treatment, but TUDD did not differ for domain-specific or GH scales between arms at FU, during which nab-PþGEM pts improved faster on some scales, including GH.

Volume 30 | Supplement 5 | October 2019

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This is consistent with the median OS observed with nab-P/G vs G in pts whose tumors were < 1 mm to the closest margin (32.5 vs 29.7 mo; n ¼ 114 and 112). Pts with both R1 resection and LNþ status had numerically longer median OS with nab-P/G vs G (30.7 vs 24.9 mo; n ¼ 87 and 83). Conclusions: Final OS data may clarify the role for adjuvant nab-P/G. Interim OS analyses suggest that continued investigation of adjuvant nab-P/G for pts with suboptimally resected PC or who may not tolerate FOLFIRINOX is warranted. Clinical trial identification: NCT01964430. Editorial acknowledgement: Rebecca Tweedell, MediTech Media, Ltd, funded by Celgene Corporation. Legal entity responsible for the study: The authors. Funding: Celgene Corporation. Disclosure: M.A. Tempero: Advisory / Consultancy: AbbVie, Inc., Advance Medical, Inc.,

Annals of Oncology