Modified FOLFIRINOX versus CisGem first-line chemotherapy for locally advanced non resectable or metastatic biliary tract cancer (AMEBICA)-PRODIGE 38: Study protocol for a randomized controlled multicenter phase II/III study

Phélip, Jean-Marc; Edeline, Julien; Blanc, Jean‐Frédéric; Barbier, E.; Michel, Pierre; Bourgeois, Vincent; Neuzillet, Cindy; Malka, David; Manfrédi, Sylvain; Desrame, Jérôme; Investigators, Prodige

doi:10.1016/j.dld.2018.11.018

Cited by 49 publications

(35 citation statements)

References 3 publications

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“…4 Time to progression (a) and overall survival (b) curves in the subgroup of 6 patients who underwent secondary surgical resection of downsized disease the single-institution experience in an academic tertiary centre for both medical oncology and hepato-biliary surgery. Thus, this retrospective report on real-life practice should warrant prospective studies to tackle these limitations like the ongoing French phase II/III randomized trial comparing modified FOLFIRINOX versus CisGem [15].…”

Section: Discussionmentioning

confidence: 99%

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A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer

et al. 2020

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Background: FOLFIRINOX is a pillar first-line regimen in the treatment of pancreatic cancer. Historically, biliary tract cancer (BTC) and pancreatic cancer have been treated similarly with gemcitabine alone or combined with a platinum compound. With growing evidence supporting the role of fluoropyrimidines in the treatment of BTC, we aimed at assessing the outcomes of patients (pts) with BTC on frontline FOLFIRINOX. Methods: We retrospectively analyzed data of all our consecutive patients with locally advanced (LA) or metastatic (M) BTC who were registered to receive FOLFIRINOX as a first-line therapy between 12/2013 and 11/2017 at Paul Brousse university hospital. The main endpoints were Overall Survival (OS), Time-to-Progression (TTP), best Objective Response Rate (ORR), Disease Control rate (DCR), secondary macroscopically-complete resection (res) and incidence of severe (grade 3-4) toxicity (tox). Results: There were 17 male (40%) and 25 female (60%) pts. aged 36 to 84 years (median: 67). They had PS of 0 (55%) or 1 (45%), and intrahepatic cholangiocarcinoma (CCA) (21 pts., 50%), gallbladder carcinoma (8 pts., 19%), perihilar CCA (7 pts., 17%), distal CCA (4 pts., 10%) and ampulloma (2 pts., 5%). BTC was LA or M in 10 (24%) and 32 pts. (76%) respectively. Biliary stent was placed in 14 pts. (33%). A median of 10 courses was given with median treatment duration of 6 months. There were no untoward toxicity issues, with no febrile neutropenia, emergency admission for toxicity or toxic death. We observed 12 partial responses (29%) and 19 disease stabilisations (45%). Six patients (14%) underwent secondary R0-R1 resection. Median TTP was 8 months [95%CL, 6-10] and median OS was 15 months [13-17]. Patients undergoing secondary resection displayed a 3-y disease-free rate of 83%. Conclusions: First-line FOLFIRINOX offers promising results in patients with LA and M-BTC. It deserves prospective evaluation to further improve outcomes for advanced BTC.

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Section: Discussionmentioning

confidence: 99%

“…Given the fairly limited number of reports on FOLFIR-INOX in BTC [15][16][17][18], we decided to perform a retrospective analysis of the outcomes of all consecutive patients with advanced BTC treated with FOLFIRINOX as first-line chemotherapy at Paul Brousse university hospital, Villejuif, France over a 4-year period.…”

Section: Introductionmentioning

confidence: 99%

A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer

et al. 2020

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“…It is noticeable that some clinical trials have shown that combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) yield promising results in patients with BTC. 21 , 22 However, none of the single program has been widely offered, since unexpected responses were deliberately taken into account, such as systemic toxicity, insufficient drug responses, and drug resistance. 23 Therefore, there are currently a large number of preclinical and clinical researches that are adding significant efforts in order to define the overall benefit of drug treatment even in the presence of adversary responses, which can be otherwise governed at a minimal level.…”

Section: Chemotherapy and Radiotherapy Of Gbcmentioning

confidence: 99%

Overview of current targeted therapy in gallbladder cancer

Song

et al. 2020

Sig Transduct Target Ther

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Gallbladder cancer (GBC) is rare, but is the most malignant type of biliary tract tumor. Unfortunately, only a small population of cancer patients is acceptable for the surgical resection, the current effective regimen; thus, the high mortality rate has been static for decades. To substantially circumvent the stagnant scenario, a number of therapeutic approaches owing to the creation of advanced technologic measures (e.g., next-generation sequencing, transcriptomics, proteomics) have been intensively innovated, which include targeted therapy, immunotherapy, and nanoparticle-based delivery systems. In the current review, we primarily focus on the targeted therapy capable of specifically inhibiting individual key molecules that govern aberrant signaling cascades in GBC. Global clinical trials of targeted therapy in GBC are updated and may offer great value for novel pathologic and therapeutic insights of this deadly disease, ultimately improving the efficacy of treatment.

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“…However, a single arm of FOLFIRINOX (18) to treat advanced BTC resulted in an objective response rate (ORR) of only 10% and a PFS of 6.2 months and an OS of 10.7 months, indicating that it was less efficacious than GEMCIS. A trial of modified FOLFIRINOX versus GEMCIS as first-line chemotherapy for locally advanced non resectable or metastatic BTC (AMEBICA)-PRODIGE 38 (NCT02591030) is now underway (19). This is a randomized controlled multicenter phase II/III study aiming to clarify the efficacy or FOLFIRINOX over GEMCIS.…”

Section: Molecular Targeted Therapymentioning

confidence: 99%