Abstract 103P
Background
For patients (pts) with advanced BTC with progression on gemcitabine plus cisplatin (GemCis), fluoropyrimidine-based chemotherapy, including liposomal irinotecan (nal-IRI) plus fluorouracil and leucovorin (5-FU/LV) and 5-FU/LV plus oxaliplatin (FOLFOX) showed clinical benefit in prior randomized trials (NIFTY and ABC-06). However, there is no trial for head-to-head comparison among these agents.
Methods
We performed IPD meta-analysis of two multicenter, randomized trials performed in South Korea, which compared efficacy of second-line chemotherapy for advanced BTC after progression on GemCis, including the phase 2b NIFTY trial (nal-IRI plus 5-FU/LV vs. 5-FU/LV, NCT03524508) and the phase 2 FIReFOX trial (modified FOLFOX [mFOLFOX] vs. modified 5-FU/LV plus irinotecan [mFOLFIRI], NCT03464968). ITT population of the two trials were included and survival outcomes were compared between the 4 treatment groups by pairwise log-rank test. Hazards ratio (HR) adjusted by potential prognostic variables was estimated by Cox proportional hazards modeling with shared frailty to account for the trials effect.
Results
A total of 278 pts were included in this analysis (178 pts from the NIFTY trial and 99 pts from the FIReFOX trial). The nal-IRI plus 5-FU/LV group (n=88) showed significantly better overall survival compared to the mFOLFOX group (n=49, p = 0.02), mFOLFIRI group (n=50, p = 0.03), and 5-FU/LV group (n=90, p = 0.008). Multivariable analysis showed consistent trends with adjusted HR of 1.44 (95% CI 0.93-2.07, p = 0.11), 1.36 (95% CI 0.92-2.03, p = 0.13), and 1.52 (95% CI 1.37-1.09-2.10, p = 0.01), respectively. Also, nal-IRI plus 5-FU/LV group showed trends toward better progression-free survival compared to the other 3 groups with adjusted HR of 1.44 (95% CI 0.98-2.11, p = 0.06), 1.29 (95% CI 0.87-1.89, p = 0.20), and 1.88 (1.38-2.55, p < 0.001), respectively.
Conclusions
Nal-IRI plus 5-FU/LV showed better survival outcomes when compared to mFOLFOX, mFOLFIRI, or 5-FU/LV alone. Nal-IRI plus 5-FU/LV may be a preferable second-line regimen for advanced BTC pts without targetable genetic alterations.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Servier.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
127P - Prognostic significance of intratumoral and peritumoral budding in distal extrahepatic bile duct carcinoma
Presenter: Sun-Young Jun
Session: Poster session 17
128P - Biliary tract cancers: Epidemiological and prognosis trends of Latin American population
Presenter: Maria del Consuelo Diaz Romero
Session: Poster session 17
129P - Prognostic factors associated with survival in resected biliary tract cancers: A multicentre Italian experience
Presenter: Michele Ghidini
Session: Poster session 17
663P - Safety and preliminary efficacy of the KRAS G12C Inhibitor MK-1084 in solid tumors and in combination with pembrolizumab in NSCLC
Presenter: Carlos Rojas
Session: Poster session 17
664P - Final results of a phase I/II study of combined BCL-xL and MEK inhibition with navitoclax and trametinib in KRAS or NRAS mutant advanced solid tumors
Presenter: Ryan Corcoran
Session: Poster session 17
666P - Updated efficacy and safety data of entrectinib in patients (pts) with locally advanced/metastatic NTRK fusion-positive (fp) solid tumours
Presenter: Shun Lu
Session: Poster session 17
667P - Efficacy and safety of larotrectinib (laro) as first-line treatment for patients (pts) with tropomyosin receptor kinase (TRK) fusion cancer
Presenter: David Hong
Session: Poster session 17
668P - Efficacy and safety of larotrectinib in a pooled analysis of patients (Pts) with tropomyosin receptor kinase (TRK) fusion cancer
Presenter: Alexander Drilon
Session: Poster session 17