A real-world analysis of second-line treatment option, gemcitabine plus anlotinib and anti-PD1, in advanced pancreatic cancer

Background: In the second -line treatment of advanced pancreatic cancer (APC), there is only one approved regimen based on the phase III NAPOLI-1 trial. However, for patients progressing after Nabpaclitaxel and Gemcitabine (Nab-P/Gem) or Nab -P combinations, second -line treatment were very limited. Methods: This is a retrospective single -center analysis of patients. Our aim was to determine the effectiveness and tolerability of a novel regimen, gemcitabine plus Anlotinib and anti-PD1, in APC patients and to compare it with oxaliplatin, irinotecan, leucovorin, and fluorouracil (FOLFIRINOX) in the second -line setting who have failed on the first -line Nab -P combinations. Results: In total, twenty-three patients received Gemcitabine plus Anlotinib and anti-PD1 in the secondline, 28 patients were treated with FOLFORINOX. There was no significant difference in overall survival (OS) or progression free survival (PFS) for either of the two sequences (p > 0.05). Patients who received Gemcitabine plus Anlotinib and anti-PD1 had a median PFS of 4.0 months (95% CI: 1.1-6.9) versus 3.5 months (95% CI 1.8-5.2) in FOLFORINOX group (p = 0.953). The median OS of Gemcitabine plus Anlotinib and anti-PD1 was 9.0 months (95% CI: 4.0-13.7) and 8.0 months (95% CI: 5.5-10.5) in FOLFORINOX group (p = 0.373). Grade >= 3 treatment -emergent adverse events (AEs) occurred for 13% of patients with Gemcitabine plus Anlotinib and anti-PD1 and 40% for FOLFORINOX. Conclusion: Our data confirms the effectiveness of Gemcitabine plus Anlotinib and anti-PD1 as a welltolerated regimen in the second -line treatment of APC and extends available data on its use as a second -line treatment option when compared with FOLFIRINOX. (c) 2024 The Authors. Published by Elsevier B.V. on behalf of IAP and EPC. This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).