Head-to-head comparison of treatment sequences in advanced pancreatic cancer-Real-world data from the prospective German TPK clinical cohort study

Int J Cancer. 2024 Nov 1;155(9):1629-1640. doi: 10.1002/ijc.35071. Epub 2024 Jul 2.

Abstract

There are no clear guidelines regarding the optimal treatment sequence for advanced pancreatic cancer, as head-to-head phase III randomised trials are missing. We assess real-world effectiveness of three common sequential treatment strategies by emulating a hypothetical randomised trial. This analysis included 1551 patients with advanced pancreatic cancer from the prospective, clinical cohort study Tumour Registry Pancreatic Cancer receiving FOLFIRINOX (n = 613) or gemcitabine/nab-paclitaxel (GEMNAB; n = 938) as palliative first-line treatment. We used marginal structural modelling to compare overall survival (OS) and time to deterioration (TTD) of health-related quality of life (HRQoL) between three common first- to second-line treatment sequences, adjusting for time-varying potential confounding. The sequences were: FOLFIRINOX→GEMNAB, GEMNAB→FOLFOX/OFF and GEMNAB→nanoliposomal irinotecan (NALIRI) + 5-fluorouracil. Outcome was also calculated stratified by patients' prognostic risk according to the Pancreatic Cancer Score. Median OS and TTD of HRQoL independent of risk were 10.7 [8.9, 11.9] and 6.4 [4.8, 7.7] months for FOLFIRINOX→GEMNAB, 8.4 [7.4, 9.7] and 5.8 [4.6, 7.1] months for GEMNAB→FOLFOX/OFF and 8.9 [7.8, 10.4] and 4.6 [4.1, 6.1] months for GEMNAB→NALIRI+5-fluorouracil. Compared to FOLFIRINOX→GEMNAB, OS and TTD were worse for poor-risk patients with GEMNAB→FOLFOX/OFF (OS: HR 2.09 [1.47, 2.98]; TTD: HR 1.97 [1.19, 3.27]) and those with GEMNAB→NALIRI+5-fluorouracil (OS: HR 1.35, [0.76, 2.39]; TTD: HR 2.62 [1.56, 4.42]). Brackets denote 95%-confidence intervals. The estimated real-world effectiveness of the three treatment sequences evaluated were largely comparable. Poor-risk patients might benefit from intensified treatment with FOLFIRINOX→GEMNAB in terms of clinical and patient-reported outcomes. Future randomised trials on sequential treatments in advanced pancreatic cancer are warranted.

Keywords: FOLFIRINOX; cohort studies; gemcitabine/nab‐paclitaxel; pancreatic carcinoma; sequential treatment.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Albumins / administration & dosage
  • Albumins / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Deoxycytidine* / administration & dosage
  • Deoxycytidine* / analogs & derivatives
  • Deoxycytidine* / therapeutic use
  • Female
  • Fluorouracil* / administration & dosage
  • Fluorouracil* / therapeutic use
  • Gemcitabine*
  • Germany / epidemiology
  • Humans
  • Irinotecan* / therapeutic use
  • Leucovorin* / therapeutic use
  • Male
  • Middle Aged
  • Organoplatinum Compounds / therapeutic use
  • Oxaliplatin* / administration & dosage
  • Oxaliplatin* / therapeutic use
  • Paclitaxel* / administration & dosage
  • Paclitaxel* / therapeutic use
  • Pancreatic Neoplasms* / drug therapy
  • Pancreatic Neoplasms* / mortality
  • Pancreatic Neoplasms* / pathology
  • Prognosis
  • Prospective Studies
  • Quality of Life*
  • Treatment Outcome

Substances

  • Fluorouracil
  • Leucovorin
  • Irinotecan
  • Gemcitabine
  • Paclitaxel
  • Oxaliplatin
  • Deoxycytidine
  • folfirinox
  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Organoplatinum Compounds