Retrospective Analysis of CA19-9 Decrease in Patients with Metastatic Pancreatic Carcinoma Treated with FOLFIRINOX or Gemcitabine in a Randomized Phase III Study (ACCORD11/PRODIGE4)

Oncology. 2017;93(6):367-376. doi: 10.1159/000477850. Epub 2017 Oct 6.

Abstract

Objectives: Carbohydrate antigen 19-9 (CA19-9) is a sensitive and specific serum marker in pancreatic cancer. Our retrospective analysis aims to evaluate CA19-9 decrease in patients with metastatic pancreatic cancer treated in ACCORD11/PRODIGE4 (FOLFIRINOX vs. gemcitabine).

Methods: A total of 342 patients were treated. CA19-9 was measured at 8 weeks (±2) in 160 patients from a total of 282 with abnormal CA19-9 values at baseline (gemcitabine arm, n = 75; FOLFIRINOX arm, n = 85). In the present study, 8-week CA19-9 decrease or greater CA19-9 decrease according to the 20 and 90% thresholds were analyzed. Progression-free survival (PFS) and overall survival (OS) were estimated in each subgroup.

Results: In the FOLFIRINOX arm, patients with an 8-week CA19-9 decrease or greater CA19-9 decrease ≥20% showed improved median OS, PFS, and objective response rate. In the overall study population, median OS and PFS were significantly improved in patients with an 8-week CA19-9 decrease ≥20% (vs. <20%). The 8-week CA19-9 decrease was predictive of PFS (interaction test significant according to treatment arm; p = 0.006).

Conclusion: An 8-week CA19-9 decrease ≥20% is a prognostic factor for OS and PFS. The 8-week CA19-9 decrease (20% threshold) is predictive of PFS. It could help to evaluate the efficacy of FOLFIRINOX and gemcitabine regimens.

Keywords: Biomarkers; CA19-9; FOLFIRINOX; Metastatic pancreatic cancer.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • CA-19-9 Antigen / blood*
  • Camptothecin / administration & dosage
  • Camptothecin / analogs & derivatives
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Disease-Free Survival
  • Female
  • Fluorouracil / administration & dosage
  • Gemcitabine
  • Humans
  • Leucovorin / administration & dosage
  • Male
  • Organoplatinum Compounds / administration & dosage
  • Pancreatic Neoplasms / blood*
  • Pancreatic Neoplasms / drug therapy*
  • Prognosis
  • Retrospective Studies

Substances

  • CA-19-9 Antigen
  • Organoplatinum Compounds
  • Deoxycytidine
  • Leucovorin
  • Fluorouracil
  • Camptothecin
  • Gemcitabine

Supplementary concepts

  • FOLFOXIRI protocol