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Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer: A Nonrandomized Controlled Trial.

Michael Cecchini1, Ronald R Salem2, Marie Robert3

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|June 20, 2024
PubMed
Summary

Neoadjuvant modified 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan (mFOLFIRINOX) demonstrated a 67% 12-month progression-free survival rate in pancreatic cancer patients. Postoperative circulating tumor DNA (ctDNA) positivity strongly predicted recurrence, highlighting its potential as a biomarker.

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Area of Science:

  • Oncology
  • Gastroenterology
  • Medical Research

Background:

  • Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with limited treatment options.
  • Durable disease control remains a challenge in PDAC, even after surgical resection.

Purpose of the Study:

  • To evaluate the efficacy of neoadjuvant modified 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan (mFOLFIRINOX) in controlling micrometastasis and improving survival in resectable PDAC.
  • To assess the role of circulating tumor DNA (ctDNA) and keratin 17 (K17) as biomarkers for treatment response and prognosis.

Main Methods:

  • An open-label, single-arm, phase 2 nonrandomized trial involving patients with resectable PDAC.
  • Patients received 6 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 6 cycles of adjuvant mFOLFIRINOX.
  • Circulating tumor DNA (ctDNA) levels and K17 expression in tumors were analyzed.

Main Results:

  • The 12-month progression-free survival (PFS) rate was 67%. Median PFS was 16.6 months and median overall survival (OS) was 37.2 months.
  • Preoperative ctDNA levels decreased significantly after mFOLFIRINOX treatment (73% to 18%).
  • Postoperative ctDNA positivity was strongly associated with worse PFS (HR, 34.0) and OS (HR, 11.7). High K17 expression showed a trend towards worse PFS and OS.

Conclusions:

  • Perioperative mFOLFIRINOX met its primary endpoint and warrants further investigation in randomized trials.
  • Postoperative ctDNA positivity is a significant predictor of recurrence in PDAC patients treated with neoadjuvant mFOLFIRINOX.
  • ctDNA and K17 show promise as biomarkers for PDAC, requiring further validation in prospective studies.