Long-term outcomes of neoadjuvant gemcitabine, nab-paclitaxel, and S1 (GAS) in borderline resectable pancreatic cancer with arterial contact: Results from a phase II trial

J Hepatobiliary Pancreat Sci. 2024 May;31(5):351-362. doi: 10.1002/jhbp.1412. Epub 2023 Dec 29.

Abstract

Background/purpose: This study reports the long-term results of a phase II trial evaluating the clinical efficacy of neoadjuvant gemcitabine, nab-paclitaxel, and S1 (GAS) in borderline resectable pancreatic cancer with arterial contact (BRPC-A).

Methods: A multicenter, single-arm, phase II trial was conducted. Patients received six cycles of GAS and patients without progressive disease were intended for R0 resection.

Results: Of the 47 patients, 45 (96%) underwent pancreatectomy. At the time of this analysis, all patients were updated with no loss to follow-up. A total of 30 patients died, while the remaining 17 patients were followed for a median of 68.1 months. The updated median overall survival (OS) was 41.0 months, with 2- and 5-year OS rates of 68.0% and 44.6%, respectively. Multivariate analysis in the preoperative model showed that a tumor diameter reduction rate ≥10% and a CA19-9 reduction rate ≥95% after neoadjuvant chemotherapy remained independently associated with favorable survival. In the postoperative multivariate model, no lymph node metastasis, no major surgical complications, and completion of adjuvant chemotherapy were independently associated with improved OS.

Conclusions: This long-term evaluation of the neoadjuvant GAS trial demonstrated the high efficacy of the regimen, suggesting that it is a promising treatment option for patients with BRPC-A.

Keywords: S‐1; borderline resectable pancreatic cancer; gemcitabine; nab‐paclitaxel; neoadjuvant chemotherapy.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Albumins* / administration & dosage
  • Albumins* / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Deoxycytidine* / analogs & derivatives
  • Deoxycytidine* / therapeutic use
  • Drug Combinations
  • Female
  • Gemcitabine*
  • Humans
  • Male
  • Middle Aged
  • Neoadjuvant Therapy*
  • Neoplasm Staging
  • Oxonic Acid / administration & dosage
  • Oxonic Acid / therapeutic use
  • Paclitaxel* / administration & dosage
  • Pancreatectomy* / methods
  • Pancreatic Neoplasms* / drug therapy
  • Pancreatic Neoplasms* / mortality
  • Pancreatic Neoplasms* / pathology
  • Pancreatic Neoplasms* / surgery
  • Survival Rate
  • Tegafur / administration & dosage
  • Tegafur / therapeutic use
  • Treatment Outcome

Substances

  • Deoxycytidine
  • Gemcitabine
  • Paclitaxel
  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Tegafur
  • S 1 (combination)
  • Oxonic Acid
  • Drug Combinations