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Background <p>Advanced pancreatic adenocarcinoma lacks a universally accepted second-line chemotherapy regimen following progression on FOLFIRINOX or Gemzar/Abraxane. In a previous retrospective study at AUBMC, the modified GTX regimen showed good tolerability and a 33% response rate. This prospective study aimed to evaluate radiological response, toxicity, and survival outcomes of modified GTX in patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma who progressed after first-line chemotherapy.</p> Methods <p>Eligible patients from the American University of Beirut Medical Center (AUBMC) treated between March 2013 and May 2019 (age ≥ 18, ECOG performance status 0–2) received modified GTX in 28-day cycles: docetaxel 40&#xa0;mg/m² (days 1, 15), gemcitabine 1000&#xa0;mg/m² (days 8, 22), and capecitabine 625&#xa0;mg/m² orally twice daily (days 6–10, 20–24). Radiological response, toxicity (CTCAE v4.0), progression-free survival (PFS), and overall survival (OS) were assessed using the Kaplan–Meier method.</p> Results <p>Among 44 patients (31 males, 13 females), 25 (56.8%) had received FOLFIRINOX and 19 (43.2%) had received gemcitabine-based regimens as first-line therapy. The median PFS was 2 months (95% CI: 1.5–2.8 months) and median OS was 8 months (95% CI: 6.2–9.8 months). Common adverse events included anemia (93.3%), neutropenia (48.9%), thrombocytopenia (24.4%), mucositis/oral thrush (33.3%), nausea/vomiting (20.5%), diarrhea (22.2%), and infection (24.4%). Grade 3/4 toxicities included anemia (19.7%), neutropenia (28.9%), and thrombocytopenia (20.1%).</p> Conclusion <p>Modified GTX demonstrated clinical activity with a manageable toxicity profile, thereby suggesting its potential as a second-line treatment option in advanced pancreatic adenocarcinoma. Larger prospective studies are warranted to further validate our findings.</p>

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Efficacy and Safety of Modified GTX as Second-Line Therapy in Advanced Pancreatic Adenocarcinoma: A Prospective Cohort Study

  • 期刊论文

  • 发表日期：

    2026年5月30日

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  • Sara El Meski,
  • Razan Al Tartir,
  • Farah Nassar,
  • Maria Mezher,
  • Ali Shamseddine,
  • Sally Temraz

摘要

Background

Advanced pancreatic adenocarcinoma lacks a universally accepted second-line chemotherapy regimen following progression on FOLFIRINOX or Gemzar/Abraxane. In a previous retrospective study at AUBMC, the modified GTX regimen showed good tolerability and a 33% response rate. This prospective study aimed to evaluate radiological response, toxicity, and survival outcomes of modified GTX in patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma who progressed after first-line chemotherapy.

Methods

Eligible patients from the American University of Beirut Medical Center (AUBMC) treated between March 2013 and May 2019 (age ≥ 18, ECOG performance status 0–2) received modified GTX in 28-day cycles: docetaxel 40 mg/m² (days 1, 15), gemcitabine 1000 mg/m² (days 8, 22), and capecitabine 625 mg/m² orally twice daily (days 6–10, 20–24). Radiological response, toxicity (CTCAE v4.0), progression-free survival (PFS), and overall survival (OS) were assessed using the Kaplan–Meier method.

Results

Among 44 patients (31 males, 13 females), 25 (56.8%) had received FOLFIRINOX and 19 (43.2%) had received gemcitabine-based regimens as first-line therapy. The median PFS was 2 months (95% CI: 1.5–2.8 months) and median OS was 8 months (95% CI: 6.2–9.8 months). Common adverse events included anemia (93.3%), neutropenia (48.9%), thrombocytopenia (24.4%), mucositis/oral thrush (33.3%), nausea/vomiting (20.5%), diarrhea (22.2%), and infection (24.4%). Grade 3/4 toxicities included anemia (19.7%), neutropenia (28.9%), and thrombocytopenia (20.1%).

Conclusion

Modified GTX demonstrated clinical activity with a manageable toxicity profile, thereby suggesting its potential as a second-line treatment option in advanced pancreatic adenocarcinoma. Larger prospective studies are warranted to further validate our findings.