Neoadjuvant Chemotherapy With Gemcitabine/Cisplatin/S-1 for Resectable Biliary Tract Cancer With FDG-PET-Positive...

Area of Science:

• Oncology
• Surgical Oncology
• Medical Oncology

Background:

• Biliary tract cancer (BTC) presents significant treatment challenges, especially with lymph node involvement.
• Neoadjuvant chemotherapy aims to improve resectability and outcomes for advanced BTC.
• Fluorodeoxyglucose-positron emission tomography (FDG-PET) is crucial for staging and assessing treatment response.

Purpose of the Study:

• To assess the safety and efficacy of neoadjuvant gemcitabine, cisplatin, and S-1 (GCS) chemotherapy.
• To evaluate GCS chemotherapy in patients with resectable BTC and FDG-PET-positive lymph nodes.
• To determine the curative resection rate as the primary endpoint in a multicenter phase II study.

Main Methods:

• A multicenter phase II study (KHBO1201) enrolled patients with resectable BTC and FDG-PET-positive lymph nodes.
• Patients received 3-6 cycles of GCS chemotherapy (gemcitabine/cisplatin and oral S-1).
• Surgery was performed 4-8 weeks post-chemotherapy if the tumor remained resectable.

Main Results:

• Ninety-two percent of patients completed GCS chemotherapy without treatment-related deaths.
• The curative resection rate was 60%, with a 40% morbidity rate.
• The 1-year survival rate was 75%, with radiological and pathological complete response rates of 24% and 28% for lymph nodes, respectively.

Conclusions:

• Neoadjuvant GCS chemotherapy is safe and feasible for resectable BTC with FDG-PET-positive lymph nodes.
• The regimen demonstrates potential efficacy, supporting its use in this patient population.
• A phase III trial (JCOG1920) is ongoing to compare neoadjuvant GCS with upfront surgery.