Investigation of neoadjuvant gemcitabine plus cisplatin-based triplet regimens on biliary tract cancer with possible lymph node metastasis

Introduction

Biliary tract cancer (BTC) is rare. The treatment outcomes in patients with lymph node (LN) metastasis diagnosed by FDG-PET or a biopsy—who are considered to be ‘biologically borderline resectable’—are poor. However, perioperative treatment is still under development. Recently, gemcitabine plus cisplatin (GC)-based triplet regimens for unresectable BTC have been developed. We applied GC-based triplet therapy in BTC with LN metastasis.

Methods

We administered GC plus S-1 therapy (GCS) or nab-paclitaxel therapy (GCnP) to 30 patients with LN metastasis diagnosed by FDG-PET or a biopsy (GC-based triplet group). A dataset of BTC with FDG-positive LNs, previously used for an analysis of the diagnosis and treatment outcomes according to FDG uptake, was used as a control (upfront surgery group, n = 19).

Results

GCS and GCnP were used by 22 and 8 patients, respectively. The median treatment period was 79 days, the objective response rate was 47 %, the tumor control rate was 87 %, and 22 patients underwent R0 resection (73 %). The groups showed no significant differences with the exception of the FDG uptake by the main tumor. The three-year overall survival (OS) rates in the GC-based triplet and upfront surgery groups were 45.4 % and 15.8 %, respectively (P = 0.0052); there were no significant differences in progression-free or recurrence-free survival. A sub-analysis showed that normalized CA19-9 levels provided better survival than non-normalized CA19-9 levels.

Conclusion

Neoadjuvant GC-based triplet regimens could provide survival benefits in BTC with LN metastasis diagnosed by FGD-PET or a biopsy. CA19-9 normalization may be useful for indicating surgery.