145P - Role of Glasgow prognostic score in chemo-naïve patients with advanced biliary tract cancer and good performance status

Background

Glasgow prognostic score (GPS), which is defined with serum levels of two parameters, albumin >3.5 g/dl and C-reactive protein <1.0 mg/dl (both as 0, either as 1, and neither as 2), has a prognostic significance in various malignant solid tumors. In a small-scale retrospective study, GPS was useful as a prognostic factor for chemo-naïve advanced biliary tract cancer (ABTC) patients with good performance status (PS; defined with ECOG PS 0 and 1). We evaluated whether GPS was useful in large-scale prospective study for ABTC patients with good PS.

Methods

ABTC patients with PS 0/1 and not missing laboratory data among the patients who received gemcitabine + cisplatin (GC) or GC + S-1 (GCS) in a phase III study (MITSUBA) were analyzed for factors with P < 0.2, using multivariate Cox proportional hazards model for overall survival (OS). In the exploratory analysis, OS was compared between GC and GCS according to GPS.

Results

Clinical data were collected from 230 patients (113 patients in the GC arm and 117 patients in the GCS arm) among 241 patients. The proportion of patients was 43% in GPS 0, 35% in GPS 1, and 22% in GPS 2, respectively. In the univariate and multivariate analyses, GPS was an independent prognostic factor (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.56-0.81; P < 0.001). The median OS was 18.0 months (95%CI, 15.3-20.7), 12.6 months (95%CI, 11.4-13.8), and 7.2 (95%CI, 4.4-10.0) for patients with GPS 0, GPS 1, and GPS 2, respectively. The HRs of GCS to GC were 1.00 (95%CI, 0.64-1.55; P = 0.99), 0.72 (95%CI, 0.45-1.15; P = 0.17), and 0.57 (95%CI, 0.32-1.04; P = 0.07), for patients with GPS 0, GPS 1, and GPS 2, respectively.

Conclusions

GPS was useful for chemo-naïve ABTC patients with good PS, and GCS might improve OS, especially in patients with poor prognosis.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Kansai Hepato-Biliary Oncology Group.

Funding

Taiho Pharmaceutical.

Disclosure

T. Moriwaki: Speaker Bureau / Expert testimony: Taiho Pharmaceutical; Speaker Bureau / Expert testimony: Lilly. Y. Yamamoto: Speaker Bureau / Expert testimony: Taiho. T. Yamada: Advisory / Consultancy: Taiho; Speaker Bureau / Expert testimony: Lilly. A. Taketomi: Honoraria (institution), Leadership role: Taiho. K. Yoshimura: Honoraria (self): Taiho; Honoraria (self): Lilly; Honoraria (self): Nippon Kayaku. E. Hatano: Honoraria (self): Taiho; Honoraria (self), Advisory / Consultancy: Lilly. T. Ioka: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Taiho. All other authors have declared no conflicts of interest.