A new clinically based staging system for gallbladder cancer.

Abstract

433 Background: Current staging systems for gallbladder cancer (GBC) are inadequate, as they are based on surgical pathology, and therefore are not relevant for unresectable patients and patients undergoing neoadjuvant chemotherapy. Methods: Patients with a confirmed diagnosis of GBC who were seen at Mayo Clinic between the years 2000 and 2016 were included in this analysis. Data on demographic and tumor characteristics and outcomes were collected by retrospective review of electronic medical records. A model predictive of overall survival was developed using Cox proportional hazard regression analysis. Harrel’s C-statistic was calculated to evaluate the predictive accuracy of the model and compared with the TNM staging system. Results: A total of 523 patients were included in the final analysis, with a median age of diagnosis of 68 years. The median duration of follow up of the entire cohort was 12 months. In multivariate analysis, factors predictive of poorer overall survival were: ages 65-74 years (HR : 1.80, 95% CI: 1.33–2.43) and ages 75+ years (HR: 2.93, 95% CI: 2.12–4.06) compared to age <55 years; tumor size ≥ 5 cm by imaging (HR: 1.24, 95% CI: 1.01–1.55); nodal involvement by imaging (HR:1.61, 95% CI: 1.23–2.10); involvement of distant organs by imaging (HR: 2.85, 95% CI: 2.16–3.75); ECOG performance score of 2 or higher (HR: 1.78, 95% CI: 1.36–2.32) compared to ECOG 0-1; albumin level <3.5 g/dL (HR: 1.40, 95% CI: 1.08–1.81); and alkaline Phosphatase level ≥ 200 IU/L (HR: 1.49, 95% CI: 1.21–1.84). Using these seven predictive factors of survival we created a four-tier staging system. The median survivals of Stages I, II, III and IV created in our novel system were 64, 34, 20 and 7 months with corresponding hazard ratios of 1, 1.5, 2.5 and 8.5 respectively. The C-statistic for this novel staging system was 0.68 compared to C-statistic of 0.69 for the TNM staging system, indicating similar performance in predicting survival. Conclusions: We have created a novel clinically-based staging system for patients with GBC based on nonoperative information at the time of diagnosis which performs on par with the current surgical pathology based TNM staging system.

Development and external validation of a nomogram for predicting the effect of tumor size on cancer specific survival of resected gallbladder cancer: a population-based study.

“…Several studies several studies have found that tumor size may be an independent prognosis factor in GBC, which is in line with our study, however, debate also exists regarding the optimal cutoff value of tumor size in GBC. Yadav et al reported that tumor size larger than 5 cm exert prognostic signi cance for GBC patients 8 . Zhang et al demonstrated that tumor size smaller than 3 cm obviously increase the survival outcome of GBC patients 7 .…”

“…The wideaccepted standard Tumor-Node-Metastasis (TNM) staging system of the American Joint Commission on Cancer (AJCC) mainly relies on pathological evaluation of tumor in ltration into the layers of gallbladder, which can only be achieved through surgical excision of the gallbladder and didn't take tumor size into account 6 . The recent studies, which proposed prognostic nomograms/systems, pointed out that patient and tumor-related factors are closely associated with prognosis of GBC patients 7,8 . Notably, several studies have found that tumor size, as an easily quanti able indicator in imaging diagnosis and preoperative assessment, can affect the survival outcome of GBC patients [7][8][9] .…”

“…The recent studies, which proposed prognostic nomograms/systems, pointed out that patient and tumor-related factors are closely associated with prognosis of GBC patients 7,8 . Notably, several studies have found that tumor size, as an easily quanti able indicator in imaging diagnosis and preoperative assessment, can affect the survival outcome of GBC patients [7][8][9] . However, the optimal cutoff value of tumor size for predicting prognosis of GBC is still controversial.…”

“…However, the optimal cutoff value of tumor size for predicting prognosis of GBC is still controversial. Yadav staging system set tumor size larger than 5 cm as a factor indicated survival disadvantage, whereas Zhang labeled 3 cm as an important prognostic factor 7,8 . In addition, no further studies were conducted to identify the association between the tumor size and other tumor-related factors, such as tumor grade and liver metastasis.…”

Integrated analysis of serum lipid profile for predicting clinical outcomes of patients with malignant biliary tumor

“…Currently, prognostic prediction of MBT mostly based on the AJCC TNM staging system [6], which mainly based on surgical pathology features including tumor size, lymph node metastasis and distant metastasis, regardless of clinical and laboratory parameters. Previous studies also proposed several staging systems including clinical parameters such as hemoglobin, alkaline phosphatase and C reactive protein, but showed a suboptimal correlation with survival or lack of validation, such as the GBC staging system created by Yadav S, et al [7]. Therefore, new prognostic factors with better predictive capability for BMT patients are needed.…”