Second-line Chemotherapy Prolongs Survival in Real World Patients With Advanced Biliary Tract and Gallbladder Cancers

Abstract

Background: Limited evidence is available regarding the survival benefit of second-line therapy in real world patients with advanced biliary tract and gallbladder cancer. Until very recently, there was a lack of randomized clinical trials to address this important question. In this multicenter population-based cohort study, the authors evaluated whether second-line therapy improves the survival of real world patients with advanced biliary tract and gallbladder cancer. Methods: Patients with biopsy-proven advanced biliary tract and gallbladder cancer who were diagnosed during the period of 2006 to 2015 and had received first-line chemotherapy were assessed. Cox proportional multivariate analysis was performed to determine the survival benefit of second-line therapy. Results: One hundred thirty-six eligible patients with a median age of 66 years and male:female ratio of 1:1.34 were identified. Sixty-eight percent of patients had metastatic disease. Primary tumor sites were as follows: gallbladder 31%, intrahepatic cholangiocarcinoma 36%, extrahepatic bile duct 23%, and ampullary cancer 10%. Overall, 37% of patients received second-line therapy. The median overall survival of the treatment group was 17 months (95% confidence interval [CI]: 12.5-21.5) compared with 7 months (95% CI: 5.3-8.7) in the control (P<0.0001). Patients who received combination chemotherapy had a median overall survival of 20 months (14.0-26.1) compared with 17 months (13.5-20.5) if they received single-agent second-line therapy (P=0.73). Multivariate analysis of second-line therapy, hazard ratio: 0.55 (95% CI: 0.36-0.83) and neutrophil to lymphocyte ratio >2, HR: 1.10 (1.05-1.15) showed a significant correlation with survival. Conclusions: This well-designed population-based retrospective cohort study suggests that second-line chemotherapy improves survival of real world patients with advanced biliary tract and gallbladder cancers and should be offered to the patients who are potential candidates for chemotherapy.

Real‐world outcomes among patients with advanced or metastatic biliary tract cancers initiating second‐line treatment

“…As with findings on disease progression, 2 L OS results from our analyses are consistent with those reported in the literature. Although the median OS of 11 months reported by Lowery et al 13 and median OS of 17 months reported in a recent multicenter, population‐based cohort study by Zaidi et al 18 are somewhat longer than the 6.6 to 7.7‐month median OS reported by others and nearly 2 to 3 times the 5.2‐month median OS of our study, our finding is in line with other studies. 7 , 8 , 9 , 10 , 14 , 16 , 17 Recent findings presented for the ABC‐06 trial describe a median OS of 6.2 months (95% CI, 5.4–7.6 months) from the start of 2 L treatment in patients treated with ASC + FOLFOX.…”

“…Existing studies report findings outside of the US, report data only from academic centers, include only older populations, or use older data. 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 Therefore, with its large cohort of patients treated in the community oncology setting, our study aimed to provide real‐world insight into the rapidly evolving and growing 2 L treatment landscape for advanced or metastatic BTC.…”

Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

“…GemCis/GemOx as CT1 and FOLFOX as CT2 have been established for patients with ABTC. [12] , [13] , [14] , [15] , 29 The survival times reported here are comparable to the OS of 9.5-11.7 months after CT1 11 , 13 , 14 and 6.7-7.2 months after CT2 [30] , [31] , [32] obtained in previous studies. In our analysis, OS was significantly dependent on the number of received therapy lines.…”

Identification of genes associated with gall bladder cell carcinogenesis: Implications in targeted therapy of gall bladder cancer

“…The combined chemotherapy regimens have been found to increase the overall survival of patients in clinical trials , but still, they have been found to have toxic effects, and resistance is developed later[ 3 , 71 , 72 ]. Whenever clinical trials were performed some unforeseen hurdles were found, including the side effects and development of resistance to a particular drug.…”