Second-Line Palliative Chemotherapy in Advanced Gall Bladder Cancer, CAP-IRI: Safe and Effective Option.

Abstract

Gall bladder cancer (GBC) has high prevalence in the Indo-Gangetic belt in India. While the first-line chemotherapy (CT1) has been established as gemcitabine-platinum doublet in advanced GBC, there is no standard recommendation or guidelines regarding feasibility of second-line therapy. We performed a retrospective analysis of all patients who received second-line of chemotherapy (CT2) at our institution from July 2012 to December 2014. Patient records were examined for efficacy and toxicity of administered CT2, along with response rates (RR) and survival. Potential prognostic factors were also evaluated. Eighty-seven patients received CT2 in the predefined period. Ninety-nine percent of patients had received a gemcitabine-based regimen as CT1 with a median progression-free survival (PFS) of 5months before CT2. 51.7% patients had undergone surgery prior with 5.7% patients having received radiotherapy previously. Prior to beginning CT2, PS was 0/1 in 67.8% patients, albumin was >4g% in 40.2% and CA 19.9 was raised in a majority (66.7%) patients, respectively. As per institution protocol, a majority of patients (89.6%) were administered CAP-IRI regimen. Overall RR and disease control rates(DCR) were 21.8 % and 41.3%, respectively. Median progression-free survival (PFS) and overall survival (OS) were 6 and 8months, with no significant differences between CAP-IRI and other regimens. Adverse effects were tolerable, with dose reduced upfront in 23% patients and 11.5% patients during subsequent cycles of CT. ECOG Performance Status (PS) of 0/1 was a significant prognostic variable for OS on multivariate analysis (p = 0.003). CAP-IRI is a well-tolerated second-line chemotherapeutic regimen in patients with advanced GBC. Careful selection of patients is required when administering second-line chemotherapy to advanced GBC patients, with particular emphasis on ECOG PS.