The impact of development of stent-related events (SRE) on morbidity and mortality in patients (pts) with advanced hepato-pancreatico-biliary (HPB) tumours receiving chemotherapy

Background: Obstructive jaundice (OJ) is a common presentation for pts with hepato-pancreatico-biliary (HPB) cancers. Biliary stents are widely used to relieve OJ prior to starting Systemic Anti-Cancer Treatment (SACT). We hypothesised that stent-related complications (particularly infection or occlusion) can lead to increased morbidity and early mortality in these pts. Methods: In this single-centre retrospective study, pts with advanced HPB adenocarcinoma who had a biliary stent inserted prior to palliative SACT between Jan-2013 and Jan-2015 were identified. Ethical approval was obtained. The primary end-point was stent-related event (SRE) rate and the time-to-SRE (defined as time from first stenting before SACT to date of SRE). Progression-free survival (PFS) and overall survival (OS) were measured from the time of starting SACT. Kaplan-Meier, Cox and Fine-Gray regression (uni-/multivariable) analyses were employed, as appropriate. For the analysis of time-to-SRE, death was considered a competing event; pts without a SRE were excluded from Kaplan-Meier analysis. Results: Of 693 pts screened; 96 were deemed eligible. Median age at diagnosis was 66.6 years (range: 26-83.8); male (56%); none/mild comorbidities (75%); ECOG performance status (PS) 0-1 (75%). Most of the pts (89%) had a metal stent in situ prior to SACT. Locally advanced (60%) and metastatic (40%) pts were included: primary pancreatic adenocarcinoma (78%), biliary tract malignancies (22%). Administered SACT included: single-agent gemcitabine (39%), gemcitabine/capecitabine (26%), cisplatin/gemcitabine (14%) and others (21%). Forty-one pts (43%) had a SRE during follow-up (median follow-up 9.6 months (range 2.2-26.4)) [cholangitis (39%), stent occlusion (29%), or both (32%)]; 14 (34%) of whom had a second SRE. Consequences of the SRE were: none (37%), SACT delayed (24%), death (22%) or discontinuation of SACT (17%). Estimated median PFS and OS were 6.7 months (95% CI 4.4-7.8) and 8.6 months (95% CI 6.8-9.8), respectively. Estimated time to SRE was 4.4 months (95% CI 3.6-5.5). Stage was an independent prognostic factor for OS (HR 1.8 (95% CI 1.06-2.9); p-value 0.029) in the multivariable analysis adjusted for primary tumour, PS and development of SRE. Pts with severe comorbidities (vs. pts with no comorbidities) (p-value 1 stent/biliary procedure before starting SACT (vs. 1) (HR 2.3 (95% CI 1.2-4.44); p-value 0.010) had shorter time to SRE on multivariable analysis.Conclusion: SREs are common and impact on patient’s morbidity and mortality. Pts with more than 1 previous biliary stenting and with severe comorbidities had a higher risk of developing a SRE during SACT. Prospective studies may be considered to investigate the role of secondary prophylaxis in this population.