ASCO 2017: BILCAP Findings Support Capecitabine For Biliary Tract Malignancy

Patients with biliary tract cancer have significantly better overall survival if given capecitabine after tumour macroscopic resection

Capecitabine after resection for biliary tract cancer significantly extends overall survival (OS) compared with surveillance, results from the BILCAP study demonstrate.

The trial participants had lower common bile duct cholangiocarcinoma (CCA), hilar CC, intrahepatic CC, or muscle-invasive gallbladder cancer that been macroscopically resected within the past 16 weeks and an ECOG performance score of 2 or less.

In all, 223 patients were randomly assigned to receive eight cycles of capecitabine 1250 mg/m2 on days 1–14 of a 28-day cycle, 55% of whom received the full number of cycles, while 224 patients were assigned to receive no further treatment after surgery.

Median OS was 51.1 months for the capecitabine-treated patients versus 36.4 months for the observation group patients according to intention-to-treat analysis. The hazard ratio (HR) of 0.81 was in favour of capecitabine therapy but did not reach statistical significance. However, sensitivity analysis achieved a highly significant HR of 0.70 after taking into consideration patient gender, nodal status and tumour grade.

And in the per protocol analysis, OS was 52.7 months for the 210 capecitabine-treated patients versus 36.1 months for the 220 patients in the observation group, giving a significant HR of 0.75.

Relapse-free survival in the intention-to-treat population was 24.6 versus 17.6 months and a significant HR of 0.76, with corresponding values in the per protocol population of 25.9 versus 17.6 months and a significant HR of 0.71.

Preplanned subgroups were too small to detect significant relationships but identified some “interesting trends”, presenting author John Primrose, from the University of Southampton in the UK, told delegates at the 2017 American Society of Clinical Oncology annual meeting in Chicago, Illinois, USA.

For example, there was a suggestion of greater efficacy in men than women, and in patients with poorly differentiated tumours, whereas nodal involvement appeared to have little impact. All tumour subtypes showed efficacy except hilar CC, he added.

Safety analysis of 213 capecitabine-treated patients indicated that toxicity was “modest”, with plantar palmar erythema the most common grade 3 or 4 side adverse event, affecting 20.1% of the group. This was followed by diarrhoea and fatigue, each reported by 8% of patients, and neutropenia by 2%. There were no treatment-related deaths.

Furthermore, global quality of life over 2 years did not significantly differ between the groups, suggesting that “quality of life was undiminished by the use of capecitabine”, John Primrose said.

“Capecitabine as [an] adjuvant improves OS in patients with resected biliary tract cancer from 36 to 51 months and should become [the] standard of care in this setting”, he concluded, recommending that “[c]apecitabine should be the control arm in future adjuvant trials in patients with biliary tract cancer.”

American Society of Clinical Oncology (ASCO) annual meeting; Chicago, Illinois, USA, 2–6th June 2017

Reference

Primrose JN, Fox R, Palmer DH, et al. Adjuvant capecitabine for biliary tract cancer: The BILCAP randomized study. J Clin Oncol 35, 2017 (suppl; abstr 4006).

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