Gemcitabine-based and fluoropyrimidine-based regimens demonstrated activity in phase II trials. Nab-paclitaxel plus gemcitabine was found well tolerated and may considered as an alternative regimen to current therapeutic approaches in advanced biliary tract cancer. This trial aims to evaluate safety and efficacy of nab-paclitaxel plus capecitabine in the first-line treatment of patients with recurrence or metastatic biliary tract cancer.
Patients of histopathology or cytology confirmed recurrence or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma ICC, extrahepatic cholangiocarcinoma ECC, gallbladder carcinoma GC), with ECOG PS 0-1 and adequate major organ function, were enrolled and treated with Nab-paclitaxel (125mg/m2, d1, q14d) plus capecitabine (2g/m2,bid,d1-7; q14d) until disease progression or unacceptable toxicity. The primary endpoint was ORR. The second endpoints were PFS, OS and safety. This study was registered with Chinese Clinical Trial Registry, number ChiCTR1900025004.
Data cutoff date for this analysis was May 16, 2020. We recruited 18 patients, 12 (66.7%) were males, median age was 64 years (range 35-74 years), ICC/ECC/GC/NE were 4 (22.2%) / 5 (27.8%)/ 8 (44.4 %)/1 (5.6%) respectively. The median treatment cycle was 6 cycles (range 1-9). 15 patients were evaluable for efficacy. The ORR and DCR were 26.7% and 80%. The median follow-up was 8.3 months (range 4.3-13.6 months), the median PFS was 6.2 months (95% CI 3.1-NR months) and median OS was not reached. Common AEs were: leucopenia 7 (38.9%), neurotoxicity 5 (27.8%), ALT increase 3 (16.7%), AST increase 3 (16.7%), blood bilirubin increased 1 (5.6%). Most were grade 1/2.
Nab-paclitaxel plus capecitabine presented a clinically meaningful efficacy and a favorable safety profile as first-line treatment for recurrence or metastatic biliary tract cancer.
ChiCTR1900025004.
The authors.
CSPC OUYI Pharmaceutical Co., Ltd.
All authors have declared no conflicts of interest.