Hyperbilirubinaemia is a common disease effect in patients (pts) with metastatic pancreatic cancer (mPC). As clinical trials often exclude them, data on management of these pts are rare. In the framework of a German observational multicenter study (QoliXane), quality of life and therapy data are currently being collected in pts with mPC receiving a combination of nab-paclitaxel and gemcitabine. This is an interim analysis on hyperbilirubinaemia management.
Pts were included to this analysis if they entered the trial with a bilirubin level ≥ 1.2 mg/dl and completed at least 2 cycles. Bilirubin levels were documented for up to 4 cycles and methods of hyperbilirubinaemia management have been assessed. A both descriptive and explorative analysis was performed using IBM SPSS V 23.
25 of 294 pts (8.5%) were included. Mean bilirubin level was 2.96 mg/dl (range 1.2-12.3) at baseline and dropped considerably by the 2nd cycle to 0.84 (range 0.29-3.9; p = 0.0001). Bilirubin levels decreased in 24 (96%) and increased in 1 (4%) pts upon treatment start. 18 (72%) pts started treatment with standard dosage, 7 (28%) with a reduced regime. 10 (40%) pts underwent additional intervention: either stenting (7 pts, 28%) or bile duct anastomosis (3 pts, 12%). Mean bilirubin values dropped from 4.59 to 1.09 in pts with and from 1.87 to 0.68 in pts without additional intervention. Grade 3/4 toxicity was seen in 60% of pts and most common 3/4 events were anemia, nausea, and fever. Mean Bilirubin Levels1.
|Baseline||Cycle 2||Cycle 3||Cycle 4|
|All pts (n = 25)||2.96||0.84||0.83||0.53|
|no add. intervention (n = 15)||1.87||0.68||0.92||0.61|
|any add. intervention (n = 10)||4.59||1.09||0.68||0.46|
|add. stenting (n = 7)||4.52||1.19||0.84||0.35|
|add. bile duct anastomosis (n = 3)||4.80||0.87||0.47||0.53|
|p (all pts)2||0.0001||0.002||0.008|
1 n's indicate # of pts at baseline 2 Wilcoxon test to baseline (related samples), level of significance p = .05
Data show that bilirubin levels drop considerably after start of nab-pac/gem therapy. The treatment seems to be feasible, although considerable frequencies of Grade 3/4 toxicities were observed.
Clinical trial identification
Clinicaltrials.gov: NCT02691052 AIO; trial number: AIO-LQ-0214/ass
Legal entity responsible for the study
Institute of Clinical Cancer Research, Krankenhaus Nordwest gGmbH, Prof. Salah-Eddin Al-Batran, Steinbacher Hohl 2-26, 60488 Frankfurt
G. zur Hausen: Travel grants: Celgene, Lilly. O. Waidmann: Consulting/Advisory: Bayer, Roche, Novartis Oncology. Research Funding: Novartis Oncology, Medac. Travel Grants: Bayer, Celgene, Ipsen, Novartis Oncology, Abbvie, Gilead. M.A. Woerns: Sponsored Lectures: Celgene. Advisory Board: Celgene. C. Springfeld: Consulting/Advisory Role: Celgene. Travel Grants: Celgene. N. Haertel: Research Grant: Celgene. A. Reichart: Travel Grants: Ipsen. T.O. Goetze: Baxalta, Celgene, BMS. S. Schwarz: Travel Grants: Hospira. J. Roemmler-Zehrer: Employment: Celgene. Stock ownership: Celgene. Travel Grants: Celgene. S-E. Al-Batran: Advisory Role: Merck, Celgene, Roche, Lilly, Nordic Pharma. Speaker: Roche, Lilly, Celgene, Nordic Pharma. Research Grants: Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly.
All other authors have declared no conflicts of interest.