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Nab-paclitaxel/gemcitabine first line therapy in patients with metastatic pancreatic carcinoma and high-bilirubin values - Data from the German QoliXane pancreatic cancer registry

Date

08 Oct 2016

Session

Poster Display

Presenters

Gerrit zur Hausen

Citation

Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371

Authors

G. zur Hausen1, O. Waidmann2, M.A. Woerns3, H.G. Hoeffkes4, S. Doerfel5, M.O. Zahn6, A. Aldaoud7, M. Stauch8, C. Springfeld9, N. Haertel10, A. Reichart1, T.O. Goetze1, S. Schwarz1, C. Pauligk1, J. Roemmler-Zehrer11, R.D. Hofheinz12, S. Al-Batran1

Author affiliations

  • 1 Institute Of Clinical Cancer Research, Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 2 Medical Hospital 1, Universitätsklinikum Frankfurt(Johannes-Wolfgang Goethe Institute), Frankfurt am Main/DE
  • 3 1. Medical Hospital, Universitätsmedizin Mainz, Mainz/DE
  • 4 Mvz Osthessen, Klinikum Fulda gAG, Fulda/DE
  • 5 Fachärzte Für Innere Medizin, Onkozentrum Dresden, Dresden/DE
  • 6 Onkologische Kooperation Harz, MVZ, Goslar/DE
  • 7 Haematologie/onkologie, Gemeinschaftspraxis, 04289 - Leipzig/DE
  • 8 Dr. Martina Stauch, Practice, Kronach/DE
  • 9 University Hospital Heidelberg, National Center for Tumor Diseases, Heidelberg/DE
  • 10 Ii. Medical Hospital, Universitätsklinikum Mannheim, Mannheim/DE
  • 11 N/a, Celgene GmbH, München/DE
  • 12 Interdisziplinäres Tumorzentrum Mannheim, Universitätsklinikum Mannheim, 68167 - Mannheim/DE
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Background

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.

Methods

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.

Results

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

Conclusions

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

Funding

Celgene GmbH

Disclosure

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.

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