Vogel, Arndt, Kasper, Stefan ORCID: 0000-0002-5947-8733, Bitzer, Michael, Block, Andreas, Sinn, Marianne, Schulze-Bergkamen, Henning, Moehler, Markus, Pfarr, Nicole, Endris, Volker, Goeppert, Benjamin ORCID: 0000-0002-4135-9250, Merx, Kirsten, Schnoy, Elisabeth, Siveke, Jens T., Michl, Patrick, Waldschmidt, Dirk, Kuhlmann, Jan, Geissler, Michael, Kahl, Christoph, Evenkamp, Ralph, Schmidt, Torben, Kuhlmann, Alexander, Weichert, Wilko and Kubicka, Stefan (2018). PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer-a randomised biomarker-driven clinical phase II AIO study. Eur. J. Cancer, 92. S. 11 - 20. OXFORD: ELSEVIER SCI LTD. ISSN 1879-0852

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Abstract

Background: Combination chemotherapy has shown benefit in the treatment of biliary cancer and further improvements might be achieved by the addition of a biological agent. We report here the effect of chemotherapy with the monoclonal EGFR antibody panitumumab as therapy for KRAS wild-type biliary cancer. Patients and methods: Patients with advanced biliary tract cancer were randomised (2:1) to receive cisplatin 25 mg/m(2) and gemcitabine 1000 mg/m(2) on day 1 and day 8/q3w with (arm A) or without panitumumab (arm B; 9 mg/kg BW, i.v q3w). The primary end-point was the evaluation of progression-free survival (PFS) at 6 months. Secondary end-points included objective response rate (ORR), overall survival (OS), and toxicity. In addition, a post hoc assessment of genetic alterations was performed. Finally, we performed a meta-analysis of trials with chemotherapy with and without EGFR antibodies. Results: Sixty-two patients were randomised in arm A and 28 patients in arm B. Patients received 7 treatment cycles in median (1-35) with a median treatment duration of 4.7 months (141 days, 8-765). PFS rate at 6 months was 54% in patients treated with cisplatin/gemcitabine and panitumumab but was 73% in patients treated with cisplatin/gemcitabine without antibody, respectively. Secondary end-points were an ORR of 45% in treatment arm A compared with 39% receiving treatment B and a median OS of 12.8 months (arm A) and of 20.1 months (arm B), respectively. In contrast to the p53-status, genetic alterations in IDH1/2 were linked to a high response after chemotherapy and prolonged survival. In accordance with our results, the meta-analysis of 12 trials did not reveal a survival advantage for patients treated with EGFR antibodies compared with chemotherapy alone. Conclusions: Panitumumab in combination with chemotherapy does not improve ORR, PFS and OS in patients with KRAS wild-type, advanced biliary cancer. Genetic profiling should be included in CCA trials to identify and validate predictive and prognostic biomarkers. (C) 2018 Elsevier Ltd. All rights reserved.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Vogel, ArndtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kasper, StefanUNSPECIFIEDorcid.org/0000-0002-5947-8733UNSPECIFIED
Bitzer, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Block, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sinn, MarianneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulze-Bergkamen, HenningUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moehler, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pfarr, NicoleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Endris, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goeppert, BenjaminUNSPECIFIEDorcid.org/0000-0002-4135-9250UNSPECIFIED
Merx, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schnoy, ElisabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siveke, Jens T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Michl, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waldschmidt, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuhlmann, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Geissler, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kahl, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Evenkamp, RalphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, TorbenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuhlmann, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weichert, WilkoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kubicka, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-195075
DOI: 10.1016/j.ejca.2017.12.028
Journal or Publication Title: Eur. J. Cancer
Volume: 92
Page Range: S. 11 - 20
Date: 2018
Publisher: ELSEVIER SCI LTD
Place of Publication: OXFORD
ISSN: 1879-0852
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
TRACT CANCER; METAANALYSIS; SURVIVALMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/19507

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