Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Vogel, Arndt UNSPECIFIED UNSPECIFIED UNSPECIFIED Kasper, Stefan UNSPECIFIED orcid.org/0000-0002-5947-8733 UNSPECIFIED Bitzer, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Block, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Sinn, Marianne UNSPECIFIED UNSPECIFIED UNSPECIFIED Schulze-Bergkamen, Henning UNSPECIFIED UNSPECIFIED UNSPECIFIED Moehler, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfarr, Nicole UNSPECIFIED UNSPECIFIED UNSPECIFIED Endris, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Goeppert, Benjamin UNSPECIFIED orcid.org/0000-0002-4135-9250 UNSPECIFIED Merx, Kirsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Schnoy, Elisabeth UNSPECIFIED UNSPECIFIED UNSPECIFIED Siveke, Jens T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Michl, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Waldschmidt, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuhlmann, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Geissler, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Kahl, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Evenkamp, Ralph UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, Torben UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuhlmann, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Weichert, Wilko UNSPECIFIED UNSPECIFIED UNSPECIFIED Kubicka, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language TRACT CANCER; METAANALYSIS; SURVIVAL Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19507