Universität zu Köln

Sinn, M., Liersch, T., Riess, H., Gellert, K., Stuebs, P., Waldschmidt, D., Lammert, F., Maschmeyer, G., Bechstein, W., Bitzer, M., Denzlinger, C., Hofheinz, R., Lindig, U., Ghadimi, M., Hinke, A., Striefler, J. K., Pelzer, U., Bischoff, S., Bahra, M. and Oettle, H. (2020). CONKO-006: A randomised double-blinded phase IIb-study of additive therapy with gemcitabine plus sorafenib/placebo in patients with R1 resection of pancreatic cancer - Final results. Eur. J. Cancer, 138. S. 172 - 182. OXFORD: ELSEVIER SCI LTD. ISSN 1879-0852

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Abstract

Background: CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles. Patients and methods: This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment. Results: 122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021). Conclusion: CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients. (C) 2020 Published by Elsevier Ltd.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Sinn, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Liersch, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Riess, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gellert, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stuebs, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Waldschmidt, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lammert, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Maschmeyer, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bechstein, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bitzer, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Denzlinger, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hofheinz, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindig, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ghadimi, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hinke, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Striefler, J. K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pelzer, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bischoff, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bahra, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Oettle, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-317504
DOI:	10.1016/j.ejca.2020.06.032
Journal or Publication Title:	Eur. J. Cancer
Volume:	138
Page Range:	S. 172 - 182
Date:	2020
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	1879-0852
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ADJUVANT CHEMOTHERAPY; OPEN-LABEL; MULTIKINASE INHIBITOR; MULTICENTER; PLACEBO Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/31750