Haas, M., Waldschmidt, D. T., Stahl, M., Reinacher-Schick, A., Freiberg-Richter, J., von Weikersthal, L. Fischer, Kaiser, F., Kanzler, S., Frickhofen, N., Seufferlein, T., Dechow, T., Mahlberg, R., Malfertheiner, P., Illerhaus, G., Kubicka, S., Abdul-Ahad, A., Snijder, R., Kruger, S., Westphalen, C. B., Held, S., Von Bergwelt-Baildon, M., Boeck, S. and Heinemann, V (2021). Afatinib plus gemcitabine versus gemcitabine alone as first-line treatment of metastatic pancreatic cancer: The randomised, open-label phase II ACCEPT study of the Arbeitsgemeinschaft Internistische Onkologie with an integrated analysis of the 'burden of therapy' method. Eur. J. Cancer, 146. S. 95 - 107. OXFORD: ELSEVIER SCI LTD. ISSN 1879-0852

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Abstract

Background: Targeting the epidermal growth factor receptor pathway remains controversial in pancreatic cancer. Afatinib is an oral irreversible ErbB family blocker approved in non-small-cell lung cancer. This open-label, multicenter, randomised phase II trial evaluated gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone as first-line treatment for metastatic pancreatic cancer. Patients and methods: Patients were randomised in a 2:1 ratio to either Gem (1000 mg/m(2) weekly for three weeks followed by one week of rest, repeated every four weeks) and afatinib (40 mg orally once daily) or Gem alone. Overall survival (OS) was the primary study endpoint. The novel BOTh(C)(TM) methodology was implemented to derive a quantitative estimate for the 'Burden of Therapy/Toxicity' (BOTh) for each patient on every day during the clinical study. Conclusion: The addition of afatinib to Gem did not improve treatment efficacy and was more toxic. The BOTh(C)(TM) methodology allowed a detailed insight into the course of treatment-related adverse events over the study period. (C) 2021 Elsevier Ltd. All rights reserved.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Haas, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waldschmidt, D. T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stahl, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reinacher-Schick, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Freiberg-Richter, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Weikersthal, L. FischerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaiser, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kanzler, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Frickhofen, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seufferlein, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dechow, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahlberg, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Malfertheiner, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Illerhaus, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kubicka, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Abdul-Ahad, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Snijder, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kruger, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Westphalen, C. B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Held, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Von Bergwelt-Baildon, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boeck, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinemann, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-601069
DOI: 10.1016/j.ejca.2020.12.029
Journal or Publication Title: Eur. J. Cancer
Volume: 146
Page Range: S. 95 - 107
Date: 2021
Publisher: ELSEVIER SCI LTD
Place of Publication: OXFORD
ISSN: 1879-0852
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ERLOTINIB; TRIAL; ADENOCARCINOMA; MULTICENTER; FOLFIRINOX; EFFICACY; SAFETYMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60106

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