Sinn, Marianne, Bahra, Marcus, Liersch, Torsten, Gellert, Klaus, Messmann, Helmut, Bechstein, Wolf ORCID: 0000-0002-3267-8145, Waldschmidt, Dirk, Jacobasch, Lutz, Wilhelm, Martin, Rau, Bettina M., Gruetzmann, Robert, Weinmann, Arndt ORCID: 0000-0003-1198-1716, Maschmeyer, Georg, Pelzer, Uwe ORCID: 0000-0001-9213-2737, Stieler, Jens M., Striefler, Jana K., Ghadimi, Michael, Bischoff, Sven, Doerken, Bernd, Oettle, Helmut and Riess, Hanno (2017). CONKO-005: Adjuvant Chemotherapy With Gemcitabine Plus Erlotinib Versus Gemcitabine Alone in Patients After R0 Resection of Pancreatic Cancer: A Multicenter Randomized Phase III Trial. J. Clin. Oncol., 35 (29). S. 3330 - 3341. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

Full text not available from this repository.

Abstract

Purpose Gemcitabine is standard of care in the adjuvant treatment of resectable pancreatic ductal adenocarcinoma (PDAC). The epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in combination with gemcitabine has shown efficacy in the treatment of advanced PDAC and was considered to improve survival in patients with primarily resectable PDAC after R0 resection. Patients and Methods In an open-label, multicenter trial, patients were randomly assigned to one of two study arms: gemcitabine 1,000 mg/m(2) days 1, 8, 15, every 4 weeks plus erlotinib 100 mg once per day (GemErlo) or gemcitabine (Gem) alone for six cycles. The primary end point of the study was to improve disease-free survival (DFS) from 14 to 18 months by adding erlotinib to gemcitabine. Results In all, 436 patients were randomly assigned at 57 study centers between April 2008 and July 2013. A total of 361 instances (83%) of disease recurrence were observed after a median follow-up of 54 months. Median treatment duration was 22 weeks in both arms. There was no difference in median DFS (GemErlo 11.4 months; Gem 11.4 months) or median overall survival (GemErlo 24.5 months; Gem 26.5 months). There was a trend toward long-term survival in favor of GemErlo (estimated survival after 1, 2, and 5 years for GemErlo was 77%, 53%, and 25% v 79%, 54%, and 20% for Gem, respectively). The occurrence or the grade of rash was not associated with a better survival in the GemErlo arm. Conclusion To the best of our knowledge, CONKO-005 is the first study to investigate the combination of chemotherapy and a targeted therapy in the adjuvant treatment of PDAC. GemErlo for 24 weeks did not improve DFS or overall survival over Gem.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Sinn, MarianneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahra, MarcusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Liersch, TorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gellert, KlausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Messmann, HelmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bechstein, WolfUNSPECIFIEDorcid.org/0000-0002-3267-8145UNSPECIFIED
Waldschmidt, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jacobasch, LutzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wilhelm, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rau, Bettina M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gruetzmann, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weinmann, ArndtUNSPECIFIEDorcid.org/0000-0003-1198-1716UNSPECIFIED
Maschmeyer, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pelzer, UweUNSPECIFIEDorcid.org/0000-0001-9213-2737UNSPECIFIED
Stieler, Jens M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Striefler, Jana K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghadimi, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bischoff, SvenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doerken, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oettle, HelmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Riess, HannoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-214366
DOI: 10.1200/JCO.2017.72.6463
Journal or Publication Title: J. Clin. Oncol.
Volume: 35
Number: 29
Page Range: S. 3330 - 3341
Date: 2017
Publisher: AMER SOC CLINICAL ONCOLOGY
Place of Publication: ALEXANDRIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DUCTAL ADENOCARCINOMA; OPEN-LABEL; SURVIVAL; CHEMORADIOTHERAPY; SUBTYPES; THERAPYMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/21436

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item