Universität zu Köln

Kruger, Stephan ORCID: 0000-0002-4138-9863, Boeck, Stefan, Heinemann, Volker, Laubender, Ruediger P., Vehling-Kaiser, Ursula, Waldschmidt, Dirk, Kettner, Erika, Maerten, Angela, Winkelmann, Cornelia, Klein, Stefan, Kojouharoff, Georgi, Gauler, Thomas C., Von Weikersthal, Ludwig Fischer, Clemens, Michael R., Geissler, Michael, Greten, Tim F., Hegewisch-Becker, Susanna, Modest, Dominik P., Stintzing, Sebastian ORCID: 0000-0002-3297-5801 and Haas, Michael (2015). Impact of hand-foot skin reaction on treatment outcome in patients receiving capecitabine plus erlotinib for advanced pancreatic cancer: A subgroup analysis from AIO-PK0104. Acta Oncol., 54 (7). S. 993 - 1001. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1651-226X

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Abstract

Background. Drug-induced skin toxicity may correlate with treatment efficacy in cancer patients receiving chemotherapy or biological agents. The correlation of the capecitabine-associated hand-foot skin reaction (HFS) on outcome parameters in pancreatic cancer (PC) has not yet been investigated. Methods. Within the multicentre phase III AIO-PK0104 trial, patients with confirmed advanced PC were randomly assigned to first-line treatment with either capecitabine plus erlotinib (150 mg/day, arm A) or gemcitabine plus erlotinib (150 mg/day, arm B). A cross-over to either gemcitabine (arm A) or capecitabine (arm B) was performed after failure of the first-line regimen. Data on skin toxicity were correlated with efficacy study endpoints using uni- and multivariate analyses. To control for guarantee-time bias (GTB), we focused on subgroup analyses of patients who had completed two and three or more treatment cycles. Results. Of 281 randomised patients, skin toxicity data were available for 255 patients. Median time to capecitabine-attributed HFS was two cycles, 36 of 47 (77%) HFS events had been observed by the end of treatment cycle three. Considering HFS during first-line treatment in 101 patients treated with capecitabine for at least two cycles within the capecitabine plus erlotinib arm, time to treatment failure after first-and second-line therapy (TTF2) and overall survival (OS) both were significantly prolonged for the 44 patients (44%) with HFS compared to 57 patients without HFS (56%) (TTF2: 7.8 vs. 3.8 months, HR 0.50, p = 0.001; OS: 10.4 vs. 5.9 months, HR 0.55, p = 0.005). A subgroup analysis of 70 patients on treatment with capecitabine for at least three cycles showed similar results (TTF2: 8.3 vs. 4.4 months, HR 0.53, p = 0.010; OS: 10.4 vs. 6.7 months, HR 0.62, p = 0.056). Conclusion. The present subgroup analysis from AIO-PK0104 suggests that HFS may serve as an independent clinical predictor for treatment outcome in capecitabine-treated patients with advanced PC.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kruger, Stephan UNSPECIFIED orcid.org/0000-0002-4138-9863 UNSPECIFIED Boeck, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Heinemann, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Laubender, Ruediger P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vehling-Kaiser, Ursula UNSPECIFIED UNSPECIFIED UNSPECIFIED Waldschmidt, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Kettner, Erika UNSPECIFIED UNSPECIFIED UNSPECIFIED Maerten, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED Winkelmann, Cornelia UNSPECIFIED UNSPECIFIED UNSPECIFIED Klein, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Kojouharoff, Georgi UNSPECIFIED UNSPECIFIED UNSPECIFIED Gauler, Thomas C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Von Weikersthal, Ludwig Fischer UNSPECIFIED UNSPECIFIED UNSPECIFIED Clemens, Michael R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Geissler, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Greten, Tim F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hegewisch-Becker, Susanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Modest, Dominik P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stintzing, Sebastian UNSPECIFIED orcid.org/0000-0002-3297-5801 UNSPECIFIED Haas, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-415951
DOI:	10.3109/0284186X.2015.1034877
Journal or Publication Title:	Acta Oncol.
Volume:	54
Number:	7
Page Range:	S. 993 - 1001
Date:	2015
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1651-226X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language METASTATIC COLORECTAL-CANCER; III COLON-CANCER; BREAST-CANCER; PHASE-III; GEMCITABINE; TRIAL; SURVIVAL; EFFICACY; THERAPY; COMBINATION Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/41595