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

Authors

  • Stephan Kruger Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany
  • Stefan Boeck Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany
  • Volker Heinemann Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany
  • Ruediger P. Laubender Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University of Munich, Munich, Germany
  • Ursula Vehling-Kaiser Practice for Medical Oncology, Landshut, Germany
  • Dirk Waldschmidt Department of Gastroenterology and Hepatology at Abdominal Center, University of Cologne, Cologne, Germany
  • Erika Kettner Department of Haematology and Oncology, Klinikum Magdeburg, Magdeburg, Germany
  • Angela Märten Department of Surgery, University of Heidelberg, Heidelberg, Germany
  • Cornelia Winkelmann Department of Internal Medicine, Krankenhaus Lutherstadt-Wittenberg, Lutherstadt-Wittenberg, Germany
  • Stefan Klein Department of Internal Medicine IV, Klinikum Bayreuth, Bayreuth, Germany
  • Georgi Kojouharoff Practice for Medical Oncology, Darmstadt, Germany
  • Thomas C. Gauler Department of Medicine (Cancer Research), West German Cancer Center, University Hospital Essen of University Duisburg-Essen, Essen, Germany
  • Ludwig Fischer von Weikersthal Department of Oncology, Gesundheitszentrum St. Marien, Amberg, Germany
  • Michael R. Clemens Department of Haematology and Oncology, Mutterhaus der Boromaeerinnen, Trier, Germany
  • Michael Geissler Department of Gastroenterology and Oncology, Klinikum Esslingen, Esslingen, Germany
  • Tim F. Greten Department of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover, Hannover, Germany
  • Susanna Hegewisch-Becker Practice for Medical Oncology, Hamburg, Germany
  • Dominik P. Modest Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany
  • Sebastian Stintzing Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany
  • Michael Haas Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany

DOI:

https://doi.org/10.3109/0284186X.2015.1034877

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.

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Published

2015-08-09

How to Cite

Kruger, S., Boeck, S., Heinemann, V., Laubender, R. P., Vehling-Kaiser, U., Waldschmidt, D., … Haas, M. (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 Oncologica, 54(7), 993–1000. https://doi.org/10.3109/0284186X.2015.1034877

Issue

Vol. 54 No. 7 (2015): Acta Oncologica

Section

Articles