Meeting
2012 ASCO Annual Meeting
Correlation of hand-foot skin reaction (HFS) with treatment efficacy in pancreatic cancer (PC) patients (pts) treated with gemcitabine/capecitabine plus erlotinib: A subgroup analysis from the AIO-PK0104 randomized, cross-over phase III trial in advanced PC.
Authors
Michael Haas
Department of Hematology and Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, LMU Munich, Munich, Germany
Michael Haas , Stefan Hubert Boeck , Ruediger Paul Laubender , Dominik Paul Modest , Ursula Vehling-Kaiser , Dirk Waldschmidt , Erika Kettner , Angela Maerten , Cornelia Winkelmann , Stefan Klein , Georgi Kojouharoff , Thomas C. Gauler , Ludwig Fischer Von Weikersthal , Michael Clemens , Michael Geissler , Tim F Greten , Susanna Hegewisch-Becker , Oleg Rubanov , Ulrich Robert Mansmann , Volker Heinemann
Organizations
Department of Hematology and Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, LMU Munich, Munich, Germany, Institute for Medical Informatics, Biometry and Epidemiology, University of Munich, Munich, Germany, Practice for Medical Oncology, Landshut, Germany, Department of Gastroenterology and Hepatology, University of Cologne, Cologne, Germany, Department of Hematology/Oncology, Universitätsklinikum Magdeburg, Magdeburg, Germany, University of Heidelberg, Heidelberg, Germany, Department of Internal Medicine, Krankenhaus Lutherstadt-Wittenberg, Lutherstadt-Wittenberg, Germany, Department of Internal Medicine IV, Klinikum Bayreuth, Bayreuth, Germany, Practice for Medical Oncology, Darmstadt, Germany, West German Tumor Center, University Hospital Essen, Essen, Germany, Gesundheitszentrum St Marien, Amberg, Germany, Mutterhaus der Boromaerinnen, Trier, Germany, Klinikum Esslingen, Esslingen, Germany, Medical School, Hannover, Germany, Private Practice for Oncology, Hamburg, Germany, Practice for Medical Oncology, Hameln, Germany
Research Funding
Other
Background: AIO-PK 0104 investigated the efficacy and safety of gemcitabine/erlotinib (G/E) followed by capecitabine (C) vs. C/E followed by G. The present subgroup analysis evaluated the correlation between C-associated skin toxicity and outcome parameters in PC. Methods: Within this multicenter phase III trial, pts with confirmed advanced PC were randomly assigned to 1st-line treatment with either C (2,000 mg/m2/d, d1-14 q d21) plus E (150 mg/d, arm A) or G (1,000 mg/m2 over 30 min weekly x 7, then d1, 8, 15 q d28) plus E (150 mg/d, arm B). A cross-over to either G (arm A) or C (arm B) was performed after treatment failure (e. g. disease progression or unacceptable toxicity). Time to treatment failure after 1st- and 2nd-line therapy (TTF2) was the primary study endpoint. Treatment-related skin toxicity was evaluated separately for each treatment arm/each regimen based on NCI-CTCv2. Results: Of 279 eligible pts, 47 had locally advanced, 232 had metastatic disease and 141 pts received second-line chemotherapy. For the present subgroup analysis data on skin toxicity were available from 255 pts. For the 73 pts (29%) with a HFS (any grade documented at any time during the treatment strategy), TTF2 and OS both were significantly prolonged compared to pts without HFS (7.4 vs 4.0 months, p<0.001 and 9.7 vs 5.5 months, p=0.002, respectively). Considering HFS during 1st-line treatment in 123 pts within the CE arm, these results could be confirmed for the 47 pts (38%) with a documented HFS of any grade (TTF2: 7.6 vs. 3.2 months, p<0.001; OS: 10.2 vs. 4.4 months, p=0.001). In pts receiving 1st-line treatment with G/E (n=132) no difference in outcome was observed for pts with (n=13) or without (n=119) HFS of any grade (TTF2: 5.7 vs. 4.2 months, p=0.375; OS: 8.4 vs. 6.6 months, p=0.505). Conclusions: The current subgroup analysis of AIO-PK0104 supports the assumption of a correlation between HFS in PC pts treated with capecitabine or capecitabine/erlotinib and efficacy endpoints like TTF2 and OS. A capecitabin-associated HFS thus might be predictive for efficacy in patients with advanced PC.
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Abstract Details
Session Type
Poster Discussion Session
Session Title
Gastrointestinal (Noncolorectal) Cancer
Track
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Sub Track
Pancreatic Cancer
Clinical Trial Registration Number
NCT00440167
Citation
J Clin Oncol 30, 2012 (suppl; abstr 4023)
DOI
10.1200/jco.2012.30.15_suppl.4023
Abstract #
4023
Poster Bd #
15
Abstract Disclosures
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