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Modest, Dominik Paul; Laubender, Ruediger Paul; Fischer von Weikersthal, Ludwig; Vehling-Kaiser, Ursula; Stauch, Martina; Hass, Holger; Dietzfelbinger, Hermann F.; Oruzio, Daniel V.; Klein, Stefan; Zellmann, Klaus; Decker, Thomas; Schulze, Mathias; Abenhardt, Wolfgang; Puchtler, Gerhard; Kappauf, Herbert W.; Mittermueller, Johann; Haberl, Christopher; Stintzing, Sebastian; Mansmann, Ulrich Robert; Heinemann, Volker

Early tumor shrinkage in patients with metastatic colorectal cancer receiving first-line treatment with cetuximab combined with either CAPIRI or CAPOX: An analysis of the AIO KRK 0104 trial

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  • Media type: E-Article
  • Title: Early tumor shrinkage in patients with metastatic colorectal cancer receiving first-line treatment with cetuximab combined with either CAPIRI or CAPOX: An analysis of the AIO KRK 0104 trial
  • Contributor: Modest, Dominik Paul; Laubender, Ruediger Paul; Fischer von Weikersthal, Ludwig; Vehling-Kaiser, Ursula; Stauch, Martina; Hass, Holger; Dietzfelbinger, Hermann F.; Oruzio, Daniel V.; Klein, Stefan; Zellmann, Klaus; Decker, Thomas; Schulze, Mathias; Abenhardt, Wolfgang; Puchtler, Gerhard; Kappauf, Herbert W.; Mittermueller, Johann; Haberl, Christopher; Stintzing, Sebastian; Mansmann, Ulrich Robert; Heinemann, Volker
  • imprint: American Society of Clinical Oncology (ASCO), 2012
  • Published in: Journal of Clinical Oncology
  • Language: English
  • DOI: 10.1200/jco.2012.30.15_suppl.3588
  • ISSN: 0732-183X; 1527-7755
  • Keywords: Cancer Research ; Oncology
  • Origination:
  • Footnote:
  • Description: <jats:p> 3588 </jats:p><jats:p> Background: This study investigated the impact of early tumor-shrinkage (ETS) on progression-free (PFS) and overall survival (OS) in patients with metastatic colorectal cancer (mCRC) treated within the AIO KRK-0104-trial. ETS was previously shown to be a predictor of treatment response to cetuximab. The present analysis, for the first time, evaluates the correlation of ETS with outcome parameters in patients undergoing capecitabine-based therapy. It also aims to correlate the predictive value of ETS and cetuximab-induced skin toxicity. Methods: The AIO KRK0104 trial was performed as a randomised study comparing capecitabine/oxaliplatin (CAPOX) plus cetuximab to capecitabine/irinotecan (CAPIRI) plus cetuximab in the first-line treatment of mCRC. 121 patients were available for evaluation of ETS at 6 weeks. ETS was defined as a relative change of ≥20% in the sum of the longest diameters of target lesions compared to baseline. Results: Tumors of 63 patients (71% KRAS wild-type (wt), 100% skin reactions) developed ETS, 58 tumors did not develop ETS (53% KRAS wt, 86% skin reactions). ETS was associated with prolonged PFS (8.9 vs. 4.7 months, p&lt;0.001, hazard ratio: 0.37) and OS (31.6 vs. 15.8 months, p=0.005, hazard ratio: 0.48) in patients with KRAS wt tumors but not in patients with KRAS mutant mCRC. ETS occurred more frequently with CAPOX- vs CAPIRI-based therapy (p=0.05). There was a highly significant correlation between the occurrence of ETS and cetuximab-related skin toxicity of any grade (I-III) (p=0.002). ETS was documented more frequently in patients with liver metastasis (p=0.09), metastatic involvement of &lt;2 organs (p=0.09), KRAS wild-type tumors (p=0.06) and no previous adjuvant chemotherapy (p=0.06). Conclusions: In patients with KRAS wild-type mCRC receiving capecitabine- and cetuximab-based first<jats:sup />-line therapy ETS correlates with prolonged PFS and OS. ETS also correlates with cetuximab-induced skin toxicity. Both parameters may therefore serve as post-randomisation surrogate markers of favourable outcome for cetuximab-based treatment. </jats:p>
  • Access State: Open Access