학술논문
Early metabolic response in sequential FDG-PET/CT under cetuximab is a predictive marker for clinical response in first-line metastatic colorectal cancer patients: results of the phase II REMOTUX trial.
Document Type
Academic Journal
Author
Berger AK; Department of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany. anne.berger@med.uni-heidelberg.de.; Lücke S; National Center for Tumor Diseases (NCT), Trial Center, German Cancer Research Center (DKFZ), Heidelberg, Germany.; Abel U; National Center for Tumor Diseases (NCT), Trial Center, German Cancer Research Center (DKFZ), Heidelberg, Germany.; Haag GM; Department of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.; Grüllich C; Department of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.; Stange A; Department of Surgery, University Hospital Dresden, Dresden, Germany.; Dietrich M; Department of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.; Apostolidis L; Department of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.; Freitag A; National Center for Tumor Diseases (NCT), Trial Center, German Cancer Research Center (DKFZ), Heidelberg, Germany.; Trierweiler C; National Center for Tumor Diseases (NCT), Trial Center, German Cancer Research Center (DKFZ), Heidelberg, Germany.; von Gall C; Siemens Medical Solutions USA, Knoxville, USA.; Ose J; Cancer Institute University of Utah, Salt Lake City, USA.; Giesel F; Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany.; Weber TF; Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Heidelberg, Germany.; Lordick F; University Cancer Center Leipzig (UCCL), University Medicine Leipzig, University of Leipzig, Leipzig, Germany.; Haberkorn U; Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany.; Jäger D; Department of Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.
Source
Publisher: Nature Publishing Group on behalf of Cancer Research UK Country of Publication: England NLM ID: 0370635 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1827 (Electronic) Linking ISSN: 00070920 NLM ISO Abbreviation: Br J Cancer
Subject
Language
English
Abstract
Background: To assess the predictive value of early metabolic response (ΔSUV) after short-term treatment with first-line cetuximab in patients (pts) with RAS-wt metastatic colorectal cancer (mCRC).
Methods: In this prospective phase II study, RAS-wt mCRC pts received a single-agent cetuximab run-in therapy of 2 weeks. ΔSUV was assessed with FDG-PET/CT on days 0 and 14. Early clinical response (ECR) was evaluated with CT on day 56 after treatment with FOLFIRI-cetuximab. Primary endpoint was the predictive significance of ΔSUV for ECR. Secondary endpoints were PFS (progression free survival), OS and the influence of ΔSUV on survival.
Results: Forty pts were enroled and 33 pts were evaluable for the primary endpoint. The CT response rate was 57.6%. For responders, ΔSUV was significantly higher (p = 0.0092). A significant association of ΔSUV with ECR was found (p = 0.02). Median PFS was 11.7 months and median OS was 33.5 months with a 1-year survival rate of 87.9%. ΔSUV was found to significantly impact the hazard for OS (p = 0.045).
Conclusions: We demonstrate that cetuximab induces metabolic responses in mCRC pts. The study endpoint was met with the ΔSUV discriminating between responders and non-responders. However, these data should be validated in larger patient cohorts.
Methods: In this prospective phase II study, RAS-wt mCRC pts received a single-agent cetuximab run-in therapy of 2 weeks. ΔSUV was assessed with FDG-PET/CT on days 0 and 14. Early clinical response (ECR) was evaluated with CT on day 56 after treatment with FOLFIRI-cetuximab. Primary endpoint was the predictive significance of ΔSUV for ECR. Secondary endpoints were PFS (progression free survival), OS and the influence of ΔSUV on survival.
Results: Forty pts were enroled and 33 pts were evaluable for the primary endpoint. The CT response rate was 57.6%. For responders, ΔSUV was significantly higher (p = 0.0092). A significant association of ΔSUV with ECR was found (p = 0.02). Median PFS was 11.7 months and median OS was 33.5 months with a 1-year survival rate of 87.9%. ΔSUV was found to significantly impact the hazard for OS (p = 0.045).
Conclusions: We demonstrate that cetuximab induces metabolic responses in mCRC pts. The study endpoint was met with the ΔSUV discriminating between responders and non-responders. However, these data should be validated in larger patient cohorts.