1. 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
- Author
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Dirk Jäger, Leonidas Apostolidis, Carsten Grüllich, Uwe Haberkorn, Claudia Trierweiler, Georg Martin Haag, Mareike Dietrich, Frederik L. Giesel, Florian Lordick, Carl von Gall, Anne Katrin Berger, Angelika Freitag, Ulrich Abel, Stephan Lücke, Annika Stange, Tim Frederik Weber, and Jennifer Ose
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Adult ,Male ,0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Colorectal cancer ,Leucovorin ,Cetuximab ,Phases of clinical research ,Article ,03 medical and health sciences ,0302 clinical medicine ,Fluorodeoxyglucose F18 ,Positron Emission Tomography Computed Tomography ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Prospective Studies ,Progression-free survival ,Survival rate ,Aged ,Response rate (survey) ,Predictive marker ,business.industry ,Middle Aged ,medicine.disease ,Progression-Free Survival ,digestive system diseases ,030104 developmental biology ,030220 oncology & carcinogenesis ,Cancer imaging ,Camptothecin ,Female ,Fluorouracil ,Colorectal Neoplasms ,business ,medicine.drug - 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.
- Published
- 2018
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