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| Annals of oncology : official journal of the European Society for Medical Oncology / ESMO. 2016 May 27. pii: mdw222. doi: 10.1093/annonc/mdw222 |
| CEA response is associated with tumor response and survival in patients with KRAS exon 2 wild-type and extended RAS wild-type metastatic colorectal cancer receiving first-line FOLFIRI plus cetuximab or bevacizumab (FIRE-3 trial). |
| Michl M1, Stintzing S2, Fischer von Weikersthal L3, Decker T4, Kiani A5, Vehling-Kaiser U6, Al-Batran SE7, Heintges T8, Lerchenmueller C9, Kahl C10, Seipelt G11, Kullmann F12, Stauch M13, Scheithauer W14, Hielscher J15, Scholz M16, Mueller S17, Lerch MM18, Modest DP19, Kirchner T20, Jung A21, Heinemann V22 |
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Abstract BACKGROUND: To examine the relation of carcinoembryonic antigen (CEA) response with tumor response and survival in patients with (K)RAS wild-type mCRC receiving first-line chemotherapy in the FIRE-3 trial comparing FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab. PATIENTS AND METHODS: CEA response assessed as the percentage of CEA decrease from baseline to nadir was evaluated for its association with tumor response and survival. ROC analysis revealed an optimal cut-off value of 75% using the maximum of sensitivity and specificity for CEA response to discriminate CEA responders from non-responders. In addition, the time to CEA nadir was calculated. RESULTS: Of 592 patients in the intent-to-treat population, 472 were eligible for analysis of CEA (cetuximab arm: 230 and bevacizumab arm: 242). Maximal %-relative CEA decrease significantly (P=0.003) differed between the cetuximab arm (median 83.0%; IQR 40.9%-94.7%) and the bevacizumab arm (median 72.3%; IQR 26.3%-91.0%). In a longitudinal analysis, the CEA decrease occurred faster in the cetuximab arm and was greater than in the bevacizumab arm at all evaluated time points until 56 weeks after treatment start. CEA nadir occurred after 3.3 months (cetuximab arm) and 3.5 months (bevacizumab arm), respectively (P=0.49). In the cetuximab arm, CEA responders showed a significantly longer PFS (11.8 months versus 7.4 months; HR 1.53; 95% Cl, 1.15-2.04; P=0.004) and longer OS (36.6 months versus 21.3 months; HR 1.73; 95% Cl, 1.24-2.43; P=0.001) than CEA non-responders. Analysis of extended RAS wild-type patients revealed similar results CONCLUSION: In the FIRE-3 trial, CEA decrease was significantly faster and greater in the cetuximab arm compared to the bevacizumab arm and correlated with the prolonged survival observed in patients receiving FOLFIRI plus cetuximab. CLINICAL TRIALS NUMBER: NCT00433927 (ClinicalTrials.gov); AIO KRK0306 FIRE-3. |
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© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. |
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KEYWORDS: CEA, FIRE-3 trial, KRAS exon 2 wild-type, extended RAS wild-type, metastatic colorectal cancer, tumor marker |
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Publikations ID: 27234640 Quelle: öffnen |
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