557P - A randomized, controlled trial of cetuximab plus chemotherapy for patients with KRAS wild-type unresectable colorectal liver-limited metastases

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Jianmin Xu
Authors J. Xu, L. Ye, L. Ren, Y. Wei
  • Department Of General Surgery, Zhongshan Hospital Fudan University, 200032 - Shanghai/CN

Abstract

Background

To assess the effect of cetuximab combined with chemotherapy in first-line treatment for unresectable colorectal liver metastases (CLM).

Methods

After resection of the primary focus, patients (pts) with non-resectable synchronous liver-limited metastases from wild-type KRAS colorectal cancer were randomly assigned to received chemotherapy (FOLFIRI or mFOLFOX6) plus cetuximab (arm A) or chemotherapy alone (arm B). The primary end point was the rate of secondary resection for liver metastases. Secondary end points included tumor response and survival.

Results

From June 2008 to December 2011, 116 pts were eligible (59 in arm A and 57 in arm B). The 3-year overall survival (OS) rate and median survival time (MST) of the total pts was 32% and 27.5 months (mo), respectively. R0 resection rate for liver metastases was 30.5% (18/59) in arm A and 8.8% (5/57) in arm B, with significant difference (Odds ratio = 4.57, p< .01). In R0 resected 18 pts from arm A, the median disease free survival and MST was 11.4 and 46.6 mo. The pts in arm A had improved objective response (OR, 66.1% v 33.3%, Odds ratio = 3.90, p< .01), increased 3-year OS rate (43% v 21%, p= .01) and prolonged MST (32.8 v 22.8 mo, HR =0.49, p= .01) compared with those in arm B. Furthermore, for the pts without liver surgery, people from arm A also got more survival benefit than those from arm B on 3-year OS rate (25% v 17%, p= .047), MST (28.2 v 21.2 mo, HR =0.55, p= .047) and progressives free survival (8.3 v 5.2 mo, HR =0.64, p= .03). In addition, in arm A, pts who experienced resection of liver metastases were significantly improved 3-year OS rate (74% v 25%, p= .02) and MST (46.6 v 28.2 mo, HR = 0.29, p= .02) than those without liver surgery, and the pts harboring BRAF wild-type tumors gained more benefit on MST (35.8 v 23.4 mo, HR =0.39, p= .045) rather than on OR ( 70.0% v 44.4%, Odds ratio = 2.92, p > .05), when compared to those with mutated BRAF tumors.

Conclusion

For initially unresectable CLM population with KRAS wild-type, cetuximab combined with chemotherapy could improve resectability of liver metastases, response rates and survival compared with chemotherapy alone (ClinicalTrials.gov number NCT01564810).

Disclosure

All authors have declared no conflicts of interest.