Impact of surgical resection of liver metastases on outcome of patients with KRAS-wildtype exon 2 (KRAS-wt) metastatic colorectal carcinoma (mCRC) treated with a cetuximab-based first-line therapy - Interim analysis of the German non-interventional study ERBITAG

Date

08 Oct 2016

Session

Poster Display

Presenters

Ulf Neumann

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

U. Neumann1, T. Goehler2, C. Hering-Schubert3, J. Janssen4, S. Sahm5, M. Schwittay6, M.O. Zahn7, K.G. Stenzel8, F. Overkamp9

Author affiliations

  • 1 Department Of General, Visceral And Transplantation Surgery, Universitaetsklinikum Aachen (UKA), 52074 - Aachen/DE
  • 2 Dresden/freiberg, Onkozentrum, Dresden/DE
  • 3 Hematology/oncology/palliative Care, St. Georg Klinikum Eisenach, 99817 - Eisenach/DE
  • 4 Medical Oncology Department, Gemeinschaftspraxis für Hämatologie und Onkologie, Westerstede/DE
  • 5 Medizinische Klinik I, Ketteler Krankenhaus gGmbH, 63071 - Offenbach/DE
  • 6 Leipziger Land, Tumorzentrum, Groitzsch/DE
  • 7 Onkologische Kooperation Harz, MVZ, Goslar/DE
  • 8 Medical Affairs, Merck Serono GmbH, 64289 - Darmstadt/DE
  • 9 Studiengesellschaft, Oncologianova GmbH, Recklinghausen/DE
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Resources

Background

Cetuximab in combination with irinotecan- or oxaliplatin-based chemotherapy (CT) has shown to increase amongst other efficacy parameter the R0 resection rate of liver metastases (LM) of primary irresectable KRAS-wt mCRC patients (pts). The non-interventional study ERBITAG aimed to evaluate safety and efficacy of cetuximab in combination with various first-line CT regimens in pts with unresectable KRAS-wt mCRC.

Methods

KRAS-wt pts on a cetuximab-based first-line treatment with written informed consent could be enrolled in this prospective, non-interventional study. Primary endpoint was ORR, secondary endpoints were amongst others PFS, OS, TTF, and resection rate of liver metastasis. Here we update the interim analysis in terms of the outcome of pts according to secondary resection of LM.

Results

456 KRAS-wt mCRC pts out of 817 recruited KRAS-wt pts were evaluable for this interim analysis. Location of metastasis was liver, lung, lymph nodes, and peritoneum in 70.6%, 23.5%, 22.4%, and 17.8% of pts, respectively. 39.7% of pts had liver-limited disease (LLD). 79.2% had surgery of the primary tumor and 15.6% had a resection of metastases before enrolment. The median [range] age was 65 [27-87] yrs, ECOG performance status was 0, 1, 2, or missing in 34.4%, 49.6%, 8.8%, and 7.2% of pts, respectively. Resection of LM and/or lung metastases was done in 17.3% of pts, 13.4% were R0 resected. For LLD-pts resection rate and R0-rate were 29.3% and 23.8%, respectively. Intraoperative and postoperative complications were observed in 1.1% and 12.4% of pts with resection of metastasis, respectively. In 4.5% of pts a revision surgery was necessary. Median PFS was 20.3 and 9.5 months for pts with and without resection of LM, respectively (p 

Conclusions

Pts with resection of LM had a significant longer PFS and OS compared to pts without resection.

Clinical trial identification

German Database on pei.de of non-interventional trials NIS-Nr.: 114

Legal entity responsible for the study

Merck Serono GmbH, Darmstadt, Germany

Funding

Merck Serono GmbH, Darmstadt, Germany

Disclosure

U. Neumann: Honoraria - Amgen; Merck Serono; Roche; corporate-sponsored research - Merck Serono (Inst). C. Hering-Schubert: Honoraria - Amgen; Boehringer Ingelheim; Bristol-Myers Squibb; Celgene; Mundipharma; Novartis; Pfizer. S. Sahm: Stock ownership - Fresenius Medical Care; Merck KGaA honoraria - Fresenius Medical Care corporate-sponsored research - Merck Serono (Inst); Roche (Inst). M.O. Zahn: Honoraria - Celgene consulting or advisory role – Novartis. K.G. Stenzel: Employment - Merck Serono GmbH stock ownership - Merck KGaA. F. Overkamp: Honoraria - Merck Serono consulting or advisory role - Merck Serono. All other authors have declared no conflicts of interest.

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