Impact of tumor epidermal growth factor receptor (EGFR) status on the outcomes of first-line FOLFOX-4 ± cetuximab in patients (pts) with RAS-wild-type (wt) metastatic colorectal cancer (mCRC) in the randomized phase 3 TAILOR trial

Date

08 Oct 2016

Session

Poster Display

Presenters

Shukui Qin

Citation

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

Authors

S. Qin1, J. Xu2, L. Wang3, Y. Cheng4, T. Liu5, J. Chen6, S..P. Eggleton7, J. Liu8, J. Li9

Author affiliations

  • 1 Department Of Medical Oncology, Nanjing Bayi Hospital, 210000 - Nanjing/CN
  • 2 Department Of Medical Oncology, 307 Hospital of PLA, 100007 - Beijing/CN
  • 3 Department Of Medical Oncology, Shanghai First People's Hospital, 200000 - Shanghai/CN
  • 4 Department Of Medical Oncology, Jilin Cancer Hospital, 130012 - Jilin/CN
  • 5 Department Of Medical Oncology, Zhongshan Hospital, Fudan University, 200000 - Shanghai/CN
  • 6 Department Of Medical Oncology, Merck Serono Co., Ltd., 100016 - Beijing/CN
  • 7 Gcdc Oncology, Merck KGaA, 64293 - Darmstadt/DE
  • 8 Department Of Biostatistics, Merck Serono Co., Ltd., 100016 - Beijing/CN
  • 9 Department Of Medical Oncology, Fudan University, Shanghai Cancer Center, 200000 - Shanghai/CN
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Background

Cetuximab in combination with chemotherapy (either FOLFIRI or FOLFOX) is a standard-of-care first-line treatment for pts with RAS-wt, EGFR-expressing mCRC. In this prospective subgroup analysis of the randomized phase 3 TAILOR trial, we evaluate the impact of EGFR status on the efficacy of FOLFOX-4 ± cetuximab in the first-line treatment of Chinese pts with RAS-wt mCRC.

Methods

TAILOR is a randomized phase 3 trial that includes a modified intention-to-treat (mITT) population of 393 Chinese pts with RAS-wt mCRC treated with FOLFOX-4 ± cetuximab. The primary endpoint of TAILOR is progression-free survival (PFS); secondary endpoints include overall survival (OS) and overall response rate (ORR). Tumor EGFR detectability was assessed in evaluable pts within the mITT population via immunohistochemistry.

Results

Within the mITT population, 193 pts with RAS-wt mCRC were randomized and treated with FOLFOX-4 + cetuximab and 200 pts received FOLFOX-4. Adding cetuximab to FOLFOX-4 significantly improved median PFS (9.2 vs 7.4 mo; HR [95% CI] = 0.691 [0.536-0.891]; p = .004), preliminary assessment of median OS (20.7 vs 17.8 mo; HR [95% CI] = 0.763 [0.607-0.958]; p = .020), and ORR (61.1% vs 39.5%; odds ratio [95% CI] = 2.410[1.607-3.614]; p  0%-10% 35 48 11.3 vs 7.4 (0.62 [0.35-1.11]) 71.4 vs 41.7 (3.50 [1.38-8.88]) > 10%-20% 15 14 9.3 vs 8.1 (0.45 [0.15-1.39]) 73.3 vs 42.9 (3.67 [0.77-17.4]) > 20%-35% 9 14 7.5 vs 9.2 (1.34 [0.47-3.86]) 44.4 vs 64.3 (0.44 [0.08-2.46]) > 35% 29 28 7.0 vs 5.2 (0.73 [0.40-1.35]) 44.8 vs 35.7 (1.46 [0.50-4.24])

Conclusions

Irrespective of tumor EGFR status, the addition of cetuximab to first-line FOLFOX-4 clearly improved PFS and ORR in Chinese pts with RAS-wt mCRC. The TAILOR study data confirm cetuximab in combination with chemotherapy as a standard-of-care first-line treatment regimen for pts with RAS-wt mCRC, independent of tumor EGFR status.

Clinical trial identification

EMR62202-057; NCT01228734

Legal entity responsible for the study

N/A

Funding

Merck KGaA, Darmstadt, Germany

Disclosure

J. Chen, J. Liu: Employee of Merck Serono Co., Ltd., Beijing, China. S.P. Eggleton: Employee of Merck KGaA, Darmstadt, Germany J. Li: Research Funding from Merck and Roche. All other authors have declared no conflicts of interest.

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