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Poster Display session 2

4455 - Impact of primary tumor side on 3-year survival outcomes of first-line (1L) FOLFOX-4 ± cetuximab in patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in the phase 3 TAILOR trial


29 Sep 2019


Poster Display session 2


Tumour Site

Colon and Rectal Cancer


Shukui Qin


Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246


S. Qin1, T. Liu2, J. Xu3, Q. Li4, Y. Cheng5, J. Nippgen6, W. Chen7, J. Li8

Author affiliations

  • 1 Cancer Center, Jinling Hospital, 210002 - Nanjing/CN
  • 2 Medical Oncology, Affiliated Zhongshan Hospital of Fudan University, 200032 - Shanghai/CN
  • 3 Department Of Gastrointestinal Oncology, 307 Hospital of the Chinese People's Liberation Army, 100071 - Beijing/CN
  • 4 Department Of Oncology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 200080 - Shanghai/CN
  • 5 Department Of Oncology, Jilin Cancer Hospital, 130031 - Jilin/CN
  • 6 Oncology, Merck Serono, 100016 - Beijing/CN
  • 7 Biostatistics, Merck Serono, 2000070 - Shanghai/CN
  • 8 Oncology, Fudan University Cancer Hospital and Tongji University East Hospital, 200000 - shanghai/CN


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Abstract 4455


The TAILOR trial demonstrated a significant survival advantage with the addition of cetuximab to 1L FOLFOX-4 in patients from China with RAS wt mCRC and met all of its endpoints. We report the impact of primary tumor side on 3-year overall survival (OS) in TAILOR.


TAILOR was a randomized, open-label, multicenter, phase 3 trial that evaluated 1L cetuximab + FOLFOX-4 vs FOLFOX-4 in patients from China with RAS wt mCRC. The primary endpoint was progression-free survival time, as determined by independent review committee; secondary endpoints included OS time, ORR, and safety/tolerability. Tumors were categorized in evaluable patients as left (L)-sided (splenic flexure, descending colon, sigmoid colon, and rectum) or right (R)-sided (appendix, cecum, ascending colon, hepatic flexure, and transverse colon).


Of the 393 treated patients with RAS wt mCRC, median follow-up time was 57.0 months (range, 1.5–75.5), and 391 patients were evaluable for tumor side. Median OS and 3-year OS rates by primary tumor side are summarized in the table.Table:


Primary tumor side: LPrimary tumor side: R
Cetuximab + FOLFOX-4 (n = 146)FOLFOX-4 (n = 162)Cetuximab + FOLFOX-4 (n = 45)FOLFOX-4 (n = 38)
Median OS (95% CI), months22.0 (18.7–25.5)18.3 (15.2–20.2)11.5 (7.5–20.4)9.4 (7.5–18.8)
3-year OS rate (95% CI), %32 (25–40)16 (11–22)23 (11–38)14 (5–28)


This updated analysis at > 4.5 years’ median follow-up is consistent with previous results from the TAILOR study, which showed improved OS with the addition of cetuximab to FOLFOX-4. Indeed, the 3-year OS rate was doubled in patients with L-sided mCRC and > 1.5 times higher in those with R-sided disease, showing that patients with mCRC might benefit from treatment with cetuximab irrespective of primary tumor side. Overall, these results confirm cetuximab in combination with FOLFOX-4 as an effective standard-of-care 1L therapy for patients with RAS wt mCRC.

Clinical trial identification

NCT01228734; EMR62202-057.

Editorial acknowledgement

Medical writing assistance (funded by Merck Healthcare KGaA, Darmstadt, Germany) was provided by Marjorie Rummelt, PhD, of ClinicalThinking, Inc, Hamilton, NJ, USA.

Legal entity responsible for the study

Merck Healthcare KGaA.


Merck Healthcare KGaA.


J. Nippgen: Full / Part-time employment: Merck Serono. W. Chen: Full / Part-time employment: Merck Serono. J. Li: Research grant / Funding (institution): Merck; Research grant / Funding (institution): Roche. All other authors have declared no conflicts of interest.

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