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. 2015 Aug 6:8:2005-13.
doi: 10.2147/OTT.S87101. eCollection 2015.

Associations between deepness of response and clinical outcomes among Japanese patients with metastatic colorectal cancer treated with second-line FOLFIRI plus cetuximab

Hiroki Osumi  1 , Satoshi Matsusaka  1 , Mitsukuni Suenaga  1 , Eiji Shinozaki  1 , Nobuyuki Mizunuma  1
Affiliations

Associations between deepness of response and clinical outcomes among Japanese patients with metastatic colorectal cancer treated with second-line FOLFIRI plus cetuximab

Hiroki Osumi et al. Onco Targets Ther. .

Abstract

Background: In the FIRE-3 trial, overall survival (OS) was significantly longer in patients treated with FOLFIRI plus cetuximab (C-mab) than in those treated with FOLFIRI plus bevacizumab (Bev), but progression-free survival (PFS) was not significantly different. This may be associated with the deepness of response (DpR) in patients treated with FOLFIRI plus C-mab. We aimed to evaluate the relationship between clinical outcome and DpR in metastatic colorectal cancer (mCRC) patients treated with second-line FOLFIRI plus C-mab.

Methods: A total of 112 patients with histopathologically confirmed mCRC treated with second-line FOLFIRI in combination with C-mab (N=42) or Bev (N=70) were retrospectively enrolled between October 2008 and June 2013. The relationship between DpR and clinical outcome in patients treated with FOLFIRI plus C-mab or Bev was determined.

Results: Forty-two patients treated with FOLFIRI plus C-mab had a mean DpR of 6.1% (inter-quartile range: -13.7%, 20.8%) and a minimum DpR of -62.7%. On the other hand, 70 patients treated with FOLFIRI plus Bev had a mean DpR of 0% (interquartile range: -16%, 10%) and a minimum DpR of -111%. DpR ≥30% was associated with significantly longer OS and PFS when compared with DpR ≤30% in patients given FOLFIRI plus C-mab. DpR (≥30%) was independently associated with prolongation of OS and PFS. In patients treated with FOLFIRI plus C-mab, there was a moderate positive correlation between DpR and clinical outcomes (OS: r=0.51, P<0.001; PFS: r=0.54, P<0.001).

Conclusion: FOLFIRI plus C-mab yielded a stronger correlation between DpR and clinical outcomes. These results indicate the potential of DpR as a new measure of efficacy in mCRC patients treated with second-line chemotherapy plus C-mab.

Keywords: cetuximab; deepness of response; metastatic colorectal cancer; second-line chemotherapy.

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Figures

Figure 1
Figure 1
Estimated correlation between deepness of response and clinical outcome in patients treated with FOLFIRI plus cetuximab as second-line chemotherapy and those treated with FOLFIRI plus bevacizumab as second-line chemotherapy. Abbreviations: Bev, bevacizumab; DpR, deepness of response; CI, confidence interval; OS, overall survival; C-mab, cetuximab; PFS, progression-free survival.
Figure 2
Figure 2
Relationship between deepness of response and clinical outcome in patients treated with FOLFIRI plus cetuximab as second-line chemotherapy. Abbreviations: DpR, deepness of response; CI, confidence interval; HR, hazard ratio; OS, overall survival; PFS, progression-free survival; NA, not available.
Figure 3
Figure 3
Relationship between deepness of response and PFS. When we also used the date of diagnosing RECIST-based progressive disease, deepness of response was not associated with significantly longer progression-free survival like the Fire-3 trial. Abbreviations: DpR, deepness of response; CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; NA, not available.
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