Abstract
Background
In 2019, researchers reported a remarkable 33% response rate and a median progression
free survival of almost 8 months in a study of Regorafenib and Nivolumab (RegoNivo)
with 24 Japanese patients with chemo-refractory MSS-mCRC. These clinical outcomes
were subsequently not replicated in clinical trials in North America. One hypothesis
that has been put forth is that trials in North America had a higher percentage of
patients with liver metastases who are less likely to respond to Regorafenib and Nivolumab.
We propose an alternate hypothesis reflected by ECOG Performance Status = 0.
Methods
We reexamined the available trial data on RegoNivo for MSS-mCRC in the original Japanese
trial and compared it to subsequent clinical trials of the same combination and setting
in North America.
Results
100% of patients on the original Japanese trial were ECOG PS = 0 whereas those in
the subsequent trials in North America included a majority of patients with ECOG PS
= 1. The percentage of patients with liver metastases is not as clearly different
among these trials compared to ECOG PS 0.
Conclusions
ECOG PS may represent a composite marker of patient physical activity and/or fitness
and disease biology. Although ECOG PS and physical activity are not completely the
same, ECOG PS and physical activity of patients has not been fully investigated in
the context of response to RegoNivo. Alternatively, it is possible that poor ECOG
PS may also reflect unfavorable tumor biology, and such tumors might progress before
RegoNivo has a chance to provide clinical benefit
Keywords
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Article info
Publication history
Published online: October 02, 2021
Accepted:
September 27,
2021
Received in revised form:
September 24,
2021
Received:
August 2,
2021
Identification
Copyright
© 2021 Elsevier Inc. All rights reserved.