1. NCCN Guidelines for Colon Cancer and Rectal Cancer V.1.2023 – Annual on 03/06/23
Guideline Page
and Request
Panel Discussion/References
Institution Vote
YES NO ABSTAIN ABSENT
REC-6
Internal Request
Based on the discussion from the annual meeting,
should FOLFIRINOX be included as a treatment
option for T3 N2 disease?
Based on a review of the data and discussion,
the panel consensus supported the removal of
the qualifier for FOLFIRINOX (T4 N+) allowing
FOLFIRINOX to be a treatment option for T3 N2
disease.
18 2 5 7
REC-6
Internal Request
Based on the discussion from the annual meeting,
should neoadjuvant FOLFIRINOX qualifier (T4 N+) be
removed, so that it would be included as a treatment
option for T3 N any; T1-2 N1-2; T4 N any; or locally
unresectable or medically inoperable?
Based on a review of the data and discussion,
the panel consensus supported the removal of
the qualifier for FOLFIRINOX (T4 N+) allowing
FOLFIRINOX to be a treatment option for T3 N
any; T1-2 N1-2; T4 N any; or locally unresectable
or medically inoperable.
16 4 5 7
REC-14
Internal Request
Should nivolumab or pembrolizumab or dostarlimab-
gxly be included as the preferred neoadjuvant
immunotherapy options for dMMR/MSI-H Rectal
Cancer?
External Request
Submission request from GlaxoSmithKline (GSK)
(06/24/2022): Add dostarlimab-gxly as a neoadjuvant
therapy option for adult patients with locally advanced,
mismatch repair deficient (dMMR) rectal cancer.
Based on a review of the data and discussion,
the panel consensus supported the inclusion of
nivolumab or pembrolizumab or dostarlimab-gxly
as the preferred neoadjuvant immunotherapy
options for dMMR/MSI-H Rectal Cancer. This is a
category 2B recommendation.
See Submission for references.
16 5 4 7
COL-14/REC-16
Internal Request
Should dostarlimab be added as an option for
neoadjuvant treatment of dMMR/MSI-H resectable
synchronous liver only and/or lung only colorectal
cancer metastases?
Based on a review of the data and discussion,
the panel consensus supported the inclusion of
dostarlimab as an option for the neoadjuvant
treatment of dMMR/MSI-H resectable
synchronous liver only and/or lung only colorectal
cancer metastases. This is a category 2A
recommendation.
19 2 4 7
COL-15/REC-17
Internal Request
Should nivolumab +/- ipilimumab, pembrolizumab,
and dostarlimab be added as primary treatment
options for dMMR/MSI-H resectable metachronous
colorectal cancer metastases with no previous
immunotherapy?
Based on a review of the data and discussion,
the panel consensus supported the inclusion of
nivolumab +/- ipilimumab, pembrolizumab, or
dostarlimab as primary treatment options for
dMMR/MSI-H resectable metachronous
colorectal cancer metastases with no previous
immunotherapy. This is a category 2A
recommendation.
19 1 5 7
2. NCCN Guidelines for Colon Cancer and Rectal Cancer V.1.2023 – Annual on 03/06/23
REC-C 1 of 3
External Request
Submission request from The Sixth Affiliated Hospital,
Sun Yat-sen University (03/10/2022): Suggest that the
specific criteria for high-risk lateral lymph nodes
should be discussed, which is currently not mentioned
in the guideline, and LLND should be considered as a
salvage approach for patients with high-risk lateral
lymph nodes after NT.
Based on a review of the data and discussion,
the panel decided that this will be deferred to a
future update.
Submission with multiple requests
COL-D/REC-F
External Request
Submission from Taiho Oncology (01/21/23)
requested the following changes:
• COL-D, 2 to 6 and REC-F, 2 to 6:
Subsequent-line (third-line), modify
recommendation to “Trifluridine + tipiracil +
bevacizumab (preferred) or trifluridine +
tipiracil”
• COL-D, 2 to 6 and REC-F, 2 to 6:
Subsequent-line (third-line), change trifluridine
+ tipiracil + bevacizumab from category 2A to
category 1
• COL-D, 2 to 6 and REC-F, 2 to 6:
Subsequent-line (third-line), add footnote:
“Trifluridine/tipiracil plus bevacizumab was
associated with a significant improvement in
overall survival compared with
trifluridine/tipiracil in the phase 3 SUNLIGHT
trial.”
• COL-D, 1 of 13 and REC-F, 1 of 13: Consider
FTD/TPI + bevacizumab as a first-line
treatment option for patients with mCRC not
appropriate for intensive combination
chemotherapy.
o with footnote: “Trifluridine/tipiracil plus
bevacizumab demonstrated similar
progression-free survival as
capecitabine plus bevacizumab in a
large phase 3 randomized trial; it may
be appropriate for select patients
based on its activity and different
safety profile.”
Based on a review of the data in the noted
references, the panel consensus supported the
following:
• COL-D, 2 to 6 and REC-F, 2 to 6: Added
“(bevacizumab combo preferred)”
• COL-D, 2 to 6 and REC-F, 2 to 6: Defer
to a future vote and additional
discussion.
• COL-D, 2 to 6 and REC-F, 2 to 6: No
change to algorithm. The panel agreed
that these data should be added to the
Discussion section rather than a
footnote. Deferred to a future update.
• COL-D, 1 of 13 and REC-F, 1 of 13: No
changes.
o Should FTD/TPI + bevacizumab
be considered as a first-line
treatment option for patients with
mCRC not appropriate for
intensive combination
chemotherapy?
o Should the following footnote be
added?
See Submission for references.
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