NCCN Guidelines for Esophageal and Esophagogastric Cancer V.4.

2022 Follow-up on 08/17/22

Guideline Page Panel Discussion/References Vote

and Request YES NO ABSTAIN ABSENT
ESOPH-F Page 3 Based on the review of the data in the noted reference
Internal request and discussion, the panel consensus was to make the
Request that the panel reassess the Checkmate 648 following changes under First-line Therapy; Preferred
trial data and the category designation for nivolumab in Regimens; HER2 overexpression negative:
combination with chemotherapy as a first-line treatment
option for patients with unresectable advanced, • As a first-line treatment option for patients with 26 0 3 3
recurrent or metastatic esophageal squamous cell unresectable advanced, recurrent or metastatic
carcinoma (ESCC). (ESOPH-F, page 3 of 17) ESCC, fluoropyrimidine (fluorouracil or
capecitabine), OXALIPLATIN, and nivolumab
External request changed from a category 2B to a category 2A
Submission from Bristol Myers Squibb (08/01/22) recommendation.
requesting the inclusion of nivolumab in combination o The panel consensus did not support a 19 5 5 3
with chemotherapy as a Category 1 recommendation as category 1 recommendation.
a first-line treatment option for patients with
unresectable advanced, recurrent or metastatic ESCC • As a first-line treatment option for patients with 26 0 3 3
(ESOPH-F, page 3 of 17) unresectable advanced, recurrent or metastatic
ESCC, fluoropyrimidine (fluorouracil or
capecitabine), CISPLATIN, and nivolumab
changed from a category 2B to a category 2A
recommendation.
o The panel consensus did not support a 19 4 6 3
category 1 recommendation.

Doki Y, Ajani JA, Kato K, et al. Nivolumab

Combination Therapy in Advanced Esophageal
Squamous-Cell Carcinoma. N Engl J Med
2022;386:449-462.

See submission for references

External request
Submission from Bristol Myers Squibb (08/01/22)
requesting the inclusion of nivolumab in combination
with ipilimumab as a Category 1 recommendation as a
first-line treatment option for patients with unresectable
advanced, recurrent or metastatic ESCC (ESOPH-F,
page 3 of 17)
• Based on review of the data and discussion, the 17 6 6 3
panel consensus did not support the category
designation change for nivolumab in combination
with ipilimumab from a category 2A to a category
1 for patients with unresectable advanced,
recurrent or metastatic ESCC that is HER2
overexpression negative. Nivolumab in
combination is still included as a preferred
regimen.

See submission for references.

NCCN Guidelines for Esophageal and Esophagogastric Cancer V.4.2022 Follow-up on 08/17/22