NCCN Guidelines for Cervical Cancer V.1.

2022 –Annual on 06/11/21

Guideline Page Panel Discussion/References Institution Vote

and Request YES NO ABSTAIN ABSENT
CERV-10 and CERV-A Based on the review of data and discussion, the panel 29 0 0 3
External Request consensus was to include the following bullets under Workup
Submission from Foundation Medicine, Inc for persistent or recurrent disease (CERV-10):
(05/14/21) requesting to • Consider comprehensive genomic profiling (CGP) via a
1. Recommend comprehensive genomic validated and/or FDA-approved assay
profiling via a validated and/or FDA-approved • If tissue biopsy of metastatic site is not feasible or tissue
assay in the workup of persistent or recurrent not available, consider CGP via a validated plasma ctDNA
disease (page CERV-10) and Principles of assay
Pathology section (CERV-A) for patients with
“recurrent, progressive, or metastatic disease”
in order to improve patient access to timely
and accurate diagnosis of NCCN-
recommended biomarkers (NTRK fusions,
MMR alterations, Microsatellite instability
(MSI), and tumor mutational burden (TMB)).
2. Allow for CGP via a validated plasma ctDNA
assay as part of the workup for recurrent
disease as a potential alternative to surgical
exploration to determine options for clinical
trial enrollment (CERV-10) and when tissue
biopsy of the metastatic site is not feasible in
metastatic disease in Principles of Pathology
section (CERV-A).
CERV-12 Based on a review of the data and discussion, the panel 0 29 0 3
External Request consensus was not to make changes to the current
Submission from Illumina, Inc (05/13/21) request recommendations.
to amend footnote ff to “Consider tumor
mutational burden (TMB) testing as determined by
a validated and/or FDA-approved
comprehensive genomic profiling (CGP)
assay.”
CERV-A 1 of 3 Based on a review of the data and discussion, the panel 0 29 0 3
External Request consensus was not to make changes to the current
Submission from Illumina, Inc (05/13/21) request recommendations.
to Amend the last bullet point to “Consider TMB
testing through a validated and/or FDA approved
comprehensive genomic profiling (CGP)
assay.”
NCCN Guidelines for Cervical Cancer V.1.2022 –Annual on 06/11/21
Guideline Page
and Request
CERV-A 1 of 3
External Request
Submission from Illumina, Inc (05/13/21) request
to add a new bullet point to the end under
Pathologic assessment: Comprehensive
genomic profiling with a validated and/or FDA-
approved assay is informative for predicting
rare pantumor targeted therapy opportunities.
CERV-F 1 of 3
Internal Request
Consider adding nivolumab for PD-L1 positive
tumors
CERV-F 1 of 3
External Request
Submission from Illumina, Inc (05/13/21) request
to amend footnote h to “For the treatment of
patients with unresectable or metastatic
tumor mutational burden-high (TMB-H) [≥10
mutations/megabase (mut/Mb)] tumors, as
determined by
a validated and/or FDA-approved
comprehensive genomic profiling (CGP) test,
that have progressed
following prior treatment and who have no
satisfactory alternative treatment options.”
Panel Discussion/References Institution Vote
YES NO ABSTAIN ABSENT
Based on a review of the data and discussion, the panel 0 29 0 3
consensus was not to make changes to the current
recommendations.
Based on the review of the data in the noted reference, the 29 0 0 3
panel consensus was to include nivolumab for PD-L1–positive
tumors as a second-line or subsequent therapy option for
recurrent or metastatic cervical cancer. The panel consensus
supported a category 2A, preferred regimen recommendation.
• Naumann RW, Hollebecque A, Meyer T, et al. Safety and
Efficacy of Nivolumab Monotherapy in Recurrent or
Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results
From the Phase I/II CheckMate 358 Trial. J Clin Oncol.
2019;37(31):2825-2834.
• Based on a review of the data and discussion, the panel 29 0 0 3
consensus supported making the following change:
Footnote h: For the treatment of patients with
unresectable or metastatic tumor mutational burden-high
(TMB-H) [≥10 mutations/megabase (mut/Mb)] tumors, as
determined by an a validated and/or FDA-approved test,
that have progressed following prior treatment and who
have no satisfactory alternative treatment options.
• Based on a review of the data and discussion, the panel 0 29 0 3
consensus was not to make changes to include
comprehensive genomic profiling (CGP) to the current
recommendations on this page.