Supplemental Evidence and Data Request on Medical Therapies for Locally Advanced Gastric Adenocarcinoma, 68904-68906 [2024-19344]
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Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
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[FR Doc. 2024–19383 Filed 8–27–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Medical Therapies for
Locally Advanced Gastric
Adenocarcinoma
Agency for Healthcare Research
and Quality (AHRQ), HHS. ACTION:
Request for Supplemental Evidence and
Data Submission SUMMARY: The
Agency for Healthcare Research and
Quality (AHRQ) is seeking scientific
information submissions from the
public. Scientific information is being
solicited to inform our review on
Medical Therapies for Locally Advanced
Gastric Adenocarcinoma, which is
currently being conducted by the
AHRQ’s Evidence-based Practice
khammond on DSKJM1Z7X2PROD with NOTICES
AGENCY:
VerDate Sep<11>2014
18:13 Aug 27, 2024
Jkt 262001
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before September 27, 2024.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers
Lane, Mail Stop 06E77D, Rockville,
MD 20857
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Medical Therapies for
Locally Advanced Gastric
Adenocarcinoma. AHRQ is conducting
this review pursuant to Section 902 of
the Public Health Service Act, 42 U.S.C.
299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Medical Therapies for
Locally Advanced Gastric
Adenocarcinoma. The entire research
protocol is available online at: https://
effectivehealthcare.ahrq.gov/products/
gastric-cancers/protocol.
This is to notify the public that the
EPC Program would find the following
information on Medical Therapies for
Locally Advanced Gastric
Adenocarcinoma helpful:
D A list of completed studies that
your organization has sponsored for this
topic. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements, if relevant: study number,
study period, design, methodology,
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
D A list of ongoing studies that your
organization has sponsored for this
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, a study
number, the study period, design,
methodology, indication and diagnosis,
proper use instructions, inclusion and
exclusion criteria, and primary and
secondary outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this topic and an index
outlining the relevant information in
each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on topics not included in
the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.ahrq.gov/
email-updates.
The review will answer the following
questions. This information is provided
as background. AHRQ is not requesting
that the public provide answers to these
questions.
Key Questions (KQ)
KQ1: What is the comparative
effectiveness and comparative harms of
medical therapies for management of
non-metastatic, locally advanced gastric
adenocarcinoma?
KQ2: Do treatment effectiveness and
harms vary by cancer stage, histology
(e.g. intestinal, diffuse, signet ring cell),
biomarkers (e.g. microsatellite
instability-high [MSI–H] or mismatch
repair-deficient [MMR-deficient],
claudin, human epidermal growth factor
receptor 2 [HER–2], programmed deathligand 1 [PDL1], Epstein–Barr virus
[EBV]), or genetic predisposition (e.g.
cadherin-1 [CDH1])?
E:\FR\FM\28AUN1.SGM
28AUN1
Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
KQ3: Do treatment effectiveness and
harms vary by age, functional status (e.g.
Karnofsky score, Eastern Cooperative
Oncology Group [ECOG] Performance
Status score), medical comorbidities or
conditions that increase risk of toxicity
68905
with specific therapy (e.g. existing
neuropathy, prior radiation therapy,
history of autoimmune disease)?
PICOTS (POPULATION, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
PICOTS
Inclusion
Exclusion
Population ................
All KQs: .................................................................................
Adults (18 years or older) with primary, non-recurrent, nonmetastatic locally advanced gastric adenocarcinoma
stage T2N0 or higher.
KQ1: Subgroups of interest may include patients who previously received endoscopic therapy or surgery, patients
who are non-surgical candidates, and patients with initially unresectable disease.
KQ2: Subgroups of interest may include patients with
gastroesophageal junction (GEJ) cancer.
All KQs.
Cancer-directed medical therapies administered either
alone or in any combination, and may be neoadjuvant,
adjuvant, or perioperative (neoadjuvant and adjuvant)
and in any sequence:.
• Chemotherapy
including
but
not
limited
to:
Fluoropyrimidine-based therapy: FOLFOX, XELOX,
FLOT, SOX, ECF.
• Radiation including but not limited to external beam radiation, intra-operative electron radiation.
• Chemoradiation .................................................................
• HIPEC ................................................................................
• Immunotherapy (e.g., ipilimumab, nivolimumab) ..............
• Targeted therapy (e.g., anti-HER2 monoclonal antibodies).
All KQs ..................................................................................
• Any comparator .................................................................
• No comparator (for biomarker-targeted interventions) ......
All KQs ..................................................................................
• Overall survival ..................................................................
• Progression-free survival ...................................................
• Nutritional assessment ......................................................
• Quality of life, using validated scales ................................
• Direct moderate-severe treatment adverse events (grade
3, 4, 5).
• Direct mild treatment adverse events (grade 1, 2) ...........
• Indirect adverse events from treatment (e.g., long-term
opioid use for pain management).
All KQs: .................................................................................
Any follow-up duration for grade 3–5 or indirect adverse
events and quality of life; minimum of 1 year for grade
1–2 adverse events; minimum of 3 months for remaining
outcomes.
All KQs: .................................................................................
• Countries rated as very high on the 2024 Human Development Index (if study is multinational, at least one study
center is in a country rated very high).
All KQs: .................................................................................
• Randomized controlled trials .............................................
• Non-randomized studies of interventions (experimental or
observational) with a concurrent comparator and wellcontrolled for confounding (at minimum account for age,
stage, functional status, and comorbidities).
• Single-arm studies (for biomarker-targeted interventions)
• Published in English-language ..........................................
• Published in 2006 or later .................................................
Recurrent cancer, metastatic cancer, early stage (T1aN0
and T1bN0), stage 4 cancer, GEJ cancer patients treated in a predominantly esophageal cancer cohort with an
esophageal treatment paradigm, gastrointestinal stromal
tumors
(GIST),
neuroendocrine
tumors,
gastric
lymphoma, MALToma, other rare gastric cancers.
Interventions .............
Comparators .............
Outcomes .................
Timing .......................
Setting ......................
khammond on DSKJM1Z7X2PROD with NOTICES
Study Design and
Other Criteria.
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• Surgical management exclusively.
• Intervention is not well specified (e.g., study reports
intervention as ‘‘adjuvant chemotherapy’’ without describing the regimen).
• Palliative interventions.
N/A.
N/A.
N/A.
N/A.
Case reports, case series, commentaries, cross-sectional
studies, reviews, qualitative studies.
E:\FR\FM\28AUN1.SGM
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68906
Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
Abbreviations: ECF = epirubicin,
cisplatin, fluorouracil; FLOT =
fluorouracil, leucovorin, oxaliplatin and
docetaxel; FOLFOX = leucovorin,
fluorouracil, and oxaliplatin; HER2 =
human epidermal growth factor receptor
2; HIPEC = hyperthermic intraperitoneal
chemotherapy; KQ = key question; SOX
= tegafur, gimeracil, oteracil, and
oxaliplatin; XELOX = capecitabine and
oxaliplatin.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–19344 Filed 8–27–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Award of a Single Source
Cooperative Agreement To Fund
California Department of Public Health;
Chicago Department of Public Health;
Delaware Department of Health and
Social Services; Florida Department of
Health; Georgia Department of Public
Health; Houston Department of Health
and Human Services; Illinois
Department of Public Health; Indiana
State Department of Health; Los
Angeles County Department of Public
Health; Michigan Department of Health
and Human Services; Mississippi State
Department of Health; New Jersey
Department of Health and Senior
Services; New York City Department of
Health and Mental Hygiene; New York
State Department of Health; North
Carolina Department of Health and
Human Services; Oregon Health
Authority; Pennsylvania Department of
Health; Philadelphia Department of
Public Health; Puerto Rico Department
of Health; San Francisco Department
of Public Health; Texas Department of
State Health Services; Virginia
Department of Health; and Washington
State Department of Health
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces 23
separate awards to fund the California
Department of Public Health; Chicago
Department of Public Health; Delaware
Department of Health and Social
Services; Florida Department of Health;
Georgia Department of Public Health;
Houston Department of Health and
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:13 Aug 27, 2024
Jkt 262001
Human Services; Illinois Department of
Public Health; Indiana State Department
of Health; Los Angeles County
Department of Public Health; Michigan
Department of Health and Human
Services; Mississippi State Department
of Health; New Jersey Department of
Health and Senior Services; New York
City Department of Health and Mental
Hygiene; New York State Department of
Health; North Carolina Department of
Health and Human Services; Oregon
Health Authority; Pennsylvania
Department of Health; Philadelphia
Department of Public Health; Puerto
Rico Department of Health; San
Francisco Department of Public Health;
Texas Department of State Health
Services; Virginia Department of Health;
and Washington State Department of
Health.
The total amount of awards is
approximately $16,305,555 in Federal
Fiscal Year (FFY) 2025, with an
expected total funding of approximately
$81,527,775 for the five-year period of
performance, subject to availability of
funds. The awards will support
implementation of the Medical
Monitoring Project (MMP), an ongoing
public health surveillance program
funded since 2005 and designed to learn
more about the experiences and needs
of adults aged 18 or older living with
HIV (PWH) in the United States.
DATES: The period for these awards will
be June 1, 2025, through May 31, 2030.
FOR FURTHER INFORMATION CONTACT:
Jason Craw, National Center for HIV,
Viral Hepatitis, STD and TB Prevention,
Centers for Disease Control and
Prevention, 1600 Clifton Road, MS H24–
5, Atlanta, GA 30333, Telephone: (404)
639–6395, E-Mail: jcraw@cdc.gov.
SUPPLEMENTARY INFORMATION: The single
source award will support the collection
of comprehensive clinical and
behavioral information from persons
carefully sampled to represent everyone
diagnosed with HIV in the U.S. The data
are collected through in-person or
telephone interviews with participants
and a two-year medical chart abstraction
for all persons who have been in care.
MMP produces nationally
representative data on important
sociodemographic, behavioral, and
clinical characteristics among PWH in
the U.S. MMP reports essential data on
barriers to care and viral suppression,
including social determinants of health
and indicators of quality of life among
PWH that are used to plan and monitor
state and local HIV programs, inform
national HIV clinical guidelines and
assess national progress towards
meeting the goals of the National HIV/
AIDS Strategy for the United States
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Frm 00058
Fmt 4703
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2022–2025, the Ending the HIV
Epidemic in the United States (EHE)
initiative, the HIV Care Continuum, and
CDC’s High-Impact Prevention (HIP)
approach.
The 23 previously listed state, local
and territorial health departments are in
a unique position to conduct this work
as (1) they are the only entities with
legal authority to mandate the collection
of public health surveillance data in
their jurisdictions, (2) they can continue
monitoring and reporting MMP data
without lapse and (3) their selection can
ensure adherence to the project’s
established scientific sampling strategy
that ensures the national
representativeness of MMP data.
Summary of the Award
Recipient: California Department of
Public Health; Chicago Department of
Public Health; Delaware Department of
Health and Social Services; Florida
Department of Health; Georgia
Department of Public Health; Houston
Department of Health and Human
Services; Illinois Department of Public
Health; Indiana State Department of
Health; Los Angeles County Department
of Public Health; Michigan Department
of Health and Human Services;
Mississippi State Department of Health;
New Jersey Department of Health and
Senior Services; New York City
Department of Health and Mental
Hygiene; New York State Department of
Health; North Carolina Department of
Health and Human Services; Oregon
Health Authority; Pennsylvania
Department of Health; Philadelphia
Department of Public Health; Puerto
Rico Department of Health; San
Francisco Department of Public Health;
Texas Department of State Health
Services; Virginia Department of Health;
and Washington State Department of
Health.
Purpose of the Award: The purpose of
these awards is to support
implementation of NOFO PS25–0008
Medical Monitoring Project (MMP), an
ongoing public health surveillance
program funded since 2005 and
designed to learn more about the
experiences and needs of adults aged 18
or older living with HIV (PWH) in the
United States.
Amount of Award: The total amount
of awards is approximately $16,305,556
in Federal Fiscal Year (FFY) 2025, with
an expected total funding of
approximately $81,527,780 for the fiveyear period of performance, subject to
availability of funds. The below table
lists proposed FFY 2025 award amounts
per recipient, subject to availability of
funds.
E:\FR\FM\28AUN1.SGM
28AUN1
]]>Agencies
[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68904-68906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19344]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Medical Therapies for
Locally Advanced Gastric Adenocarcinoma
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION:
Request for Supplemental Evidence and Data Submission SUMMARY: The
Agency for Healthcare Research and Quality (AHRQ) is seeking scientific
information submissions from the public. Scientific information is
being solicited to inform our review on Medical Therapies for Locally
Advanced Gastric Adenocarcinoma, which is currently being conducted by
the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to
published and unpublished pertinent scientific information will improve
the quality of this review.
DATES: Submission Deadline on or before September 27, 2024.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Medical Therapies for
Locally Advanced Gastric Adenocarcinoma. AHRQ is conducting this review
pursuant to Section 902 of the Public Health Service Act, 42 U.S.C.
299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Medical Therapies for Locally Advanced Gastric
Adenocarcinoma. The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/gastric-cancers/protocol.
This is to notify the public that the EPC Program would find the
following information on Medical Therapies for Locally Advanced Gastric
Adenocarcinoma helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on ClinicalTrials.gov along with the ClinicalTrials.gov
trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements, if
relevant: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for information, and all costs for complying with this request
must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ1: What is the comparative effectiveness and comparative harms of
medical therapies for management of non-metastatic, locally advanced
gastric adenocarcinoma?
KQ2: Do treatment effectiveness and harms vary by cancer stage,
histology (e.g. intestinal, diffuse, signet ring cell), biomarkers
(e.g. microsatellite instability-high [MSI-H] or mismatch repair-
deficient [MMR-deficient], claudin, human epidermal growth factor
receptor 2 [HER-2], programmed death-ligand 1 [PDL1], Epstein-Barr
virus [EBV]), or genetic predisposition (e.g. cadherin-1 [CDH1])?
[[Page 68905]]
KQ3: Do treatment effectiveness and harms vary by age, functional
status (e.g. Karnofsky score, Eastern Cooperative Oncology Group [ECOG]
Performance Status score), medical comorbidities or conditions that
increase risk of toxicity with specific therapy (e.g. existing
neuropathy, prior radiation therapy, history of autoimmune disease)?
PICOTS (Population, Interventions, Comparators, Outcomes, Timing, and Setting)
----------------------------------------------------------------------------------------------------------------
PICOTS Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population......................... All KQs:............................. Recurrent cancer, metastatic cancer,
Adults (18 years or older) with early stage (T1aN0 and T1bN0),
primary, non-recurrent, non- stage 4 cancer, GEJ cancer patients
metastatic locally advanced gastric treated in a predominantly
adenocarcinoma stage T2N0 or higher. esophageal cancer cohort with an
KQ1: Subgroups of interest may esophageal treatment paradigm,
include patients who previously gastrointestinal stromal tumors
received endoscopic therapy or (GIST), neuroendocrine tumors,
surgery, patients who are non- gastric lymphoma, MALToma, other
surgical candidates, and patients rare gastric cancers.
with initially unresectable disease.
KQ2: Subgroups of interest may
include patients with
gastroesophageal junction (GEJ)
cancer.
Interventions...................... All KQs..............................
Cancer-directed medical therapies Surgical management
administered either alone or in any exclusively.
combination, and may be neoadjuvant, Intervention is not well
adjuvant, or perioperative specified (e.g., study reports
(neoadjuvant and adjuvant) and in intervention as ``adjuvant
any sequence:. chemotherapy'' without describing
Chemotherapy including but the regimen).
not limited to: Fluoropyrimidine- Palliative interventions.
based therapy: FOLFOX, XELOX, FLOT,
SOX, ECF.
Radiation including but not
limited to external beam radiation,
intra-operative electron radiation.
Chemoradiation..............
HIPEC.......................
Immunotherapy (e.g.,
ipilimumab, nivolimumab).
Targeted therapy (e.g., anti-
HER2 monoclonal antibodies).
Comparators........................ All KQs.............................. N/A.
Any comparator..............
No comparator (for biomarker-
targeted interventions).
Outcomes........................... All KQs.............................. N/A.
Overall survival............
Progression-free survival...
Nutritional assessment......
Quality of life, using
validated scales.
Direct moderate-severe
treatment adverse events (grade 3,
4, 5).
Direct mild treatment
adverse events (grade 1, 2).
Indirect adverse events from
treatment (e.g., long-term opioid
use for pain management).
Timing............................. All KQs:............................. N/A.
Any follow-up duration for grade 3-5
or indirect adverse events and
quality of life; minimum of 1 year
for grade 1-2 adverse events;
minimum of 3 months for remaining
outcomes.
Setting............................ All KQs:............................. N/A.
Countries rated as very high
on the 2024 Human Development Index
(if study is multinational, at least
one study center is in a country
rated very high).
Study Design and Other Criteria.... All KQs:............................. Case reports, case series,
Randomized controlled trials commentaries, cross-sectional
Non-randomized studies of studies, reviews, qualitative
interventions (experimental or studies.
observational) with a concurrent
comparator and well-controlled for
confounding (at minimum account for
age, stage, functional status, and
comorbidities).
Single-arm studies (for
biomarker-targeted interventions).
Published in English-
language.
Published in 2006 or later..
----------------------------------------------------------------------------------------------------------------
[[Page 68906]]
Abbreviations: ECF = epirubicin, cisplatin, fluorouracil; FLOT =
fluorouracil, leucovorin, oxaliplatin and docetaxel; FOLFOX =
leucovorin, fluorouracil, and oxaliplatin; HER2 = human epidermal
growth factor receptor 2; HIPEC = hyperthermic intraperitoneal
chemotherapy; KQ = key question; SOX = tegafur, gimeracil, oteracil,
and oxaliplatin; XELOX = capecitabine and oxaliplatin.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-19344 Filed 8-27-24; 8:45 am]
BILLING CODE 4160-90-P
