[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]


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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published and unpublished pertinent scientific information will improve 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