[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60681-60683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Treatment of Stage I-
III Squamous Cell Anal Cancer

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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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 Treatment of 
Stage I-III Squamous Cell Anal Cancer, 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Access to published and unpublished pertinent scientific information 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 October 5, 2023.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#3e5b4e5d7e5f564c4f1056564d10595148"><span class="__cf_email__" data-cfemail="0c697c6f4c6d647e7d2264647f226b637a">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#6a0f1a092a0b02181b44020219440d051c"><span class="__cf_email__" data-cfemail="6207120122030a10134c0a0a114c050d14">[email protected]</span></a>.

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 Treatment of Stage I-
III Squamous Cell Anal Cancer. 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 Treatment of Stage I-III Squamous Cell Anal Cancer. The 
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/anal-cancer-treatment/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Treatment of Stage I-III Squamous Cell Anal 
Cancer 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://www.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)

    KQ 1. What are the effectiveness and harms of different modalities 
of initial treatment for stages I-III squamous cell anal cancer?
    KQ 2. What are the effectiveness and harms of different modalities 
of radiation therapy for initial treatment of stages I-III squamous 
cell anal cancer?
    KQ 3. What are the effectiveness and harms of different radiation 
therapy doses, volumes, and fractionation schema for initial treatment 
of stage I-III squamous cell anal cancer?
    KQ 4. What are the effectiveness and harms of different 
combinations of chemotherapy and radiation therapy, and dose de-
escalation or dose escalation for initial treatment of stages I-III 
squamous cell anal cancer?
    KQ 5. What are the effectiveness and harms of immunotherapy for 
initial treatment of stages I-III squamous cell anal cancer?
    KQ 6. What are the effectiveness and harms of different frequencies 
and modalities for post-treatment surveillance strategies after initial 
treatment of stages I-III squamous cell anal cancer?
    For all KQs, do the outcomes differ by patient characteristics such 
as age, sex, immunocompromised status, or other characteristics 
associated with health inequities (such as race/ethnicity)?

[[Page 60682]]



                 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
----------------------------------------------------------------------------------------------------------------
                                                      Inclusion                             Exclusion
----------------------------------------------------------------------------------------------------------------
Population:
    All KQ.........................  Adults with stages I-III squamous cell      Adults with:
                                      anal cancer (anal canal and anal margin).  <bullet> Stage IV anal cancer.
                                                                                 <bullet> Lower rectal cancer
                                                                                  that has spread to the anal
                                                                                  canal.
                                                                                 <bullet> Non-squamous cell anal
                                                                                  cancer (e.g., adenocarcinomas,
                                                                                  undifferentiated cancer).
                                     Patient characteristics such as age, sex,
                                      immunocompromised status, or other
                                      characteristics associated with health
                                      inequities (such as race/ethnicity).
                                     ..........................................  Studies including mixed
                                                                                  populations with Stages I-IV
                                                                                  squamous cell anal cancer
                                                                                  which contain 20% or greater
                                                                                  proportion of stage IV
                                                                                  squamous cell anal cancer.
Interventions:
    KQ1............................  Alone or in combination as neoadjuvant/     <bullet> Reconstructive
                                      adjuvant or as induction/maintenance:.      surgery.
                                     <bullet> Surgery, radiation therapy, or     <bullet> Palliative therapy
                                      chemotherapy.                               (includes chemotherapy with
                                                                                  palliative intent).
                                                                                 <bullet> Treatment for
                                                                                  premalignant lesions.
    KQ2............................  Different modalities of radiation therapy   <bullet> Palliative therapy.
                                      such as, but not limited to, IMRT, proton
                                      radiation therapy, and Brachytherapy
                                      boost.
    KQ3............................  Radiation therapy; varying:...............  <bullet> Palliative therapy.
                                     <bullet> Doses............................
                                     <bullet> Target (primary and nodal)
                                      volumes.
                                     <bullet> Fractionation schema.............
    KQ4............................  <bullet> Chemotherapy and radiation         <bullet> Palliative therapy.
                                      therapy combinations (e.g., 5-
                                      Fluorouracil, Mitomycin-C, Cisplatin).
                                     <bullet> Variations in dose of:...........
                                     [cir] Radiation therapy...................
                                     [cir] Chemotherapy........................
    KQ5............................  Immunotherapy (e.g., pembrolizumab,
                                      nivolumab).
    KQ6............................  Post-treatment surveillance strategies:...  <bullet> Screening for primary
                                                                                  prevention.
                                     <bullet> Frequency........................
                                     <bullet> Modalities (e.g., MRI, PET scans,  <bullet> Initial staging.
                                      biopsy, DRE, anoscopy, flexible
                                      sigmoidoscopy).
                                     <bullet> Strategies for surveillance post
                                      non-initial treatment.
Comparison:
    KQ1............................  Alone or in combination as neoadjuvant/     <bullet> Reconstructive
                                      adjuvant or as induction/maintenance:.      surgery.
                                                                                 <bullet> Palliative therapy
                                                                                  (includes chemotherapy with
                                                                                  palliative intent).
                                     <bullet> Surgery, radiation therapy, or     <bullet> Treatment for
                                      chemotherapy.                               premalignant lesions.
    KQ2............................  Comparators for different modalities of     <bullet> Palliative therapy.
                                      radiation therapy such as, but not
                                      limited to, 3-D CRT, photon or electron
                                      radiation therapy, and external beam
                                      radiation therapy boost.
    KQ3............................  Radiation therapy; varying:...............  <bullet> Palliative therapy.
                                     <bullet> Doses............................
                                     <bullet> Target (primary and nodal)
                                      volumes.
                                     <bullet> Fractionation schema.............
    KQ4............................  <bullet> Chemotherapy and radiation         <bullet> Palliative therapy.
                                      therapy combinations (e.g., 5-
                                      Fluorouracil, Mitomycin-C, Cisplatin).
                                     <bullet> Variations in dose...............
                                     [cir] Radiation therapy...................
                                     [cir] Chemotherapy........................
    KQ5:...........................  Other treatment (e.g., chemotherapy,        ...............................
                                      radiation therapy, chemotherapy +
                                      radiation therapy).
    KQ6............................  Post-treatment surveillance strategies:...  <bullet> Screening for primary
                                                                                  prevention.
                                                                                 <bullet> Initial staging.
                                                                                 <bullet> Strategies for
                                                                                  surveillance post non-initial
                                                                                  treatment.
                                     <bullet> Frequency........................
                                     <bullet> Modalities (e.g., MRI, PET scans,
                                      biopsy, DRE, anoscopy, flexible
                                      sigmoidoscopy).
Outcomes:
    All KQ.........................  <bullet> Overall survival.................
                                     <bullet> Disease specific survival........
                                     <bullet> Disease-free survival (including
                                      persistence, recurrence, or relapse).
                                     <bullet> Colostomy-free survival..........
                                     <bullet> Local control....................
                                     <bullet> Complete clinical response.......
                                     <bullet> Salvage rate.....................
                                     <bullet> Sphincter preservation...........
                                     <bullet> Health-related quality of life...

[[Page 60683]]

 
                                     <bullet> Treatment breaks (frequency or
                                      duration), treatment discontinuation,
                                      interruptions, or median treatment days.
                                     <bullet> Bleeding per rectum..............
                                     <bullet> Functional outcomes (e.g., fecal
                                      or urinary incontinence, erectile
                                      dysfunction, sexual dysfunction, use of
                                      vaginal dilators).
                                     <bullet> Harms of treatment including
                                      acute and late toxicity (e.g.,
                                      myelosuppression, gastrointestinal
                                      toxicity, such as diarrhea, vomiting, and
                                      bowel obstruction, secondary malignancy,
                                      radiation dermatitis, radiation
                                      proctitis, radiation cystitis, pelvic
                                      insufficiency fractures, vaginal
                                      stenosis).
Timing:
    All KQ.........................  No restrictions on duration of treatments
                                      or follow-up.
Setting:
    All KQ.........................  Cancer care settings......................
Study design:
    All KQ.........................  Randomized controlled trials, non-          Case reports, case series,
                                      randomized controlled trials,               commentaries, cross-sectional
                                      observational cohort with concurrent        studies, reviews, qualitative
                                      comparator, interrupted time-series, and    studies, studies with sample
                                      other quasi-experimental designs using      size less than 30 patients (or
                                      appropriate analytic techniques.            less than 15 per treatment
                                                                                  group/arm), non-randomized
                                                                                  studies with unspecified or
                                                                                  poorly defined intervention/
                                                                                  treatment protocol (e.g., lack
                                                                                  of names of chemotherapy
                                                                                  agents used), non-randomized
                                                                                  studies with analytic
                                                                                  techniques that don't allow
                                                                                  drawing causal inferences.
----------------------------------------------------------------------------------------------------------------
Abbreviations: 3-D CRT= three-dimensional conformal radiation therapy; DRE= digital rectal exam; IMRT=intensity-
  modulated radiation therapy; KQ=key question; MRI= magnetic resonance imaging; PET= positron emission
  tomography; RCT=randomized controlled trial; VMAT= Volumetric modulated arc therapy.


Marquita Cullom,
Associate Director.
[FR Doc. 2023-19031 Filed 9-1-23; 8:45 am]
BILLING CODE 4160-90-P


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