[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62169-62172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24403]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Partial Breast 
Irradiation for Breast Cancer

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

ACTION: Request for supplemental evidence and data submissions.

-----------------------------------------------------------------------

[[Page 62170]]

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 Partial Breast 
Irradiation for Breast 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published and unpublished pertinent scientific information will improve 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 December 9, 2021.

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:  Jenae Benns, Telephone: 301-427-1496 
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 Partial Breast 
Irradiation for Breast Cancer. AHRQ is conducting this technical brief 
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 Partial Breast Irradiation for Breast Cancer, including 
those that describe adverse events. The entire research protocol is 
available online at: https://effectivehealthcare.ahrq.gov/products/accelerated-partial-breast-irradiation/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Partial Breast Irradiation for Breast Cancer 
helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. 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: 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 indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including 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 indication 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 indications 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 systematic 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. In adult women with early stage breast cancer, what are the 
comparative effectiveness, adverse events, and cosmetic outcomes of 
partial breast irradiation compared to whole breast irradiation?
    KQ1a. How does effectiveness of partial breast irradiation vary by 
clinical-pathologic characteristics?
    KQ1b. How do the effectiveness, adverse events, and cosmetic 
outcomes of partial breast irradiation vary by target volumes, dose-
fractionation schemes, motion management, and planning parameters?
    KQ 2. In adult women with early stage breast cancer, what are the 
comparative effectiveness, adverse events, and cosmetic outcomes of 
different partial breast irradiation modalities (including 
multicatheter interstitial brachytherapy, single-entry catheter 
brachytherapy, 3-dimensional conformal external beam radiation therapy, 
intensity modulated radiation therapy, proton radiation therapy, and 
intraoperative radiotherapy)?
    KQ 2a. When there are no eligible comparative studies to address 
KQ2 for a particular PBI modality, what are the rates of adverse events 
in noncomparative series of such modality?
    KQ 2b. When there are no eligible comparative studies to address 
KQ2 for a particular PBI modality, what are the rates of long-term (>5 
years) effectiveness outcomes and cosmesis in noncomparative series of 
such modality?

Contextual Question (CQ)

    CQ 1. In adult women with early stage breast cancer, to what extent 
does financial toxicity differ between partial and whole breast 
irradiation?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and 
Settings)

----------------------------------------------------------------------------------------------------------------
             PICOTS elements                          Inclusion criteria                  Exclusion criteria
----------------------------------------------------------------------------------------------------------------
Population..............................   Adult women (i.e., 18 years and     Animals.
                                           older) with early stage breast cancer       Children (i.e.,
                                           (i.e., a small tumor less than or equal     age <18 years).
                                           to 3 cm that has minimal or no lymph node   Men.
                                           involvement (N0/1)).                        Recurrent breast
                                                                                       cancer.
Interventions...........................  For all KQs and CQ1, PBI includes the        Combination of
                                           following modalities:.                      PBI and WBI.
                                           Multicatheter interstitial
                                           brachytherapy..

[[Page 62171]]

 
                                           Single-entry catheter
                                           brachytherapy.
                                           3-dimensional conformal external
                                           beam radiation therapy.
                                           Intensity modulated radiation
                                           therapy.
                                           Proton radiation therapy.
                                           Intraoperative radiotherapy.
Comparators.............................  KQ 1, CQ 1: WBI...........................  None.
                                          KQ 2: A different PBI modality.
                                           Multicatheter interstitial
                                           brachytherapy.
                                           Single-entry catheter
                                           brachytherapy.
                                           3-dimensional conformal external
                                           beam radiation therapy.
                                           Intensity modulated radiation
                                           therapy.
                                           Proton radiation therapy.
                                           Intraoperative radiotherapy.
                                          KQ 2a and 2b: No comparator.
Outcomes................................  KQ 1 and 2:...............................  None.
                                           Ipsilateral breast cancer
                                           recurrence (i.e., tumor bed ipsilateral
                                           breast cancer recurrence, elsewhere
                                           ipsilateral breast cancer recurrence).
                                           Mastectomy-free survival.
                                           Overall survival.
                                           Cancer-free survival.
                                           Contralateral breast cancer
                                           recurrence.
                                           Distant breast cancer recurrence.
                                           Regional breast cancer
                                           recurrence.
                                           Any breast cancer recurrence.
                                           Breast conservation.
                                           Quality of life (e.g., BCTOS,
                                           FACT-B, SF-36, Breast Q scale).
                                           Patient-reported and physician-
                                           assessed cosmesis (e.g., including
                                           Harvard Breast Cosmesis Scale, Global
                                           Cosmesis Scale, or the EORTC breast
                                           cancer cosmetic rating system).
                                           Sexual health.
                                           Adverse events, including scales
                                           measuring radiation toxicity:
                                          [cir] RTOG/EORTC scores.
                                          [cir] LENT-SOMA scales.
                                          [cir] CTCAE scores.
                                          CQ 1: Contextual information about the
                                           construct of financial toxicity (i.e.,
                                           financial distress and hardship).
Timing..................................  At the following intervals:...............  None.
                                          For effectiveness and cosmetic outcomes:
                                           >=1 year to 5 years.
                                           >5 years to 10 years.
                                           >10 years.
                                          For adverse events:
                                           <3 months.
                                           >=3 months.
Settings................................  Any.......................................  None.
Study design............................  KQ1:......................................   In vitro studies.
                                           RCTs.............................   Nonoriginal
                                          KQ 2:.....................................   studies (e.g., narrative
                                           RCTs.............................   reviews, editorials,
                                           Comparative observational           letters, or erratum).
                                           studies..                                   Cross-sectional
                                          KQ 2a:....................................   (i.e., nonlongitudinal)
                                           Single-arm observational studies    studies.
                                           (>=50 patients)..
                                          KQ 2b:....................................
                                           Single-arm observational studies
                                           (>=50 patients and >=5 year followup).
                                          CQ 1:
                                           RCTs.
                                           Comparative observational
                                           studies.
                                           Qualitative studies.
                                           Cost-benefit analyses.
                                           Surveys.
                                          All KQs and CQ 1:
                                           Relevant systematic reviews or
                                           meta-analyses (used for identifying
                                           additional studies).
Subgroup analysis.......................  KQ 1 and 2:...............................  None.
                                           Age.
                                           Treatment schedule (i.e.,
                                           accelerated, nonaccelerated).
                                           Race/ethnicity.
                                           Socioeconomic status.
                                           Area Deprivation Index.
                                           DCIS vs. invasive disease.
                                           Breast size.
                                           BMI.
                                           Cup size.
                                           Breast implants.

[[Page 62172]]

 
                                           Mental health comorbidities.
                                           Menopausal status.
                                           Receipt of systemic therapy
                                           (i.e., none, endocrine therapy, and/or
                                           chemotherapy, both).
                                           Histologic subtype (e.g.,
                                           invasive ductal carcinoma, invasive
                                           lobular carcinoma, DCIS, other).
                                           Nodal status (i.e., N0, N1, NX,
                                           number of positive nodes).
                                           Nodal assessment (i.e., sentinel
                                           lymph node biopsy, axillary lymph node
                                           dissection, none).
                                           Tumor grade.
                                           Tumor size (i.e., <1 cm, 1-2 cm,
                                           2-3 cm, >3 cm).
                                           Focality (unifocal vs
                                           multifocal).
                                           Margin status (i.e., positive, <2
                                           mm, 2-3 mm, >3 mm).
                                           Extensive intraductal component.
                                           Ki-67 (<20% vs. >= 20%).
                                           ASTRO or ESTRO risk category
                                           (i.e., suitable, cautionary, unsuitable;
                                           low, intermediate, high).
                                           Germline genetic mutation (e.g.,
                                           BRCA1, BRCA2, CHEK2, PALB2, ATM, etc.).
                                           Cancer-predisposing syndrome.
                                           Estrogen receptor status.
                                           Progesterone receptor status.
                                           Hormone receptor status.
                                           Lymphovascular invasion.
                                           HER2 status.
                                           Prior chemotherapy.
                                           Monoelectron therapy.
                                           Dermatologic Rheumatologic
                                           conditions (i.e., lupus, scleroderma,
                                           rheumatoid arthritis).
                                           Dose-fractionation schemes (i.e.,
                                           accelerated, nonaccelerated, daily vs
                                           every other day vs twice daily, total
                                           dose, EQD2).
                                           Target volumes (i.e., size of
                                           expansion on cavity, diameter of the
                                           inflated balloon, size of the planning
                                           target volume).
                                           Motion management.
                                           Planning parameters (i.e., the
                                           diameter of the inflated balloon, the
                                           planning target volume, and the dose
                                           distribution organ-at-risk constraints
                                           and dose received [such as ipsilateral
                                           breast V50 and V100], number of beams,
                                           PTV coverage goals and constraints).
                                           Number of treatment fields.
                                           Image guidance (i.e., MV imaging,
                                           kV imaging, cone beam CT, use of clips
                                           for localization).
                                           Risk of bias (i.e., low,
                                           moderate, high).
Publications............................      Studies published in English     Foreign language
                                              as peer reviewed full text..             studies.
                                           Published after Year 2000........   Conference
                                                                                       abstracts.
----------------------------------------------------------------------------------------------------------------
Abbreviations: ASTRO = American Society for Radiation Oncology; ATM = ataxia telangiectasia mutated; BCTOS =
  Breast Cancer Treatment Outcomes Scale; BMI = body mass index; BRCA1 = breast cancer 1; BRCA2 = breast cancer
  2; CHEK2 = checkpoint kinase 2; cm = centimeter; CQ = contextual question; CT = computed tomography; CTCAE =
  Common Terminology Criteria for Adverse Events; DCIS = ductal carcinoma in situ; EORTC = European Organisation
  for Research and Treatment of Cancer; ESTRO = European Society for Radiotherapy and Oncology; FACT-B =
  Functional Assessment of Cancer Therapy-Breast; EQD2 = Equivalent Dose in 2 Gy fractions; HER2 = human
  epidermal growth factor receptor 2; KQ = key question; kV = kilovoltage; LENT-SOMA = Late Effects Normal
  Tissue Task Force- Subjective, Objective, Management, Analytic; mm = millimeter; MV = megavoltage; N0 = no
  involved lymph nodes; N1 = 1-3 involved lymph nodes; NX = lymph nodes not assessed; PALB2 = partner and
  localizer Of BRCA2; PBI = partial breast irradiation; PICOTS = populations, interventions, comparators,
  outcomes, timing, and settings; PTV = planning target volume; RCT = randomized controlled trial; RTOG =
  Radiation Therapy Oncology Group; SF-36 = Short Form (36) Health Survey; V50 = volume (%) receiving >= 50% of
  the prescription dose; V100 = volume (%) receiving >= 100% of the prescription dose; WBI = whole breast
  irradiation.


    Dated: November 2, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-24403 Filed 11-8-21; 8:45 am]
BILLING CODE 4160-90-P