[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]
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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.
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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 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published and unpublished pertinent scientific information will improve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)
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PICOTS elements Inclusion criteria Exclusion criteria
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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..
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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.
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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.
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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