Supplemental Evidence and Data Request on Partial Breast Irradiation for Breast Cancer, 62169-62172 [2021-24403]
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
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SUMMARY:
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62169
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[FR Doc. 2021–24485 Filed 11–8–21; 8:45 am]
BILLING CODE 6820–WY–P
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 for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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62170
Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
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 Evidencebased 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Access to published and unpublished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: 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
jspears on DSK121TN23PROD with NOTICES1
Jenae Benns, Telephone: 301–427–1496
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 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-breastirradiation/protocol.
This is to notify the public that the
EPC Program would find the following
information on Partial Breast Irradiation
for Breast Cancer helpful:
D 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.
D 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.
D 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.
D 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://
PICOTS elements
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, 3dimensional 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)
Inclusion criteria
Exclusion criteria
Population ............................
• Adult women (i.e., 18 years and older) with early stage breast cancer (i.e., a
small tumor less than or equal to 3 cm that has minimal or no lymph node involvement (N0/1)).
Interventions .........................
For all KQs and CQ1, PBI includes the following modalities: .....................................
• Multicatheter interstitial brachytherapy.
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• Animals.
• Children (i.e., age <18
years).
• Men.
• Recurrent breast cancer.
• Combination of PBI and
WBI.
62171
Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
PICOTS elements
Comparators ........................
Outcomes .............................
Timing ..................................
Settings ................................
Study design ........................
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Subgroup analysis ...............
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Inclusion criteria
Exclusion criteria
• Single-entry catheter brachytherapy.
• 3-dimensional conformal external beam radiation therapy.
• Intensity modulated radiation therapy.
• Proton radiation therapy.
• Intraoperative radiotherapy.
KQ 1, CQ 1: WBI .........................................................................................................
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.
KQ 1 and 2: ..................................................................................................................
• 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:
Æ RTOG/EORTC scores.
Æ LENT–SOMA scales.
Æ CTCAE scores.
CQ 1: Contextual information about the construct of financial toxicity (i.e., financial
distress and hardship).
At the following intervals: .............................................................................................
For effectiveness and cosmetic outcomes:
• >=1 year to 5 years.
• >5 years to 10 years.
• >10 years.
For adverse events:
• <3 months.
• >=3 months.
Any ...............................................................................................................................
KQ1: .............................................................................................................................
• RCTs.
KQ 2:
• RCTs.
• Comparative observational studies.
KQ 2a:
• Single-arm observational 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).
KQ 1 and 2: ..................................................................................................................
• 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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None.
None.
None.
None.
• In vitro studies.
• Nonoriginal studies (e.g.,
narrative reviews, editorials, letters, or erratum).
• Cross-sectional (i.e., nonlongitudinal) studies.
None.
62172
Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
PICOTS elements
Publications ..........................
Inclusion criteria
Exclusion criteria
• 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).
• Studies published in English as peer reviewed full text. ..................................
• Published after Year 2000.
• Foreign language studies.
• 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2021–24403 Filed 11–8–21; 8:45 am]
Centers for Medicare & Medicaid
Services
BILLING CODE 4160–90–P
jspears on DSK121TN23PROD with NOTICES1
[Document Identifier: CMS–10790]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction of notice.
AGENCY:
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This document corrects the
information provided for [Document
Identifier: CMS–10790] titled
‘‘Medicare-Funded GME Residency
Positions in accordance with Section
126 of the Consolidated Appropriations
Act, 2020.’’
FOR FURTHER INFORMATION CONTACT:
William N. Parham, III, (410) 786–4669.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In the October 22, 2021, issue of the
Federal Register (86 FR 58664), we
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]]>Agencies
[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
