Evidence map›Paper›PMID 36216274›Full record

Trial reportInternational journal of radiation oncology, biology, physics2023

Optimizing Preventive Adjuvant Linac-Based (OPAL) Radiation: A Phase 2 Trial of Daily Partial Breast Irradiation.

Jay P Reddy, Xiudong Lei, Elizabeth S Bloom, Valerie K Reed, Pamela J Schlembach, Isidora Arzu, Lauren Mayo, Stephen G Chun, Neelofur R Ahmad, Michael C Stauder and 5 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Jay P ReddyDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Xiudong LeiDepartments of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, Texas.
Elizabeth S BloomDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Valerie K ReedDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Pamela J SchlembachDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Isidora ArzuDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Lauren MayoDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Stephen G ChunDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Neelofur R AhmadDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael C StauderDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Ramesh GopalDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Kels KaiserDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Penny FangDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Benjamin D SmithDepartments of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas; Departments of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: bsmith3@mdanderson.org.
OPAL Trial Investigators
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
Estimating the Cost Trajectories and Projecting the Cost of Cancer Care in the United States: Methodology and ApplicationR01CA225646 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI LI, LIANG, SHIH, YA-CHEN TINA · 2018 to 2022
$1.8M
Technology Diffusion in Cancer: Geographic Variations, Facilitators, Outcomes, and CostsR01CA207216 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHIH, YA-CHEN TINA · 2016 to 2020
$1.6M
A radiation oncology clinician scientist devoted to building an inclusive clinical research program in an integrated academic satellite network in service to the National Cancer InstituteR50CA275822 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Stephen G Chun · 2023 to 2026
$347k
NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA207216NCI NIH HHS R01 CA225646NCI NIH HHS R50 CA275822
6 · The paper itself

Abstract

purposeEvidence supports use of partial-breast irradiation (PBI) in the management of early breast cancer, but the optimal dose-fractionation remains unsettled. METHODS AND MATERIALS: We conducted a phase 2 clinical trial (OPAL trial) to evaluate a novel PBI dosing schedule of 35 Gy in 10 daily fractions. Patients with close (<2 mm) margins also received a boost of 9 Gy in 3 fractions. Eligible patients underwent margin-negative lumpectomy for ductal carcinoma in situ or estrogen receptor-positive invasive breast cancer, up to 3 cm, pTis-T2 N0. The primary outcome was any grade ≥2 toxic effect occurring from the start of radiation through 6 months of follow-up. Secondary outcomes included patient-reported cosmesis, breast pain, and functional status, measured using the Breast Cancer Treatment Outcomes Scale, and physician-reported cosmesis, measured using the Radiation Therapy and Oncology Group scale. The Cochran-Armitage trend test and multivariable mixed-effects longitudinal growth curve models compared outcomes for the OPAL study population with those for a control group of similar patients treated with whole-breast irradiation (WBI) plus boost.

resultsAll 149 patients enrolled on the OPAL trial received the prescribed dose, and 17.4% received boost. The median age was 64 years; 83.2% were White, and 73.8% were overweight or obese. With median follow-up of 2.0 years, 1 patient (0.7%) experienced in-breast recurrence. Prevalence of the primary toxicity outcome was 17.4% (26 of 149 patients) in the OPAL trial compared with 72.7% (128 of 176 patients) in the control WBI-plus-boost cohort (P < .001). In longitudinal multivariable analysis, treatment on the OPAL trial was associated with improved patient-reported cosmesis (P < .001), functional status (P = .004), breast pain (P = .004), and physician-reported cosmesis (P < .001).

conclusionsTreatment with daily PBI was associated with substantial reduction in early toxicity and improved patient- and physician-reported outcomes compared with WBI plus boost. Daily external-beam partial-breast irradiation with 13 or fewer fractions merits further prospective evaluation.

Indexed as

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingMastodyniaFemaleHumansMastectomy, SegmentalMiddle AgedRadiotherapy, AdjuvantTreatment Outcome

Identifiers

PMID36216274
PMCPMC11744773
OpenAlexW4303520759

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.