On the sensitivity of PROMs during breast radiotherapy.
Ontology highlight
ABSTRACT: Purpose
To investigate the sensitivity of patient-reported outcome measures (PROMs) to detect treatment-related side effects in patients with breast cancer undergoing external beam photon radiotherapy.Methods
As part of daily clinical care, an in-house developed PROM tool was used to assess side effects in patients during a) whole-breast irradiation (WBI) to 40 Gy, b) WBI with a sequential boost of 10 Gy, and c) partial-breast irradiation (PBI) to 40 Gy.Results
414 patients participated in this prospective study between October 2020 and January 2022, with 128 patients (31 %) receiving WBI, 241 (58 %) receiving WBI followed by a sequential boost, and 50 patients (12 %) receiving PBI. Significant differences in the reported toxicities (itching, radiation skin reaction, skin darkening, and tenderness and swelling) were reported between the WBI cohorts with and without boost (p < 0.001, p < 0.001, p < 0.001, and p = 0.002, respectively). The comparison of PBI with WBI (no-boost) yielded significant differences for radiation skin reaction (p < 0.001).Conclusion
The results highlight the high sensitivity of PROMs to detect treatment-related side effects in patients with breast cancer. Thus, PROMs may be a valuable tool for quality control and may support evidence-based learning from real-world data originating from daily routine care.
SUBMITTER: Heilemann G
PROVIDER: S-EPMC9827355 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
Publications
On the sensitivity of PROMs during breast radiotherapy.
Heilemann Gerd G Renner Andreas A Kauer-Dorner Daniela D Konrad Stefan S Simek Inga-Malin IM Georg Dietmar D Widder Joachim J
Clinical and translational radiation oncology 20221226
<h4>Purpose</h4>To investigate the sensitivity of patient-reported outcome measures (PROMs) to detect treatment-related side effects in patients with breast cancer undergoing external beam photon radiotherapy.<h4>Methods</h4>As part of daily clinical care, an in-house developed PROM tool was used to assess side effects in patients during a) whole-breast irradiation (WBI) to 40 Gy, b) WBI with a sequential boost of 10 Gy, and c) partial-breast irradiation (PBI) to 40 Gy.<h4>Results</h4>414 patien ...[more]
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Project description:PurposeThe fragile-site associated tumor suppressor (FATS) is a newly identified tumor suppressor involved in radiation-induced tumorigenesis. The purpose of this study was to characterize FATS expression in breast cancers about radiotherapy benefit, patient characteristics, and prognosis.ResultsThe expression of FATS mRNA was silent or downregulated in 95.2% of breast cancer samples compared with paired normal controls (P < .0001). Negative status of FATS was correlated with higher nuclear grade (P = .01) and shorter disease-free survival (DFS) of breast cancer (P = .036). In a multivariate analysis, FATS expression showed favorable prognostic value for DFS (odds ratio, 0.532; 95% confidence interval, 0.299 to 0.947; (P = .032). Furthermore, improved survival time was seen in FATS-positive patients receiving radiotherapy (P = .006). The results of multivariate analysis revealed independent prognostic value of FATS expression in predicting longer DFS (odds ratio, 0.377; 95% confidence interval, 0.176 to 0.809; P = 0.012) for patients receiving adjuvant radiotherapy. In support of this, reduction of FATS expression in breast cancer cell lines, FATS positive group significantly sensitized than Knock-down of FATS group.Materials and methodsTissue samples from 156 breast cancer patients and 42 controls in tumor bank were studied. FATS gene expression was evaluated using quantitative reverse transcription polymerase chain reaction (qRT-PCR). FATS function was examined in breast cancer cell lines using siRNA knock-downs and colony forming assays after irradiation.ConclusionsFATS status is a biomarker in breast cancer to identify individuals likely to benefit from radiotherapy.
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Project description:ImportanceUnderstanding whether physicians accurately detect symptoms in patients with breast cancer is important because recognition of symptoms facilitates supportive care, and clinical trials often rely on physician assessments using Common Toxicity Criteria for Adverse Events (CTCAE).ObjectiveTo compare the patient-reported outcomes (PROs) of patients with breast cancer who received radiotherapy from January 1, 2012, to March 31, 2020, with physicians' CTCAE assessments to assess underrecognition of symptoms.Design, setting, and participantsThis cohort study included a total of 29 practices enrolled in the Michigan Radiation Oncology Quality Consortium quality initiative. Of 13 725 patients with breast cancer who received treatment with radiotherapy after undergoing lumpectomy, 9941 patients (72.4%) completed at least 1 PRO questionnaire during treatment with radiotherapy and were evaluated for the study. Of these, 9868 patients (99.3%) were matched to physician CTCAE assessments that were completed within 3 days of the PRO questionnaires.ExposuresPatient and physician ratings of 4 symptoms (pain, pruritus, edema, and fatigue) were compared.Main outcomes and measuresWe used multilevel multivariable logistic regression to evaluate factors associated with symptom underrecognition, hypothesizing that it would be more common in racial and ethnic minority groups.ResultsOf 9941 patients, all were female, 1655 (16.6%) were Black, 7925 (79.7%) were White, and 361 (3.6%) had Other race and ethnicity (including American Indian/Alaska Native, Arab/Middle Eastern, and Asian), either as self-reported or as indicated in the electronic medical record. A total of 1595 (16.0%) were younger than 50 years, 2874 (28.9%) were age 50 to 59 years, 3353 (33.7%) were age 60 to 69 years, and 2119 (21.3%) were 70 years or older. Underrecognition of symptoms existed in 2094 of 6781 (30.9%) observations of patient-reported moderate/severe pain, 748 of 2039 observations (36.7%) of patient-reported frequent pruritus, 2309 of 4492 observations (51.4%) of patient-reported frequent edema, and 390 of 2079 observations (18.8%) of patient-reported substantial fatigue. Underrecognition of at least 1 symptom occurred at least once for 2933 of 5510 (53.2%) of those who reported at least 1 substantial symptom. Factors independently associated with underrecognition were younger age (younger than 50 years compared with 60-69 years: odds ratio [OR], 1.35; 95% CI, 1.14-1.59; P < .001; age 50-59 years compared with 60-69 years: OR, 1.19; 95% CI, 1.03-1.37; P = .02), race (Black individuals compared with White individuals: OR, 1.56; 95% CI 1.30-1.88; P < .001; individuals with Other race or ethnicity compared with White individuals: OR, 1.52; 95% CI, 1.12-2.07; P = .01), conventional fractionation (OR, 1.26; 95% CI, 1.10-1.45; P = .002), male physician sex (OR, 1.54; 95% CI, 1.20-1.99; P = .002), and 2-field radiotherapy (without a supraclavicular field) (OR, 0.80; 95% CI, 0.67-0.97; P = .02).Conclusions and relevanceThe results of this cohort study suggest that PRO collection may be essential for trials because relying on the CTCAE to detect adverse events may miss important symptoms. Moreover, since physicians in this study systematically missed substantial symptoms in certain patients, including younger patients and Black individuals or those of Other race and ethnicity, improving symptom detection may be a targetable mechanism to reduce disparities.
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Project description:The aim of this pilot study was to assess the compliance of breast cancer (BC) patients with fitness tracker (FT) monitoring program during radiotherapy (RT) and to characterize radiation-induced fatigue (RIF) status through objective evaluation using FT-collected parameters. Thirty-six BC patients were invited to wear FT during their RT course for continuous monitoring of heart rate (HR) and step counts (STP). RIF assessment was performed weekly, according to CTCAE v5.0 and dichotomized into G0 vs. any-grade. A novel concept based on patient Repeated Activity Window (RAW) was introduced to evaluate HR and STP variations during RT. Several Machine Learning (ML) methods were trained to characterize RIF on the basis of HR and STP collected data. RIF of any grade was reported by 17 out of 36 patients (47%) included in the study. None of patient clinical variables were significantly correlated with RIF. All patients accepted the FT monitoring program, and for 32 patients FT collection efficiency was greater than 60%. For each patient, a distinct distribution of RAWs was identifiable over RT and across the entire patient cohort, with a total of 7950 RAWs processed. Six features related to RAWs, HR and STP were identified as associated with RIF. The best-performing classifier was the Bagged Trees model, showing a cross-validated ROC-AUC of 89% (95% CI 88-90%). This study confirms the feasibility of continuous biomedical monitoring of BC patients by FT. We successfully identify objective indicators of RIF through HR and STP variation measures within each patient's RAW, thus providing a novel and practical approach to assess and manage RIF. This can significantly aid medical staff in evaluating RIF trajectories, potentially leading to better individualized care strategies and improved patient outcomes.
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Project description:PurposeSurgical clips are used as a target for postoperative breast radiotherapy, and displacement of surgical clips would result in inaccurate delivery of radiation. We investigated the displacement range of surgical clips in the breast during postoperative radiotherapy following breast-conserving surgery.MethodsA total of 178 patients who received breast-conserving surgery and postoperative radiation of 59.4 Gy in 33 fractions to the involved breast for 6.5 weeks were included. Surgical clips were used to mark the lumpectomy cavity during breast-conserving surgery. Patients undertook planning computed tomography (CT) scan for whole breast irradiation. Five weeks after beginning radiation, when the irradiation dose was 45 Gy, planning CT scan was performed again for a boost radiotherapy plan in all patients. The surgical clips were defined in both CT images and compared in lateromedial (X), anteroposterior (Y), superoinferior (Z), and three-dimensional directions.ResultsThe 90th percentile of displacement of surgical clips was 5.31 mm (range, 0.0-22.2 mm) in the lateromedial direction, 7.1 mm (range, 0.0-14.2 mm) in the anteroposterior direction, and 6.0 mm (range, 0.0-10.0 mm) in the superoinferior direction. The 90th percentile of three-dimensional displacement distance was 9.8 mm (range, 0.0-28.2 mm). On the multivariate analysis, seroma ≥15 mL was the only independent factor associated with the displacement of surgical clips. In patients with seroma ≥15 mL, the 90th percentile of displacement of surgical clips was 15.1 mm in the lateromedial direction, 12.7 mm in the anteroposterior direction, 10.0 mm in the superoinferior direction, and 21.8 mm in the three-dimensional distance.ConclusionA target volume expansion of 10 mm from surgical clips may be sufficient to compensate for the displacement of clips during postoperative radiotherapy after breast-conserving surgery. For patients who had a seroma, a replanning CT scan for a boost radiation should be considered to ensure exact postoperative radiotherapy in breast cancer.
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Project description:ObjectivesTo determine whether patient-reported outcome measures (PROMs) capturing activity limitations, health impact, pain, fatigue and work ability are responsive and sensitive to changes in disease activity status in patients with early and established RA.MethodsAll early RA patients (n = 557) from the tREACH trial and established RA patients (n = 188) from the TARA trial were included. Both studies were multicentre, single-blinded trials with a treat-to-target management approach. The following PROMs were studied: HAQ Disability Index (HAQ-DI), morning stiffness severity, EQ-5D, general health, 36-item short form (SF-36), joint pain, fatigue and productivity loss. Mean changes in PROMs between two consecutive visits were compared with changes in disease activity status (remission, low disease activity and active disease) using linear mixed models and standardized response means. Additionally, the proportion of individual observations that showed an expected PROM response to disease activity status alterations was calculated.ResultsHAQ-DI, morning stiffness severity, general health, EQ-5D and joint pain demonstrated responsiveness to improvement or worsening of disease activity status in both early and established RA. SF-36 physical and mental component scale, fatigue and productivity loss did not show this effect in both groups. Across nearly all PROMs, the magnitude of change and the proportion of individual observations that reflect a shift from and to active disease remained low.ConclusionHAQ-DI, morning stiffness severity, EQ-5D, general health and joint pain are responsive to disease activity status alterations on a group level in both early and established RA. For the individual patient the responsiveness of these PROMs is poor.Clinical trial registrationtREACH trial (www.isrctn.com, ISRCTN26791028) and TARA trial (www.onderzoekmetmensen.nl, NTR2754).
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