Patient-Reported Symptoms of Late Toxicity in Patients With Breast Cancer Treated With Hypofractionated Radiation Therapy and the Association With Quality of Life

Batenburg, Marilot C T; Molen, Dieuwke R Mink van der; Leij, Femke van der; Doeksen, A.; Dalen, Thijs van; Schoenmaeckers, Ernst J. P.; Bijlsma, Rhodé M; Witkamp, Arjen J.; Ernst, Miranda F.; Sier, M.; Maarse, Wiesje; Bongard, H.J.G.D. Van den; Verkooijen, Helena M.

doi:10.1016/j.ijrobp.2022.11.008

Cited by 7 publications

(6 citation statements)

References 24 publications

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“…Late PROs were similar between the two fractionation arms and also similar to the recent literature on this topic [ 37 , 38 , 39 ]. Importantly, there was only poor to slight concordance between late CRO and PRO, which has previously been described for acute toxicity only [ 8 , 40 , 41 ].…”

Section: Discussionsupporting

confidence: 87%

Objective, Clinician- and Patient-Reported Evaluation of Late Toxicity Following Adjuvant Radiation for Early Breast Cancer: Long-Term Follow-Up Results of a Randomised Series

Dejonckheere

Abramian

Lindner

et al. 2023

JCM

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Background and Purpose: This study aimed to differentially assess the frequency and severity of late radiation-induced toxicity following adjuvant whole-breast irradiation for early breast cancer with conventional fractionation (CF) and moderate hypofractionation (mHF). Materials and Methods: Patients recruited in a previous randomised controlled trial comparing acute toxicity between CF and mHF without disease recurrence were included in a post hoc analysis. Spectrophotometric and ultrasonographic examinations were performed for an objective evaluation and subsequent comparison of long-term skin toxicity. Furthermore, patient- and clinician-reported outcomes were recorded. Results: Sixty-four patients with a median age of 58 (37–81) years were included. The median follow-up was 57 (37–73) months. A total of 55% underwent CF and 45% mHF. A total of 52% received a sequential boost to the tumour bed. A significant decrease in mean L* (p = 0.011) and an increase in a* (p = 0.040) and b* values (p < 0.001) were observed, indicating hyperpigmentation. In comparison with the non-irradiated breast, there was a significant increase in both cutis (+14%; p < 0.001) and subcutis (+17%; p = 0.011) thickness, significantly more pronounced in CF patients (p = 0.049). In CF patients only, a sequential boost significantly increased the local cutis thickness and oedema compared to non-boost regions in the same breast (p = 0.001 and p < 0.001, respectively). Conclusions: mHF objectively resulted in reduced long-term skin toxicity compared to CF. A sequential boost increased the local fibrosis rate in CF, but not in mHF. This might explain the subjectively reported better cosmetic outcomes in patients receiving mHF and reinforces the rationale for favouring mHF as the standard of care.

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Section: Discussionsupporting

confidence: 87%

Objective, Clinician- and Patient-Reported Evaluation of Late Toxicity Following Adjuvant Radiation for Early Breast Cancer: Long-Term Follow-Up Results of a Randomised Series

Dejonckheere

Abramian

Lindner

et al. 2023

JCM

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“…To identify eligible participants, a late toxic effects questionnaire was developed and sent out to UMBRELLA cohort participants (eAppendix in Supplement 2). 6 Women were eligible for HONEY when meeting the following criteria: (1) provided consent for randomization to intervention studies within UMBRELLA, (2) finished primary breast cancer treatment with curative intent (except for hormonal therapy), and (3) had patient-reported late local toxic effects 12 months or longer after adjuvant radiotherapy. Late local toxic effects were defined as moderate or severe breast, chest wall, and/or shoulder pain in combination with at least 1 symptom of mild, moderate, or severe fibrosis, breast edema, and/or movement restriction.…”

Section: Patient Recruitmentmentioning

confidence: 99%

“…Approximately 70% of patients with breast cancer in the Netherlands receive adjuvant radiotherapy, as it reduces local recurrence rates and increases disease-free survival . Radiotherapy is associated with an increased risk of late local toxic effects, including pain, fibrosis, edema, movement restriction, and impaired cosmetic outcome . In a large Dutch breast cancer cohort, late toxic effects after radiotherapy were reported by 16% of patients, which was also associated with reduced quality of life (QOL) .…”

Section: Introductionmentioning

confidence: 99%

“…[1][2][3][4] Radiotherapy is associated with an increased risk of late local toxic effects, including pain, fibrosis, edema, movement restriction, and impaired cosmetic outcome. 5,6 In a large Dutch breast cancer cohort, late toxic effects after radiotherapy were reported by 16% of patients, which was also associated with reduced quality of life (QOL). 6 Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for reduction of late local toxic effects.…”

mentioning

confidence: 99%

“…5,6 In a large Dutch breast cancer cohort, late toxic effects after radiotherapy were reported by 16% of patients, which was also associated with reduced quality of life (QOL). 6 Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for reduction of late local toxic effects. 7 HBOT involves breathing 100% oxygen at 2.0 to 2.5 atmospheres absolute (ATA).…”

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confidence: 99%

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Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

Mink van der Molen,

Batenburg,

Maarse

et al. 2024

JAMA Oncol

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ImportanceHyperbaric oxygen therapy (HBOT) is proposed as treatment for late local toxic effects after breast irradiation. Strong evidence of effectiveness is lacking.ObjectiveTo assess effectiveness of HBOT for late local toxic effects in women who received adjuvant radiotherapy for breast cancer.Design, Setting, and ParticipantsThis was a hospital-based, pragmatic, 2-arm, randomized clinical trial nested within the prospective UMBRELLA cohort following the trials within cohorts design in the Netherlands. Participants included 189 women with patient-reported moderate or severe breast, chest wall, and/or shoulder pain in combination with mild, moderate, or severe edema, fibrosis, or movement restriction 12 months or longer after breast irradiation. Data analysis was performed from May to September 2023.InterventionReceipt of 30 to 40 HBOT sessions over a period of 6 to 8 consecutive weeks.Main Outcomes and MeasuresBreast, chest wall, and/or shoulder pain 6 months postrandomization measured by the European Organization for Research and Treatment of Cancer QLQ-BR23 questionnaire. Secondary end points were patient-reported fibrosis, edema, movement restriction, and overall quality of life. Data were analyzed according to intention-to-treat (ITT) and complier average causal effect (CACE) principles.ResultsBetween November 2019 and August 2022, 125 women (median [range] age at randomization, 56 [37-85] years) with late local toxic effects were offered to undergo HBOT (intervention arm), and 61 women (median [range] age at randomization, 60 [36-80] years) were randomized to the control arm. Of those offered HBOT, 31 (25%) accepted and completed treatment. The most common reason for not accepting HBOT was high treatment intensity. In ITT, moderate or severe pain at follow-up was reported by 58 of 115 women (50%) in the intervention arm and 32 of 52 women (62%) in the control arm (odds ratio [OR], 0.63; 95% CI, 0.32-1.23; P = .18). In CACE, the proportion of women reporting moderate or severe pain at follow-up was 32% (10 of 31) among those completing HBOT and 75% (9.7 of 12.9) among control participants expected to complete HBOT if offered (adjusted OR, 0.34; 95% CI, 0.15-0.80; P = .01). In ITT, moderate or severe fibrosis was reported by 35 of 107 (33%) in the intervention arm and 25 of 49 (51%) in the control arm (OR, 0.36; 95% CI, 0.15-0.81; P = .02). There were no significant differences in breast edema, movement restriction, and quality of life between groups in ITT and CACE.Conclusions and RelevanceIn this randomized clinical trial, offering HBOT to women with late local toxic effects was not effective for reducing pain, but was effective for reducing fibrosis. In the subgroup of women who completed HBOT, a significant reduction in pain and fibrosis was observed. A smaller than anticipated proportion of women with late local toxic effects was prepared to undergo HBOT.Trial RegistrationClinicalTrials.gov Identifier: NCT04193722

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Evaluating the effect of upper-body morbidity on quality of life following primary breast cancer treatment: a systematic review and meta-analysis

et al. 2023

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Purpose Improvements in breast cancer management continue to increase survival and life expectancy after treatment. Yet the adverse effects of treatment may persist long term, threatening physical, psychological, and social wellbeing, leading to impaired quality of life (QOL). Upper-body morbidity (UBM) such as pain, lymphoedema, restricted shoulder range of motion (ROM), and impaired function are widely reported after breast cancer treatment, but evidence demonstrating its impact on QOL is inconsistent. Therefore, the aim of the study was to conduct a systematic review and meta-analysis evaluating the effect of UBM on QOL following primary breast cancer treatment. Methods The study was prospectively registered on PROSPERO (CRD42020203445). CINAHL, Embase, Emcare, PsycInfo, PubMed/Medline, and SPORTDiscus databases were searched for studies reporting QOL in individuals with and without UBM following primary breast cancer treatment. Primary analysis determined the standardised mean difference (SMD) in physical, psychological, and social wellbeing scores between UBM + /UBM − groups. Secondary analyses identified differences in QOL scores between groups, according to questionnaire. Results Fifty-eight studies were included, with 39 conducive to meta-analysis. Types of UBM included pain, lymphoedema, restricted shoulder ROM, impaired upper-body function, and upper-body symptoms. UBM + groups reported poorer physical (SMD = − 0.99; 95%CI = − 1.26, − 0.71; p < 0.00001), psychological (SMD = − 0.43; 95%CI = − 0.60, − 0.27; p < 0.00001), and social wellbeing (SMD = − 0.62; 95%CI = − 0.83, − 0.40; p < 0.00001) than UBM − groups. Secondary analyses according to questionnaire showed that UBM + groups rated their QOL poorer or at equal to, UBM − groups across all domains. Conclusions Findings demonstrate the significant, negative impact of UBM on QOL, pervading physical, psychological, and social domains. Implications for Cancer Survivors Efforts to assess and minimise the multidimensional impact of UBM are warranted to mitigate impaired QOL after breast cancer.

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Patient-Reported Symptoms of Late Toxicity in Patients With Breast Cancer Treated With Hypofractionated Radiation Therapy and the Association With Quality of Life

Cited by 7 publications

References 24 publications

Objective, Clinician- and Patient-Reported Evaluation of Late Toxicity Following Adjuvant Radiation for Early Breast Cancer: Long-Term Follow-Up Results of a Randomised Series

Objective, Clinician- and Patient-Reported Evaluation of Late Toxicity Following Adjuvant Radiation for Early Breast Cancer: Long-Term Follow-Up Results of a Randomised Series

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

Evaluating the effect of upper-body morbidity on quality of life following primary breast cancer treatment: a systematic review and meta-analysis

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