17 februari 2023: Bron: The BREAST VOLUME 67, P46-54, FEBRUARY 2023
Een systematische review waar uiteindelijk 9 gerandomiseerde studies met totaal 1308 patiënten met borstkanker van overbleven voor de analyse bevestigt het goede effect van hyperbare zuurstoftherapie op symptomen van lokale late bijwerkingen veroorzaakt door radiotherapie / bestraling zoals pijn, lymfoedeem, fibrose en arm- en schoudermobiliteit bij patiënten die lokaal werden bestraald voor borstkankertumoren.
Het systematisch literatuuronderzoek leverde na verwijdering van duplicaten in totaal 177 artikelen op. Tijdens de titel- en abstractreview werden 151 artikelen uitgesloten (Fig. 1). Na full-text screening voldeden negen artikelen met in totaal 1308 patiënten aan de in- en exclusiecriteria en werden opgenomen in de systematische review. (Table 1 [23, 24, 25, 26, 27, 28, 29, 30, 31)
Belangrijkste conclusies van de studie:
- •Pijn significant verminderd in vier van de vijf onderzoeken.
- •Fibrose significant verminderd in één op de twee onderzoeken.
- •Lymfoedeem van de borst en arm significant verminderd in vier van de zeven studies.
- •Een gerandomiseerde gecontroleerde studie wordt aanbevolen voor toekomstig onderzoek.
- •Een combinatie van door de patiënt en de arts gerapporteerde uitkomstmaten zou waardevol zijn.
Highlights
- •
Pain significantly reduced in four out of five studies.
- •
Fibrosis significantly reduced in one out of two studies.
- •
Lymphedema of the breast and arm significantly reduced in four out of seven studies.
- •
A randomized controlled trial is recommended for future research.
- •
A combination of patient- and clinician reported outcome measures would be valuable.
Abstract
Purpose
This systematic review aims to provide an overview of the literature on the effect of hyperbaric oxygen therapy (HBOT) on symptoms of local late radiation toxicity (LRT) in patients treated for breast cancer.
Methods
A systematic search was performed in September 2021. All studies with a sample size of ≥10 patients reporting the effect of HBOT for symptoms of LRT after radiotherapy of the breast and/or chest wall were included. The ROBINS-I tool was used for critical appraisal of methodological quality. The toxicity outcomes pain, fibrosis, lymphedema, necrosis/skin problems, arm and shoulder mobility, and breast and arm symptoms were evaluated.
Results
Nine studies concerning a total of 1308 patients were included in this review. Except for one study, sample sizes were small. Most studies had inadequate methodology with a substantial risk of bias. Post-HBOT, a significant reduction of pain was observed in 4/5 studies, of fibrosis in 1/2 studies, and of lymphedema of the breast and/or arm in 4/7 studies. Skin problems of the breast were significantly reduced in 1/2 studies, arm- and shoulder mobility significantly improved in 2/2 studies, and breast- and arm symptoms were significantly reduced in one study.
Conclusion
This systematic review indicates that HBOT might be useful for reducing symptoms of LRT in breast cancer patients, however evidence is limited. A randomized controlled trial in a larger cohort of patients including a combination of patient- and clinician-reported outcome measures would be valuable to assess the effect of HBOT on symptoms of LRT.
6. Discussion
This systematic review provides an overview of the current literature on the effect of HBOT on symptoms of LRT in breast cancer patients. In four out of five studies, HBOT was associated with a significant reduction in pain [
,
,
,
]. A significant reduction in fibrosis after HBOT was found in one out of three studies and four out of seven studies reported a significant reduction in breast and/or arm lymphedema after HBOT [
,
,
,
]. Skin problems of the breast were significantly reduced in one out of two studies [
] and a significant improvement in arm and shoulder mobility was seen in two out of two studies [
,
]. One study reported a significant reduction in breast and arm symptoms [
].
As four out of five studies reported a significant reduction in pain at the end of HBOT, both in the breast, chest wall, and arm, HBOT might be used as a treatment for symptoms of pain after radiotherapy [
,
,
,
]. This is in line with a meta-analysis by Yuan et al. evaluating the effect of HBOT on pelvic radiation-induced gastrointestinal complications in six studies with 93 patients, where an improvement rate in pain of 0.58 (95% CI: 0.38–0.79) after HBOT was observed [
]. However, since a control group was lacking in most studies, it remains difficult to determine whether a reduction in pain or other symptoms of LRT can be attributed to HBOT, or to other factors such as the natural disease course over time. For future studies, an assessment of the use of analgesics might also be helpful to objectify the effect of HBOT on pain.
Only one study reported a significant reduction in fibrosis after HBOT [
]. Here, fibrosis at 3 and 12 months post-HBOT was scored through a telephone consultation (patient-reported outcome) and not by clinical assessments, therefore lacking standardized measurement of fibrosis. As most studies in this review did not perform clinical assessments to measure the grade of fibrosis, it might be valuable to evaluate the effect of HBOT on fibrosis through clinical assessments. To maintain reliability, clinical assessment should preferably be done by the same physician(s). However, interobserver reproducibility of clinical assessment of toxicity outcomes is poor, as seen in studies using the Common Terminology Criteria for Adverse Events (CTCAE) and LENT-SOMA scale for assessing fibrosis and lymphedema of breast or chest wall [
,
]. As patient reported outcomes concerning symptoms and severity of LRT are important outcomes for evaluating quality of life, a combination of patient- and clinician-reported outcomes would be most valuable for the assessment of symptoms of LRT.
In the majority of the studies assessing the effect of HBOT on lymphedema of breast and arm, information about (type of) axillary treatment was missing, as two studies reported no information about the performance of axillary surgery [
,
], one study did not further specify the type of axillary treatment [
], and one study reported exact details of axillary surgery, but axillary clearance was not correlated with higher lymphedema scores at 12 months post-HBOT [
]. Axillary treatment (surgery with or without regional radiotherapy) is associated with a greater risk of developing lymphedema, but there is no evidence that HBOT is associated with the recovery of axillary lymph nodes or improvement of lymphatic drainage [
,
]. As a result, the effectiveness of HBOT in reducing lymphedema after radiotherapy might be different for breast cancer patients having undergone various axillary treatments (axillary node dissection vs. radiotherapy vs. axillary node dissection in combination with radiotherapy) and patients without axillary treatment. Moreover, as the included studies were conducted from 1995 onwards, patients were treated with different radiotherapy techniques, such as 2D radiotherapy, 3D conformal radiotherapy or intensity modulated radiotherapy (IMRT). Therefore, it is important that future studies evaluate to what extent patients receiving HBOT for symptoms of lymphedema had undergone axillary treatment, to provide clinically relevant evidence for its effectiveness.
Late radiation toxicity in breast cancer patients encompasses a wide range of symptoms and there are few objective outcome measures to evaluate the effectiveness of HBOT for symptoms of LRT. Providing evidence for diagnosing and treating LRT remains challenging, as studies are often based on a variety of patient-reported outcome measures [
,
,
]. In the included studies of this systematic review, nine different toxicity measures were used to assess the effect of HBOT on symptoms of LRT. As a result of this heterogeneity, comparing toxicity outcomes is difficult. This implies the need for consensus in the literature about a definition and assessment tools for evaluating symptoms of LRT.
In most studies, patient-reported outcome measures were used and no blinding of outcome assessors was performed, which was seen as serious risk of bias according to the ROBINS-I tool [
]. However, patient-reported outcome measures are the most relevant outcomes in studies evaluating the success of a treatment aiming to reduce symptoms and improve quality of life, such as the use of HBOT for reducing symptoms of LRT.
The findings of this systematic review should be interpreted in the context of its limitations. First, as a control group was lacking in most studies, serious risk of bias should be considered for these studies. However, a classic randomized controlled trial assessing the effect of HBOT on symptoms of LRT is difficult to conduct, since patients might refuse to participate beforehand or participants allocated to the control group may get disappointed and seek to undergo HBOT on their own initiative [
].
Second, relevant baseline characteristics including type of radiotherapy and axillary surgery were not reported in most studies. As a result, it remains unclear to what extent type of breast cancer treatment, such as type of axillary treatment and radiotherapy, is associated with the effectiveness of HBOT in reducing symptoms of LRT. Third, sample sizes of most included studies were small, and it is unclear whether they were adequately powered, although the study of Batenburg et al. included 1005 patients [
]. Fourth, different study designs were used among all included studies resulting in heterogeneous methodology. Due to this heterogeneity in combination with the diversity of toxicity outcome measures in the included studies, performing a meta-analysis was judged to be inappropriate. As a result, it remains difficult to provide high-quality evidence for the effect of HBOT on symptoms of LRT with the current literature. Last, the majority of the included studies reported relatively short follow-up periods after HBOT with a range from the end of HBOT to 12 months post-HBOT, which makes it difficult to assess the durability of the effectiveness of HBOT in reducing symptoms of LRT. A notable strength of this systematic review is that two reviewers independently screened articles for eligibility and independently evaluated the risk of bias of included studies. Also, this review encompasses the effect of HBOT on a broad range of symptoms of LRT due to its wide inclusion criteria.
Future randomized controlled trials with adequate statistical power and longer follow-up time post-HBOT are recommended to assess the effectiveness of HBOT for reducing symptoms of LRT in breast cancer patients. Also, a combination of patient- and clinician-reported outcome measures might be valuable to assess the effect of HBOT on symptoms of LRT [
].
7. Conclusion
Evidence supporting the use of HBOT as treatment for reducing symptoms of LRT in breast cancer patients is limited. According to the current literature, HBOT might be effective in reducing breast, chest wall, and arm pain. Future randomized controlled trials including a combination of patient- and clinician-reported outcome measures are needed to further assess the effectiveness of HBOT in reducing symptoms of LRT in breast cancer patients.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgment
No acknowledgements.
Appendix A. Supplementary data
The following is the Supplementary data to this article:
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Multimedia component 1
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Article info
Publication history
Published online: December 22, 2022
Accepted: December 19, 2022
Received in revised form: December 15, 2022
Received: November 16, 2022
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