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Radiation Oncology (London, England) Jan 2023Radiation dermatitis is a major concern in intensity modulated proton therapy (IMPT) for head and neck cancer (HNC) despite its demonstrated superiority over... (Comparative Study)
Comparative Study
Radiation dermatitis is a major concern in intensity modulated proton therapy (IMPT) for head and neck cancer (HNC) despite its demonstrated superiority over contemporary photon radiotherapy. In this study, dose surface histogram data extracted from forty-four patients of HNC treated with IMPT was used to predict the normal tissue complication probability (NTCP) of skin. Grades of NTCP-skin were clustered using the K-means clustering unsupervised machine learning (ML) algorithm. A new skin-sparing IMPT (IMPT-SS) planning strategy was developed with three major changes and prospectively implemented in twenty HNC patients. Across skin surfaces exposed from 10 (S10) to 70 (S70) GyRBE, the skin's NTCP demonstrated the strongest associations with S50 and S40 GyRBE (0.95 and 0.94). The increase in the NTCP of skin per unit GyRBE is 0.568 for skin exposed to 50 GyRBE as compared to 0.418 for 40 GyRBE. Three distinct clusters were formed, with 41% of patients in G1, 32% in G2, and 27% in G3. The average (± SD) generalised equivalent uniform dose for G1, G2, and G3 clusters was 26.54 ± 6.75, 38.73 ± 1.80, and 45.67 ± 2.20 GyRBE. The corresponding NTCP (%) were 4.97 ± 5.12, 48.12 ± 12.72 and 87.28 ± 7.73 respectively. In comparison to IMPT, new IMPT-SS plans significantly (P < 0.01) reduced SX GyRBE, gEUD, and associated NTCP-skin while maintaining identical dose volume indices for target and other organs at risk. The mean NTCP-skin value for IMPT-SS was 34% lower than that of IMPT. The dose to skin in patients treated prospectively for HNC was reduced by including gEUD for an acceptable radiation dermatitis determined from the local patient population using an unsupervised MLA in the spot map optimization of a new IMPT planning technique. However, the clinical finding of acute skin toxicity must also be related to the observed reduction in skin dose.
Topics: Humans; Head and Neck Neoplasms; Organs at Risk; Proton Therapy; Radiodermatitis; Radiotherapy Dosage; Radiotherapy Planning, Computer-Assisted; Radiotherapy, Intensity-Modulated; Unsupervised Machine Learning
PubMed: 36639667
DOI: 10.1186/s13014-023-02201-y -
Clinical and Translational Radiation... Mar 2023To assess the impact and optimize the prescription of tissue-equivalent bolus in postmastectomy radiotherapy (PMRT), we compared the use of different bolus regimens...
PURPOSE
To assess the impact and optimize the prescription of tissue-equivalent bolus in postmastectomy radiotherapy (PMRT), we compared the use of different bolus regimens tailored by skin involvement status.
METHODS
Patients with breast cancer who required PMRT were recruited (NCT01925651) and classified into two groups: standard-risk (SR, without skin involvement) and high-risk (HR, with skin involvement). SR was randomized between no bolus or 5 mm-bolus on alternate days and HR between 5 mm-bolus on alternate days or daily. Conventional fractionation (50.4 Gy; 1.8 Gy/daily) was used. Acute skin toxicity was evaluated blindly and the radiodermatitis-specific toxicity index [rads-TI] calculated. Subsequently, patients were followed up to assess oncologic outcomes, focusing on chest wall (CW) local control.
RESULTS
Fifty-eight patients were enrolled (34 SR and 24 HR). Baseline characteristics were similar between arms within the same risk group. Overall, maximal radiodermatitis rates were 29.4 % (G2) and 15.7 % (G3). In the SR group, no difference existed in G2 radiodermatitis incidence between the subgroups (p = 0.70) and no G3 events occurred. In the HR group, incidences of G2 (100 % vs 44.5 %, p = 0.01) and G3 radiodermatitis (70 % vs 11.1 %, p = 0.02) were higher with daily bolus. After adjusting for confounders, the daily bolus had a higher incidence of G2 (p = 0.03), G3 radiodermatitis (p = 0.04), and worse rads-TI (p < 0.01). After a median follow-up of 6.2 years, the 5-year local control was 95.8 % (95 %CI: 88.2 %-100 %) in the SR and 91.7 % (95 %CI: 77.3 %-100 %) in the HR groups. Per risk group, there was no difference in local control between the SR (p = 0.90) or the HR bolus regimens (p = 0.70).
CONCLUSION
Daily 5 mm bolus prescription significantly increased the overall toxicity burden. In this preliminary study, within the same risk group, no detriment in CW local control was detected with less intense bolus regimens (SR: no bolus; HR: alternate-days bolus). Additionally, the rads-TI was able to distinguish overall radiodermatitis burden.
PubMed: 36594077
DOI: 10.1016/j.ctro.2022.100570 -
Acta Dermatovenerologica Alpina,... Dec 2022Fluoroscopy-induced chronic radiation dermatitis (FICRD) is an uncommon but increasing complication that is challenging to diagnose due to its varied symptoms and...
Fluoroscopy-induced chronic radiation dermatitis (FICRD) is an uncommon but increasing complication that is challenging to diagnose due to its varied symptoms and delayed onset, usually from months to years after radiation exposure. For patients undergoing cardiac catheterization, high-risk factors for radiodermatitis include obesity, the presence of complex or chronic total occlusion lesions, the use of a fixed large beam angulation, and a procedure time of more than 2 hours. We present an individual with FICRD that had an indurated plaque on his back for 7 years to familiarize physicians with high-risk groups and early recognition of the disease.
Topics: Humans; Radiodermatitis; Fluoroscopy; Risk Factors; Alopecia; Cardiac Catheterization
PubMed: 36541397
DOI: No ID Found -
Annals of Oncology : Official Journal... Jan 2023To evaluate potential synergistic effect of pembrolizumab with radiotherapy (RT) compared with a standard-of-care (SOC) cetuximab-RT in patients with locally... (Randomized Controlled Trial)
Randomized Controlled Trial
Pembrolizumab versus cetuximab concurrent with radiotherapy in patients with locally advanced squamous cell carcinoma of head and neck unfit for cisplatin (GORTEC 2015-01 PembroRad): a multicenter, randomized, phase II trial.
BACKGROUND
To evaluate potential synergistic effect of pembrolizumab with radiotherapy (RT) compared with a standard-of-care (SOC) cetuximab-RT in patients with locally advanced-squamous cell carcinoma of head and neck (LA-SCCHN).
PATIENTS AND METHODS
Patients with nonoperated stage III-IV SCC of oral cavity, oropharynx, hypopharynx, and larynx and unfit for receiving high-dose cisplatin were enrolled. Patients received once-daily RT up to 69.96 Gy in 33 fractions with weekly cetuximab (cetuximab-RT arm) or 200 mg Q3W pembrolizumab during RT (pembrolizumab-RT arm). The primary endpoint was locoregional control (LRC) rate 15 months after RT. To detect a difference between arms of 60%-80% in 15-month LRC, inclusion of 66 patients per arm was required to achieve a power of at least 0.85 at two-sided significance level of 0.20.
RESULTS
Between May 2016 and October 2017, 133 patients were randomized to cetuximab-RT (n = 66) and pembrolizumab-RT (n = 67). Two patients (one in each arm) were not included in the analysis (a consent withdrawal and a progression before treatment start). The median age was 65 years (interquartile range 60-70 years), 92% were smokers, 60% were oropharynx (46% of oropharynx with p16+) and 75% were stage IV. Median follow-up was 25 months in both arms. The 15-month LRC rate was 59% with cetuximab-RT and 60% with pembrolizumab-RT ]odds ratio 1.05, 95% confidence interval (CI) 0.43-2.59; P = 0.91]. There was no significant difference between arms for progression-free survival (hazard ratio 0.85, 95% CI 0.55-1.32; P = 0.47) and for overall survival (hazard ratio 0.83, 95% CI 0.49-1.40; P = 0.49). Toxicity was lower in the pembrolizumab-RT arm than in the cetuximab-RT arm: 74% versus 92% patients with at least one grade ≥3 adverse events (P = 0.006), mainly due to mucositis, radiodermatitis, and rash.
CONCLUSION
Compared with the SOC cetuximab-RT, pembrolizumab concomitant with RT did not improve the tumor control and survival but appeared less toxic in unfit patients with LA-SCCHN.
Topics: Aged; Humans; Middle Aged; Cetuximab; Chemoradiotherapy; Cisplatin; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
PubMed: 36522816
DOI: 10.1016/j.annonc.2022.10.006 -
Revista Da Escola de Enfermagem Da U S P 2022To analyze the incidence, dose of occurrence, grade, severity, and associated risk factors for the development of radiodermatitis, by area of the irradiated breast, in...
OBJECTIVE
To analyze the incidence, dose of occurrence, grade, severity, and associated risk factors for the development of radiodermatitis, by area of the irradiated breast, in women with breast cancer, during hypofractionated radiotherapy.
METHOD
Observational, prospective, and longitudinal study, according to the guidelines of the Strengthening the Reporting of Observational studies in Epidemiology, carried out between May 2019 and May 2021.
RESULTS
A total of 104 women participated in the study, and 73.1% (95%CI: 64-82) developed signs of radiodermatitis during treatment. The majority (63.5%, 95%CI: 54-73) developed erythema in the axillary region with about 36.5 Grays. Women with large breasts and statin users are more likely to develop radiodermatitis. However, women with Phototype III skin color classification (light brown skin) are less likely to develop radiodermatitis, with skin color being a protective factor.
CONCLUSION
The incidence of radiodermatitis in women with breast cancer during hypofractionated radiotherapy is significant. Therefore, the development of protocols for the management of this radiotoxicity is suggested, considering the cumulative dose and associated risk factors.
Topics: Humans; Female; Radiodermatitis; Breast Neoplasms; Incidence; Longitudinal Studies; Prospective Studies
PubMed: 36469486
DOI: 10.1590/1980-220X-REEUSP-2022-0173en -
Breast (Edinburgh, Scotland) Dec 2022To assess the planned dose, in vivo dosimetry, acute skin toxicity, pain, and distress using Thermoplastic Elastomer (TPE) bolus for postmastectomy radiotherapy (PMRT).
PURPOSE
To assess the planned dose, in vivo dosimetry, acute skin toxicity, pain, and distress using Thermoplastic Elastomer (TPE) bolus for postmastectomy radiotherapy (PMRT).
MATERIAL AND METHODS
Thirty-two PMRT patients with TPE bolus (17 patients for 25 fractions, 15 patients for the first 20 fractions) were selected for the study. The acute skin toxicity, pain, and psychological distress were assessed from the first treatment week to the fourth week after the end of treatment. At the first treatment, the MOSFET was used in vivo dosimetry measurement.
RESULTS
In vivo dosimetry with the bolus, the dose deviation ranged from -6.22% to -1.56% for 5 points. The presence of grade 1 and 2 skin toxicity reached its peak (70.0% and 13.3%) in the sixth week. Two patients (6.6%) with 25 fractions bolus experienced moist desquamation in the fifth and seventh week, with pain score 2 and 3, and interruptions of 3 and 5 days, respectively. The incidence of pain score 1, 2, and 3 peaked in the fifth (33.3%), fourth (33.3%), and seventh (10.0%) week. No patients experienced grade 3 skin toxicity and severe pain. One patient had significant anxiety, and two patients had significant depression.
CONCLUSION
The TPE bolus can accurately fit skin and improve the surface dose to more than 90%. Twenty fractions with TPE bolus had similar skin toxicity and pain to those without bolus and did not increase patients' distress and clinical workload, compared with the literature's data, which is an alternative to the 3D printing bolus for PMRT.
Topics: Humans; Female; Breast Neoplasms; Mastectomy; Skin; Radiodermatitis; Radiotherapy Planning, Computer-Assisted; Pain; Radiotherapy Dosage
PubMed: 36463642
DOI: 10.1016/j.breast.2022.11.008 -
Actas Dermo-sifiliograficas 2023
Topics: Humans; Radiodermatitis; Fluoroscopy
PubMed: 36370832
DOI: 10.1016/j.ad.2022.09.017 -
BMC Cancer Nov 2022Our previous study reported that recombinant human epidermal growth factor (rhEGF)-triggered EGFR internalization promoted radioresistance. Here, we aimed to evaluate...
BACKGROUND
Our previous study reported that recombinant human epidermal growth factor (rhEGF)-triggered EGFR internalization promoted radioresistance. Here, we aimed to evaluate the effect of rhEGF on the skin protection of rectal and anal cancer patients receiving radiotherapy.
METHODS
One hundred and ninety-three rectal and anal cancer patients who received radiotherapy were prospectively enrolled from January 2019 to December 2020. To perform self-controlled study, the left and right pelvic skin area (separated by midline) were randomly assigned to the rhEGF and control side. The association between radiation dermatitis and factors including rhEGF, the dose of radiotherapy and tumor distance from anal edge were analyzed.
RESULTS
Among 193 enrolled patients, 41 patients (21.2%) did not develop radiation dermatitis, and 152 patients (78.8%) suffered radiation dermatitis on at least one side of pelvic skin at the end of radiotherapy. For the effect on radiation dermatitis grade, rhEGF had improved effect on 6 (4.0%) patients, detrimental effect on 2 (1.3%) patients, and no effect on 144 (94.7%) patients. Whereas for the effect on radiation dermatitis area, rhEGF showed improved effect on the radiation dermatitis area of 46 (30.2%) patients, detrimental effect on 15 (9.9%) patients, and no effect on 91 (59.9%) patients. The radiation dermatitis area of rhEGF side was significantly smaller than that of control side (P = 0.0007).
CONCLUSIONS
rhEGF is a skin protective reagent for rectal and anal cancer patients receiving radiotherapy.
TRIAL REGISTRATION
Chinese Clinical Trial Registry identifier: ChiCTR1900020842; Date of registration: 20/01/2019.
Topics: Humans; Anus Neoplasms; Epidermal Growth Factor; Radiodermatitis; Research Design
PubMed: 36335306
DOI: 10.1186/s12885-022-10226-x -
BMC Cancer Oct 2022Radiation therapy is one of the standard methods in the treatment of breast cancer. Radiotherapy-induced dermatitis (RID) is a common complication of radiotherapy (RT)... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Radiation therapy is one of the standard methods in the treatment of breast cancer. Radiotherapy-induced dermatitis (RID) is a common complication of radiotherapy (RT) resulting in less tolerance in RT and even discontinuation of treatment. Timolol is a β-adrenergic receptor antagonist that presents the best wound healing effects on both chronic and incurable wound healing. Topical forms of timolol could be effective in the prevention of RID due to the role of β-adrenergic receptors in skin cells and keratinocyte migration, as well as the anti-inflammatory effect of timolol. However, no placebo-controlled randomized trial is available to confirm its role. The current trial aimed to evaluate the efficacy of topical timolol 0.5% (w/w) on the RID severity and patients' quality of life (QOL).
METHOD
Patients aged older than 18 years with positive histology confirmed the diagnosis of invasive and localized breast cancer were included. Patients were randomized based on the random number table to receive each of the interventions of timolol 0.5% (w/w) or placebo topical gels from the first day of initiation of RT and for 6 weeks, a thin layer of gel twice daily. Patients were asked to use a thin layer of gel for at least two hours before and after radiation therapy. Primary outcomes were acute radiation dermatitis (ARD) grade using Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) scale and severity of desquamation based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Secondary outcomes were QOL based on Skindex16 (SD-16), maximum grade of ARD, and time of initial RD occurrence.
RESULTS
A total of 64 female patients with an age range of 33 to 79 years were included. The means (SD) of age were 53.88 (11.02) and 54.88 (12.48) in the control and timolol groups, respectively. Considering the RTOG/EORTC and CTCAE scores the difference between groups was insignificant (P-Value = 0.182 and P-Value = 0.182, respectively). In addition, the mean (SD) of time of initial RID occurrence in placebo and timolol groups were 4.09 (0.588) and 4.53 (0.983) weeks, respectively (P-Value = 0.035). The maximum grade of RID over time was significantly lower in the timolol group. During the study period, 75.0% of patients in placebo groups had grade 2 of ARD while in the timolol group it was 31.3% (P-Value = 0.002). QoL was not significantly different between groups (P-Value = 0.148).
CONCLUSION
Although the topical formulation of timolol, 0.5% (w/w), was found to reduce the average maximum grade of ARD and increase the mean (SD) time of initial RID occurrence, it showed no effect on ARD, severity, and QOL. However, future clinical trials should be performed to assess timolol gel formulation in larger study populations.
TRIAL REGISTRATION
https://irct.ir/ IRCT20190810044500N11 (17/03/2021).
Topics: Adult; Aged; Female; Humans; Middle Aged; Adrenergic beta-Antagonists; Anti-Inflammatory Agents; Breast Neoplasms; Quality of Life; Radiodermatitis; Receptors, Adrenergic, beta; Timolol
PubMed: 36266613
DOI: 10.1186/s12885-022-10064-x -
BMC Cancer Sep 2022Radiotherapy of head-and-neck cancer (SCCHN) is often associated with acute toxicity. In a previous trial, daily reminders by staff members to perform skin care resulted... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Radiotherapy of head-and-neck cancer (SCCHN) is often associated with acute toxicity. In a previous trial, daily reminders by staff members to perform skin care resulted in less dermatitis. This randomized trial investigated whether a mobile application can replace these reminders.
METHODS
Patients were stratified according to tumor site, treatment and center. Fifty-three patients were eligible for per-protocol-set (25 with, 28 without app). Primary endpoint was grade ≥ 2 dermatitis until 60 Gy. Secondary endpoints included dermatitis grade ≥ 2 until end of radiotherapy (EOT), dermatitis grade ≥ 3, and mucositis grade ≥ 2 and ≥ 3.
RESULTS
After an interim analysis, the study was terminated (delayed and slow accrual). Until 60 Gy, grade ≥ 2 dermatitis rates were 72% with vs. 82% without app (p = 0.38), grade ≥ 3 dermatitis rates 20% vs. 11% (p = 0.45). Until EOT, grade ≥ 2 and ≥ 3 dermatitis rates were 72% vs. 86% (p = 0.22) and 24% vs. 18% (p = 0.58). Until 60 Gy, grade ≥ 2 and ≥ 3 mucositis rates were 76% vs. 82% (p = 0.58) and 20% vs. 36% (p = 0.20). Until EOT, corresponding mucositis rates were 76% vs. 82% (p = 0.58) and 28% vs. 43% (p = 0.26).
CONCLUSION
Given the limitations of this trial, the reminder app led to non-significant reduction of grade ≥ 2 dermatitis, grade ≥ 2 mucositis and ≥ 3 mucositis. Additional studies are required to define the value of reminder apps during radiotherapy for SCCHN.
Topics: Head and Neck Neoplasms; Humans; Mobile Applications; Mucositis; Radiation Injuries; Radiodermatitis
PubMed: 36115962
DOI: 10.1186/s12885-022-10088-3