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LUX-Head & Neck 2 investigators., [Importance] Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC., [Objective] To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC., [Design, Setting, and Participants] This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population., [Interventions] Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal., [Main Outcomes and Measures] The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life., [Results] A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group)., [Conclusions and Relevance] This study’s findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended., [Trial Registration] ClinicalTrials.gov identifier: NCT01345669., The study was funded by Boehringer Ingelheim.

Background The aim is to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute radiodermatitis (RD) in breast cancer patients undergoing radiotherapy (RT). Study Design/Materials and Method This randomized, placebo-controlled trial enrolled 66 breast cancer patients that underwent an identical RT regime post-lumpectomy. Patients were randomly assigned to the laser (n=34) or placebo group (n=32). There were no significant differences between the two groups with respect to patient- and treatment-related characteristics. Laser or placebo was applied two days a week, immediately after the RT session, starting at the first day of RT. PBMT was delivered using a class IV MLS® M6 laser that combines two synchronized laser diodes in the infrared range (808-905 nm) with a fixed energy density (4 J/cm2). Clinical scoring of RD (Radiation Therapy Oncology Group (RTOG) grading scale) and biophysical measurements (skin hydration, transepidermal water loss (TEWL), and degree of erythema) were determined at the first day, at fraction 20 and at the end of RT. In the results section, only preliminary results of the RTOG scores are shown. Results At fraction 20 of RT, there was no significant difference between the groups in the distribution of RTOG grades (p= .524), with most of the patients presenting RTOG grade 1. Towards the end of RT, the skin reactions worsened in the placebo group (p= 0.016), while they remained stable in the laser group (p= .207). There was a significant difference in the severity of RD between the two groups (p= .021) with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g. moist desquamation) in the placebo group (28.1% vs. 5.9%, for the placebo and laser group, resp.) at the last day of RT. Conclusion The preliminary results of this first randomized, placebo-controlled trial show that PBMT can prevent aggravation of acute RD in breast cancer patients. LCRP; Limburgs Kankerfonds; ASA srl

Photobiomodulation therapy is based on the application of visible and/or (near-)infrared light on the target tissue. We performed a review of 34 articles on the use of photobiomodulation therapy in the management of cancer related lymphoedema, oral mucositis, radiodermatitis, chemotherapy-induced peripheral neuropathy, osteonecrosis of the jaw, and xerostomia/hyposalivation. The findings suggest that photobiomodulation therapy is a promising option for the management of these cancer therapy-related side effects. This study is part of the Limburg Clinical Research Program (LCRP) UHasselt-ZOL-Jessa, supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg and Jessa Hospital. Additionally, this research is supported by the foundations Limburgs Kankerfonds, Kom op Tegen Kanker and ASA srl.

Purpose To assess the standardized implementation and reporting of surveillance [18F]fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) scan of the neck in locoregionally advanced head-and-neck squamous cell carcinoma (LAHNSCC) after concurrent chemoradiotherapy (CCRT). Patients and Methods We performed a prospective multicenter study of FDG-PET/CT scanning 12 weeks after CCRT in newly diagnosed patients with LAHNSCC (stage IVa/b) that used standardized reconstruction and Hopkins reporting criteria. The reference standard was histology or > 12 months of clinical follow-up. The primary outcome measure was the negative predictive value (NPV) of FDG-PET/CT scans and other supporting diagnostic test characteristics, including time dependency with increasing follow-up time. Results Of 152 patients, 125 had adequate primary tumor control after CCRT and entered follow-up (median, 20.4 months). Twenty-three (18.4%) had residual neck disease. Overall, NPV was 92.1% (95% CI, 86.9% to 95.3%; null hypothesis: NPV = 85%; P = .012) with sensitivity of 65.2% (95% CI, 44.9% to 81.2%), specificity of 91.2% (95% CI, 84.1% to 95.3%), positive predictive value of 62.5% (95% CI, 45.5% to 76.9%), and accuracy of 86.4% (95% CI, 79.3% to 91.3%). Sensitivity was time dependent and high for residual disease manifesting up to 9 months after imaging but lower (59.7%) for disease detected up to 12 months after imaging. Standardized reporting criteria reduced the number of equivocal reports (95% CI for the difference, 2.6% to 15.0%; P = .003). Test characteristics were not improved with the addition of lymph node CT morphology criteria. Conclusion FDG-PET/CT surveillance using Hopkins criteria 12 weeks after CCRT is reliable in LAHNSCC except for late manifesting residual disease, which may require an additional surveillance scan at 1 year after CCRT to be detected.

ispartof: Tijdschrift voor Belgisch Burgerlijk Recht / Revue Générale de Droit Civil issue:5 pages:189-199 status: published

Objectives: The evidence demonstrating the efcacy of photobiomodulation (PBM) therapy for preventing and managing acute radiation dermatitis (ARD) is growing steadily. The question that arises from many clinicians is, if PBM is safe for oncologic patients. This study aimed to evaluate the diseasefree survival (DFS), cancerfree survival (CFS), and overall survival (OS) of breast cancer patients treated with PBM for ARD. Methods: Clinical data of 120 breast cancer patients treated with prophylactic PBM (n = 60, 2x/week, 808−905 nm, 4 J/cm 2) or placebo (n = 60) during conventional fractionation (CF) radiotherapy (RT) between April 2015 and June 2017 were retrospectively analyzed (TRANSDERMIS trial). During followup (April 2015 to May 2022), patients underwent a complete clinical evaluation every 6 months and blood analysis and mammography yearly in the rst 5 years after the end of RT. The DFS, CFS, and OS were estimated. Results: At a median followup time of 66 months (range 4−81), there was no signicant difference in DFS (73.7% vs. 98.3%, resp., p = 0.54), CFS (68.4% vs. 77.8%, resp., p = 0.79), and OS (87.9% vs. 98.3%, resp., p = 0.30) between the placebo and PBM group. Conclusions: This paper is the rst to describe the results of a longterm followup in earlystage breast cancer patients who underwent PBM for ARD. Results suggest that using PBM in breast cancer patients undergoing CF RT does not inuence the locoregional recurrence, the development of new primary tumors, or OS. We would like to thank all patients, doctors, and nurses for their participation in TRANSDERMIS trial. In addition, we want to thank Jessa Hospital and Hasselt University for providing the needed infrastructure and software packages. This study is part of the Limburg Clinical Research Center (LCRC)UHasselt‐ZOL‐Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost‐Limburg, and Jessa Hospital. Additionally, this study is supported by Kom op Tegen Kanker (Stand up to Cancer), the Flemish cancer society, LimburgsKankerfonds, and ASA Srl.

Background and purpose The purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients. Materials and methods A randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2×/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire. Results PBMT significantly reduced NCI-CTCAE grade 2–3 ARD with 49% at the end of RT. Conclusion The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology – radiotherapy practice. This research is part of the Limburg Clinical Research Center (LCRC) UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. Additionally, this research project is funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl.

The aim of this Letter to the Editor was to report some methodological shortcomings in the recently published article “Application of red light phototherapy in the treatment of radioactive dermatitis in patients with head and neck cancer” by Zhang et al. There are some issues regarding the incomplete photobiomodulation (PBM) parameters, the chosen outcome measures, and some missing reference articles. In conclusion, the results of this study should be interpreted with caution and further research is necessary. JR and JM received funding from the following organisations: Limburg Clinical Research Program supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. ASA srl. Limburgs Kankerfonds Kom op Tegen Kanker

Purpose The purpose of this study was to evaluate objectively the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) by using biophysical skin measurements. Methods A randomized, placebo-controlled trial with 120 breast cancer patients who underwent an identical radiotherapy (RT) regimen post-lumpectomy was performed (TRANSDERMIS trial). Patients were randomized to receive PBM (808 nm CW/905 nm pulsed, 168 mW/cm2, spot size 19.6 cm2, fluence 4 J/cm2) or placebo treatments from the first day of RT (2×/week). Biophysical skin measurements were collected to assess the skin pigmentation and barrier function. Measurements were collected at the first day of RT, a RT dose of 40 Gray (Gy), and the end of RT (66 Gy). Results The incidence of moist desquamation was significantly higher in the control than in the PBMT group at the end of RT (30 vs. 7%, respectively, odds ratio = 6, p = 0.004). The biophysical skin measures showed that the mean percentage change from the baseline transepidermal water loss (TEWL), erythema, and melanin values was significantly higher in the control than in the PBMT group at the end of RT (ps 800 cc) breast volume (odds ratio = 4, p = 0.017). Conclusions This is the first randomized controlled trial demonstrating by objective measurements that PBMT is effective in reducing the incidence of moist desquamation in breast cancer patients undergoing RT. Additionally, a large breast volume is an important risk factor for the development of moist desquamation. This research is part of the Limburg Clinical Research Program (LCRP) UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. Additionally, this research is supported by Kom op Tegen Kanker, Limburgs Kankerfonds, and ASA Srl.

Background: The aim of our study was to investigate the efficacy of photobiomodulation therapy (PBMT) for the prevention of radiodermatitis (RD) in breast cancer patients. Methods: This is a randomized controlled, patient-blinded study with breast cancer patients that underwent an identical radiotherapy (RT) regime post-lumpectomy. A total of 57 patients were enrolled and randomly assigned to the intervention group to receive laser therapy (LT, n = 30) or the control group to receive a sham treatment (n = 27). LT or sham was applied two days a week, immediately after the RT session, starting at the first day of RT. LT was delivered using a class IV MLS® laser that combines two synchronized laser diodes in the infrared range (808-905 nm) with a fixed energy density (4 J/cm2). There were no significant differences between the two groups with respect to patient- and treatment-related characteristics. The skin reactions were evaluated by trained, blinded nurses at fraction 20 and at the end of RT (fraction 33) according to the criteria of the Radiation Therapy Oncology Group (RTOG). Results: At fraction 20 of RT the distribution of the RTOG grades was comparable between both groups ( p= .238), with most of the patients presenting RTOG grade 1. At the end of RT, the severity of RD significantly differed between the two groups ( p= .035), with a greater proportion of patients experiencing RD grade 2 or higher in the control group (30% vs. 7%, for the control and LT group, resp.). The skin reactions of the patients in the control group aggravated ( p= .006), while they remained stable in the LT group ( p= .205).Conclusions: In the control group the skin reactions developed into more severe forms (e.g. moist desquamation) towards the end of RT, whereas in the LT group the skin reactions remained stable. Results of this study show that PBMT is able to prevent aggravation of acute skin reactions of breast cancer patients undergoing RT. Hasselt University, Limburg Sterk Merk, Province of Limburg, Jessa Hospital, Flemish Government, Limburgs Kankerfonds, ASA srl