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DisclaimerThis article is based on recommendations from the 12th WALT Congress, Nice, October 3-6, 2018, and a follow-up review of the existing data and the clinical observations of an international multidisciplinary panel of clinicians and researchers with expertise in the area of supportive care in cancer and/or PBM clinical application and dosimetry. This article is informational in nature. As with all clinical materials, this paper should be used with a clear understanding that continued research and practice could result in new insights and recommendations. The review reflects the collective opinion and, as such, does not necessarily represent the opinion of any individual author. In no event shall the authors be liable for any decision made or action taken in reliance on the proposed protocols.ObjectiveThis position paper reviews the potential prophylactic and therapeutic effects of photobiomodulation (PBM) on side effects of cancer therapy, including chemotherapy (CT), radiation therapy (RT), and hematopoietic stem cell transplantation (HSCT).BackgroundThere is a considerable body of evidence supporting the efficacy of PBM for preventing oral mucositis (OM) in patients undergoing RT for head and neck cancer (HNC), CT, or HSCT. This could enhance patients’ quality of life, adherence to the prescribed cancer therapy, and treatment outcomes while reducing the cost of cancer care.MethodsA literature review on PBM effectiveness and dosimetry considerations for managing certain complications of cancer therapy were conducted. A systematic review was conducted when numerous randomized controlled trials were available. Results were presented and discussed at an international consensus meeting at the World Association of photobiomoduLation Therapy (WALT) meeting in 2018 that included world expert oncologists, radiation oncologists, oral oncologists, and oral medicine professionals, physicists, engineers, and oncology researchers. The potential mechanism of action of PBM and evidence of PBM efficacy through reported outcomes for individual indications were assessed.ResultsThere is a large body of evidence demonstrating the efficacy of PBM for preventing OM in certain cancer patient populations, as recently outlined by the Multinational Association for Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Building on these, the WALT group outlines evidence and prescribed PBM treatment parameters for prophylactic and therapeutic use in supportive care for radiodermatitis, dysphagia, xerostomia, dysgeusia, trismus, mucosal and bone necrosis, lymphedema, hand-foot syndrome, alopecia, oral and dermatologic chronic graft-versus-host disease, voice/speech alterations, peripheral neuropathy, and late fibrosis amongst cancer survivors.ConclusionsThere is robust evidence for using PBM to prevent and treat a broad range of complications in cancer care. Specific clinical practice guidelines or evidence-based expert consensus recommendations are provided. These recommendations are aimed at improving the clinical utilization of PBM therapy in supportive cancer care and promoting research in this field. It is anticipated these guidelines will be revised periodically.

Purpose The purpose of this study was to investigate the effectiveness of photobiomodulation (PBM) therapy for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients. Methods A prospective, randomized placebo-controlled pilot trial (NEUROLASER) was set up with 32 breast cancer patients who underwent chemotherapy (ClinicalTrials.gov; NCT03391271). Patients were randomized to receive PBM (n = 16) or placebo treatments (n = 16) (2 × /week) during their chemotherapy. The modified Total Neuropathy Score (mTNS), six-minute walk test (6MWT), Numeric pain Rating Scale (NRS), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Taxane (FACT/GOG-Taxane) were used to evaluate the severity of CIPN and the patients’ quality of life (QoL). Outcome measures were collected at the first chemotherapy session, 6 weeks after initiation of chemotherapy, at the final chemotherapy session, and 3 weeks after the end of chemotherapy (follow-up). Results The mTNS score increased significantly over time in both the control and the PBM group. A significantly higher score for FACT/GOG-Taxane was observed in the PBM group during chemotherapy compared to the control group. Questions of the FACT/GOG-Taxane related to sensory peripheral neuropathy symptoms showed a significant increase in severeness over time in the control group, whereas they remained constant in the PBM group. At follow-up, a (borderline) significant difference was observed between both groups for the 6MWT and patients’ pain level, in benefit of the PBM group. Conclusions This NEUROLASER trial shows promising results concerning the prevention of CIPN with PBM in breast cancer patients. Furthermore, a better QoL was observed when treated with PBM.

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.

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.

ObjectiveBecause elderly patients with ovarian cancer are underrepresented in randomized studies, this study aimed to expand our knowledge on the safety and effectiveness of frontline treatment with bevacizumab in combination with standard carboplatin and paclitaxel chemotherapy in patients aged 70 years and older with a diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage IV ovarian cancer in routine clinical practice in Belgium.MethodsPatients aged 70 years and older with FIGO stage IV ovarian cancer were included in a multicenter, non-interventional prospective studyto evaluate the safety and effectiveness of treatment with bevacizumab in combination with frontline carboplatin and paclitaxel chemotherapy. Comprehensive geriatric assessments were performed at baseline and during treatment.ResultsThe most frequently reported adverse events for bevacizumab were hypertension (55%), epistaxis (32%) and proteinuria (21%). The Kaplan-Meier estimate of progression-free survival was 14.5 months. The results of the comprehensive geriatric assessments during treatment indicated a slight improvement in the geriatric eight health status screening tool score for general health status and the mini-nutritional assessment score for nutritional status. The median change from baseline score was close to zero for the instruments measuring independency, activity of daily living and instrumental activities of daily living, and for the mobility-tiredness test measuring self-perceived fatigue.ConclusionsNo new safety signals were registered in this study in patients aged 70 years and older treated with bevacizumab and frontline carboplatin and paclitaxel for FIGO stage IV ovarian cancer. Elderly patients should not be excluded from treatment for advanced ovarian cancer based on age alone.EU PAS registerENCEPP/SDPP/13849.ClinicalTrials.gov identifierNCT02393898.

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.

PRECISION is an initiative from the Belgian Society of Medical Oncology (BSMO) in collaboration with several stakeholders, encompassing four programs that aim to boost genomic and clinical knowledge with the ultimate goal to offer patients with metastatic solid tumors molecularly guided treatments. The PRECISION 1 study has led to the creation of a clinico-genomic database. The Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT) and GeNeo studies will increase the number of patients with advanced cancer that have comprehensive genotyping of their cancer. The PRECISION 2 project consists of investigator-initiated phase II studies aiming to provide access to a targeted drug for patients whose tumors harbor actionable mutations in case the matched drug is not available through reimbursement or clinical trials in Belgium. This work was supported by grants from the 1 study and grants from the Belgian Foundation against Cancer and Kom op Tegen Kanker to the PRECISION 1 and 2 studies and the Biltema Foundation (no grant number). GeNeo is funded by a grant from Roche (no grant number). BALLETT is funded by grants from Illumina and OncoDNA (no grant number).

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.

Objectives: Our aim was to evaluate locoregional relapse (LR) patterns after induction chemotherapy and surgery for stage III-N2 NSCLC staged with current standard methods and their impact on radiation target volumes for postoperative radiotherapy (PORT). Methods: A total of 150 patients with stage III-N2 NSCLC from a prospective database of patients who underwent surgical resection at the University Hospitals of Leuven or the Oncologic Centre Limburg between 1998 and 2012 were included. Patients were staged with fluorodeoxyglucose F 18 positron emission tomography/computed tomography and brain imaging and treated with induction chemotherapy and surgery. PORT was performed for incomplete resection (R1/R2) and/or persistent nodal disease (ypN2). For the non-PORT group, we created a virtual planning target volume (PTV). In general, the clinical target volume encompassed the bronchial stump, the ipsilateral hilum, the subcarinal region (station 7), and the initially involved mediastinal lymph nodes. Results: After a mean follow-up time of 49 months, the 5-year overall survival was 35.1% in all patients; disease free survival was 31.8%. PORT was delivered to 70 patients. LR was seen in 26 patients in the PORT group (37%) and 32 in the non-PORT group (40%). Fifty-eight nodal relapse sites were seen in the PORT group (2.2 sites per patient) versus 113 in the non-PORT group (3.5 sites per patient) (p < 0.01). In the PORT group, the most frequent sites of LR were the ipsilateral hilum (21%), lymph node station 7 (15%), ipsilateral station 4 (9%), ipsilateral station 5 (9%) and ipsilateral station 6 (9%). For the non PORT group these were station 7 (19%), ipsilateral 4 (16%), and ipsilateral hilum (14%). The dominant pattern of failure was inside (inside or both inside and outside) the PTV. Regarding the out-of-PTV relapses, 47% and 69% of LRs occurred in the contralateral mediastinum for the PORT and non-PORT groups, respectively. Out-of-PTV relapses occurred mostly in initially left-sided tumors. Conclusions: Despite the limitations of this retrospective study, our data support the role of PORT in decreasing local relapses. Because of the large number of out-of-PTV relapses in the contralateral mediastinum, inclusion of elective contralateral lymph node stations in the PTV could be considered in left-sided tumors. However, prospective randomized trials are needed to verify this. This study is part of the Limburg Clinical Research Program UHasselt-ZOL-Jessa, which is supported by the foundation Limburg Sterk Merk, Province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. Dr. Billiet is supported by the Cancer Foundation Limburg.

Background The Cancer Rehabilitation Evaluation System (CARES) is a quality of life (QOL) and needs assessment instrument of US origin that was developed in the 90’s. Since November 2012 the copyright and user fee were abolished and the instrument became publicly available the present study aims to reinvestigate the psychometric properties of the CARES for the Flemish population in Belgium. Methods The CARES was translated into Flemish following a translation-back translation process. A sample of 192 cancer patients completed the CARES, concurrent measures, and questions on socio-demographic and medical data. Participants were asked to complete the CARES a second time 1 week later, followed by some questions on their experiences with the instrument. Internal consistency, test-retest reliability, content validity, construct validity, concurrent validity and feasibility of the CARES were subsequently assessed. Results The Flemish CARES version demonstrated excellent reliability with high internal consistency (range .87–.96) and test-retest ratings (range .70–.91) for all summary scales. Factor analysis replicated the original factor solution of five higher order factors with factor loadings of .325–.851. Correlations with other instruments ranging from |.43|–|.75| confirmed concurrent validity. Feasibility was indicated by the low number of missing items (mean 2.3; SD 5.0) and positive feedback of participants on the instrument. Conclusions The Flemish CARES has strong psychometric properties and can as such be a valid tool to assess cancer patients’ QOL and needs in research, for example in international comparisons. The positive feedback of participants on the CARES support the usefulness of this tool for systematic assessment of cancer patients’ well-being and care needs in clinical practice. Trial registration ClinicalTrials.gov: NCT02282696 (July 16, 2014). Electronic supplementary material The online version of this article (doi:10.1186/s12885-016-2728-9) contains supplementary material, which is available to authorized users.

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