Jeroen Mebis

Photobiomodulation for the management of radiation dermatitis: the DERMIS trial, a pilot study of MLS® laser therapy in breast cancer patients

PurposeThe aim of this study was to assess the effectiveness and acceptability of photobiomodulation using MLS® laser therapy (LT) in the management of acute radiation dermatitis (RD).MethodsWe compared two successive groups of breast cancer patients undergoing identical radiotherapy regimens post-lumpectomy. Both groups received our standard skin care but the second group received six additional LT sessions (beam area 19.635xa0cm2, 0.168xa0W/cm2, 4xa0J/cm2), starting at fraction 20 of radiotherapy (control and LT group, Nu2009=u200941 and 38, respectively). The clinical outcomes were the severity of RD (using the Radiation Therapy Oncology Group [RTOG] criteria and the Radiotherapy-Induced Skin Reaction Assessment Scale [RISRAS]) and dermatology-specific quality of life (Skindex-16) before the start of LT and at the end of radiotherapy. Secondary outcomes were patients’ ratings of skin care or LT (pleasantness, soothing effect, and global satisfaction).ResultsSkin toxicity was equivalent between the groups before the start of LT but significantly differed at the end of radiotherapy, with an aggravation in the control but not in the LT group (e.g., 29 versus 3xa0% of RTOG grade 2 RD, respectively, Pu2009<u20090.005). We found no significant group differences with respect to quality of life. However, the RISRAS subjective score decreased in the LT group only, implying a decreased impact of RD on patients’ quality of life. Finally, patients’ ratings were significantly higher for LT than for standard care.ConclusionsThese findings suggest that LT might be effective to manage acute RD and warrant further research.Trial registrationClinical trial number: NCT01932073. https://clinicaltrials.gov/ct2/show/NCT01932073.

Outcome after PORT in ypN2 or R1/R2 versus no PORT in ypN0 Stage III-N2 NSCLC after Induction Chemotherapy and Resection

Introduction We investigated patients with contemporarily staged and treated stage III‐N2 NSCLC treated with induction chemotherapy and surgery with or without postoperative radiotherapy (PORT). We focused on survival and toxicity and investigated what additional PORT may offer in patients with ypN2 status or incomplete resection. Methods We identified 161 patients with pathologically proven, resectable stage III‐N2 NSCLC from our prospective database who were treated between 1998 and 2012. Of these patients, 150 without progressive disease after chemotherapy underwent resection. Patients with ypN2 status or R1/2 resection received three‐dimensional PORT (n = 70) to a dose of 50 to 66 Gy in 2‐Gy fractions. Results The mean follow‐up time was 49 months. The 5‐year overall survival (OS) rate was 35.1% in intention‐to‐treat analysis; relapse‐free survival was 31.8%, the cumulative local recurrence (LR) rate was 50.9%, and the distant metastasis rate was 63.4%. The 5‐year OS, relapse‐free survival, and cumulative LR and distant metastasis rates were 32.0%, 32.9%, 47.0%, and 63.9% in the PORT group versus 38.1%, 30.7%, 54.1%, and 63.2% in the non‐PORT group. These results were not significantly different, even though patients in the PORT group had worse prognostic features. Cardiac toxicity was higher in the non‐PORT group (p = 0.02), but pulmonary toxicity was similar (p = 0.15). There was no difference between the two groups regarding dyspnea (p = 0.32), cough (p = 0.37), forced expiratory volume in 1 second (p = 0.30), and diffusing capacity of the lung for carbon monoxide (p = 0.61). Conclusions A similar outcome (OS, LR, and toxicity) was seen in both patient groups (PORT versus non‐PORT group). Despite the limitations of this retrospective study, PORT can be both effective and safe for patients with stage III‐N2 NSCLC with an R1/R2 resection or yN2 after induction chemotherapy and surgery.

Assessing cancer patients’ quality of life and supportive care needs: Translation-revalidation of the CARES in Flemish and exhaustive evaluation of concurrent validity

BackgroundThe prevalence of cancer increases every year, leading to a growing population of patients and survivors in need for care. To achieve good quality care, a patient-centered approach is essential. Correct and timely detection of needs throughout the different stages of the care trajectory is crucial and can be supported by the use of screening and assessment in a stepped-care approach. The Cancer Rehabilitation Evaluation System (CARES) is a valuable and comprehensive quality of life and needs assessment instrument. For use in Flemish research and clinical practice, the CARES tool was translated for the Dutch-speaking part of Belgium (Flanders) from its original English format. This protocol paper describes the translation and revalidation of this Flemish CARES version.MethodsAfter forward-backward translation of the CARES into Flemish we aim to recruit 150 adult cancer patients with a primary cancer diagnosis (stage I, II or III) for validation. In this study with a combination of qualitative and a quantitative approach, qualitative data will be collected through focus groups and supplemented by two phases of quantitative data collection: i) an initial patient survey containing questions on socio-demographic and medical data, the CARES and seven concurrent instruments; and ii) a second survey administered after 1 week containing the CARES and supplementary questions to explore their impressions on the content and the feasibility of the CARES.DiscussionWith this extensive data collection process, psychometric validity of the Flemish CARES can be tested thoroughly using classical test theory. Internal consistency of summary scales, test-retest reliability, content validity, construct validity, concurrent validity and feasibility of the instrument will be examined. If the Flemish CARES version is found reliable, valid and feasible, it will be used in future research and clinical practice. Comprehensive assessment with the CARES in a stepped-care approach can facilitate timely identification of cancer patients’ psychosocial concerns and care needs so it can contribute to efficient provision of patient-centered quality care.Trial registrationClinicalTrials.gov: NCT02282696 (July 16, 2014).

Patterns of Locoregional Relapses in Patients with Contemporarily Staged Stage III-N2 NSCLC Treated with Induction Chemotherapy and Resection: Implications for Postoperative Radiotherapy Target Volumes.

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.

Abstract P5-15-05: Evaluation of the effect of low level laser therapy on oral mucositis in breast cancer patients: A retrospective analysis

Background The goal of this retrospective study was to investigate the effectiveness of low level laser therapy (LLLT) in managing chemotherapy-induced oral mucositis (OM) in breast cancer patients. Methods Breast cancer patients treated with chemotherapy at the Jessa Hospital (Hasselt, Belgium) and having received LLLT for OM were retrospectively selected from our database, provided sufficient data with regard to OM was available. LLLT treatment was provided using an AsGA diode laser (γ = 665 nm; output power: 100mW) combined with an infrared laser (continuous emission, output power: 500mW), delivered by an optical fiber with a diameter of 600µm. The energy delivered was 4 J per point of application. Treatment was applied to a maximum of seven sites (tongue, palate, tonsil, left and right inside of the cheek, floor of the mouth, and lips), depending on the location of OM. Patients received treatment two times a week until healing of each lesion. Endpoints were the number of treated areas and the severity of OM at the start and the end of LLLT, graded by trained nurses according to the WHO scale (0 = no change; 1 = soreness, erythema; 2 = erythema, ulcers, can eat solids; 3 = ulcers, requires liquid diet only; 4 = oral alimentation not possible; if more than one location was treated, the highest grade was taken into account). An OM score was calculated for each patient by summing the WHO grades of all treated areas. Finally, where available, pain scores (obtained through a visual analogue scale ranging from 0, no pain, to 10, worst possible pain) were taken into account. Results Data from 93 patients with stage 0-IV breast cancer were included in these analyses. Mean age was 55.37 years (standart deviation [SD] = 9.72, median = 56). Most of the patients received anthracycline-based chemotherapy (65%). At the start of LLLT, mean time since start of chemotherapy was 48.92 days (SD = 39.43, median = 39). The median duration of LLLT was 2 weeks. OM outcomes at the start and the end of LLLT are presented in Table 1. At the end of LLLT, the number of areas that had to be treated significantly decreased. More importantly, there was a significant improvement in the severity of OM (highest WHO grade and OM score) and in pain. This improvement was also observed when patients were categorized according to their status at the end of LLLT (for each OM outcome: worsened, unchanged, or improved). Conclusion This retrospective analysis showed that LLLT, a standard management strategy for OM in head and neck cancer, significantly reduced the severity of chemotherapy-induced oral mucositis and relieved pain in patients with breast cancer. This is the first study in this population. Further research, preferably high-quality randomized controlled trials, is warranted to better investigate its usefulness in this population. Citation Format: Jeroen Mebis, Sandrine Censabella, Annelies Maes, Leen Noe, Paul Bulens. Evaluation of the effect of low level laser therapy on oral mucositis in breast cancer patients: A retrospective analysis [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-15-05.

Postoperative radiotherapy for lung cancer: Is it worth the controversy?

INTRODUCTIONnThe role of postoperative radiation therapy (PORT) in patients with completely resected non-small cell lung cancer (NSCLC) with pathologically involved mediastinal lymph nodes (N2) remains unclear. Despite a reduction of local recurrence (LR), its effect on overall survival (OS) remains unproven. Therefore we conducted a review of the current literature.nnnMETHODSnTo investigate the benefit and safety of modern PORT, we identified published phase III trials for PORT. We investigated modern PORT in low-risk (ypN0/1 and R0) and high-risk (ypN2 and/or R1/2) patients with stage III-N2 NSCLC treated with induction chemotherapy and resection.nnnRESULTSnSeventeen phase III trials using PORT were selected. Of all PORT N2 studies, 4 were eligible for evaluation of LR, all in high-risk patients only. In these high-risk patients receiving PORT, the mean LR rate at 5years was 20.9% (95% CI 16-24). Two trials were suitable to assess LR rates after chemotherapy and surgery without PORT. In these low-risk patients, the mean 5-year LR was 33.1% (95% CI 27-39). No significant difference in non-cancer deaths between PORT vs. non-PORT patients was observed in N2 NSCLC.nnnCONCLUSIONnPORT is worth the controversy because data illustrate that PORT may increase the OS. However, prospective randomized trials are needed to verify this.