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Introduction: This study investigates the pretherapeutic neutrophil-to-lymphocyte ratio (NLR) with markers of tumor metabolism in 18-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) and their potential prognostic value in head and neck cancer patients prior to primary chemoradiation. Materials and Methods: NLR and metabolic markers of primary tumor and nodal metastases including maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) were retrospectively assessed in a consecutive cohort of head and neck squamous cell cancer patients undergoing primary chemoradiation. The main outcome measure was survival. Results: The study included 90 patients of which 74 had lymph node metastases at diagnosis. Median follow-up time of nodal positive patients (n=74) was 26.5 months (IQR 18–44). The NLR correlated significantly with metabolic markers of the primary tumor (TLG: rs=0.47, P <0.001; MTV: rs=0.40, P <0.001; SUVmax: rs=0.34, P =0.003), but much less with FDG-PET/CT surrogate markers of metabolic activity in nodal metastases (TLG: rs=0.15, P =0.19; MTV: rs=0.25, P =0.034; SUVmax: rs=0.06, P =0.63). For nodal positive cancer patients, multivariate analysis showed that an increased NLR (HR=1.19, 95% CI=1.04-1.37, P =0.012) and SUVmax of lymph node metastasis (HR=1.09; 95% CI=0.99-1.19; P =0.081) are independently predictive of disease-specific survival. High NLR had a negative prognostic value for overall survival (HR=1.16, 95% CI=1.02-1.33, P =0.021). Conclusion: NLR correlates positively with metabolic markers of the primary tumor, suggestive of an unspecific inflammatory response in the host as a possible reflection of increased metabolism of the primary tumor. SUVmax of lymph node metastases and the NLR, however, show no correlation and are independently predictive of disease-specific survival. Therefore, their addition could be used to improve survival prediction in nodal positive head and neck cancer patients undergoing primary chemoradiation. [ABSTRACT FROM AUTHOR]

Background: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.Methods: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.Results: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.Conclusion: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options. [ABSTRACT FROM AUTHOR]

Approximately 70% of head and neck cancer (HNC) patients present with locoregionally advanced disease. The curative rate for early disease is 80-95%; for advanced tumors, locoregional recurrence rate remains at about 50-60% despite advances in treatment, and 20-30% will have distant metastases. Further, patients will develop a second primary malignancy (SPM) with a rate of 2-4% per year. Follow-up (FU) is important to detect recurrence (REC) and SPM at an early stage, to enable effective salvagetherapy, manage treatment-related sequelae, and provide functional rehabilitation and psychosocial support. In the absence of high-level evidence, there is no clear international consensus in FU regimens. There are only retrospective studies addressing this topic, mostly showing no difference in overall survival between patients with REC detected during routine FU and symptom-driven self-referral visits. The value of imaging is also subject of debate. Moreover, many of the hitherto published studies did not include the logistical, psychological and financial consequences and the relevant cost evaluations in today's healthcare systems facing increasing financial pressure. We propose a large multicenter, randomized prospective trial in HNC patients with complete remission 6 months after curative treatment to compare two FU schemes differing in frequency of scheduled clinical examinations and imaging. We hypothesize that implementing an individualized de-intensified FU with active patient involvement does not differ from a conventional regular FU in terms of death from any cause up to 5 years (=primary endpoint). We also hypothesize that symptom-driven self-referral FU visits have a higher diagnostic yield in detection of REC/SPM than regular scheduled clinical and radiological examinations. Consequently, we assume that fewer scheduled exams in well-instructed patients will not lead to worse outcome. The secondary objectives are the comparison of death from HNC and any cancer, detection of first REC/SPM, health-related quality of life, fear of recurrence, compliance with FU assessments, number of visits and HNC-specific health-care utilization. The objective of the herein presented Pilot 1 study was to assess the feasibility of patients' recruitment, motivation for trial participation and compliance in completing a monthly, paper-based symptoms' monitoring (patient-reported outcome [PRO], symptom tracker). This Pilot is supported by Swiss Cancer Research. The study design is shown in Figure 1 (RMST: restricted mean survival time). [Display omitted] The main study is a randomized-controlled combined non-inferiority and superiority trial with explicit Pilot 1 and 2. After curative treatment, participants are randomized to an individualized de-intensified FU with monthly symptoms' monitoring (Figure 2) (experimental arm) or to standard FU. [Display omitted] Alerting symptoms possibly indicating REC/SPM or non-completion of the PROs will result in an urgent clinical FU appointment in the experimental arm. Minimal FU within Pilot 1 is 12 months (as opposed to 60 months in the main trial). Recruitment was done in three Swiss tertiary referral centers, which committed to enroll at least 20 patients during one year. The primary aim of Pilot 1, evaluating the feasibility of patient recruitment, has been confirmed faster than expected (20 committed patients randomized after 7 and 29 patients randomized after 11 months accrual time, respectively). Six unscheduled visits were triggered by our paper-based PRO. Within Pilot 1, a prescreening survey was conducted to better understand the specific motivation of patients to participate in the trial or not. We surveyed 41 potential participants of which 27 (66%) agreed to participate. The potential reduction in imaging was the main reason for the patients to participate in the trial (52%). Additionally, we collected feedback on the design of the paper-based PRO questionnaire at the 6-month FU visit when participants had already gained some experience. Participants expressed that the PRO questionnaire was easy to understand and comprehensive, thus facilitating them to communicate with their corresponding study center. The completion time for the PRO was between 5-10 minutes in 63% of the participants. In addition, 63% of the patients were in favor of transitioning the paper-based PRO to an electronic version (ePRO), the other 37% felt unsure about using an ePRO. Interim compliance data will be presented. The recruitment and symptoms' monitoring for HNC patients have been proofed as feasible. Pilot 2 is in planning to allow for a smooth continuation of Pilot 1 with following specific goals: 1) to expand the trial to 12 Swiss and 4 European sites; 2) to recruit up to 200 participants; 3) to implement a web-based version of the symptom tracker (ePRO); 4) to develop an enhanced training strategy for HNC patients; 5) to evaluate the usability of the ePRO; and 6) to assess the safety of omitting systematic lung imaging. [ABSTRACT FROM AUTHOR]

Introduction: This study investigates the pretherapeutic neutrophil-to-lymphocyte ratio (NLR) with markers of tumor metabolism in 18-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) and their potential prognostic value in head and neck cancer patients prior to primary chemoradiation., Materials and Methods: NLR and metabolic markers of primary tumor and nodal metastases including maximum standardized uptake value (SUV max ), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) were retrospectively assessed in a consecutive cohort of head and neck squamous cell cancer patients undergoing primary chemoradiation. The main outcome measure was survival., Results: The study included 90 patients of which 74 had lymph node metastases at diagnosis. Median follow-up time of nodal positive patients (n=74) was 26.5 months (IQR 18-44). The NLR correlated significantly with metabolic markers of the primary tumor (TLG: r s =0.47, P <0.001; MTV: r s =0.40, P <0.001; SUV max : r s =0.34, P =0.003), but much less with FDG-PET/CT surrogate markers of metabolic activity in nodal metastases (TLG: r s =0.15, P =0.19; MTV: r s =0.25, P =0.034; SUV max : r s =0.06, P =0.63). For nodal positive cancer patients, multivariate analysis showed that an increased NLR (HR=1.19, 95% CI=1.04-1.37, P =0.012) and SUV max of lymph node metastasis (HR=1.09; 95% CI=0.99-1.19; P =0.081) are independently predictive of disease-specific survival. High NLR had a negative prognostic value for overall survival (HR=1.16, 95% CI=1.02-1.33, P =0.021)., Conclusion: NLR correlates positively with metabolic markers of the primary tumor, suggestive of an unspecific inflammatory response in the host as a possible reflection of increased metabolism of the primary tumor. SUV max of lymph node metastases and the NLR, however, show no correlation and are independently predictive of disease-specific survival. Therefore, their addition could be used to improve survival prediction in nodal positive head and neck cancer patients undergoing primary chemoradiation., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Werner, Strobel, Lehnick and Rajan.)