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Background: In a randomized phase II/III trial (JCOG1008), weekly cisplatin (40 mg/m2) was non‐inferior to 3‐weekly cisplatin (100 mg/m2) for postoperative high‐risk head and neck cancer. We investigated how acute kidney injury (AKI), a major dose‐limiting toxicity effect of cisplatin, affects overall survival (OS). Methods: We analyzed 251 patients from JCOG1008 receiving chemoradiotherapy. AKI was defined based on AKI Network criteria (serum creatinine increase of ≥0.3 mg/dL or ≥1.5‐fold [≥ stage I]) within 30 days after completing chemoradiotherapy. OS in the two arms was compared according to AKI development using the log‐rank test. Results: The total incidence of AKI was lower in the weekly arm than in the 3‐weekly arm (38/122 [31.1%] vs. 56/129 [43.4%]). Additionally, stage II/III AKI occurred less frequently in the weekly arm than in the 3‐weekly arm (8/122 [6.6%] vs. 19/129 [14.7%]). Cisplatin doses were similar in the weekly arm for patients with and without AKI (median, 238.6 mg/m2 vs. 239.2 mg/m2; p = 0.94), but lower in the 3‐weekly arm for those who developed AKI (median, 276.3 mg/m2 vs. 297.4 mg/m2; p = 0.007). In the weekly arm, there was no difference in OS between patients with and without AKI (hazard ratio [HR], 1.06; 95% confidence interval [CI], 0.53 to 2.10). However, in the 3‐weekly arm, patients with AKI had poorer OS than those without AKI (HR, 1.83; 95% CI, 1.04 to 3.21). Conclusions: In this supplementary analysis of JCOG1008 data, AKI impacted the OS of patients with head and neck cancer undergoing postoperative chemoradiotherapy in the 3‐weekly arm but not in the weekly arm. Our results further endorse the utilization of weekly cisplatin at 40 mg/m2 in this setting. [ABSTRACT FROM AUTHOR]

Purpose: There have been few reports on the evaluation of cancer cachexia based on skeletal muscle mass index (SMI) in patients with head and neck cancer. Patients and Methods: One hundred and ninety-two head and neck cancer patients were enrolled. In definitive and adjuvant chemoradiotherapy settings, clinical outcomes were compared between cachexia and non-cachexia patients. Results: Forty patients were diagnosed with cachexia (20.8%). In the definitive setting, overall survival (OS) was significantly shorter in the cachexia group (3-year OS: 50.0% vs 88.5%; p < 0.01), and multivariate analysis identified UICC stage IV, baseline albumin of < 4 and cachexia as poor prognostic factors. However, cachexia was not significant in the adjuvant setting. Conclusion: Cancer cachexia was negatively associated with prognosis in patients with HNC who received definitive chemoradiotherapy. Nutritional intervention during chemoradiotherapy may improve survival in these patients. [ABSTRACT FROM AUTHOR]

Background: Interstitial lung disease (ILD) is known as a potentially severe adverse event associated with epidermal growth factor receptor (EGFR)‐targeted therapy. The incidence and risk factors of ILD in patients with head and neck squamous cancer (HNSCC) treated with cetuximab, an anti‐EGFR monoclonal antibody, have not been established. Methods: We retrospectively reviewed patients with HNSCC who received cetuximab from December 2012 to December 2016 at our institute and evaluated the incidence and risk factors of ILD. Results: Of the 201 patients with HNSCC, ILD was observed in 9 patients (4.5%), 8 of whom had grade 3 or higher. High Krebs von den Lungen‐6 (KL‐6) and ≥50 pack‐years of smoking were significantly predictive of associated with ILD (P = 0.00011 and 0.05, respectively). Conclusion: The incidence of ILD in patients with HNSCC treated with cetuximab was <5%, but most of the ILD cases were severe. High KL‐6 and smoking histories might be predictive for ILD among patients with HNSCC. [ABSTRACT FROM AUTHOR]

Immune checkpoint inhibitors (ICIs) are now widely used to many malignant diseases, but some patients suffer from immune-related adverse events during or after ICI treatments. The monoclonal antibody infliximab is usually chosen as a salvage treatment to combat corticosteroid-resistant adverse events, but infliximab is not recommended as a response to hepatitis because of the potential risk of liver failure. An alternative treatment option has not been established. We treated a head and neck cancer patient (a 50-year-old Japanese male) who suffered from corticosteroid-resistant hepatitis during treatment with nivolumab, an anti-PD-1 ICI, and that was recovered by mycophenolate mofetil salvage therapy. [ABSTRACT FROM AUTHOR]

Concurrent chemoradiotherapy (CCRT) is a standard treatment for locally advanced head and neck cancer (LAHNC) in the definitive setting. The Geriatric Nutritional Risk Index (GNRI) is a screening tool to predict the risk of morbidity and mortality in the older adult. Nutritional management is key during CCRT but the association between prognosis and initial nutritional status in older adults with LAHNC undergoing CCRT remains unknown. Patients ≥65 years old with LAHNC who received definitive CCRT with cisplatin (80 mg/m2 or 100 mg/m2, every three weeks, three times) between 2012 and 2018 were included. Patients without completion of radiotherapy were excluded. Patients were stratified into two groups based on the GNRI (≦98 or > 98). Overall survival (OS) and event-free survival (EFS) were analyzed by the Kaplan-Meier method and the log-rank test. The Cox proportional hazards model was adopted to identify prognostic factors. GNRI, sex, T and N categories were prespecified as variables for multivariable analysis. The median age of 111 patients (88 male, 79%) was 69 years (interquartile range: 67–71), among which 23 patients had low GNRI (20 male, 87%) and 88 patients had high GNRI (68 male, 77%). Baseline clinical characteristics were not statistically different between the two groups. OS was significantly worse in the low GNRI group than in the high GNRI group (p = 0.048). There was no statistical difference in EFS between the two groups (p = 0.12). Multivariable analysis revealed that low GNRI (hazard ratio [HR]: 3.17, 95% confidence interval [95%CI]: 1.12–8.96, p = 0.029) and higher N category (HR: 4.37, 95% CI: 1.58–12.06, p = 0.004) were associated with worse OS. For EFS, the higher N category was significantly associated with a worse outcome (HR: 2.54, 95% CI: 1.16–5.59, p = 0.02). Poorer nutritional status before initiation of CCRT was associated with worse OS in older adults with LAHNC in the definitive setting. The GNRI is a convenient tool for predicting OS in older adult patients with LAHNC treated with CCRT. [ABSTRACT FROM AUTHOR]

• We developed a risk prediction model for cisplatin-induced acute kidney injury. • Three-weekly high-dose cisplatin administration was counted as a risk factor. • The primary site, serum albumin level, and creatinine clearance were also included. • Patients undergoing postoperative chemoradiotherapy prefer a weekly regimen. Acute kidney injury (AKI) represents a major toxicity associated with cisplatin. We developed a risk prediction model for cisplatin-induced AKI in patients with postoperative high-risk head and neck cancer who received chemoradiotherapy during a randomized phase II/III trial, JCOG1008. Two hundred and fifty-one patients received radiotherapy with weekly cisplatin at 40 mg/m2 (weekly arm) or 3-weekly cisplatin at 100 mg/m2 (3-weekly arm). AKI was defined using the AKI Network classification/staging system as increased serum creatinine of ≥0.3 mg/dL or a ≥1.5-fold increase from baseline 30 days after completing chemoradiotherapy. The Akaike information criterion was used to explore the optimal model by combining explanatory variables at registration. Among the 251 patients (210 men and 41 women (median age; 62 years)), 94 (37.5 %) developed cisplatin-induced AKI. The optimal cisplatin-induced AKI risk prediction model comprised four factors, including a primary site of hypopharynx/larynx (vs. oral cavity/oropharynx), 3-weekly arm (vs. weekly arm), serum albumin of ≤3.5 g/dL (vs. >3.5 g/dL) and creatinine clearance (CCr) of <90 mL/min (vs. ≥90 mL/min). The incidence of cisplatin-induced AKI rose with cumulative count of the four factors. When the cumulative count was ≥2, the positive predictive value for cisplatin-induced AKI was 50.3 %. We developed a risk prediction model for cisplatin-induced AKI in patients with head and neck cancer who received postoperative chemoradiotherapy using primary site, cisplatin administration method, serum albumin, and CCr. Patients with risk factors unrelated to the cisplatin administration method should adopt a weekly cisplatin regimen. [ABSTRACT FROM AUTHOR]

Abstract: Objective: There have been few reports addressing methods of dealing with free flap thrombosis after reconstructive surgery for head and neck cancer. The present study, through a detailed analysis of the subsequent course of patients who developed postoperative flap thrombosis, aims to clarify possible methods of salvage surgery in the event of vascular occlusion despite rigorous postoperative follow-up. Methods: We analyzed 59 cases of postoperative thrombosis in 1031 patients who underwent free flap transfer and considered the most appropriate salvage surgery in the event of total flap necrosis. Results: The flap salvage rate through vascular reanastomosis was highest for radial forearm flaps, with salvage of jejunal flaps being problematic if postoperative thrombosis occurred. For cases of postoperative thrombosis among patients who underwent reconstruction using a jejunal flap, the period of hospitalization was significantly extended for those patients in whom a second jejunal flap grafting was impossible. For cases of postoperative thrombosis among patients who underwent reconstruction using a radial forearm flap (FA), rectus abdominis flap (RA), or anterior lateral thigh flap (ALT), no significant difference was observed between those undergoing re-grafting with a free flap and those with a pedicled flap. Conclusion: We concluded that, among patients who undergo reconstruction using a jejunal flap, thrombosis should be discovered at an early stage to enable another jejunal flap re-grafting. For patients who undergo reconstruction using a FA, RA, or ALT, if thrombosis can be discovered at an early stage, there is a possibility of salvaging the flap by means of vascular reanastomosis. If it should prove impossible to salvage the flap, however, primary suture of the defect or reconstruction with a pedicled flap may also be considered. [Copyright &y& Elsevier]