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Background A high incidence of severe acute radiation dermatitis (ARD) has been reported for cancer patients treated by proton beam therapy (PBT). This prospective study investigated the prognostic factors and treatment outcomes of ARD among patients with nasopharyngeal carcinoma (NPC) treated with PBT. Methods Fifty-seven patients with newly diagnosed NPC and treated with PBT were enrolled. ARD was recorded weekly based on the criteria of Common Terminology Criteria for Adverse Events version 4.0 in a prospective fashion at treatment visits (1st to 7th weeks) and 1 week (8th week) and 1 month (11th week) after the completion of PBT. Topical corticosteroid was used when grade 1 ARD appeared, and silver sulfadiazine was added if ARD progressed to grade 2 or more. Results The maximum ARD grade was 1, 2, and 3 in 26 (45.6%), 24 (42.1%), and 7 (12.3%) of the patients, respectively. The peak incidence of grade 2 and 3 ARD was observed during the period of the 6th to 8th weeks. Twenty-four (42.1%) patients received topical corticosteroid alone; 33 (57.9%) patients received the combination of topical corticosteroid and silver sulfadiazine. In the 11th week, most grade 2 and 3 ARD had disappeared and 93.0% of the patients had ARD of grade 1 or lower. In the binary logistic regression model, we identified habitual smoking [odds ratio (OR): 5.2, 95% confidence interval (CI): 1.3–18.8, P = 0.012] and N2 to N3 nodal status (OR: 4.9, 95% CI: 1.6–15.4, P = 0.006) as independent predictors of grade 2 and 3 ARD. Conclusion The results show ARD is a major concern for patients with NPC treated with PBT, especially those with habitual smoking or advanced nodal status. Topical corticosteroid and silver sulfadiazine are effective for treating ARD induced by PBT.

Concurrent chemoradiation therapy (CCRT) is the mainstay treatment for patients with nasopharyngeal carcinoma (NPC). Baroreflex impairment can be a late sequela in patients after neck radiotherapy. We hypothesized that cardiovascular autonomic dysfunction is a progressive process that can begin after CCRT and persists for a longer period.Cardiovascular autonomic function was assessed in 29 newly diagnosed patients with NPC using standardized measures including heart rate response to deep breathing (HRDB), Valsalva ratio (VR), baroreflex sensitivity (BRS), and analyses of heart rate variability (HRV), biomarkers of oxidative stress, and inflammation at three different time points (baseline, immediately after CCRT, and 9 years after enrollment). A healthy control group was recruited for the comparison.Although there was an aging effect on autonomic parameters in both groups during the 9 years of follow-up, the between-group comparison showed that there was a significant decrease in HRDB, VR, and HRV at the 9th year of follow-up in the NPC group. Repeated measures ANOVA after controlling for age and sex showed that both HRDB and triangle index of HRV had statistically significant differences between the two groups.Based on our results, cardiovascular autonomic dysfunction after CCRT is a progressive and dynamic process. Cardiovagal impairment occurs in the early phase and persists in decline, while adrenergic dysfunction is significant only after a 9-year follow-up. In contrast to the current opinion, our study showed that both afferent and efferent baroreflex pathways can be involved after CCRT.

This study explored the effect of transdermal buprenorphine on quality of life and six symptoms in cancer patients with pain.Transdermal opioids offer advantages over traditional routes of administration. The impact of transdermal buprenorphine on quality of life for patients with cancer in Asian populations is unknown.This study employed a single-arm observational repeated measures design. Cancer patients with pain were evaluated prior to treatment (baseline). Over a 4-week treatment period, quality of life and symptoms were assessed at 2 and 4 weeks. This study adhered to the recommendations of STROBE guidelines.This multi-site study was conducted in six hospitals located across northern, middle and southern Taiwan. Adult cancer patients whose pain was previously stable with opioid analgesics and, based on clinical judgement, were able to convert to transdermal buprenorphine treatment were invited to participate. Quality of life was measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).Generalised estimating equations showed participants who completed at least one follow-up measurement (N = 80) over 4-weeks had a significant improvement in overall quality of life. Functional status only improved for social functioning. However, symptom severity decreased significantly for nausea/vomiting, pain, insomnia and constipation.The study provides initial evidence supporting transdermal buprenorphine for providing beneficial effects of improving quality of life and reducing severity of symptoms in Asian patients with cancer.The findings of this study can inform the clinical practice that the use of transdermal buprenorphine in cancer patients with pain may also reduce the severity of other symptoms and improve overall quality of life.This study was registered in ClinicalTrials.gov. Identifier: NCT04315831.

Background: Growing patients with nasopharyngeal carcinoma (NPC) were treated with intensity-modulated proton therapy (IMPT). However, a high probability of severe acute radiation dermatitis (ARD) was observed. The objective of the study is to investigate the dosimetric parameters related to ARD for NPC patients treated with IMPT. Methods: Sixty-two patients with newly diagnosed NPC were analyzed. The ARD was recorded based on the criteria of Common Terminology Criteria for Adverse Events version 4.0. Logistic regression model was performed to identify the clinical and dosimetric parameters related to ARD. Receiver operating characteristic (ROC) curve analysis and the area under the curve (AUC) were used to evaluate the performance of the models. Results: The maximum ARD grade was 1, 2, and 3 in 27 (43.5%), 26 (42.0%), and 9 (14.5%) of the patients, respectively. Statistically significant differences (p < 0.01) in average volume to skin 5 mm with the respective doses were observed in the range 54–62 Cobalt Gray Equivalent (CGE) for grade 2 and 3 versus grade 1 ARD. Smoking habit and N2-N3 status were identified as significant predictors to develop grade 2 and 3 ARD in clinical model, and V58CGE to skin 5 mm as an independent predictor in dosimetric model. After adding the variable of V58CGE to the metric incorporating two parameters of smoking habit and N status, the AUC value of the metric increases from 0.78 (0.66–0.90) to 0.82 (0.72–0.93). The most appropriate cut-off value of V58CGE to skin 5 mm as determined by ROC curve was 5.0 cm3, with a predicted probability of 54% to develop grade 2 and 3 ARD. Conclusion: The dosimetric parameter of V58CGE to skin 5 mm < 5.0 cm3 could be used as a constraint in treatment planning for NPC patients treated by IMPT.

Buprenorphine is one of the strongest opioids used for the relief of cancer pain. This study aims to evaluate the real-world clinical experiences of transdermal buprenorphine used in moderate to severe cancer pain in the Asian population.This is an open-labeled, multicenter, 4-week observational study. Stable cancer pain patients who decided to switch the previous opioid to transdermal buprenorphine will be enrolled in this study. The safety and effectiveness were observed and collected. Pain assessment was performed using a numerical rating scale by the investigators and the Brief Pain Inventory Short Form (BPI-SF) by the patient. The safety profiles included concomitant medications and adverse events (AEs).A total of 83 patients were enrolled in this study. The global pain scores in the BPI, as well as the four individual pain parameters (worst, least, average, and right now), showed a continued decrease (p .05) from week 2 to week 4. Significant improvements were observed in normal work activities, relations with other people, sleep, enjoyment of life, and global BPI pain interference score on week 4. Pain assessments conducted by investigators demonstrated significant, continuous improvements during the study periods. In addition, transdermal buprenorphine demonstrated good safety/tolerability with limited drug-related AEs in the Asian population with cancer pain.This study demonstrated that transdermal buprenorphine in the Asian population has good safety profiles and continued improvements in pain relief, sleep, and pain interferences. Transdermal buprenorphine can be an effective and convenient option as a transdermal opioid for patients with moderate to severe cancer pain in Taiwan. (NCT Number: NCT04315831).

5-methyltetrahydrofolate-homocysteine methyltransferase reductase (MTRR) is responsible for folate metabolism, and we aimed to investigate its genetic role in colorectal cancer (CRC) among Taiwanese.A total of 362 cases and 362 controls were recruited and their MTRR rs1801394 (A66G) and rs1532268 (C524T) genotypes were examined. The behavioral factors and clinicalpathological factors were also analyzed.MTRR rs1801394 genotypes were associated with CRC risk (p for trend=0.0087). In detail, G/G genotype was associated with lower risk (p=0.0049, OR=0.39, 95%CI=0.20-0.76). As for allelic frequency analysis, G allele was also associated with decreased CRC risk (p=0.0026, OR=0.68, 95%CI=0.53-0.88). There was no significant association as for MTRR rs1532268. Among non-smokers and non-alcohol drinkers, those with G/G genotype were at 0.38- and 0.46-fold odds of having CRC. There were no significant protective effects among smokers or alcohol drinkers.MTRR rs1801394 GG genotype can be a protective marker for CRC risk in Taiwan.

Radiation-related extracranial vasculopathy is a common late effect after radiation in patients with nasopharyngeal carcinoma (NPC). We proposed the hypothesis that radiation-related extracranial vasculopathy is a progressive process that can begin immediately after radiotherapy and persist for a longer period, and inflammation and oxidative stress may play a pivotal role in this process. Thirty-six newly diagnosed NPC patients were assessed with B-mode ultrasound for the common carotid artery (CCA) intima media thickness (IMT) measurement as well as surrogate markers at three different stages (baseline, immediately after concurrent chemoradiation therapy (CCRT), and 9 years after enrollment). A healthy control group was also recruited for comparison. Surrogate markers including a lipid profile, HbA1c, inflammation, oxidative stress, and platelet activation markers were assessed. The mean CCA IMT in the NPC group were increased immediately after CCRT (p = 0.043). The mean CCA IMT value after a 9-year follow-up also showed a significant increase in NPC and control group, respectively (p < 0.0001 and p < 0.0001, paired t test). The annual increase mean CCA IMT (mm) was 0.053 ± 0.025 and 0.014 ± 0.013 in NPC and control group, respectively (p < 0.0001). The baseline high sensitivity CRP (hs-CRP), thiol, TBARS, and CD63 level were significantly higher in the NPC group (hs-CRP, p = 0.001, thiol, p < 0.0001, TBARS, p = 0.05, and CD63 level, p = 0.04). The thiol and TBARS levels were significantly lower in NPC patients immediately after CCRT (thiol, p < 0.0001, and TBARS, p = 0.043). The CD62P level was significantly higher while the thiol level was significantly lower in the NPC group after a 9-year follow-up (CD62P level, p = 0.007; and thiol level, p = 0.004). Radiation-related extracranial vasculopathy is a progressive process that begins immediately after radiotherapy with significantly increased carotid IMT compared to the control group during the 9-year follow-up. Chronic inflammation and oxidative stress might serve to drive the process and also contribute to increased platelet activation.

e18013 Background: Cetuximab significantly improved survival outcomes of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) when combined with chemotherapy. The aim of this study was to explore clinical outcomes, prognostic factors, and risk stratification model for R/M HNSCC patients who received cetuximab-containing regimens based on a real-world, multicenter Taiwanese patient cohort. Methods: This is a retrospective study involving 12 oncology institutions in Taiwan. All R/M HNSCC patients who received cetuximab-containing regimens from January 2017 to December 2020 were included in this study. Prognostic factors were evaluated by univariate/ multivariate analysis. The factors that showed significant differences (p < 0.05) were selected to establish the prediction model. The receiver operating characteristic (ROC) curve was obtained to select cut-off values as a reference for continuous variables. The risk score system incorporated both continuous and categorical factors. The score was determined according to hazard ratio. Results: A total of 818 R/M HNSCC patients were included in this study. Patient characteristics were as following: median age, 56 years; performance status (PS) 0/1/≧2, 16.0%/70.4%/13.3%; oral/ oropharynx/ hypopharynx/ larynx/ others, 51.5%/17.5%/19.7%/6.4%/5.0%; stage at initial diagnosis (AJCC8), 0/I/II/III/IVA/IVB/IVC/unknown, 0.2%/5.9%/8.1%/7.1%/ 35.5%/18.0%/6.7%/18.6%; locoregional recurrence/ distant metastasis/ unknown, 38.4%/ 56.0%/ 5.6%; site of distant metastasis, lung/ distant lymph node/ bone/ liver/ skin/ brain, 60.3%/ 37.1%/ 18.8%/ 6.3%/ 8.1%/ 3.3%; cetuximab-PF/ cetuximab-non-PF regimen, 56.6%/ 43.4%. The median overall survival (mOS) was 10.0 months (95% confidence interval [CI] 9.1-10.9 months). Multivariate analysis disclosed poor prognostic factors on OS, including poor PS, smoking history, R2 resection of primary surgery, present distant metastasis at bone, cetuximab combined with non-PF regimen. In addition, HB and neutrophil to lymphocyte ratio (NLR) were shown to have significant difference between treatment responders and non-responders (inc. SD pts). Risk-stratification model was established including factors: PS, smoking history, bone metastasis, hemoglobin level, and NLR. The mOS of the three risk groups stratified from the prediction model were 13.0/7.0/4.0 months (p < 0.001). Conclusions: Poor prognostic factors for R/M HNSCC treated with cetuximab-based regimens includes poor PS, smoking history, R2 resection of primary surgery, bone metastasis, and non-PF regimen. In this study, the risk-stratification model for cetuximab-based treatment was established using some of the identified prognostic factors help to predict the overall survival for R/M HNSCC patients.