The Establishment of China Bronchiectasis Registry and Research Collaboration (BE-China): Protocol of a prospective multicenter observational study.

BACKGROUND: Bronchiectasis is a highly heterogeneous chronic airway disease with marked geographic and ethnic variations. Most influential cohort studies to date have been performed in Europe and USA, which serve as the examples for developing a cohort study in China where there is a high burden of bronchiectasis. The Establishment of China Bronchiectasis Registry and Research Collaboration (BE-China) is designed to: (1) describe the clinical characteristics and natural history of bronchiectasis in China and identify the differences of bronchiectasis between the western countries and China; (2) identify the risk factors associated with disease progression in Chinese population; (3) elucidate the phenotype and endotype of bronchiectasis by integrating the genome, microbiome, proteome, and transcriptome with detailed clinical data; (4) facilitate large randomized controlled trials in China. METHODS: The BE-China is an ongoing prospective, longitudinal, multi-center, observational cohort study aiming to recruit a minimum of 10,000 patients, which was initiated in January 2020 in China. Comprehensive data, including medical history, aetiological testing, lung function, microbiological profiles, radiological scores, comorbidities, mental status, and quality of life (QoL), will be collected at baseline. Patients will be followed up annually for up to 10 years to record longitudinal data on outcomes, treatment patterns and QoL. Biospecimens, if possible, will be collected and stored at - 80 °C for further research. Up to October 2021, the BE-China has enrolled 3758 patients, and collected 666 blood samples and 196 sputum samples from 91 medical centers. The study protocol has been approved by the Shanghai Pulmonary Hospital ethics committee, and all collaborating centers have received approvals from their local ethics committee. All patients will be required to provide written informed consent to their participation. CONCLUSIONS: Findings of the BE-China will be crucial to reveal the clinical characteristics and natural history of bronchiectasis and facilitate evidence-based clinical practice in China. Trial registration Registration Number in ClinicalTrials.gov: NCT03643653.

Treatment outcomes of cetuximab-containing regimen in locoregional recurrent and distant metastatic head and neck squamous cell carcinoma.

BACKGROUND: Recurrent/ metastatic squamous cell carcinoma of head and neck (R/M SCCNH) is still a difficult-to-treat disease with poor clinical outcomes and limited treatment choices. In view of locoregional recurrent versus distant metastatic SCCHN, the therapeutic efficacy of cetuximab-containing regimen and relevant prognostic factors for these two groups may be different. Thus, the aim of this study was to explore the treatment outcomes of cetuximab-containing regimen in locoregional recurrent and distant metastatic SCCHN groups, and to identify clinical factors correlated with better survival outcomes. METHODS: From 2016 to 2020, patients with R/M SCCHN who received cetuximab-containing regimen in our institute were enrolled in this study. Clinical outcomes including overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were evaluated in both locoregional recurrence and distant metastasis groups. Exploratory analysis were conducted to investigate major clinical features associated with better outcomes. RESULTS: A total of 107 patients with locoregional recurrent SCCHN (N = 66) and distant metastatic SCCNH (N = 41) who received cetuximab-containing regimen were enrolled in this retrospective study. Patients with oral cavity cancer and patients with disease recurrence within 6 months after radiation therapy were significantly increased in locoregional recurrence group. The median OS (15.6 vs. 9.7 months, P = 0.004) and PFS (5.8 months vs. 4.2 months, P = 0.008) were longer in locoregional recurrence group than in distant metastasis group. In multivariate analysis of clinical features, locoregional recurrence was still an important risk factor associated with better OS (Hazzard ratio (HR) 0.64, p = 0.06) and PFS (HR 0.67, p = 0.075). In addition, a trend of favorable disease control rate (DCR; 62.5% vs. 45.0%, p = 0.056) was noted in locoregional recurrence group. In locoregional recurrence group, prior salvage surgery was associated with longer OS (HR = 0.24, P = 0.008) and PFS (HR = 0.30, P = 0.005). CONCLUSION: SCCHN with locoregional recurrence is associated with better disease control and survival outcomes comparing to distant metastatic SCCHN when treated with cetuximab-containing regimen. Salvage surgery for locoregional recurrence may further improves clinical outcome.

Relationship between prescribed opioids, pain management satisfaction, and pain intensity in oncology outpatients.

BACKGROUND: Pain is the most severe and commonest symptom for patients with cancer. Patients' pain management satisfaction is an essential indicator of quality care and further affects their willingness to seek care. PURPOSE: This study aimed to examine the correlations between patients' prescribed opioids, pain management satisfaction, and pain intensity. METHODS: This study adopted a cross-sectional correlation design, recruited a total of 123 patients with cancer pain through convenience sampling, and used two research scales, namely the Chinese version of the Pain Treatment Satisfaction Scale and the Brief Pain Inventory-Short Form. RESULTS: The findings indicated that the correlations of prescribed opioid dosage with pain management satisfaction (r = - .10, p > .05) and pain intensity (worst pain, least pain, average pain, and pain right now; r = - .05 to .01, p > .05) were nonsignificant. The correlations of pain management satisfaction with pain intensity (r = .24 to .32, p < .01), pain interference (r = .32, p < .01), and pain relief (r = - .25, p < .01) were all significant, but that with the worst pain (r = .06, p > .05) was nonsignificant. CONCLUSIONS: Medical professionals providing cancer pain management should focus on medicines strategies and individuals' pain relief requirements. In particular, patients with the worst pain require extra investigations into their needs, and their satisfaction with their level of pain should be further evaluated.

The influence of opioid-taking self-efficacy and social support on pain management satisfaction in outpatients with cancer pain.

PURPOSE: The purpose of this study was to explore the correlations between patients' opioid-taking self-efficacy, social support, and their pain management satisfaction, and to evaluate the effect of social support and opioid-taking self-efficacy in explaining the variance in pain management satisfaction. METHODS: We used a cross-sectional and correlational research design and recruited 123 cancer patients via convenience sampling. We used the following instruments: the Opioid-Taking Self-Efficacy Scale, the Inventory of Socially Supportive Behavior, and the Chinese version of the Pain Treatment Satisfaction Scale. RESULTS: There were significant and negative correlations between opioid-taking self-efficacy and pain management satisfaction (r = - .43, p < .001) and between social support and pain management satisfaction (r = - .47, p < .001). Using a hierarchical regression analysis, social support and opioid-taking self-efficacy explained 17.20% and 5.20%, respectively, of the variance in pain management satisfaction. CONCLUSIONS: The results of this study confirm the importance of social support and opioid-taking self-efficacy in influencing pain management satisfaction. We recommend that professional care providers develop relevant intervention aimed at improving patients' pain management satisfaction.

Development and psychometric evaluation of the Caregiver Caregiving Self-Efficacy Scale for family members with oral cancer.

AIM: The aim of this study was to develop and initially assess the psychometric properties of the Caregiver Caregiving Self-Efficacy Scale-Oral Cancer (CSES-OC). METHODS: In total, 28 items in the Caregiver Caregiving Self-Efficacy Scale-Oral Cancer were originally employed for a reliability and validity test based on expert suggestions and qualitative findings. The Cronbach's alpha coefficient and test-retest reliability were evaluated with the pilot sample, which included 30 caregivers. The main test, which included 107 caregivers during May 2016 to 2018, was used to execute the exploratory factor analysis (EFA) and concurrent validity. RESULTS: The results of the main test showed a Cronbach's alpha coefficient of .95 for the revised 18-item total scale after EFA. Four factors (acquiring resources, managing sudden and uncertain patient conditions, managing patient-related nutritional issues and exploring and making decisions on patient care) were classified from EFA of the Caregiver Caregiving Self-Efficacy Scale-Oral Cancer. The r coefficient was .59 (P < .01), which supported the concurrent validity between CSES-OC and General Self-Efficacy Scale. CONCLUSION: The study results show appropriate psychometric properties for the Caregiver Caregiving Self-Efficacy Scale-Oral Cancer that was constructed for evaluating caregiver caregiving self-efficacy in caring for family members with oral cancer.

Oncologic results and quality of life in patients with T3 glottic cancer after transoral laser microsurgery.

PURPOSE: CO2 transoral laser microsurgery (CO2 TOLMS) is an alternative approach to non-surgical organ preservation in selected T3 glottic squamous cell carcinoma (SCC). This study aimed to assess the oncologic results and quality of life (QOL) of patients with T3 glottic SCC after CO2 TOLMS. METHODS: Of the 44 patients who underwent CO2 TOLMS, 38 underwent QOL evaluations. QOL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and head and neck module, Voice Handicap Index-30, and M. D. Anderson Dysphagia Inventory at least 6 months postoperatively. RESULTS: The patients were predominantly male (98%), with a median age of 61 years. Cordectomy type included 1 type III, 4 type IV, 31 type V, and 8 type VI according to European Laryngological Society classification. Two patients (5%) had cervical lymph node metastasis and 21 patients (48%) underwent postoperative radiotherapy. With a mean follow-up of 65 months for all patients, 10 (23%) had tumor recurrence (9 local, 1 distant). After salvage surgery, four patients lived without disease, and the larynx was preserved in two. The 5-year local control and overall and disease-specific survival rates were 78%, 75%, and 84%, respectively. The overall laryngeal preservation rate was 82% (36/44). Most patients had satisfactory QOL. CONCLUSIONS: In selected T3 glottic SCC cases, CO2 TOLMS can achieve favorable oncologic results and a satisfactory QOL.

Oncologic results and quality of life in patients with squamous cell carcinoma of hypopharynx after transoral laser microsurgery.

OBJECTIVE: Transoral laser microsurgery (TLM) is an alternative method for organ preservation in squamous cell carcinoma of hypopharynx (HPSCC). The purpose of this study was to analyze the oncologic results and quality of life (QOL) in HPSCC patients after TLM. METHODS: Forty-six patients who underwent TLM were included, 34 of them had QOL evaluations. The QOL analyses were measured with EORTC QLQ-C-30, QLQ-H&N35, VHI-30, and MDADI at least 6 months postoperatively. RESULTS: Most patients were male (96%) with a median age of 60 years. Four patients (9%) were at the T1 category, 24 (52%) at T2, 15 (33%) at T3, and 3 (7%) at T4. Twenty-nine patients (63%) had cervical lymph node metastases and 26 (57%) received postoperative radiotherapy. With a median follow-up of 61 months for all patients, 18 (39%) had tumor recurrence, including 4 local, 7 regional, and 7 distant. The 5-year overall and disease-specific survival (DSS) rates were 59% and 77%, respectively. The 5-year laryngeal preservation rate was 89%. Most patients had satisfactory QOLs. CONCLUSION: In early and selective moderately advanced HPSCC, TLM can achieve optimal oncologic results and satisfactory QOL. Lasers Surg. Med. 50:117-124, 2018. © 2017 Wiley Periodicals, Inc.

Celecoxib plus chemoradiotherapy for locally advanced rectal cancer: a phase II TCOG study.

BACKGROUND: To report the results of a phase II trial combining celecoxib and preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer. PATIENTS AND METHODS: Patients with clinical stage II or III rectal cancer were treated with radiotherapy of 44 Gy in 22 fractions. Concurrent chemotherapy consisted of oral tegafur-uracil and folinate on days 1-30 and 38-65. Celecoxib (400 mg/day) given from days 1 to 65. Surgery was done on day 70. The expression of cyclooxygenase 2 (COX-2) in tumor tissues was evaluated microscopically as a prognostic factor. RESULTS: From 2008 to 2011, 53 patients completed CRT+ celecoxib therapy and 47 received radical surgery. Grade 3 diarrhea developed in 5 (9%). Grade 4 anemia was seen in 2 (4%). Pathological complete response (pCR) was seen in 6 (13%). T or N downstaging found in 38 (81%). Sphincter preservation was achieved in 77% of low-positioned tumors. Patients with tumors expressing high-level COX-2 after CRT + celecoxib treatment had inferior pelvic control (P = 0.01), disease-free survival (P = 0.04), and overall survival (P = 0.03) than those with low-level expression. CONCLUSIONS: Celecoxib can be safely combined with preoperative CRT for rectal cancer. More intensified adjuvant therapy may be considered for tumors expressing high-level COX-2 after CRT and surgery.

Induction chemotherapy followed by transoral laser microsurgery with or without adjuvant therapy for advanced hypopharyngeal cancer patients: A preliminary result.

BACKGROUND: Hypopharyngeal squamous cell carcinoma (HPSCC) has the poorest prognosis among head and neck cancers. Its treatment may significantly affect breathing, speaking, and swallowing. Induction chemotherapy (ICT) followed by transoral laser microsurgery (TLM) could reduce these adverse effects and achieve good outcomes. METHODS: This was a retrospective study of 11 patients with advanced HPSCC. All patients underwent ICT and TLM alongside tailor-made adjuvant therapy based on the pathological features. RESULTS: Adjuvant therapy was done in seven of 11 patients (64%). The 3-year disease-free survival and laryngeal preservation rates were 78% and 91%, respectively. At the last follow-up, 10 of 11 patients (91%) had no tracheostomy or feeding tube. CONCLUSION: ICT followed by TLM is an appropriate treatment for good tumor control in select patients with advanced HPSCC while preserving laryngeal function.

The impact of ZTE-based MR attenuation correction compared to CT-AC in 18F-FBPA PET before boron neutron capture therapy.

Tumor-to-normal ratio (T/N) measurement of 18F-FBPA is crucial for patient eligibility to receive boron neutron capture therapy. This study aims to compare the difference in standard uptake value ratios on brain tumors and normal brains using PET/MR ZTE and atlas-based attenuation correction with the current standard PET/CT attenuation correction. Regarding the normal brain uptake, the difference was not significant between PET/CT and PET/MR attenuation correction methods. The T/N ratio of PET/CT-AC, PET/MR ZTE-AC and PET/MR AB-AC were 2.34 ± 0.95, 2.29 ± 0.88, and 2.19 ± 0.80, respectively. The T/N ratio comparison showed no significance using PET/CT-AC and PET/MR ZTE-AC. As for the PET/MRI AB-AC, significantly lower T/N ratio was observed (- 5.18 ± 9.52%; p < 0.05). The T/N difference between ZTE-AC and AB-AC was also significant (4.71 ± 5.80%; p < 0.01). Our findings suggested PET/MRI imaging using ZTE-AC provided superior quantification on 18F-FBPA-PET compared to atlas-based AC. Using ZTE-AC on 18F-FBPA-PET /MRI might be crucial for BNCT pre-treatment planning.

Enhancing regional control in p16-negative oropharyngeal cancer: A propensity score-matched analysis of upfront neck dissection and definitive chemoradiotherapy.

BACKGROUND: The presence of p16 and neck disease is important predictors of prognosis for oropharyngeal squamous cell carcinoma (OPSCC). Patients who are p16-negative and have clinically node-positive (cN+) disease generally have worse oncologic outcomes. This study aimed to investigate whether upfront neck dissection (UFND) could provide potential benefits for patients with cN+ p16-negative OPSCC. METHODS: Through this retrospective study, 76 patients with cN+ p16-negative OPSCC were analyzed, those who received either definite concurrent chemoradiotherapy (CCRT group) or UFND followed by chemoradiotherapy (UFND group). The primary endpoints were regional recurrence-free survival (RRFS), disease-specific survival (DSS), and overall survival (OS). Factors associated with survival were evaluated by univariate and multivariate analysis. Survival between the two groups was compared by propensity score-matched analysis. RESULTS: Matched 23 patients in each group through propensity analysis, the UFND group showed a significantly better 5-year RRFS (94.1% vs 61.0%, p = 0.011) compared to the CCRT group. Univariate analysis revealed that UFND was the sole factor associated with regional control (hazard ratio [HR] = 0.110; 95% CI, 0.014-0.879; p = 0.037). Furthermore, the study found that the CCRT group was associated with a higher dose of radiotherapy and exhibited a significantly higher risk of mortality due to pneumonia. CONCLUSION: The study indicated that UFND followed by CCRT may be a potential treatment option for patients with cN+ p16-negative OPSCC, as it can reduce the risk of regional recurrence. Additionally, the study highlights that definite CCRT is connected to a larger dose of radiotherapy and a higher risk of fatal pneumonia. These findings could be beneficial in informing clinical decision-making and improving treatment outcomes for patients with OPSCC.

Prognostic assessment of 18F-boronophenylalanine positron emission tomography (BPA-PET) in salvage boron neutron capture therapy for malignant brain tumors.

Background: Boron neutron capture therapy (BNCT) stands out as a propitious anti-cancer modality. 18F-boronophenylalanine positron emission tomography (BPA-PET) holds the potential to ascertain the concentration of BPA within the tumor, enabling meticulous treatment planning and outcome evaluation. However, no studies have been conducted on comparing the outcomes of those treated with BNCT to those who did not undergo this therapy. This study endeavors to analyze the correlation between BPA-PET and BNCT in the context of malignant brain tumors, and assess the survival outcomes following BNCT. Methods: A cohort study was performed on patients who underwent BPA-PET between February 2017 and April 2022 in our hospital. Patients were stratified into two groups: those subjected to BNCT (Group 1) and those not (Group 2). The tumor to normal tissue (T/N) ratio derived from BPA-PET was set at 2.5. The findings were scrutinized based on clinical follow-up. Student's t-test and Chi-squared test were employed to discern differences between the groups. A cumulative survival curve was constructed employing the Kaplan-Meier method. Differences were considered statistically significant at P<0.05. Results: In total, 116 patients with T/N ratios obtained from BPA-PET were enrolled. BNCT was administered to 58 patients, while mortality was observed in 100 patients. The median overall survival (OS) for the two groups was 8.5 and 6.0 months, respectively. The cumulative OS exhibited no significant discrepancy between the two groups, nor in their T/N ratios. Within Group 1, 44 out of 58 (75.9%) patients exhibited T/N ratios exceeding 2.5. Excluding 3 patients who expired within 3 months, 55 out of 58 patients were evaluated for response after BNCT. The objective response rate (ORR) was 30.9%. Patients achieving ORR displayed substantially higher survival rates compared to those without (median OS 13.5 vs. 8.3 months, P=0.0021), particularly when T/N ratio exceeded 2.5 (median OS 14.8 vs. 9.0 months, P=0.0199). Conclusions: BNCT does not appear indispensable for prolonging the survival of patients afflicted with malignant brain tumors. Nevertheless, it proves advantageous when ORR is attained, a condition closely linked to the values of T/N ratio derived from BPA-PET.

A phase 4 multicentre, 2×2 factorial randomised, double-blind, placebo-controlled trial to investigate the efficacy and safety of tobramycin inhalation solution for Pseudomonas aeruginosa eradication in bronchiectasis: ERASE.

Chronic Pseudomonas aeruginosa (PA) infection significantly contributes to morbidity and mortality in bronchiectasis patients. Initiating antibiotics early may lead to the eradication of PA. Here we outline the design of a trial (ERASE; NCT06093191) assessing the efficacy and safety of inhaled tobramycin, alone or with oral ciprofloxacin, in bronchiectasis patients with a new isolation of PA. This multicentre, 2×2 factorial randomised, double-blind, placebo-controlled, parallel-group trial includes a 2-week screening period, a 12-week treatment phase (with a combination of ciprofloxacin or a placebo at initial 2 weeks) and a 24-week follow-up. 364 adults with bronchiectasis and a new PA isolation will be randomly assigned to one of four groups: placebo (inhaled saline and ciprofloxacin placebo twice daily), ciprofloxacin alone (750 mg ciprofloxacin and inhaled saline twice daily), inhaled tobramycin alone (inhaled 300 mg tobramycin and ciprofloxacin placebo twice daily) or a combination of both drugs (inhaled 300 mg tobramycin and 750 mg ciprofloxacin twice daily). The primary objective of this study is to assess the proportion of patients successfully eradicating PA in each group by the end of the study. Efficacy will be evaluated based on the eradication rate of PA at other time points (12, 24 and 36 weeks), the occurrence of exacerbations and hospitalisations, time to first pulmonary exacerbations, patient-reported outcomes, symptom measures, pulmonary function tests and the cost of hospitalisations. To date no randomised trial has evaluated the benefit of different PA eradication strategies in bronchiectasis patients. The ERASE trial will therefore generate crucial data to inform future clinical guidelines.

Predisposing factors, management, and prognostic evaluation of acute carotid blowout syndrome.

BACKGROUND: Massive hemorrhages occur in 6%-10% of patients with advanced cancer. Acute carotid blowout syndrome is the most severe massive hemorrhagic complication in head and neck cancer patients. METHODS: This was a single institute, retrospective, case control study. A total of 45 patients were enrolled in this study. The predisposing factors, management, and prognosis of acute carotid blowout syndrome were evaluated. RESULTS: Among the baseline characteristics, the site of the primary tumor (P = .003), origin of bleeding (P = .048), method of intervention (P = .005), and time to intervention (P = .006) were significantly different factors between survivor and nonsurvivor patients. After 24 hours of onset, a Glasgow Coma Scale score (P = .000), the use of inotropic agents (P = .007), and neutrophil-to-lymphocyte ratio (P = .019) were significantly predicting factors for outcome. Multivariate logistic regression analyses revealed bleeding from common carotid artery was an independent factor for long-term survival (odds ratio, 25.951; 95% confidence interval [CI], 1.373-490.441; P < .030). The median overall survival of survivors and nonsurvivors were 12.1 (range, 3.7-118.7; 95% CI, 4.33-54.87) and 11.9 (range, 0.7-53.5; 95% CI, 5.78-25.69) months, respectively (P = .092). CONCLUSIONS: Early and aggressive intervention is important for the successful management of acute carotid blowout syndrome. The Glasgow Coma Scale score, the use of inotropic agents, and neutrophil-to-lymphocyte ratio 24 hours after the onset were predictive factors for patients' outcomes. Bleeding from common carotid artery is an independent prognostic factor in multivariate analysis. Long-term survival can be achieved after successful management.

Sphincter-preserving surgery for rectal cancer: a population-based study in Taiwan.

BACKGROUND/AIMS: Sphincter-preserving surgery (SPS) has been considered a surrogate for surgical quality for rectal cancer. This study aims to assess its rate for rectal cancer between centers and over time in Taiwan. METHODOLOGY: Data from 1997 to 2006 on patients undergoing sphincter-preserving surgery (anterior resection or AR) and proctectomy with colostomy (abdominoperineal resection or APR) were extracted from a national health insurance database. Hierarchical logistic regression was used to identify independent factors associated with SPS. RESULTS: Data on 19,919 patients were analyzed. Among them, 12,164 (61%) received AR and 7,755 (39%) underwent APR at total of 115 centers. Multifactorial analysis revealed higher SPS rates with female gender (p<0.001) and patients paying higher insurance premiums (p=0.005). Higher APR rates were seen in those receiving surgery at metropolitan hospitals (p=0.001) and hospitals outside higher volume regions (Taipei City and North, p≦0.005). For hospitals with initial low surgical volumes, significant improvement of SPS rate was found (p<0.001) with increasing volume over the study period. CONCLUSIONS: The disparity due to sphincter loss in rectal cancer between hospitals of various regions and levels narrowed in Taiwan. Characteristics of hospital (level, region, volume) and patient (gender, premium level) influenced SPS rate.

Development of a tumor control probability model for boron neutron capture therapy of head and neck cancer.

The tumor control probability (TCP) model has been used for estimating the response of the radiation (photon) therapy for a given treatment dose (distribution). In Taiwan, boron neutron capture therapy (BNCT) is still at the stage of the clinical trials without standard dose prescription. In this study, universal survival curve (USC) model was selected as the TCP model for BNCT. The tumor response and dose distribution from protocol I of the clinical trial of the recurrent head and neck (H&N) cancer conducted by Taipei Veterans General Hospital and National Tsing Hua University were used to verify the TCP model established in this study. The results showed that, using the USC model as a biological model of dose conversion, the TCP calculated by the generalized Equivalent Uniform Dose (gEUD)-based TCP model can be used to well correlate the relationship between the tumor response and dose distribution of the patients of recurrent H&N cancer. The result shows that 25% and 60% of TCP correspond to partial response and complete response of H&N cancer, respectively. This study also indicated that, when BNCT was used to treat recurrent H&N cancer, the minimum dose was an important factor on the efficacy of the treatment. Minimum dose of 18 Gy-w corresponds to at least 60% of TCP.

Radiomic features derived from pretherapeutic MRI predict chemoradiation response in locally advanced rectal cancer.

BACKGROUND: The standard treatment for locally advanced rectal cancer (LARC) is neoadjuvant concurrent chemoradiotherapy (CRT) followed by surgical excision. Current evidence suggests a favorable prognosis for those with pathological complete response (pCR), and surgery may be spared for them. We trained and validated regression models for CRT response prediction with selected radiomic features extracted from pretreatment magnetic resonance (MR) images to recruit potential candidates for this watch-and-wait strategy. METHODS: We retrospectively enrolled patients with LARC who underwent pre-CRT MR imaging between 2010 and 2019. Pathological complete response in surgical specimens after CRT was defined as the ground truth. Quantitative features derived from both unfiltered and filtered images were extracted from manually segmented region of interests on T2-weighted images and selected using variance threshold, univariate statistical tests, and cross-validation least absolute shrinkage and selection operator (Lasso) regression. Finally, a regression model using selected features with high coefficients was optimized and evaluated. Model performance was measured by classification accuracies and area under the receiver operating characteristic (AUROC). RESULTS: We extracted 1223 radiomic features from each MRI study of 133 enrolled patients. After tumor excision, 34 (26 %) of 133 patients had pCR in resected specimens. When 25 image-derived features were selected from univariate analysis, classification AUROC was 0.86 and 0.79 with the addition of six clinical features on the hold-out internal validation dataset. When 11 image-derived features were used, the optimized linear regression model had an AUROC value of 0.79 and 0.65 with the addition of six clinical features on the hold-out dataset. Among the radiomic features, texture features including gray level variance, strength, and cluster prominence had the highest coefficient by Lasso regression. CONCLUSION: Radiomic features derived from pretreatment MR images demonstrated promising efficacy in predicting pCR after CRT. However, radiomic features combined with clinical features did not result in remarkable improvement in model performance.

Survival analyses of different treatment modalities and clinical stage for hypopharyngeal carcinoma.

Objective: We investigated the effects of different treatment modalities and clinical stage for hypopharyngeal carcinoma (HPC) patients. Methods: Between February 2004 and December 2012, 167 HPC patients were reviewed. We calculated overall survival (OS), progression-free survival (PFS), local failure-free survival (LFFS), regional failure-free survival (RFFS), and distant metastasis failure-free survival (DMFFS) using the Kaplan-Meier method and compared various survival outcomes between definitive chemoradiotherapy (CRT) and surgery-based therapy (SBT). Results: There were no significant differences in baseline characteristics between SBT (n = 102) and definitive CRT (n = 65) groups. The 5-year rates of OS (59.7% vs. 24.0%, p < 0.0001) and PFS (49.9% vs. 22.6%, p = 0.0002) were significantly better in patients who received SBT than in those who received definitive CRT. The SBT group also obtained better LFFS (p < 0.0001), RFFS (p = 0.0479), and DMFFS (p = 0.0110). We did similar analyses by different T-classification (T1-2, T3, and T4) and found that SBT had better OS (p < 0.0001 and p = 0.0020), PFS (p < 0.0001 and p = 0.0513), LFFS (p = 0.0002 and p = 0.0075), RFFS (p = 0.1949 and p = 0.0826), and DMFFS (p = 0.0248 and p = 0.0436) in the T4 and T1-2 subgroups but similar OS (p = 0.9598), PFS (p = 0.5052), RFFS (p = 0.9648), and DMFFS (p = 0.8239) in T3 patients. Analyses by different overall stages revealed no differences between definitive CRT and SBT for stage III patients but significantly better results for stage IV patients who received SBT. Conclusions: SBT can obtain significant survival benefits when compared with definitive CRT for the whole cohort of patients. Definitive CRT has similar survival outcomes compared with SBT only for T3 tumors or overall stage III disease.

Boron Neutron Capture Therapy Followed by Image-Guided Intensity-Modulated Radiotherapy for Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial.

BACKGROUND: This trial investigated the efficacy and safety of salvage boron neutron capture therapy (BNCT) combined with image-guided intensity-modulated radiotherapy (IG-IMRT) for recurrent head and neck cancer after prior radiotherapy (RT). METHODS: BNCT was administered using an intravenous boronophenylalanine-fructose complex (500 mg/kg) in a single fraction; multifractionated IG-IMRT was administered 28 days after BNCT. For BNCT, the mucosa served as the dose-limiting organ. For IG-IMRT, the clinical target volume (CTV) and the planning target volume (PTV) were generated according to the post-BNCT gross tumor volume (GTV) with chosen margins. RESULTS: This trial enrolled 14 patients, and 12 patients received combined treatment. The median BNCT average dose for the GTV was 21.6 Gy-Eq, and the median IG-IMRT dose for the PTV was 46.8 Gy/26 fractions. After a median (range) follow-up period of 11.8 (3.6 to 53.2) months, five patients had a complete response and four had a partial response. One patient had grade 4 laryngeal edema; another patient had a grade 4 hemorrhage. Most tumor progression occurred within or adjacent to the CTV. The 1-year overall survival and local progression-free survival rates were 56% and 21%, respectively. CONCLUSION: Despite the high response rate (64%) of this trial, there was a high incidence of in-field and marginal failure with this approach. Future studies combining BNCT with modalities other than radiation may be tried.

Anti-VEGF Therapy Possibly Extends Survival in Patients With Colorectal Brain Metastasis by Protecting Patients From Neurologic Disability.

BACKGROUND: Colorectal brain metastases (CBMs) are rare with poor prognosis. There is still no standard systemic treatment for multiple or unresectable CBM. our study aimed to explore the impact of anti-VEGF therapy on overall survival, brain-specific disease control, and neurologic symptom burden in patients with CBM. METHODS: A total of 65 patients with CBM under treatment were retrospectively enrolled and divided into anti-VEGF based systemic therapy or non-anti-VEGF based therapy. A total of 25 patients who received at least 3 cycles of anti-VEGF agent and 40 patients without anti-VEGF therapy were analyzed by endpoints of overall survival (OS), progression-free survival (PFS), intracranial PFS (iPFS) and neurogenic event-free survival (nEFS). Gene expression in paired primary metastatic colorectal cancer (mCRC), liver, lung and brain metastasis from NCBI data was analyzed using top Gene Ontology (GO) and cBioPortal. RESULTS: Patients who treated with anti-VEGF therapy had significantly longer OS (19.5 vs. 5.5 months, P = .009), iPFS (14.6 vs. 4.1 months, P < .001) and nEFS (17.6 vs. 4.4 months, P < .001). Patients who received anti-VEGF therapy beyond any disease progression presented with superior OS (19.7 vs. 9.4 months, P = .039). Top GO and cBioPortal analysis revealed a stronger molecular function of angiogenesis in intracranial metastasis. CONCLUSIONS: Anti-VEGF based systemic therapy showed favorable efficacy that was reflected in longer overall survival, iPFS and NEFS in patients with CBM.