Objective:To compare the efficacy and safety of immunotherapy combined with induction chemotherapy followed by radiotherapy alone or one cycle of concurrent chemoradiotherapy with cisplatin versus induction chemotherapy followed by two cycles of concurrent chemoradiotherapy with cisplatin in patients with locally advanced nasopharyngeal carcinoma. Methods:A total of 173 patients with locally advanced nasopharyngeal carcinoma treated at our hospital from November 2019 to September 2024 were retrospectively analyzed. Patients received induction therapy with immunotherapy (toripalimab or tislelizumab) combined with chemotherapy (TPC or GP) followed by radiotherapy alone or one cycle of concurrent chemoradiotherapy with cisplatin (immunochemotherapy group). Patients received TPC or GP induction chemotherapy followed by 2 cycles of concurrent chemoradiotherapy with cisplatin (IC-CCRT group). Immunotherapy was given on day 1 of each cycle of induction therapy. The efficacy and toxicities of the two groups were evaluated. Results:After induction therapy, 20 patients (29.4%) in the immunochemotherapy group and 15 patients (14.3%) in the IC-CCRT group achieved complete remission (p=0.02). At a median follow-up of 27.5 months, recurrence or metastasis occurred in 7.4%(5/68) of the patients in the immunochemotherapy group and 19.0%(20/105) of those in the IC-CCRT group. The 2-year event-free survival (EFS), overall survival (OS), locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS) in the immunochemotherapy group were 93.5% vs 81.1% (p=0.03), 100.0% vs 97.9% (p=0.3), 96.9% vs 91.4% (p=0.2), 95.0% vs 88.2% (p=0.1) compared with the IC-CCRT group. There were 28 cases (41.1%) in the immunochemotherapy group and 58 cases (55.2%) in the IC-CCRT group experienced grade 3-4 acute adverse events. In the immunochemotherapy group, 4 patients developed grade 3-4 immune-related adverse events. Conclusions:Compared with induction chemotherapy followed by two cycles of concurrent chemoradiotherapy with cisplatin, immunotherapy combined with induction chemotherapy followed by radiotherapy alone or one cycle of concurrent chemoradiotherapy with cisplatin may improve the EFS of patients with locally advanced nasopharyngeal carcinoma with low adverse events. However, this data requires prospective randomized controlled studies to be confirmed in the future.
BackgroundThe optimal management for newly diagnosed glioblastoma (GBM) patients with poor prognostic features, such as RPA class IV-VI or rapid early progression, remains debated. This study evaluated the efficacy and safety of postoperative hypofractionated radiotherapy (HFRT) with concurrent temozolomide in this population.MethodsSingle-institution retrospective analysis (Jan 2021-Aug 2025) included patients with histologically confirmed GBM and RPA class IV-VI or rapid early progression who completed postoperative HFRT (≥3 Gy/fraction) with concurrent temozolomide.ResultsAmong 18 eligible patients, most had unfavorable characteristics (subtotal resection: 66.7%, biopsy-only: 33.3%). With a median follow-up of 22.3 months, the median progression-free survival was 8.4 months and median overall survival was 17.7 months. The disease control rate was 77.8%. Recurrence patterns were in-field (46.2%), marginal (38.5%), and out-of-field (15.4%). Acute grade ≥3 toxicities occurred in 16.7% of patients, all managed conservatively. No radiation necrosis was observed. Corticosteroid dependence occurred in 44.4% of patients but was manageable.ConclusionIn this exploratory single-center retrospective study, individually tailored HFRT with concurrent temozolomide demonstrated promising survival outcomes and controllable toxicity in poor-prognosis GBM patients unsuitable for standard therapy. The recurrence pattern observed in this small sample cohort suggests a potential need for optimized target volume delineation for HFRT in this population. HFRT represents a potential viable therapeutic alternative in this challenging population, warranting further large-sample prospective validation.
Radiotherapy-induced oral mucositis (RTOM) is a common side effect of radiotherapy in locoregionally advanced nasopharyngeal carcinoma (LA-NPC) receiving concurrent chemoradiotherapy (CCRT). In this phase 3 trial, we aim to evaluate the efficacy and safety of Ulinastatin (UTI) for the prevention and treatment of RTOM in LA-NPC patients (NCT03387774). The primary endpoint is the incidence of grade ≥3 acute RTOM during radiotherapy. Secondary endpoints include cumulative incidence of RTOM, recovery rate, the onset time and duration of grade ≥3 RTOM, oral pain (severe), safety and survival outcomes. 179 eligible patients are randomly assigned to UTI Group ( n = 89) or Control group ( n = 90). All UTI group patients complete UTI treatment as planned, and both groups complete scheduled CCRT. The incidence of grade 3 RTOM is significantly lower in UTI group compared with control group (25.8% vs 41.1%, P = 0.030). The trial meet its prespecified primary endpoint. No Ulinastatin related adverse events are observed during treatment. The 3-year overall survival (OS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS) and progression-free survival (PFS) in UTI group and control group are similar between two groups. In this work, Ulinastatin can effectively reduce the severity of RTOM and oral pain without increasing toxicity and compromising survivals.
PURPOSE:To evaluate the risk factor of level Ib lymph node metastasis (LNM) and the clinical outcome of its selectively prophylactic irradiation (pRT) in nasopharyngeal carcinoma (NPC) patients treated with IMRT. METHODS:518 NPC patients receiving radical IMRT were collected. The structures of primary tumor invasions and neck LNM levels were analyzed bilaterally to estimate the risk factors of level Ib LNM. Patients with level Ib LNM and submandibular gland (SMG) invasion received level Ib pRT. The level Ib recurrence-free survival (RFSIb), regional recurrence-free survival (RRFS), and the incidence of ≥ grade 2 xerostomia at 1-year post-IMRT were compared in negative level Ib LNM patients who omitted, received unilateral, or bilateral level Ib pRT. RESULTS:Thirteen (2.5 %) patients with 18 sides had level Ib LNM. Ipsilateral SMG invasion was an independent risk factor for level Ib LNM. With a median follow-up time of 98.0 months, the 5-year RFSIb, 5-year RRFS and the incidence of xerostomia ≥ grade 2 at 1-year post-IMRT in negative level Ib LNM patients who omitted pRT, received unilateral, bilateral pRT to the level Ib were 99.7 % vs.100 % vs. 97.5 % (P = 0.110), 98.0 % vs. 92.1 % vs. 95.1 % (P = 0.120) and 28.0 % vs. 38.3 % vs. 90.0 % (P < 0.001), respectively. CONCLUSIONS:Our study revealed that ipsilateral SMG invasion was the independent risk factor for the level Ib LNM. Omitting pRT in patients without ipsilateral level Ib LNM and SMG invasion did not increase the RFSIB and RRFS, and reduced the incidence of xerostomia. Further multi-center prospective randomized clinical trial is warranted.
6105 Background: Severe oral mucositis is a common radiation-induced toxicity in locoregionally advanced nasopharyngeal carcinoma (LA-NPC) patients treated with concurrent chemo-radiotherapy (CCRT). Ulinastatin (UTI) can reduce the inflammatory response by inhibiting the release of inflammatory factors, but its role in radiotherapy-induced oral mucositis (RTOM) is unclear. Therefore, we conducted a multicenter, open-label, randomized controlled clinical trial to investigate the efficacy and safety of UTI in the prevention and treatment of RTOM in LA-NPC patients. Methods: Patients with histologically confirmed LA-NPC who met the eligibility criteria were randomly assigned to UTI group and control group. All patients received radical intensity modulated radiation therapy (IMRT) and concurrent chemotherapy (cisplatin 100 mg/m 2 /3 weeks for 2 or 3 cycles). UTI of 100,000 units three times daily (5 days/week) was intravenously administrated from day 1 to the end of radiotherapy for UTI Group. The primary endpoint was the incidence of grade ≥ 3 acute RTOM during CCRT (Radiation Therapy Oncology Group, RTOG grading). The secondary endpoints included the cumulative incidence of RTOM, recovery rate (proportion of patients with grade ≥ 3 RTOM who recovered to grade ≤ 2 during CCRT), the onset time and duration of grade ≥ 3 RTOM, oral pain (Numerical rating scale, NRS), safety and survival outcomes. Results: From January, 2018, to December, 2021, 182 patients from 5 hospitals were enrolled. 179 patients were included for efficacy, safety and survival analysis (89 in the UTI group and 90 in the control group). All UTI group patients completed UTI treatment as planned, and both groups completed scheduled CCRT. The incidence of grade ≥ 3 RTOM was significantly lower in UTI group compared with control group (25.8% vs. 41.1%; P = 0.030). The recovery rate in UTI group was higher than that in control group (39.1% vs. 10.8%; P = 0.023). However, the onset time and the duration of grade ≥ 3 RTOM were similar between the two groups (Median [IQR] 26.00 [19.00, 33.00] days vs. 32.00 [20.50, 36.00] days; P= 0.621 and 12.00 [7.00, 18.00] days vs. 15.00 [8.00, 25.50] days; P= 0.209). The incidence of severe oral pain ( NRS score≥ 7 ) was significantly reduced in UTI group compared with the control group (22.5% vs. 36.7; P = 0.038). No UTI related adverse events were observed during treatment. With a median follow-up time of 41.6 months (IQR, 38.2 - 45.0 months), The 3-year OS, LRRFS, DMFS and PFS in UTI group and Control group were 96.5% vs. 94.3%, 91.2% vs. 87.2%, 95.2% vs. 92.1% and 89.9% vs. 85.1%, respectively (all P > 0.05). Conclusions: Our study revealed that UTI can effectively reduce the incidence of graded ≥ 3 RTOM and severe oral pain without increasing adverse events and compromising survivals. Clinical trial information: NCT03387774 .
Background Post-radiation nasopharyngeal necrosis (PRNN) is a severe adverse event following re-radiotherapy for patients with locally recurrent nasopharyngeal carcinoma (LRNPC) and associated with decreased survival. Biological heterogeneity in recurrent tumors contributes to the different risks of PRNN. Radiomics can be used to mine high-throughput non-invasive image features to predict clinical outcomes and capture underlying biological functions. We aimed to develop a radiogenomic signature for the pre-treatment prediction of PRNN to guide re-radiotherapy in patients with LRNPC. Methods This multicenter study included 761 re-irradiated patients with LRNPC at four centers in NPC endemic area and divided them into training, internal validation, and external validation cohorts. We built a machine learning (random forest) radiomic signature based on the pre-treatment multiparametric magnetic resonance images for predicting PRNN following re-radiotherapy. We comprehensively assessed the performance of the radiomic signature. Transcriptomic sequencing and gene set enrichment analyses were conducted to identify the associated biological processes. Results The radiomic signature showed discrimination of 1-year PRNN in the training, internal validation, and external validation cohorts (area under the curve (AUC) 0.713–0.756). Stratified by a cutoff score of 0.735, patients with high-risk signature had higher incidences of PRNN than patients with low-risk signature (1-year PRNN rates 42.2–62.5% vs. 16.3–18.8%, P < 0.001). The signature significantly outperformed the clinical model ( P < 0.05) and was generalizable across different centers, imaging parameters, and patient subgroups. The radiomic signature had prognostic value concerning its correlation with PRNN-related deaths (hazard ratio (HR) 3.07–6.75, P < 0.001) and all causes of deaths (HR 1.53–2.30, P < 0.01). Radiogenomics analyses revealed associations between the radiomic signature and signaling pathways involved in tissue fibrosis and vascularity. Conclusions We present a radiomic signature for the individualized risk assessment of PRNN following re-radiotherapy, which may serve as a noninvasive radio-biomarker of radiation injury-associated processes and a useful clinical tool to personalize treatment recommendations for patients with LANPC.
OBJECTIVES:To determine the extent of research waste in the field of nasopharyngeal carcinoma (NPC). MATERIALS AND METHODS:In this cross-sectional study, we explored the rates, causes and predictors of discontinuation and nonpublication of NPC clinical trials. The sample was derived using the ClinicalTrials.gov advanced search function. Adjusted logistic regression was used to ascertain the effect of trial characteristics on completion and publication status. If a trial discontinuation explanation or publication status could not be determined through the systematic search, the corresponding author was emailed. RESULTS:Ultimately, 311 NPC clinical trials were included (255 [82.0 %] completed and 56 [18.0 %] discontinued trials). The most common reason for trial discontinuation was poor accrual (50 %, 23/46). Industry funding (adjusted OR, 3.12; P = 0.003) and recurrent/metastatic setting (adjusted OR, 11.95; P = 0.003) were significantly associated with increased likelihood of trial discontinuation. Of the 207 completed trials included in the publication query, 141 (68.1 %) were published in peer-reviewed journals, 10 (4.8 %) had results only available on ClinicalTrials.gov, and 56 (27.1 %) remained unpublished 3 or more years after trial completion. Radiation with or without pharmacologic interventions significantly increased the potential of publication (adjusted OR, 3.20; P = 0.048). Among published trials, the median time to publication was 28.47 months (interquartile range, 15.27-44.98 months). CONCLUSION:We identified the difficulties inherent in NPC clinical trials from completion to publication. This represents considerable research waste in NPC, thus raising ethical concerns about the concealment of clinical data and futile patient participation and attendant risks.
Objective: In this study, we aimed to establish and validate an integrated prognostic model for locally recurrent nasopharyngeal carcinoma (lrNPC) patients, and evaluate the benefit of re-radiotherapy (reRT) in patients with different risk levels. Materials and methods: In total, 531 patients with lrNPC were retrospectively reviewed in this study, including 271 patients from 2006 to 2012 as the training cohort and 260 patients from 2013 to 2016 as the validation cohort. Overall survival (OS) was the primary endpoint. Multivariate analysis was performed to select the significant prognostic factors (P < 0.05). A prognostic model for OS was derived by recursive partitioning analysis (RPA) combining independent predictors using the algorithm of optimized binary partition. Results: Three independent prognostic factors (age, relapsed T [rT] stage, and Epstein-Barr virus [EBV] DNA) were identified from multivariate analysis. Five prognostic groups were derived from an RPA model that combined rT stage and EBV DNA. After further pair-wise comparisons of survival outcome in each group, three risk groups were generated. We investigated the role of re-RT in different risk groups, and found that re-RT could benefit patients in the low (P < 0.001) and intermediate-risk subgroups (P = 0.017), while no association between re-RT and survival benefit was found in the high-risk subgroup (P = 0.328). The results of risk stratification and re-RT efficacy were verified in the validation cohort. Conclusion: Age, rT stage and EBV DNA were identified as independent predictors for lrNPC. We established an integrated RPA-based prognostic model for OS incorporating rT stage and EBV DNA, which could guide individual treatment for lrNPC. (C) 2022 Elsevier B.V. All rights reserved.
Purpose This study was aimed to investigate long-term survivals and toxicities of early-stage nasopharyngeal carcinoma (NPC) in endemic area, evaluating the role of chemotherapy in stage II patients.Materials and Methods Totally 187 patients with newly diagnosed NPC and restaged American Joint Committee on Cancer/ International Union Against Cancer 8th T1-2N0-1M0 were retrospectively recruited. All received intensity-modulated radiotherapy (IMRT)±chemotherapy (CT) from 2001 to 2010.Results With 15.7-year median follow-up, 10-year locoregional recurrence-free survival, distant metastasis-free survival (DMFS), disease-specific survival (DSS), and overall survival (OS) were 93.3%, 93.5%, 92.9% and 88.2%, respectively. Multivariable analyses showed cervical lymph nodes positive and pre-treatment prognostic nutritional index ≥ 52.0 could independently predict DMFS (p=0.036 and p=0.011), DSS (p=0.014 and p=0.026), and OS (p=0.002 and p < 0.001); Charlson comorbidity index < 3 points could predict DSS (p=0.011); age > 45 years (p=0.002) and pre-treatment lactate dehydrogenase ≥ 240 U/L (p < 0.001) predicted OS. No grade 4 late toxicity happened; grade 3 late toxicities included subcutaneous fibrosis (4.3%), deafness or otitis (4.8%), skin dystrophy (2.1%), and xerostomia (1.1%). No differences on survivals were shown between IMRT+CT vs. IMRT alone in stage II patients, even in T2N1M0 (p > 0.05). Unsurprising, patients in IMRT+CT had more acute gastrointestinal reaction, myelosuppression, mucositis, late ear toxicity, and cranial nerve injury (all p < 0.05) than IMRT alone group.Conclusion Superior tumor control and satisfying long-term outcomes could be achieved with IMRT in early-stage NPC with mild late toxicities. As CT would bring more toxicities, it should be carefully performed to stage II patients.
Objective: The aim of this study was to establish a nomogram for predicting radiation-induced hypothyroidism (RHT) based on an equivalent dose at 2 Gy per fraction (EQD2) in patients with nasopharyngeal carcinoma (NPC) treated with intensity-modulated radiation therapy (IMRT) with or without chemotherapy. Methods: Two hundred forty-four eligible patients with NPC were recruited for this study. Patients' clinical factors and dose-volume parameters of the thyroid gland were retrieved from medical records and the IMRT treatment planning system, respectively. The irradiation doses were converted into EQD2 for analysis. Least absolute shrinkage and selection operator (LASSO) regression analysis and multivariate logistic regression analysis were performed to identify optimal predictors of RHT for constructing the nomogram. Results: With a median follow-up of 63.0 months, the cumulative incidence rates of RHT at 3 months and 1-, 2-, 3, 4- and 5- year after IMRT were 10.2%, 36.2%, 47.6%, 54.2%, 58.8% and 69.4%, respectively. Four independent factors for predicting RHT, including gender, age, pretreatment volume of the thyroid gland and V35Gy(3Gy) of the thyroid gland, were identified and incorporated into the nomogram. The area under the ROC curve of the nomogram was 0.747 (95% confidence interval 0.685 - 0.809). Calibration curves and DCA curves showed that the nomogram was in good agreement with the actual observations and clinical usefulness. Conclusions: The nomogram proposed in this study provides a reliable estimate of RHT risk in patients with NPC after IMRT and appears to have the potential to be a useful tool for widespread clinical applications.
Background: Accurate pre-treatment assessment of the risk of post-radiation nasopharyngeal necrosis (PRNN) is crucial to patient selection and tailoring re-radiotherapy regimens. We aimed to develop a radiomic signature for the pre-treatment prediction of PRNN to guide salvage re-radiotherapy in patients with locally recurrent nasopharyngeal carcinoma (LRNPC).Methods: This multicentre study included 761 patients with LRNPC who were treated with curative re-radiotherapy at four centres in China and divided them into training, internal validation, and external validation cohorts. We built a machine learning (random forest) radiomic signature based on the pre-treatment multiparametric magnetic resonance images for predicting PRNN following re-radiotherapy. We comprehensively assessed the performance of the radiomic signature. Gene set enrichment analyses were conducted to identify the associated biological processes.Findings: The radiomic signature showed optimal discrimination of 1-year PRNN in the training (area under the curve (AUC) 0.722, 95% confidence interval (CI) 0.676-0.765), internal validation (AUC 0.713, 95% CI 0.653-0.772), and external validation (AUC 0.756, 95% CI 0.673-0.838) cohorts. Stratified by a cutoff radiomics score of 0.735, patients with high-risk signature had higher incidences of PRNN than patients with low-risk signature in all cohorts (1-year PRNN rates 42.2%-62.5% vs. 16.3%-18.8%, P<0.001). The signature significantly outperformed the clinical model (P<0.05) and was generalizable across different centres, imaging parameters and patient subgroups. Radiogenomics analyses revealed associations between the radiomic signature and signaling pathways involved in tissue fibrosis and vascularity.Interpretation: We present a radiomic signature for the individualized risk assessment of PRNN following re-radiotherapy, which may serve as a noninvasive radio-biomarker of radiation injury-associated processes and a useful clinical tool to personalize treatment recommendations for patients with LANPC.Funding Information: This study was funded by grants from the National Key R&D Program of China (2017YFC0908500, 2017YFC1309003), the National Natural Science Foundation of China (No. 81425018, No. 81672868, No.81802775,No. 82073003, No.82002852, No. 82003267, No. 82022036, No. 91959130, No. 81971776, No. 81771924, No. 62027901, No. 81930053), the Sci-Tech Project Foundation of Guangzhou City (201707020039), the Sun Yat-sen University Clinical Research 5010 Program (No. 2019023), the Special Support Plan of Guangdong Province (No. 2014TX01R145), the Natural Science Foundation of Guangdong Province (No.2017A030312003, No.2018A0303131004), the Natural Science Foundation of Guangdong Province for Distinguished Young Scholar (No. 2018B030306001), the Sci-Tech Project Foundation of Guangdong Province (No. 2014A020212103), the Health & Medical Collaborative Innovation Project of Guangzhou City (No. 201400000001, No.201803040003), the Planned Science and Technology Project of Guangdong Province (2019B020230002), the National Science & Technology Pillar Program during the Twelfth Five-year Plan Period (No. 2014BAI09B10), Natural Science Foundation of Guangdong Province (2017A030312003), the Key Youth Teacher Cultivating Program of Sun Yat-sen University (20ykzd24), the Fundamental Research Funds for the Central Universities, the Beijing Natural Science Foundation (L182061), the Strategic Priority Research Program of Chinese Academy of Sciences (XDB 38040200), and the Youth Innovation Promotion Association CAS (2017175).Declaration of Interests: The authors declared no conflict of interest.Ethics Approval Statement: This study was approved by the clinical research committee of the study centres, and written informed consent was retrieved from all included patients.
Background: The goal of this study was to explore the benefits of S-1/capecitabine as maintenance therapy in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with different risks of treatment failure. Methods: A total of 2205 eligible, locoregionally advanced NPC patients were recruited for this retrospective study. Multivariate Cox regression analysis was performed to identify optimal predictors of overall survival (OS) and distant metastasis-free survival (DMFS) for constructing the nomograms. Patients were stratified into high-risk or low-risk groups based on the total score of the nomograms. Propensity score matching (PSM) was performed to match the maintenance and non-maintenance cohorts in different risk groups. A log-rank test was performed to evaluate correlations between maintenance therapy and survival. Results: A nomogram for OS was established (C-index, 0.664; 95% confidence interval, 0.635-0.693). The 5-year OS rate was significantly higher in the low-risk group than in the high-risk group (83.5% vs. 67.2%, P < 0.001). Patients in the high-risk group who received S-1/capecitabine maintenance therapy achieved significant improvement in the 5-year OS rate (82.8% vs. 67.1%, p = 0.034), whereas patients in the low-risk group did not (86.7% vs. 80.9%, P = 0.081). There was no significant difference in OS, DMFS, progression-free survival (PFS), or toxicities between the 5-1 and capecitabine groups (all P > 0.05), and overall treatment-related adverse events (AEs) were not severe (grade 1-2). Conclusion: S-1/capecitabine maintenance therapy could prolong OS for locoregionally advanced NPC patients in the high-risk group. The toxicities of S-1/capecitabine maintenance therapy were mild and tolerable. Our findings can help guide maintenance therapy in locoregionally advanced NPC.
PURPOSE:Current guideline recommends a uniform method of delineation of subclinical disease within the primary clinical target volume (CTVp) for all stages of nasopharyngeal carcinoma (NPC). We performed a prospective observational study to investigate the outcomes with a reduced CTVp and radiation dose for early-stage NPC. METHODS AND MATERIALS:Patients with newly diagnosed, biopsy-proven World Health Organization type II-III and American Joint Committee on Cancer/Union for International Cancer Control sixth edition stage T1-2N0-1 disease were enrolled. All patients were treated with intensity modulated radiation therapy alone. We categorized CTVp into CTVp1 (high risk) and CTVp2 (low risk). CTVp1 comprised of gross tumor (on magnetic resonance imaging or contrast-enhanced computed tomography) plus a 5-mm margin (3-mm posteriorly) and was prescribed to 60 Gy in 30 fractions (fr). CTVp2 was generated from CTVp1 plus a 5-mm margin (3 mm posteriorly), excluding the maxillary and cavernous sinuses, and was prescribed to 54 Gy in 30 fr. The prescribed doses to the primary and nodal gross tumor volume (GTVp and GTVn) were 68 Gy in 30 fr and 60 to 66 Gy in 30 fr, respectively. Primary endpoint was local recurrence-free survival. This study was registered in ClinicalTrials.gov, number NCT03839602. RESULTS:From May 2001 to August 2006, 103 patients were recruited and completed IMRT. With a median follow-up of 15.2 years (range, 2.1-18.1 years), only 1 patient had local failure. Ten-year local recurrence-free survival, regional recurrence-free survival, distant metastasis-free survival, and overall survival were 90.3%, 88.3%, 90.3%, and 91.2%, respectively. Among late IMRT-related adverse events, we recorded 2 patients with G1 cranial nerve injury, 3 patients with G3 hearing loss, and 3 patients with G3 subcutaneous fibrosis. No patients had temporal lobe necrosis, brain stem injury, or trismus. CONCLUSIONS:Decreased CTV margins and radiation doses can achieve long-term tumor control with mild late toxicities for patients with early-stage NPC.
Objective To evaluate the validity and reliability of the Chinese version of Xerostomia Questionnaire ( XQ-C) in nasopharyngeal carcinoma patients treated with radiotherapy. Methods XQ-C was translated according to the International Quality of Life Assessment project approach. Patients with nasopharyngeal carcinoma in different radiotherapy stages were enrolled in this study and assessed by using the XQ-C. The validity and reliability of the questionnaire results were evaluated. The content validity was assessed by experts grading method. The construct validity was assessed by exploratory factor analysis. The discriminant validity was determined by non-parametric method. The reliability was evaluated by Cronbach′s α and split-half reliability to assess the internal consistency. Results A total of 212 questionnaires were completely filled out. Content validity showed that the item content validity index ( I-CVI) ≥0.80, Scale-CVI/Ave=0.97, and P value of Kendall′s W test was 0.701. Exploratory factor analysis revealed that XQ-C was a unidimensional scale. The scale scores of patients at different stages of radiotherapy significantly differed, suggesting that the discriminant validity was good. Cronbach′s α of the scale was 0.951 and Guttman′s semi-reliability coefficient was 0.940. Conclusion The XQ-C is valid and reliable, which can be widely applied in the clinical diagnosis, treatment and research of xerostomia in Chinese nasopharyngeal carcinoma patients after radiotherapy.
Purpose: To evaluate the long-term locoregional control, failure patterns, and late toxicity after reducing the target volume and radiation dose in patients with locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT). Methods and Materials: Previously untreated patients with locoregionally advanced nasopharyngeal carcinoma were recruited into this prospective study. All patients received 2 cycles of IC followed by CCRT. The gross tumor volumes of the nasopharynx (GTVnx) and the neck lymph nodes (GTVnd) were delineated according to the post-IC tumor extension and received full therapeutic doses (68 Gy and 62-66 Gy, respectively). The primary tumor shrinkage after IC was included in the high-risk clinical target volume (CTV1) with a reduced dose of 60 Gy. The locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and overall survival (OS) were calculated using the Kaplan-Meier method. The location and extent of locoregional recurrences were transferred to pretreatment planning computed tomography for dosimetry analysis. Results: There were 112 patients enrolled in this study. The average mean dose of post-GTVnx, post-GTVnd (left), post-GTVnd (right), post-CTV1, and post-low-risk clinical target volume (CTV2) was 75.24, 68.97, 69.16, 70.49, and 63.37 Gy, respectively. With a median follow-up of 125.95 months, the 10-year LRRFS, DMFS and OS were 89.0%, 83.3%, and 75.9%, respectively. There were 8 local recurrences and 6 regional recurrences in 12 patients. All 8 of the local recurrences were in-field; among the 6 regional recurrences, 4 were in-field, 1 was marginal, and 1 was out-field. The most common late toxicities were grade 1 to 2 subcutaneous fibrosis, hearing loss, and xerostomia. No grade 4 late toxicities were observed. Conclusions: Reduction of the target volumes according to the post-IC tumor extension and radiation dose to the post-IC tumor shrinkage could yield excellent long-term locoregional control with limited marginal and out-field recurrences and mild late toxicities. (C) 2019 Elsevier Inc. All rights reserved.
The purpose of this study was to investigate the influence of neoadjuvant chemotherapy (NACT) combined with concurrent chemoradiotherapy (CCRT) on nutritional status in patients with locoregionally advanced nasopharyngeal carcinoma (LANPC). This is a prospective, non-interventional, multicenter study. Patients were recruited from ten hospitals in China with the key inclusion criteria of untreated LANPC. All eligible patients received NACT with docetaxel (75mg/m2) and cisplatin (75mg/m2) once every 3 weeks for 2 cycles, followed by CCRT with cisplatin (100mg/m2) and intensity-modulated radiotherapy. Nutrition related parameters including weight loss (WL), body mass index (BMI), the score of Nutrition Risk Screening 2002 (NRS2002) and Patient-Generated Subjective Global Assessment (PG-SGA), and Quality of life (QOL) score (EORTC QLQ-C30), acute toxicities (CTCAE v4.0), treatment compliance were recorded before, during, and after treatment. Statistical analyses are using SPSS 22.0. The study was registered on ClinicalTrials.gov, number NCT02575547. From Jun 2015 to Nov 2016, we enrolled 186 patients, of whom 171 were eligible for analysis. The overall incidence of mild and severe malnutrition was 68.5% and 37.4%, respectively. The incidence of nutritional related parameters and the average QOL score on each observation point were shown in Table 1. During the treatment, patients with ≥ 2 grade oral mucositis have higher risks of WL ≥ 10% (p = 0.037), NRS2002 ≥ 3 points (p = 0.002) and PG-SGA ≥ 9 points (p < 0.001). 97.7% and 87.7% patients finished NACT and CCRT, respectively, and 99.4% patients finished radiotherapy. Patients with PG-SGA ≥ 9 points and C30-QOL < 50 points had poor chemotherapy compliance (p = 0.014 and p < 0.001), and patients with BMI < 18.5 had poor radiotherapy compliance (p = 0.036). Malnutrition was prevalent in LANPC patients treated with NACT plus CCRT, and mainly occurred in CCRT period, even lasted until 1 year after treatment in some patients. Furthermore, its impact on clinical outcomes need long-term follow-up.Abstract MO_33_2782; Table 1Incidence of nutrition related parameters and the average quality of life score on each observation pointsprior NACTafter 1 cycle NACTprior RT4th week of RTend of RT3 months after RT1 year after RTWL ≥ 5% (mild malnutrition)5.3%6.0%5.4%38.7%68.5%64.1%54.1%WL ≥ 10% (severe malnutrition)01.8%1.8%7.7%33.3%37.4%28.4%BMI < 18.55.8%7.1%6.5%12.5%19.4%16.8%13.5%NRS2002 ≥ 3 points (high risk of malnutrition)8.2%-6.9%54.4%79.4%10.9%6.7%PG-SGA ≥ 4 points (need nutrition treatment)16.8%-23.6%96.7%96.6%38.3%12.2%PG-SGA ≥ 9 points (need nutrition treatment urgently)3.0%-3.9%72.0%76.6%6.3%0C30-QOL score73.65-71.8250.7648.4971.0376.64 Open table in a new tab
•High-dose IMRT greatly improved local control and outcomes in elderly NPC patients.•No grade 4 toxicities were observed, except for acute haematologic toxicities.•CCRT did not seem to improve long-term survival of stage II–IVb elderly NPC patients.