Interventional hepatic arterial infusion chemotherapy of infusional fluorouracil, leucovorin, and oxaliplatin (HAIC-FO) displayed an encouraging safety profile and antitumor activity in a previous ...phase II trial and a propensity-score-matching study involving patients with locally advanced hepatocellular carcinoma (HCC).
In this open-label, phase III trial, patients with advanced HCC, previously untreated with systemic therapy, were randomly assigned in a 1:1 ratio to receive HAIC-FO or sorafenib. The primary end point was overall survival (OS) in the intention-to-treat population. An exploratory model for predicting the efficacy of HAIC-FO on the basis of genomic sequencing was developed.
Between May 2017 and May 2020, 262 patients were randomly assigned. The median tumor size was 11.2 cm (interquartile range, 8.5-13.7 cm). Macrovascular invasion was present in 65.6%, and the percentage of patients with > 50% tumor volume involvement of the liver and/or Vp-4 portal vein tumor thrombosis was 49.2%. At data cutoff (October 31, 2020), median OS was 13.9 months for HAIC-FO and 8.2 for sorafenib (hazard ratio HR 0.408; 95% CI, 0.301 to 0.552;
< .001). Tumor downstaging occurred in 16 (12.3% of 130) patients receiving HAIC-FO, including 15 receiving curative surgery or ablation, and finally achieving a median OS of 20.8 months, with a 1-year OS rate of 93.8%. In high-risk subpopulations, OS was significantly longer with HAIC-FO than with sorafenib (10.8 months
5.7 months; HR 0.343; 95% CI, 0.219 to 0.538;
< .001). A newly developed 15-mutant-gene prediction model identified 83% of patients with response to HAIC-FO. HAIC-FO responders had longer OS than HAIC-FO nonresponders (19.3 months
10.6 months; HR 0.323; 95% CI, 0.186 to 0.560;
= .002).
HAIC-FO achieved better survival outcomes than sorafenib in advanced HCC, even in association with a high intrahepatic disease burden.
Background
An artificial intelligence (AI)–assisted contouring system benefits radiation oncologists by saving time and improving treatment accuracy. Yet, there is much hope and fear surrounding such ...technologies, and this fear can manifest as resistance from health care professionals, which can lead to the failure of AI projects.
Objective
The objective of this study was to develop and test a model for investigating the factors that drive radiation oncologists’ acceptance of AI contouring technology in a Chinese context.
Methods
A model of AI-assisted contouring technology acceptance was developed based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model by adding the variables of perceived risk and resistance that were proposed in this study. The model included 8 constructs with 29 questionnaire items. A total of 307 respondents completed the questionnaires. Structural equation modeling was conducted to evaluate the model’s path effects, significance, and fitness.
Results
The overall fitness indices for the model were evaluated and showed that the model was a good fit to the data. Behavioral intention was significantly affected by performance expectancy (β=.155; P=.01), social influence (β=.365; P<.001), and facilitating conditions (β=.459; P<.001). Effort expectancy (β=.055; P=.45), perceived risk (β=−.048; P=.35), and resistance bias (β=−.020; P=.63) did not significantly affect behavioral intention.
Conclusions
The physicians’ overall perceptions of an AI-assisted technology for radiation contouring were high. Technology resistance among Chinese radiation oncologists was low and not related to behavioral intention. Not all of the factors in the Venkatesh UTAUT model applied to AI technology adoption among physicians in a Chinese context.
Full text
Available for:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
The aim of this trial was to address whether elective ipsilateral upper-neck irradiation (UNI) sparing the uninvolved lower neck provides similar regional relapse-free survival compared with standard ...whole-neck irradiation (WNI) in patients with nasopharyngeal carcinoma.
This open-label, non-inferiority, randomised, controlled, phase 3 trial was done at three Chinese medical centres. Patients aged 18–65 years with untreated, non-keratinising, non-distant metastatic (M0) nasopharyngeal carcinoma; with N0–N1 disease (according to International Union Against Cancer–American Joint Committee on Cancer TNM classification, seventh edition); and a Karnofsky performance status score of 70 or higher were randomly assigned (1:1) to receive elective UNI or WNI of the uninvolved neck. Total radiation doses of 70 Gy (for the primary tumour volume and the enlarged retropharyngeal nodes), 66–70 Gy (for the involved cervical lymph nodes), 60–62 Gy (for the high-risk target volume), and 54–56 Gy (for the low-risk target volume) were administered in 30–33 fractions, five fractions per week. Patients with stage II–IVA disease were recommended to receive combined intravenous cisplatin-based chemotherapy (either induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy alone). Randomisation was done centrally by the Clinical Trials Centre of Sun Yat-sen University Cancer Centre by means of a computer-generated random number code with a block size of four. Patients were stratified according to treatment centre and nodal status. Investigators and patients were not masked to treatment allocation. The primary endpoint was regional relapse-free survival in the intention-to-treat population. Non-inferiority was indicated if the upper limit of the 95% CI of the difference in 3-year regional relapse-free survival between the UNI and WNI groups was within 8%. Adverse events were analysed in the safety population (defined as all patients who commenced the randomly assigned treatment). This study is registered with ClinicalTrials.gov, NCT02642107, and is closed.
Between Jan 22, 2016, and May 23, 2018, 446 patients from 469 screened were randomly assigned to receive UNI (n=224) or WNI (n=222). Median follow-up was 53 months (IQR 46–59). 3-year regional relapse-free survival was similar in the UNI and WNI groups (97·7% 95% CI 95·7–99·7 in the UNI group vs 96·3% 93·8–98·8 in the WNI group; difference −1·4% 95% CI −4·6 to 1·8; pnon-inferiority<0·0001). Although acute radiation-related toxic effects were similar between the groups, the incidence of late toxicity was lower in the UNI group than in the WNI group, including any-grade hypothyroidism (66 30% of 222 patients vs 87 39% of 221), skin toxicity (32 14% vs 55 25%), dysphagia (38 17% vs 71 32%), and neck tissue damage (50 23% vs 88 40%). No patients died during treatment. After treatment, one patient in the WNI group died from a non-cancer-related cause (dermatomyositis).
Elective UNI of the uninvolved neck provides similar regional control and results in less radiation toxicity compared with standard WNI in patients with N0–N1 nasopharyngeal carcinoma.
Sun Yat-sen University Clinical Research 5010 Program, the Natural Science Foundation of Guangdong Province, and the Overseas Expertise Introduction Project for Discipline Innovation.
For the Chinese translation of the abstract see Supplementary Materials section.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
ObjectiveTo evaluate the prevalence and temporal trends of presarcopenia and related body composition measurements.DesignCross-sectional study.SettingNational Health and Nutrition Examination Survey ...(NHANES) 1999–2006.MethodsPresarcopenia was defined according to the guidelines from the European Working Group on Sarcopenia. Logistic or linear regression models were used to evaluate the linear trend of the prevalence of presarcopenia, obesity and related body composition measurements.ParticipantsA total of 29 947 participants aged 18–90 years from five waves of the NHANES were included in the analysis.Outcome measuresPresarcopenia was sex-specifically defined as having a skeletal mass index ≤7.26 kg/m2 in men and ≤5.5 kg/m2 in women. Body composition measurements, including total body fat percentage, total body fat mass, total lean body mass, appendicular skeletal muscle mass and bone mineral density, were obtained by dual-energy X-ray absorptiometry.ResultsThe overall prevalence of presarcopenia ranged from 16.4% in 1999–2000 to 14.8% in 2005–2006 (p for trend=0.78). Presarcopenia was stable in both males (p for trend=0.36) and females (p for trend=0.20). The presarcopenia prevalence was significantly elevated among the age group of 18–39 years old (from 11.3% to 14.1%, p for trend=0.04) and among non-Hispanic blacks (p for trend <0.001). Adults aged ≥80 years old had the highest prevalence.ConclusionsThe prevalence of presarcopenia increased among young individuals over time. Non-Hispanic blacks also demonstrated an increasing trend in the prevalence over time.
To explore whether single-incision laparoscopic surgery (SILS) has the better short-term clinical and pathological outcomes than conventional multiport laparoscopic surgery (CLS) for sigmoid colon ...and rectal cancer.
A literature investigation of MEDLINE, PubMed, Ovid, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Chinese Biological Medicine (CBM), and Wanfang databases for relevant researches was performed. Fixed effects and random effects models were used to calculate the corresponding outcomes. Standardized mean difference and risk ratio were calculated for continuous and dichotomous variables separately.
Nine clinical controlled trials were composed of two randomized clinical trials and seven non-randomized clinical trials with a total of 829 patients. Two hundred ninety-nine (36.1%) patients underwent SILS, and 530 (63.9%) patients underwent CLS. The meta-analysis showed that SILS had more lymph node resection (SMD - 0.25, 95% CI - 0.50 to - 0.002) and less defecation time (SMD - 0.46, 95% CI - 0.75 to - 0.17), exhaust time (SMD - 0.46, 95% CI - 0.75 to - 0.18), and hospital stay (SMD - 0.30, 95% CI - 0.45 to - 0.15 than CLS. SILS was also accompanied with shorter incision length (SMD - 2.46, 95% CI - 4.02 to - 0.90), less pain score (SMD - 0.56, 95% CI - 0.91 to - 0.21), and lower complication rate (RR 0.66, 95% CI 0.47 to 0.91). Blood loss, operative time, distal margin, conversion rate, anastomotic fistula, readmission, local recurrence, and distant metastasis showed no statistical differences in two groups. In all subgroup analysis, SILS also had advantages of incision length, operative time, defecation time, exhaust time, and hospitalization time than CLS.
SILS could be a more safe and reliable surgical technique than CLS for sigmoid colon and rectal cancer. However, further high-quality studies between these two techniques need to be further developed.
Full text
Available for:
IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
•1. Salivary gland was the most common primary site in HNLELC.•2. Cervical lymph nodes metastases were common and spread orderly in HNLELC.•3. EBERs status might be a potential independent prognostic ...factor for OS in HNLELC.•4. Surgery and postoperative radiotherapy had better outcomes than surgery alone in HNLELC.
We aimed to elucidate the clinical characteristics, prognostic factors and optimal treatment modalities of head and neck lymphoepithelioma-like carcinoma (HNLELC).
Consecutive patients newly-diagnosed with non-metastatic HNLELC between December 2001 and March 2021 treated with curative intent were retrospectively reviewed.
A total of 288 patients were included, of whom 87 (30.2%) underwent radical surgery alone, 43 (14.9%) underwent definitive radiotherapy with or without concurrent chemotherapy, and 158 (54.9%) underwent surgery followed by postoperative radiotherapy (SRT). Epstein-Barr virus-encoded small RNA (EBER) was positive in 94.8% (239/252) of patients. Cervical node infiltration was seen in 52.8% (152/288) of patients. No significant difference was found in nodal metastasis rate between T1 – 2 and T3 – 4 classifications (49.5% vs. 56.5%, p = 0.308). The 3-year overall survival (OS), disease-free survival (DFS), locoregional relapse-free survival (LRRFS), and distant metastasis-free survival rates were 89.4%, 78.7%, 89.2%, and 87.7%, respectively. Compared to SRT, surgery alone associated with significant reduced 3-year local (92.8% vs. 96.5%, p = 0.012) and regional relapse-free survival rates (89.3% vs. 96.8%, p = 0.002). Definitive radiotherapy and SRT demonstrated comparable results in all 3-year survival outcomes (all p＞0.05). Multivariate analysis found EBER status was an independent favorable prognostic factor for OS (HR = 0.356, 95% CI: 0.144 – 0.882, p = 0.026).
HNLELC was observed to associate with EBV infection and cervical nodal infiltration. Definitive radiotherapy achieved similar survival outcomes compared to SRT, and may serve as a good substitute for patients unfit or unwilling to undergo surgery.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Capecitabine maintenance therapy is safe and efficacious for early-stage triple-negative breast cancer (TNBC) patients, but the cost-effectiveness of its long-term use has not been ...investigated. Here, we evaluated the cost-effectiveness of capecitabine maintenance therapy, compared with routine follow-up, in early-stage TNBC patients after standard treatment from a perspective of Chinese society. Methods A three-state Markov model based on the data from the SYSUCC-001 trial was constructed to estimate the cost-effectiveness of capecitabine maintenance therapy in a month cycle over a period of 30-year time horizon. A 5% annual discount rate was set for all costs and benefits. One-way and probabilistic sensitivity analyses were performed to explore the model uncertainties. The main outcomes include quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICER), and the number needed to treat (NNT) to prevent one additional event. Results Compared with routine follow-up, 1-year capecitabine maintenance therapy yielded an additional 1.29 quality-adjusted life years (QALYs) at an additional cost of $3391.70, with an ICER of $2630.53 (95% CI: $1159.81-$5090.12) per QALY gained. The ICER was considerably lower than the recommended willingness-to-pay (WTP) threshold (i.e., $28,130.00 per QALY). The results were sensitive to the discount rate, drug cost, and treatment cost after relapse. Further, the NNT to prevent one additional relapse case was 29.2 (95% CI: 13.2-196.6), 16.7 (95% CI: 8.4-111.6), and 12.0 (95% CI: 5.7-82.6) at 1, 2, and 5 years, respectively. Conclusions One-year capecitabine maintenance therapy for early-stage TNBC after standard treatment, compared with routine follow-up, was found to be highly cost-effective with promising clinical benefits and acceptable increased costs. Real-world studies are warranted to validate our findings in the future. Keywords: Cost-effectiveness, Quality-adjusted life years, Capecitabine maintenance therapy, Early-stage triple-negative breast cancer
Full text
Available for:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The Eleventh Revision of International Classification of Diseases (ICD-11) newly listed gaming disorder, including internet gaming disorder (IGD), as a disease. The level of awareness and potential ...positive and negative impacts of this medicalization among adolescents were unknown.
This study investigated the levels, associated factors, and potential positive and negative impacts of awareness of the medicalization of IGD among adolescents in China.
In a cross-sectional survey, 1343 middle school students in Guangzhou, China, self-administered an anonymous questionnaire in classrooms (October to December 2019). Three risk subgroups were identified: those who scored ≥5 items in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition checklist (IGD-S), those who self-perceived having IGD currently (IGD-PC), and those who self-perceived having IGD within 12 months (IGD-P12M).
Of the internet gamers, 48.3% (460/952) were aware of the medicalization of IGD; they were more likely to belong to the IGD-P12M/IGD-S risk subgroups. Within the IGD-PC/IGD-P12M (but not IGD-S) risk subgroups, IGD medicalization awareness was positively associated with favorable outcomes (reduced internet gaming time in the past 12 months, seeking help from professionals if having IGD, and fewer maladaptive cognitions). After being briefed about the ICD-11 inclusion of IGD, 54.2% (516/952) and 32.8% (312/952) expressed that it would lead to the reduction of gaming time and help-seeking behaviors, respectively; however, 17.9% (170/952), 21.5% (205/952), 15.9% (151/952), and 14.5% (138/952) perceived self-doubt for being diseased, stronger pressure from family members, negative emotional responses, and labeling effect, respectively. With a few exceptions, such perceived positive or negative impacts were stronger among the IGD-S, IGD-PC, and IGD-P12M risk subgroups.
The exploratory study shows that the medicalization of IGD may have benefits that need maximization and potentially harmful effects that need minimization. Future studies should test the efficacies of health promotion that increases IGD medicalization awareness.
Full text
Available for:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
AbstractObjectivesTo address whether sparing the medial retropharyngeal lymph node (MRLN) region from elective irradiation volume provides non-inferior local relapse-free survival versus standard ...radiotherapy in patients with nasopharyngeal carcinoma.DesignOpen-label, non-inferiority, multicentre, randomised, phase 3 trial.SettingThree Chinese hospitals between 20 November 2017 and 3 December 2018.ParticipantsAdults (18-65 years) with newly diagnosed, non-keratinising, non-distant metastatic nasopharyngeal carcinoma without MRLN involvement.InterventionsRandomisation was done centrally by the Clinical Trials Centre at Sun Yat-sen University Cancer Center. Eligible patients were randomly assigned (1:1; block size of four) to receive MRLN sparing radiotherapy or standard radiotherapy (both medial and lateral retropharyngeal lymph node groups), and stratified by institution and treatment modality as follows: radiotherapy alone; concurrent chemoradiotherapy; induction chemotherapy plus radiotherapy or concurrent chemoradiotherapy.Main outcome measuresNon-inferiority was met if the lower limit of the one sided 97.5% confidence interval of the absolute difference in three year local relapse-free survival (MRLN sparing radiotherapy minus standard radiotherapy) was greater than −8%.Results568 patients were recruited: 285 in the MRLN sparing radiotherapy group; 283 in the standard radiotherapy group. Median follow-up was 42 months (interquartile range 39-45), intention-to-treat analysis showed that the three year local relapse-free survival of the MRLN sparing radiotherapy group was non-inferior to that of the standard radiotherapy group (95.3% v 95.5%, stratified hazard ratio 1.04 (95% confidence interval 0.51 to 2.12), P=0.95) with a difference of −0.2% ((one sided 97.5% confidence interval –3.6 to ∞), Pnon-inferiority<0.001). In the safety set (n=564), the sparing group had a lower incidence of grade ≥1 acute dysphagia (25.5% v 35.1%, P=0.01) and late dysphagia (24.0% v 34.3%, P=0.008). Patient reported outcomes at three years after MRLN sparing radiotherapy were better in multiple domains after adjusting for the baseline values: global health status (mean difference −5.6 (95% confidence interval –9.1 to –2.0), P=0.002), role functioning (−5.5 (–7.4 to –3.6), P<0.001), social functioning (−6.2 (–8.9 to –3.6), P<0.001), fatigue (7.9 (4.0 to 11.8), P<0.001), and swallowing (11.0 (8.4 to 13.6), P<0.001). The difference in swallowing scores reached clinical significance (>10 points difference).ConclusionCompared with standard radiotherapy, MRLN sparing radiotherapy showed non-inferiority in terms of risk of local relapse with fewer radiation related toxicity and improved patient reported outcomes in patients with non-metastatic nasopharyngeal carcinoma.Trial registrationClinicalTrials.gov NCT03346109
To compare intensity‐modulated radiotherapy (IMRT) with cisplatin (CDDP) versus cetuximab (CTX) and nimotuzumab (NTZ) for Stage II‐IVb Nasopharyngeal Carcinoma (NPC). A total of 1,837 patients with ...stage II–IVb NPC who received IMRT plus CTX or NTZ, or CDDP between January 2009 and December 2013 were included in the current analysis. Using propensity scores to adjust for potential prognostic factors, a well‐balanced cohort of 715 patients was created by matching each patient who underwent IMRT plus concomitant NTZ/CTX with four patients who underwent IMRT plus concomitant CDDP (1:4). Efficacy and safety were compared between the CTX/NTZ and CDDP groups of this well‐balanced cohort. Furthermore, we conducted multivariate analysis and subgroup analysis based on all the 1,837 eligible cases. There was no significant difference between CTX/NTZ group and CDDP group in terms of DFS (3‐year, 86.7% vs. 86.2%, p > 0.05), LRRFS (96.2% vs. 96.3%, p > 0.05), DMFS (91.1% vs. 92.3%, p > 0.05) and OS (91.7% vs. 91.9%, p > 0.05). Subgroup analysis demonstrated a significant interaction effect between patients with IMRT plus CTX/NTZ and N3 node stage on LRRFS with the highest risk of loco‐regional relapse (HR 8.85, p = 0.001). Significantly increased hematologic toxicities, gastrointestinal reactions were observed in the CDDP group (p < 0.05). Patients of 3.4–4.7% experienced severe hematologic toxicities during the treatment with concomitant CTX and NTZ. Increased rate of CTX related‐skin reaction and mucositis was observed in the CTX group. CTX/NTZ used concurrently with IMRT may be comparable to those of the standard CDDP‐IMRT combination for maximizing survival for patients with stage II‐IVb NPC.
What's new?
Standard treatment for nasopharyngeal carcinoma (NPC) that has spread to lymph nodes in the head and neck entails concurrent cisplatin (CDDP) and intensity‐modulated radiotherapy (IMRT). High toxicity rates, however, limit the utility of this approach. The present study examines an alternative strategy: cetuximab (CTX) and nimotuzumab (NTZ) plus IMRT. No differences in risk of disease progression, relapse, metastasis or death were observed in a direct comparison between CDDP plus IMRT and CTX/NTZ plus IMRT in NPC patients. Both regimens were associated with hematologic toxicities and with toxicities targeting different tissues, warranting further investigation of side effects specific to CTX/NTZ.
Full text
Available for:
BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
PDF
