Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial.

BACKGROUND: Cisplatin-based induction chemotherapy plus concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma has been recommended in the National Comprehensive Cancer Network Guidelines. However, cisplatin is associated with poor patient compliance and has notable side-effects. Lobaplatin, a third-generation platinum drug, has shown promising antitumour activity against several malignancies with less toxicity. In this study, we aimed to evaluate the efficacy of lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy over a cisplatin-based regimen in patients with locoregional, advanced nasopharyngeal carcinoma. METHODS: In this open-label, non-inferiority, randomised, controlled, phase 3 trial done at five hospitals in China, patients aged 18-60 years with previously untreated, non-keratinising stage III-IVB nasopharyngeal carcinoma; Karnofsky performance-status score of at least 70; and adequate haematological, renal, and hepatic function were randomly assigned (1:1) to receive intravenously either lobaplatin-based (lobaplatin 30 mg/m2 on days 1 and 22, and fluorouracil 800 mg/m2 on days 1-5 and 22-26 for two cycles) or cisplatin-based (cisplatin 100 mg/m2 on days 1 and 22, and fluorouracil 800 mg/m2 on days 1-5 and 22-26 for two cycles) induction chemotherapy, followed by concurrent lobaplatin-based (two cycles of intravenous lobaplatin 30 mg/m2 every 3 weeks plus intensity-modulated radiotherapy) or cisplatin-based (two cycles of intravenous cisplatin 100 mg/m2 every 3 weeks plus intensity-modulated radiotherapy) chemoradiotherapy. Total radiation doses of 68-70 Gy (for the sum of the volumes of the primary tumour and enlarged retropharyngeal nodes), 62-68 Gy (for the volume of clinically involved gross cervical lymph nodes), 60 Gy (for the high-risk target volume), and 54 Gy (for the low-risk target volume), were administered in 30-32 fractions, 5 days per week. Randomisation was done centrally at the clinical trial centre of Sun Yat-sen University Cancer Centre by means of computer-generated random number allocation with a block design (block size of four) stratified according to disease stage and treatment centre. Treatment assignment was known to both clinicians and patients. The primary endpoint was 5-year progression-free survival, analysed in both the intention-to-treat and per-protocol populations. If the upper limit of the 95% CI for the difference in 5-year progression-free survival between the lobaplatin-based and cisplatin-based groups did not exceed 10%, non-inferiority was met. Adverse events were analysed in all patients who received at least one cycle of induction chemotherapy. This trial is registered with the Chinese Clinical Trial Registry, ChiCTR-TRC-13003285 and is closed. FINDINGS: From June 7, 2013, to June 16, 2015, 515 patients were assessed for eligibility and 502 patients were enrolled: 252 were randomly assigned to the lobaplatin-based group and 250 to the cisplatin-based group. After a median follow-up of 75·3 months (IQR 69·9-81·1) in the intention-to-treat population, 5-year progression-free survival was 75·0% (95% CI 69·7-80·3) in the lobaplatin-based group and 75·5% (70·0 to 81·0) in the cisplatin-based group (hazard ratio [HR] 0·98, 95% CI 0·69-1·39; log-rank p=0·92), with a difference of 0·5% (95% CI -7·1 to 8·1; pnon-inferiority=0·0070). In the per-protocol population, the 5-year progression-free survival was 74·8% (95% CI 69·3 to 80·3) in the lobaplatin-based group and 76·4% (70·9 to 81·9) in the cisplatin-based group (HR 1·04, 95% CI 0·73 to 1·49; log-rank p=0·83), with a difference of 1·6% (-6·1 to 9·3; pnon-inferiority=0·016). 63 (25%) of 252 patients in the lobaplatin-based group and 63 (25%) of 250 patients in the cisplatin-based group had a progression-free survival event in the intention-to-treat population; 62 (25%) of 246 patients in the lobaplatin-based group and 58 (25%) of 237 patients in the cisplatin-based group had a progression-free survival event in the per-protocol population. The most common grade 3-4 adverse events were mucositis (102 [41%] of 252 in the lobaplatin-based group vs 99 [40%] of 249 in the cisplatin-based group), leucopenia (39 [16%] vs 56 [23%]), and neutropenia (25 [10%] vs 59 [24%]). No treatment-related deaths were reported. INTERPRETATION: Lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy resulted in non-inferior survival and fewer toxic effects than cisplatin-based therapy. The results of our trial indicate that lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy might be a promising alternative regimen to cisplatin-based treatment in patients with locoregional, advanced nasopharyngeal carcinoma. FUNDING: National Science and Technology Pillar Program, International Cooperation Project of Science and Technology Program of Guangdong Province, Planned Science and Technology Project of Guangdong Province, and Cultivation Foundation for the Junior Teachers at Sun Yat-sen University. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

Coronary CT 3D post-processing standardized display and construction of digital teaching platform / 医疗卫生装备

Objective To explore coronary CT three-dimensional post-processing standardized display and the construction of digital teaching platform. Methods The conventional display positions of 3D post-processing image were summarized during daily coronary CTA examination, the common place was refined. The construction mode was explored for CTA digital teaching demonstration platform. Results Coronary CTA 3D post-processing standardized display with common and individual property contributed to enhancing the display of coronary images. The CTA digital teaching demonstration platform met the teaching requirements. Conclusion The coronary CT 3D post-processing standardized display and digital teaching platform facilitate the student to master related knowledge.

Application of quality control circle for improving coronary sinus CT examination / 医疗卫生装备

Objective To compare the image quality of sinus coronal CT scan before and after the involvement of quality control circle (QCC) to explore QCC's effect.Methods A QCC team was founded in April 2014,in which 10 key steps of QCC activities were executed,and the related data from April to November 2014 were analyzed to determine the effect of QCC on coronary sinus CT examination.Results The rate of excellent film was increased from 69.5％ to 96.3％ after the involvement of QCC,and the desired requirement was met.Conclusion QCC contributes to improving coronary sinus CT examination and enhancing the ability of the members,and thus is worthy promoting clinically.

Application of quality control circle for improving coronary sinus CT examination / 医疗卫生装备

Objective To compare the image quality of sinus coronal CT scan before and after the involvement of quality control circle (QCC) to explore QCC's effect.Methods A QCC team was founded in April 2014,in which 10 key steps of QCC activities were executed,and the related data from April to November 2014 were analyzed to determine the effect of QCC on coronary sinus CT examination.Results The rate of excellent film was increased from 69.5％ to 96.3％ after the involvement of QCC,and the desired requirement was met.Conclusion QCC contributes to improving coronary sinus CT examination and enhancing the ability of the members,and thus is worthy promoting clinically.

Inhibition effect of methylene blue on the acids production of Streptococcus mutans / 华西口腔医学杂志

<p><b>OBJECTIVE</b>To study the effect of methylene blue on the growth and acid production of Streptococcus mutans, and the effect of methylene blue on acid production metabolism in plaque glycolysis model (i-PGM) in vitro, and investigate the practicability of methylene blue as a new kind of dental caries prevention agent.</p><p><b>METHODS</b>Nephelometer method was used to measure OD value of Streptococcus mutans culture fluid in the different incubation conditions. The kinds and quantities of acid produced by Streptococcus mutans in the different incubation conditions were measured with gas chromatography. pH values of glycolysis buffer media of i-PGM in the different treatment conditions were measured by ORION electrode.</p><p><b>RESULTS</b>(1) The OD value of Streptococcus mutans treated by methylene blue was lower than that by normal saline, and there was significant statistical difference between them. (2) The kinds of acid in three different culture fluid were same, but the total quantities of acid were significantly different among three different culture fluid, in which the total quantities of acid of culture fluids treated by glucose was the greatest, and treated by methylene blue was the lest. (3) The pH value of i-PGM treated by methylene blue was significantly different compared with negative control group, but was not significantly different compared with positive control group.</p><p><b>CONCLUSION</b>Methylene blue can inhibit the growth and acid production metabolism of Streptococcus matans and acid production metabolism of i-PGM.</p>