Nonintubated video-assisted thoracic surgery （VATS） that is also defined awake VATS entails thoracoscopic procedures performed by regional anesthesia in spontaneously ventilating,mildly sedated or fully awake patients.
AIM To evaluate the long-term effectiveness and late toxicities of paclitaxel(PTX) plus cisplatin(DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer.METHODS Between 2008 and 2011, 76 pat...AIM To evaluate the long-term effectiveness and late toxicities of paclitaxel(PTX) plus cisplatin(DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer.METHODS Between 2008 and 2011, 76 patients were enrolled in a phase Ⅱ study on the treatment of loco-regionally advanced esophageal cancer with radiotherapy(68.4 Gy/44 fractions or 61.2 Gy/34 fractions) combined with 4-cycle chemotherapy consisting of DDP(25 mg/m^2 per day for 3 d) and PTX(175 mg/m^2 for 3 h). The primary endpoints were overall survival and progression-free survival, and the secondary endpoints were toxicity and the treatment failure pattern.RESULTS A total of 76 patients were enrolled in this study, of whom 63.2% finished the whole regimen. The 5-year survival rates for the per-protocol population and intent-to-treat population were 25.4% and 26.4%, respectively, and the median survival rates were 23.7 mo and 28.5 mo, respectively. Grade 3 or 4 late toxicity was observed in only one patient(heart failure). In log-rank analysis, the pretreatment stage(stage Ⅱ + Ⅲ: 36.1 mo vs stage Ⅳ: 14.9 mo) and the completed cycle(1-3 cycles: 16.1 mo vs 4 cycles: 35.5 mo) were significant prognostic factors(P = 0.037 < 0.05 and P = 0.013 < 0.05).CONCLUSION Radiotherapy combined with chemotherapy consisting of PTX and DDP is a safe and effective definitive treatment for loco-regionally advanced esophageal squamous cancer.展开更多
临床试验是评估新药或新疗法有效性和安全性最有效的方法,可以提供高质量的循证医学证据。近年来全球的临床试验数量逐渐增加,试验结果为阴性十分常见。当临床试验的主要结果为阴性时,并不一定就意味着研究的失败,研究者还需要多方考虑...临床试验是评估新药或新疗法有效性和安全性最有效的方法,可以提供高质量的循证医学证据。近年来全球的临床试验数量逐渐增加,试验结果为阴性十分常见。当临床试验的主要结果为阴性时,并不一定就意味着研究的失败,研究者还需要多方考虑以便从中找到潜在益处的线索。本文阐述了临床试验主要结局为阴性时需要考虑的12个要点,并以吲哚布芬对比阿司匹林治疗急性缺血性卒中(indobufen versus aspirin in acute ischemic stroke,INSURE)研究为例进行讨论,以期为后续的临床试验设计和结果解读提供经验。展开更多
文摘Nonintubated video-assisted thoracic surgery （VATS） that is also defined awake VATS entails thoracoscopic procedures performed by regional anesthesia in spontaneously ventilating,mildly sedated or fully awake patients.
基金Supported by National Natural Science Foundation of China,No.21172043 and No.21441010
文摘AIM To evaluate the long-term effectiveness and late toxicities of paclitaxel(PTX) plus cisplatin(DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer.METHODS Between 2008 and 2011, 76 patients were enrolled in a phase Ⅱ study on the treatment of loco-regionally advanced esophageal cancer with radiotherapy(68.4 Gy/44 fractions or 61.2 Gy/34 fractions) combined with 4-cycle chemotherapy consisting of DDP(25 mg/m^2 per day for 3 d) and PTX(175 mg/m^2 for 3 h). The primary endpoints were overall survival and progression-free survival, and the secondary endpoints were toxicity and the treatment failure pattern.RESULTS A total of 76 patients were enrolled in this study, of whom 63.2% finished the whole regimen. The 5-year survival rates for the per-protocol population and intent-to-treat population were 25.4% and 26.4%, respectively, and the median survival rates were 23.7 mo and 28.5 mo, respectively. Grade 3 or 4 late toxicity was observed in only one patient(heart failure). In log-rank analysis, the pretreatment stage(stage Ⅱ + Ⅲ: 36.1 mo vs stage Ⅳ: 14.9 mo) and the completed cycle(1-3 cycles: 16.1 mo vs 4 cycles: 35.5 mo) were significant prognostic factors(P = 0.037 < 0.05 and P = 0.013 < 0.05).CONCLUSION Radiotherapy combined with chemotherapy consisting of PTX and DDP is a safe and effective definitive treatment for loco-regionally advanced esophageal squamous cancer.
文摘临床试验是评估新药或新疗法有效性和安全性最有效的方法,可以提供高质量的循证医学证据。近年来全球的临床试验数量逐渐增加,试验结果为阴性十分常见。当临床试验的主要结果为阴性时,并不一定就意味着研究的失败,研究者还需要多方考虑以便从中找到潜在益处的线索。本文阐述了临床试验主要结局为阴性时需要考虑的12个要点,并以吲哚布芬对比阿司匹林治疗急性缺血性卒中(indobufen versus aspirin in acute ischemic stroke,INSURE)研究为例进行讨论,以期为后续的临床试验设计和结果解读提供经验。
