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Phase III Non-inferiority Study Evaluating Efficacy and Safety of Low Dose Gemcitabine Compared to Standard Dose Gemcitabine With Platinum in Advanced Squamous Lung Cancer

机译：三期非劣效性研究评估低剂量吉西他滨与标准剂量吉西他滨联合铂类药物在晚期鳞癌中的疗效和安全性

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BackgroundProlonged infusion of low dose gemcitabine (PLDG) in combination with platinum has shown promising activity in terms of improved response rate and progression free survival (PFS); especially in squamous non-small cell lung cancer (NSCLC). Hence, we conducted a phase 3 randomized non-inferiority study with the primary objective of comparing the overall survival (OS) between PLDG and standard dose of gemcitabine with platinum.

机译：背景长期输注低剂量吉西他滨（PLDG）与铂类药物相比，在改善应答率和无进展生存（PFS）方面显示出令人鼓舞的活性。特别是鳞状非小细胞肺癌（NSCLC）。因此，我们进行了一项3期随机非劣效性研究，其主要目的是比较PLDG和标准剂量吉西他滨与铂之间的总生存期（OS）。

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期刊名称 EClinicalMedicine
作者
Vijay Patil; Vanita Noronha; Amit Joshi; Anuradha Chougule; Sadhana Kannan; Atanu Bhattacharjee; Supriya Goud; Sucheta More; Arun Chandrasekharan; Nandini Menon; Sujay Srinivas; Dilip Harindran Vallathol; Hollis Dsouza; Swaratika Majumdar; Sudeep Das; Abhinav Zawar; Satvik Khaddar; Amit Kumar; Gunjesh Singh; Kanteti Aditya Pavan Kumar; Rahul Ravind; Vaishakhi Trivedi; Vichitra Behel; Abhishek Mahajan; Amit Janu; Nilendu Purandare; Kumar Prabhash;
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年(卷),期 2019(9),-1
年度 2019
页码 19–25
总页数 7
原文格式 PDF
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关键词
Gemcitabine Low dose Prolonged infusion Squamous cell cancer NSCLC;

机译：吉西他滨;小剂量;长时间输注;鳞状细胞癌;NSCLC;

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1. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer [J] . Paz-Ares L., Socinski M. A., Shahidi J., Annals of oncology: official journal of the European Society for Medical Oncology . 2016,第8期

机译：EGFR表达与SQUIRE中安全性和疗效的相关性：吉西他滨-顺铂加尼西单抗与单独吉西他滨-顺铂在一线治疗IV期鳞状非癌患者中的随机，多中心，开放性，III期研究小细胞肺癌
2. 6503 ORAL Efficacy and safety results from BO17704, a randomised, placebo-controlled phase III study of bevacizumab in combination with cisplatin and gemcitabine in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) [J] . C.Manegold, J.vonPawel, P.Zatloukal, European Journal of Cancer Supplements . 2007,第4期

机译：6503口服功效的有效性和安全性来自BO17704，这是一项贝伐单抗联合顺铂和吉西他滨对晚期或复发性非鳞状非小细胞肺癌（NSCLC）患者进行的随机，安慰剂对照的III期临床研究
3. Concomitant chemoradiotherapy using low-dose weekly gemcitabine versus low-dose weekly paclitaxel in locally advanced head and neck squamous cell carcinoma: a phase III study. [J] . Amal Ahmed-Fouad Halim, Hanan Ahmed Wahba, Hend Ahmed El-Hadaad, Medical oncology . 2012,第1期

机译：低剂量每周吉西他滨与低剂量每周紫杉醇在局部晚期头颈部鳞状细胞癌中同时放化疗：III期研究。
4. Dose response relationship for bladder and lung cancer mortality in low-dose villages (<150 μg/L) in the blackfoot disease endemic area of southwest Taiwan—Implications in risk analysis [C] . S.H. Lamm, R. Lizewski, S. Robbins International Congress: Arsenic in the Environment . 2010

机译：膀胱和肺癌死亡率的剂量反应关系（<150μg/ L）在危险分析中西南地区的黑脚疾病地方患者中的低剂量村（<150μg/ L）
5. A dose finding method in joint modeling of efficacy and safety endpoints in phase II studies - an extension of the MCP-MOD method. [D] . Tao, Aiyang. 2010

机译：II期研究中疗效和安全性终点联合建模中的一种剂量寻找方法-MCP-MOD方法的扩展。
6. Induction gemcitabine in standard dose or prolonged low-dose with cisplatin followed by concurrent radiochemotherapy in locally advanced non-small cell lung cancer: a randomized phase II clinical trial [O] . Martina Vrankar, Matjaz Zwitter, Tanja Bavcar, 2014

机译：在局部晚期非小细胞肺癌中以标准剂量或长期低剂量顺铂诱导吉西他滨联合放射化学治疗：一项II期随机临床试验
7. Induction gemcitabine in standard dose or prolonged low-dose with cisplatin followed by concurrent radiochemotherapy in locally advanced non-small cell lung cancer: a randomized phase II clinical trial [O] . Vrankar Martina, Zwitter Matjaz, Bavcar Tanja, 2014

机译：标准剂量诱导吉西他滨或长期低剂量顺铂，然后同时放化疗治疗局部晚期非小细胞肺癌：一项随机II期临床试验

Phase III Non-inferiority Study Evaluating Efficacy and Safety of Low Dose Gemcitabine Compared to Standard Dose Gemcitabine With Platinum in Advanced Squamous Lung Cancer

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