Long-term results of a randomized, double-blind, and placebo-controlled phase III trial: Endostar (rh-endostatin) versus placebo in combination with vinorelbine and cisplatin in advanced non-small cell lung cancer
| Autor: | Jie Jun Wang, Yong Yu Liu, Yiping Zhang, Wei Lian Li, Qi Tao Yu, Feng Zhan Qin, Jin Wan Wang, Ke Jun Nan, Xiaoqing Liu, Hou Jie Liang, Chen Yao, Jing Min Zhou, Kai Li, Yuan Rong Tu, Wei Liu, Qing Hua Zhou, Hui Shan Lu, Zheng Tang Chen, Wen Chao Liu, Qiang Chen, Yan Sun, Shu Ping Song, Li Yan Xu, Xiu Wen Wang, Su Xia Luo |
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| Rok vydání: | 2013 |
| Předmět: |
Pulmonary and Respiratory Medicine
Cisplatin Chemotherapy medicine.medical_specialty business.industry medicine.medical_treatment General Medicine Vinorelbine medicine.disease Placebo Gastroenterology Surgery Regimen Oncology Internal medicine Medicine Endostatin business Adverse effect Lung cancer medicine.drug |
| Zdroj: | Thoracic Cancer. 4:440-448 |
| ISSN: | 1759-7706 |
| Popis: | Background: Phase II-III trials in patients with untreated and previously treated locally advanced or non-small cell lung cancer (NSCLC) suggested that Endostar was able to enhance the effect of platinum-based chemotherapy (NP regimen) with tolerable adverse effects. Methods Four hundred and eighty six patients were randomized into two arms: study arm A: NP plus Endostar (n = 322; vinorelbine, cisplatin, Endostar), and study arm B: NP plus placebo (n = 164; vinorelbine, cisplatin, 0.9% sodium chloride). Patients were treated every third week for two to six cycles. Results: Overall response rates were 35.4% in arm A and 19.5% in arm B (P = 0.0003). The median time to progression was 6.3 months for arm A and 3.6 months for B, respectively (P 0.05). There were two treatment related deaths in arm A and one in arm B (P > 0.05). The median overall survival was longer in arm A than in arm B (P < 0.0001). Conclusion: Long-term follow-up revealed that the addition of Endostar to an NP regimen can result in a significant clinical and survival benefit in advanced NSCLC patients, compared with NP alone. |
| Databáze: | OpenAIRE |
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