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首页> 外文期刊>Oral oncology >A phase II study of pemetrexed combined with cisplatin in patients with recurrent or metastatic nanopharyngeal carcinoma
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A phase II study of pemetrexed combined with cisplatin in patients with recurrent or metastatic nanopharyngeal carcinoma

机译：培美曲塞联合顺铂治疗复发或转移性纳米咽癌的II期临床研究

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Pemetrexed is a novel chemotherapy agent with good efficacy and toxicity profiles. This phase II study aimed at evaluating its use in combination with cisplatin for recurrent or metastatic nasopharyngeal carcinoma (NPC). All participating patients had metastatic or recurrent NPC with prior treatment by platinum-based chemotherapy. The study regimen comprised of pemetrexed 500 mg/m 2 and cisplatin 75 mg/m 2, repeated 3-weekly for 4 cycles. Efficacy evaluation was based on both radiological and biochemical responses. Patients with no progressive disease and good tolerance were given another 2-4 cycles. Fifteen patients were treated for a total of 4-8 cycles (median, 6 cycles); 9 had distant metastases and 6 had loco-regional recurrences only. Reduction of DNA copies of EB virus by ≥50% was observed in 93% accessible patients, with 21% of them being biochemical complete response (CR). Radiologically, 1 (7%) patient achieved CR, 2 (13%) achieved partial response and 8 (53%) had stable diseases. The median time to progression was 30 weeks. Treatment was well tolerated with only 1 (7%) patient developing grade 4 toxicity (of anemia). The most common grade 3 toxicities were neutropenia (27%) and anemia (20%). The baseline mean total QOL scores (as measured with FACT-H&N version 4) was 100.4 and showed no significant change after the fourth cycle (95.6, p = 0.20) and sixth cycle (91.9, p = 0.15). Pemetrexed in combination with cisplatin is a well tolerated regimen with encouraging efficacy for metastatic and recurrent NPC. Further evaluation of its role in the management of NPC is warranted.
机译：培美曲塞是一种新型的化疗药物，具有良好的疗效和毒性。这项II期研究旨在评估其与顺铂联合用于复发或转移性鼻咽癌（NPC）的用途。所有参与的患者均患有转移性或复发性鼻咽癌，并事先接受了铂类化学疗法治疗。研究方案包括培美曲塞500 mg / m 2和顺铂75 mg / m 2，每周3次，共4个周期。疗效评估基于放射和生化反应。没有进展性疾病和良好耐受性的患者再接受2-4个周期。 15名患者接受了总共4-8个周期的治疗（中位数为6个周期）; 9例发生远处转移，6例仅发生局部复发。在93％的易接近患者中观察到EB病毒的DNA拷贝减少了≥50％，其中21％是生化完全应答（CR）。放射学上，有1名（7％）患者获得了CR，2名（13％）获得了部分缓解，8名（53％）患有稳定的疾病。中位进展时间为30周。只有1（7％）的患者出现4级（贫血）毒性反应，治疗耐受性良好。最常见的3级毒性是中性粒细胞减少症（27％）和贫血（20％）。基线平均QOL总得分（以FACT-H＆N版本4进行测量）为100.4，在第四周期（95.6，p = 0.20）和第六周期（91.9，p = 0.15）之后没有显示任何显着变化。培美曲塞与顺铂联用是一种耐受良好的方案，对转移性和复发性鼻咽癌的疗效令人鼓舞。有必要进一步评估其在人大管理中的作用。

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