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首页> 外文期刊>Lung cancer: Journal of the International Association for the Study of Lung Cancer >Administration of pemetrexed immediately following gemcitabine as front-line therapy in advanced non-small cell lung cancer: a phase II trial.
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Administration of pemetrexed immediately following gemcitabine as front-line therapy in advanced non-small cell lung cancer: a phase II trial.

机译：后立即培美曲塞吉西他滨在先进的一线治疗非小细胞肺癌:第二阶段试验。

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BACKGROUND: Pemetrexed and gemcitabine have demonstrated independent anti-tumor activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The combination of these two therapies may produce synergistic anti-tumor effects. Previous studies of this combination have included a 90-min separation between the two drugs. More recent preclinical studies have suggested that this delay in administration might be unnecessary. This phase II study was designed to determine the objective tumor response rate and toxicity when pemetrexed was administered immediately after gemcitabine on day 1. METHODS: Chemonaive patients stage IIIB with pleural effusion or stage IV NSCLC were enrolled. Treatment consisted of gemcitabine 1250 mg/m2 (30-min intravenous infusion on days 1 and 8) and pemetrexed 500 mg/m2 (10-min i.v. infusion, immediately following gemcitabine, on day 1) every 21 days. All patients received folic acid, vitamin B12, and steroid prophylaxis. RESULTS: The 53 enrolled patients completed a total of 199 cycles (median=4.0, mean=3.8). Best tumor response consisted of 1 complete response (2.0%), 15 partial responses (30.6%), 17 with stable disease (34.7%), and 16 with progressive disease (32.7%). Median time to disease progression was 3.3 months and median survival was 10.3 months. Grades 3/4 hematologic toxicities (% patients) consisted of: neutropenia (43.4), anemia (9.4), febrile neutropenia (7.5%) and thrombocytopenia (1.9). The most common grades 3 or 4 non-hematologic events were: dyspnea (15.1), fatigue (11.3), and pyrexia (9.4). One patient (1.9%) experienced grade 2 alopecia. CONCLUSION: This schedule of pemetrexed plus gemcitabine is tolerable and offered the advantage of not requiring a 90-min delay between the two drugs. Response rate, survival, time to disease progression, and toxicity were acceptable and similar to other NSCLC regimens.
机译：背景:培美曲塞和吉西他滨证明了独立的抗肿瘤活性患者局部晚期或转移性非小细胞肺癌(NSCLC)。这两种治疗方法可能产生的组合协同抗肿瘤效应。这种组合的包括90分钟两种药物之间的分离。临床前研究表明,这个问题延迟政府可能是不必要的。这第二阶段的研究是为了确定目的肿瘤反应率和毒性培美曲塞后立即进行吉西他滨在第一天。病人希望与胸腔积液或阶段四期NSCLC登记。吉西他滨1250 mg / m2(30分钟静脉输液在500天1和8)和培美曲塞毫克/平方米(10分钟注入静脉输液,立即吉西他滨后,第一天)每21天。所有患者接受叶酸、维生素B12和类固醇预防。病人总共完成了199次(值= 4.0,意味着= 3.8)。由1完全缓解(2.0%),15局部反应(30.6%),17与稳定的疾病与进步的疾病(34.7%)和16(32.7%)。疾病进展时间中位数为3.3个月和平均生存期是10.3个月。患者血液毒性(%)包括:嗜中性白血球减少症(43.4),贫血(9.4),发热嗜中性白血球减少症(7.5%)和血小板减少症(1.9)。最常见的成绩3或4 non-hematologic事件:呼吸困难(15.1),疲劳(11.3),和发热(9.4)。2级脱发。培美曲塞+吉西他滨是可以忍受的提供的优势是不需要90分钟两种药物之间的延迟。生存,疾病进展时间,毒性是可以接受的,类似于其他非小细胞肺癌治疗方案。

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