A phase II study of cisplatin and docetaxel administered as three consecutive weekly infusions for advanced non-small-cell lung cancer in elderly patients
A phase II study of cisplatin and docetaxel administered as three consecutive weekly infusions for advanced non-small-cell lung cancer in elderly patients
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DOI：
10.1093/annonc/mdh015
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发表时间：
2004-01-01
影响因子：
50.5
通讯作者：
Nishiwaki, Y
中科院分区：
文献类型：
--
作者：
Ohe, Y;Niho, S;Nishiwaki, Y
背景：为了评估75岁或以上高龄晚期非小细胞肺癌患者治疗的有效性和安全性，我们进行了一项II期研究，顺铂和多西他赛每周连续输注三次。患者和方法：研究的资格标准包括：首次化疗的晚期非小细胞肺癌，年龄大于或等于75岁，东部肿瘤合作组的表现状态为0或1，可测量的病变，足够的器官功能和签署的知情同意书。化疗方案包括顺铂（25 mg/m(2)）和多西他赛（20 mg/m(2)），每4周进行第1、8和15天。结果：2000年2月至2002年3月，34例老年非小细胞肺癌患者入组研究，33例患者接受治疗。33例治疗患者获得2例完全缓解和15例部分缓解，客观缓解率为52%。中位生存期为15.8个月，1年生存率为64%。毒性较轻，无4级毒性。仅观察到3级白细胞减少（6%）、中性粒细胞减少（12%）、贫血（3%）、低钠血症（3%）和恶心/呕吐（3%）。结论：顺铂联合多西他赛连续3周输注治疗老年化疗初治非小细胞肺癌安全有效。
Background: To evaluate the efficacy and safety of treatments for advanced non-small-cell lung cancer in elderly patients aged 75 years or older, we conducted a phase II study of cisplatin and docetaxel administered in three consecutive weekly infusions.Patients and methods: The eligibility criteria for the study included the presence of chemotherapy-naive advanced non-small-cell lung cancer, age greater than or equal to75 years, Eastern Cooperative Oncology Group performance status of 0 or 1, a measurable lesion, adequate organ functions and signed informed consent. The chemotherapy regimen consisted of cisplatin (25 mg/m(2)) and docetaxel (20 mg/m(2)) on days 1, 8 and 15 every 4 weeks.Results: Between February 2000 and March 2002, 34 elderly patients with non-small-cell lung cancer were enrolled in the study and 33 patients were treated. Two complete responses and 15 partial responses were obtained for an objective response rate of 52% in 33 treated patients. The median survival period was 15.8 months, and the 1-year survival rate was 64%. Toxicities were mild with no grade 4 toxicities. Only grade 3 leukopenia (6%), neutropenia (12%), anemia (3%), hyponatremia (3%) and nausea/vomiting (3%) were observed.Conclusion: Cisplatin and docetaxel administered in three consecutive weekly infusions was safe and effective for the treatment of elderly patients with chemotherapy-naive non-small-cell lung cancer.