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老年晚期非小细胞肺癌患者的顺铂(CDDP)和长春瑞滨(VNB)分阶段化疗:II期试验

Fractionated dose of cisplatin (CDDP) and vinorelbine (VNB) chemotherapy for elderly patients with advanced non-small cell lung cancer: phase II trial.

作者信息

Buffoni Lucio, Dongiovanni Diego, Barone Carla, Fissore Camilla, Ottaviani Davide, Dongiovanni Vincenzo, Grillo Raffaella, Salvadori Angelica, Birocco Nadia, Schena Marina, Bertetto Oscar

机构信息

Oncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera San Giovanni Battista Molinette, Via Cherasco 15, 10126 Torino, Italy.

出版信息

Lung Cancer. 2006 Dec;54(3):353-7. doi: 10.1016/j.lungcan.2006.08.013. Epub 2006 Oct 17.

DOI:10.1016/j.lungcan.2006.08.013
PMID:17049672
Abstract

BACKGROUND

The incidence of non-small cell lung cancer (NSCLC) is increasing among the elderly representing about 30% of NSCLC patients over 70 years old. The aim of this study was to evaluate the response, survival and tolerability of a modified schedule with cisplatin-vinorelbine in elderly patients with advanced NSCLC.

METHODS

Between November 2001 and March 2003, 30 patients were included into the study. Median age was 73 (range 70-77). Male/female 27/3 (90%/10%); 60% of patients were stage IV at diagnosis and only one patient presented with brain metastasis. Treatment consisted of cisplatin 30 mg/m(2) on days 1 and 8, and vinorelbine 25 mg/m(2) on days 1 and 8 every 21 days.

RESULTS

A total of 120 cycles were administered with a median of four cycles per patient. The most relevant WHO toxicities were: neutropenia grade 3 in 6 (20%) patients and grade 4 in 13 (43%) patients. There were three (10%) treatment-related deaths: two caused by neutropenic fever and one due to acute pulmonary oedema. No other relevant hematological and non-hematological toxicities occurred. By intention-to-treat analysis, 10 patients (33%) showed stable disease and 10 patients (33%) showed a partial response while 10 patients (33%) showed treatment failure. Median survival time was 7.4 months; 1-year survival was 36.6% and median time to progression was 5.14 months.

CONCLUSION

At this dose and schedule, the combination of vinorelbine and cisplatin obtained a response rate and survival comparable to the most active regimens. Non-hematologic toxicity was mild while neutropenia was the most relevant toxicity.

摘要

背景

非小细胞肺癌(NSCLC)在老年人中的发病率正在上升,70岁以上的NSCLC患者约占30%。本研究的目的是评估顺铂-长春瑞滨改良方案对老年晚期NSCLC患者的疗效、生存率和耐受性。

方法

2001年11月至2003年3月,30例患者纳入本研究。中位年龄为73岁(范围70 - 77岁)。男女比例为27/3(90%/10%);60%的患者在诊断时为IV期,只有1例患者有脑转移。治疗方案为每21天第1天和第8天给予顺铂30mg/m²,第1天和第8天给予长春瑞滨25mg/m²。

结果

共进行了120个周期的治疗,每位患者中位治疗周期数为4个。世界卫生组织(WHO)定义的最主要毒性反应为:6例(20%)患者出现3级中性粒细胞减少,13例(43%)患者出现4级中性粒细胞减少。有3例(10%)与治疗相关的死亡:2例死于中性粒细胞减少性发热,1例死于急性肺水肿。未出现其他显著的血液学和非血液学毒性反应。意向性分析显示,10例患者(33%)病情稳定,10例患者(33%)部分缓解,10例患者(33%)治疗失败。中位生存时间为7.4个月;1年生存率为36.6%,中位疾病进展时间为5.14个月。

结论

在此剂量和方案下,长春瑞滨与顺铂联合使用的有效率和生存率与最有效的方案相当。非血液学毒性较轻,而中性粒细胞减少是最主要的毒性反应。

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