老年（>=70 岁）、体能状态差的晚期非小细胞肺癌患者单药口服长春瑞滨的 II 期临床试验。

Phase II trial of single-agent oral vinorelbine in elderly (> or =70 years) patients with advanced non-small-cell lung cancer and poor performance status.

机构信息

Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.

出版信息

Ann Oncol. 2010 Jun;21(6):1290-1295. doi: 10.1093/annonc/mdp525. Epub 2009 Nov 13.

DOI:10.1093/annonc/mdp525

PMID:19914959

Abstract

BACKGROUND

Elderly patients with advanced non-small-cell lung cancer (NSCLC) with poor performance status (PS) are a special population requiring particular attention. Single-agent oral vinorelbine could be an attractive option.

PATIENTS AND METHODS

A total of 43 patients with stage IIIB-IV NSCLC and Eastern Cooperative Oncology Group (ECOG) PS of two or more with good functional status were prospectively recruited. Oral vinorelbine was administered at the dose of 60 mg/m(2) on days 1-8 every 3 weeks. Primary end points were response rate and safety.

RESULTS

Overall response rate was 18.6% with 8 partial responses; 18 of 43 (41.8%) experienced stable disease lasting >12 weeks and 17 of 43 (39.6%) disease progression for an overall clinical benefit of 60.4%. Median time to progression was 4.0 (range 2-22) months and median overall survival 8.0 (range 3-35) months. Treatment was well tolerated. Of 187 cycles, we did not observe any grade 3/4 toxicity with the exception of a single not-febrile G3 neutropenia. Regardless of severity, main toxic effects observed were nausea in 48.1% and vomiting in 22.9% of patients, anemia in 43.2%, fatigue in 32.6% and leukopenia in 23.2%.

CONCLUSION

Single-agent oral vinorelbine is extremely safe in elderly patients with advanced NSCLC and ECOG PS of two or more and may represent a valid option in this very special population.

摘要

背景

体力状况（PS）较差的晚期非小细胞肺癌（NSCLC）老年患者是一个需要特别关注的特殊群体。单药口服长春瑞滨可能是一个有吸引力的选择。

患者和方法

共前瞻性招募了 43 名体力状况（PS）为 2 或 2 以上的 IIIB-IV 期 NSCLC 和东部肿瘤协作组（ECOG）的患者。口服长春瑞滨剂量为 60mg/m²，第 1-8 天，每 3 周一次。主要终点为缓解率和安全性。

结果

总缓解率为 18.6%，其中 8 例部分缓解；43 例中有 18 例（41.8%）疾病稳定持续超过 12 周，43 例中有 17 例（39.6%）疾病进展，总临床获益率为 60.4%。中位无进展生存期为 4.0（范围 2-22）个月，总生存期为 8.0（范围 3-35）个月。治疗耐受性良好。在 187 个周期中，我们未观察到任何 3/4 级毒性，除了一例非发热性 3 级中性粒细胞减少症。无论严重程度如何，主要毒性作用为 48.1%的患者出现恶心，22.9%的患者出现呕吐，43.2%的患者出现贫血，32.6%的患者出现乏力，23.2%的患者出现白细胞减少。