Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Ann Oncol. 2010 Jun;21(6):1290-1295. doi: 10.1093/annonc/mdp525. Epub 2009 Nov 13.
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.
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.
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%.
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.
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。
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。
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。
单药口服长春瑞滨在体力状况（PS）较差的晚期 NSCLC 和 ECOG PS 为 2 或 2 以上的老年患者中非常安全，可能是这一非常特殊人群的有效选择。
