Wibmer Thomas, Kropf Cornelia, Merk Tobias, Schumann Christian, Hombach Vinzenz, Krüger Stefan
Medical Clinic II, University Hospital, Ulm, Germany.
Lung Cancer. 2008 May;60(2):231-9. doi: 10.1016/j.lungcan.2007.09.020. Epub 2007 Nov 19.
Aim of this study was to evaluate efficacy, toxicity and tolerability of chemotherapy with a combination of mitomycin and vinorelbine (M/V) in patients with advanced non-small cell lung cancer (NSCLC).
We enrolled 110 patients (median age 67 years) with locally advanced or metastatic NSCLC, who had no prior chemotherapy or progressive disease after at least one prior chemotherapy regimen. 45 patients (41%) were > or =70 years old. All patients received vinorelbine 25mg/m(2) (d1,8) and mitomycin 8mg/m(2) (d1) every 3-4 weeks. Restaging was performed by CT-scan after every two courses M/V according to RECIST criteria.
M/V was well tolerated, even in patients with a poor performance status or > or =70 years Median progression free survival was 4.4 months. Median overall survival was 9.0 months with a 1-year survival rate of 39%. Partial response was observed in 15% and stable disease in 51% of patients. Both hematological and non-hematological toxicities were generally mild. CTC grade 3 toxicities observed included neutropenia in 3%, anemia in 3%, thrombocytopenia in 1% and suspected pneumonitis in 2% of patients. Except neutropenia in 2% and acute dyspnea in 1%, there were no other grade 4 toxicities and no treatment associated casualties. There was no relevant difference in outcome or toxicity between patients > or =70 and <70 years.
M/V seems to be a well-tolerated and effective chemotherapy regimen with low toxicity in patients with advanced NSCLC. It seems to be an interesting option even for patients > or =70 years or with a reduced performance status.
本研究旨在评估丝裂霉素和长春瑞滨联合化疗（M/V）对晚期非小细胞肺癌（NSCLC）患者的疗效、毒性和耐受性。
我们纳入了110例局部晚期或转移性NSCLC患者（中位年龄67岁），这些患者既往未接受过化疗或在至少一种既往化疗方案后出现疾病进展。45例（41%）患者年龄≥70岁。所有患者每3 - 4周接受长春瑞滨25mg/m²（第1、8天）和丝裂霉素8mg/m²（第1天）治疗。根据RECIST标准，每两个疗程M/V后通过CT扫描进行重新分期。
M/V耐受性良好，即使是身体状况较差或年龄≥70岁的患者。中位无进展生存期为4.4个月。中位总生存期为9.0个月，1年生存率为39%。15%的患者观察到部分缓解，51%的患者病情稳定。血液学和非血液学毒性一般较轻。观察到的CTC 3级毒性包括3%的患者出现中性粒细胞减少、3%的患者出现贫血、1%的患者出现血小板减少以及2%的患者疑似肺炎。除2%的患者出现中性粒细胞减少和1%的患者出现急性呼吸困难外，没有其他4级毒性，也没有与治疗相关的死亡病例。年龄≥70岁和＜70岁的患者在疗效或毒性方面没有相关差异。
M/V似乎是一种耐受性良好且有效的化疗方案，对晚期NSCLC患者毒性较低。即使对于年龄≥70岁或身体状况较差的患者，它似乎也是一个有吸引力的选择。
