多西他赛联合洛铂二线治疗晚期非小细胞肺癌的临床研究

Clinical study of lobaplatin combined with docetaxel in the second-line treatment of advanced non-small cell lung cancer

目的比较多西他赛(DOC)联合洛铂(LBP)组成的DL方案与单药DOC二线治疗晚期非小细胞肺癌(NSCLC)的有效性和安全性。方法 132名一线化疗失败的晚期NSCLC患者,二线治疗分别采用DL方案和DOC单药化疗。DL方案组患者61例,采用LBP 30 mg/m2,静滴,第1天,DOC75 mg/m2,静滴,第1天;DOC单药组患者71例,DOC 75 mg/m2,静滴,第1天。上述方案每21 d重复,至少接受2个周期化疗。结果 DL方案组和DOC单药组的总有效率(RR)和疾病控制率(DCR)分别为29.5%(18/61)和67.2%(41/61)以及11.3%(8/71)和45.1%(32/71),LD方案组RR和DCR明显高于单药组(P<0.05);DL方案组的中位无进展生存(PFS)时间为4.37个月,单药组PFS为3.17个月,两组比较差异有统计学意义(P=0.014)。两组常见的不良反应为恶心呕吐、可逆性骨髓抑制、乏力和脱发,其他毒性少见,DL方案组不良反应高于单药DOC组(P<0.05)。结论 DOC联合LBP组成的DL方案二线治疗晚期NSCLC疗效确切,不良反应可耐受,值得进一步研究。

Objective To observe the efficacy and safety of second-line chemotherapy consisted of lobaplatin （LBP） combined with docetaxel （DOC） in the patients with advanced non-small cell lung cancer （NSCLC） compared with DOC alone. Methods 132 patients who failed in the first-line chemotherapy received second-line chemotherapy with LBP plus DOC （DL regimen） and DOC alone respectively. In the DL regimen group, 61 patients were administrated intravenously with LBP 30mg/m2 and DOC 75mg/mEon dl, where as in DOC alone group, 71 patients received DOC at the same dose as in DL regimen group except LBP usage. Each cycle was repeated every 21 days and patient must receive at least 2 cycles for evaluation.Results The response rate （RR） and disease control rate （DCR） in DL regimen group and DOC alone group were 29. 5% （ 18/61 ） ,67. 2% （41/61） and 11.3% （ 8/71 ） ,45. 1% （32/71） respectively which have obvious statistics differences between the two groups （P 〈0. 05）. The progression free survival （PFS） were 4. 37 months in DL regimen group, where as in DOC alone group were 3. 17 months. There were obvious statistics differences between each other （P =0. 014）. The major toxicities were nausea and vomiting, reversible bone marrow suppression, alopecia, and fatigue while other toxieities were rare. The DL regimen group has more toxicities than DOC alone group （P 〈0. 05）. Conclusions DL regimen composed of LBP and DOC is effective and well tolerated for second-line treatment in patients with advanced NSCLC. It is worth further randomized controlled clinical trail.