托瑞米芬联合长春瑞滨和顺铂二线治疗中晚期非小细胞肺癌的疗效

目的:前瞻性研究托瑞米芬(toremifene, TOR)联合NP方案(顺铂加长春瑞滨)二线治疗含铂联合化疗方案一线治疗失败的中晚期非小细胞肺癌(non-small cell lung cancer, NSCLC)患者的疗效和安全性.方法:2004年1月-2006年2月,44例接受含铂联合化疗方案一线治疗失败的ⅡB～Ⅳ期NSCLC患者接受了TOR联合NP方案的二线治疗.化疗2个周期后评价疗效和不良反应,并分析生存情况.结果:44例患者的中位化疗周期数为1.8个(范围:1～3个),其中可评价疗效者为37例(既往曾经接受NP方案化疗者21名,接受其他含铂联合化疗方案者16例).37例患者接受二线治疗后,4例获得部分缓解,19例为疾病稳定,14例为疾病进展,无完全缓解者,总有效(完全缓解+部分缓解)率为10.8%(4/37),疾病控制(完全缓解+部分缓解+疾病稳定)率为62.2%(23/37).其中,肺鳞癌患者的有效率和疾病控制率分别为27.3%(3/11)和72.7%(8/11),高于肺腺癌患者的0%(0/18)和44.4%(8/18)(P<0.05).44例患者的中位生存期为8.2个月,中位疾病稳定时间为4.0个月(1.0～10.2个月),总的1年生存率为24.4%.其中,肺鳞癌患者的中位生存期和1年生存率分别为9.2个月和33.3%,肺腺癌患者的中位生存期和1年生存率分别为7.1个月和27.7%,两者比较差异均无统计学意义(P>0.05).男性与女性患者的生存差异也无统计学意义.化疗中,1例患者因肝功能损害(高胆红素血症)中止治疗.化疗不良反应主要包括胃肠反应、骨髓抑制和肝功能损害等,无严重不良反应发生.结论:TOR联合NP方案二线治疗NSCLC患者的疗效与目前的一线含铂联合化疗方案相似,尤其对于肺鳞癌患者而言,且不良反应未见明显增加.

Clinical efficacy of toremifene combined with second line drugs novelbine/cisplatin on advanced non-small cell lung cancer

Objective:To make a prospective study on the effectiveness and safety of toremifene (TOR) combined with novelbine/cisplatin (NP) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose first line platinum-based chemotherapy was failure. Methods:Forty-four patients with stage ⅡB-Ⅳ NSCLC, who failed in the first line cisplatin-based chemotherapy from January 2004 to February 2006, were enrolled in this study. All the patients received TOR combined with NP second line chemotherapy for two cycles. The response rate and adverse reaction were evaluated. The survival rate was analyzed.Results:The 44 patients received average 1.8 cycles of chemotherapy (1-3 cycles). The response of 37 patients could be evaluated including 21 patients who received NP regimen before and 16 patients who received platinum-based chemotherapy. After second line therapy, 4 of the 37 patients had partial response (PR), 19 had stable disease (SD), 14 had progressive disease (PD), and no patient had complete response (CR). The total response rate (CR+PR) was 10.8% (4/37). The disease-controlling rate (CR+PR+SD) was 62.2% (23/37). The response rate and disease-controlling rate of squamous cell lung cancer (SCC) were 27.3% (3/12) and 72.7% (8/12), which were significantly higher than adenocarcinoma 0% (0/18) and 44.4% (8/18), P<0.05]. The median survival time was 8.2 months, the median time for SD was 4.0 months (1.0-10.2 months), and the 1-year survival rate was 24.4%. The median survival time and 1-year survival rate of SCC patients had no significant difference compared with adenocarcinoma patients (9.2 vs 7.1 months; 33.3% vs 27.7%, P＝0.72). There was no significant difference in survival rate between male and female patients. One patient stopped therapy for liver function injury (hyperbilirubinemia). The adverse reactions induced by chemotherapy mainly included gastrointestinal reaction, bone marrow suppression, and liver function injury. No serious adverse reaction occurred. Conclusion:The clinical efficacy of second line TOR combined with NP regimen is similar with the first line regimen for NSCLC patients, especially for SCC patients. The frequency of adverse reaction is not increased.