紫杉醇化疗联合三维适形放射治疗老年局部晚期非小细胞肺癌患者的临床安全性

Clinical safety of paclitaxel chemotherapy plus three dimensional conformal radiotherapy for elderly patients with locally advanced non-small cell lung cancer

目的:探讨紫杉醇单药每周化疗联合三维适形放射(3D-CRT)疗法治疗老年局部晚期非小细胞肺癌(NSCLC)的临床安全性。方法:采用多中心、开放模式进行研究。2006年1月至2008年12月共56例Ⅲ期NSCLC患者纳入研究,其中男39例,女17例,年龄60～78岁,中位年龄67岁。56例患者中鳞癌36例,腺癌20例;Ⅲa期NSCLC34例,Ⅲb期NSCLC22例。给予紫杉醇40mg/m2静脉滴注,1次/周;给药后3h采用3D-CRT(6MV-X射线,95%PTV/60Gy/2Gy/30次),1次/d,疗程均为连续6周。4周为1周期,治疗期间及治疗结束后第2周记录原发病灶和纵隔淋巴结转移病灶的变化、不良反应和生存情况。结果:56例患者均完成6周治疗。NSCIC原发病灶总有效率为82.1%(46/56),纵隔淋巴结转移病灶总有效率为91.1%(51/56)。鳞癌、腺癌原发病灶总有效率分别为88.9%(32/36)和70.0%(14/20),纵膈淋巴结转移病灶总有效率分别为97.2%(35/36)和80.0%(16/20),不同病理类型之间疗效差异无统计学意义。化疗急性不良反应以骨髓抑制为主,白细胞减少、血红蛋白减少和血小板减少发生率分别为42.9%(24/56)、51.8%(29/56)和30.4%(17/56),恶心、呕吐发生率为42.9%(24/56);放疗急性不良反应主要为放射性肺炎和放射性食管炎,发生率为17.9%(10/56)和58.9%(33/56),上述不良反应多为轻度反应。鳞癌和腺癌患者疾病进展中位时间为7.8和5.6个月,中位生存期为11.3和10.2个月,1年生存率为47.2%和35.0%,2年生存率为25.0%和15.0%。结论:紫杉醇单药每周化疗联合3D-CRT对老年晚期局部NSCIC近期疗效及安全性均较好。

Objective：To explore the clinical safety of weekly single-agent paclitaxel chemotherapy plus three dimensional conformal radiotherapy for locally advanced non-small cell lung cancer（NSCLC） in elderly patients.Methods：A multicentre,open-lable trial was performed.From January 2006 to December 2008,56 patients with stage Ⅲ NSCLC were enrolled in this study.They comprised 39 men and 17 women with age of 60~78 years and the mean age was 67 years.These 56 patients included squamous carcinoma（36 patients）,adenocarcinoma（20）;Ⅲa stage NSCLC（34） and Ⅲb stage NSCLC（22）.An intravenous infusion of paclitaxel 40 mg/m2 was given once a week,followed by 3D-CRT（6MV-X ray,95%PTV/60Gy/2Gy/30f） once daily 3 hours after paclitaxel infusion completion.The duration of treatment was 6 weeks.Each cycle was 4 weeks.The changes in primary focus and mediastinal lymphatic metastasis as well as adverse reactions and survival situation were recorded during treatment and in week 2 after treatment completion.Results：All 56 patients completed 6-week therapy.The total effective rate to primary focus of NSCLC was 82.1%（46/56） and the total effective rate to mediastinal lymphatic metastasis was 91.1%（51/56）.The total effective rate to primary foci of squamous carcinoma and adenocarcinoma was 88.9%（32/56） and 70.0%（14/20）,respectively,and the total effective rate to mediastinal lymphatic metastasis of squamous carcinoma and adenocarcinoma was 97.2%（35/36） and 80.0%（16/20）,respectively.There was no statistically significant difference among different types of pathology.Acute adverse reactions to chemotherapy were mainly bone marrow suppression,the incidence of a reduction of white cells,hemoglobin,and platelets were 42.9%（24/56）,51.8%（29/56）,and 30.4%（17/56）,respectively,and the incidence of nausea and vomiting were 42.9%（24/56）.Acute adverse reactions to radiotherapy were mainly radiation-induced esophagitis and pneumonia,and their incidence was 17.9%（10/56） and 58.9%（33/56）,respectively.All the adverse reactions mentioned above in the patients with squamous carcinoma and adenocarcinoma were mild.The mean time to disease progression was respectively 7.8 months and 5.6 months,the mean survival time was respectively 11.3 months and 10.2 months,one-year survival rate was respectively 47.2% and 35.0%,and two-year survival rate was respectively 25.0% and 15.0%.Conclusion：Weekly single-agent paclitaxel chemotherapy plus 3D-CRT has better short-term efficacy and safety in treatment of elder patients with locally advanced NSCLC.