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奈达铂或顺铂联合其他化疗方案治疗晚期非小细胞肺癌的随机对照研究

Randomized control study of nedaplatin or cisplatin concomitant with other chemotherapy in the treatment of advanced non-small cell lung cancer.

作者信息

Li Chun-Hong, Liu Mei-Yan, Liu Wei, Li Dan-Dan, Cai Li

机构信息

Department of Internal Medical Oncology, The Affiliated Tumor Hospital of Harbin Medical University, Harbin, China E-mail :

出版信息

Asian Pac J Cancer Prev. 2014;15(2):731-6. doi: 10.7314/apjcp.2014.15.2.731.

DOI:10.7314/apjcp.2014.15.2.731
PMID:24568487
Abstract

OBJECTIVE

To observe the short-term efficacy, long-term survival time and adverse responses with nedaplatin (NDP) or cisplatin (DDP) concomitant with other chemotherapy in treating non-small cell lung cancer.

MATERIALS AND METHODS

A retrospective, randomized, control study was conducted, in which 619 NSCLC patients in phases III and IV who were initially treated and re-treated were randomly divided into an NDP group (n=294) and a DDP group (n=325), the latter being regarded as controls. Chemotherapeutic protocols (CP/DP/GP/NP/TP) containing NDP or DDP were given to both groups. Patients in both groups were further divided to evaluate the clinical efficacies according to initial and re-treatment stage, pathological pattern, type of combined chemotherapeutic protocols, tumor stage and surgery.

RESULTS

The overall response rate (ORR) and disease control rate (DCR) in the NDP group were 48.6% and 95.2%, significantly higher than in the DDP group at 35.1% and 89.2%, respectively (P<0.01). In NSCLC patients with initial treatment, squamous carcinoma and phase III, there were significant differences in ORR and DCR between the groups (P<0.05), while ORR was significant in patients with adenocarcinoma, GP/TP and in phase IIIa (P<0.05). There was also a significant difference in DCR in patients in phase IIIb (P<0.05). According to the statistical analysis of survival time of all patients and of those in clinical phase III, the NDP group survived significantly longer than the DDP group (P<0.01). The rates of decreased hemoglobin and increased creatinine, nausea and vomiting in the NDP group were evidently lower than in DDP group (P<0.05).

CONCLUSION

NDP concomitant with other chemotherapy is effective for treating NSCLC, with higher clinical efficacy than DDP concomitant with chemotherapy, with advantages in prolonging survival time and reducing toxic and adverse responses.

摘要

目的

观察奈达铂(NDP)或顺铂(DDP)联合其他化疗药物治疗非小细胞肺癌的近期疗效、远期生存时间及不良反应。

材料与方法

进行一项回顾性、随机对照研究,将619例初治及复治的Ⅲ、Ⅳ期非小细胞肺癌患者随机分为NDP组(n = 294)和DDP组(n = 325),后者作为对照组。两组均给予含NDP或DDP的化疗方案(CP/DP/GP/NP/TP)。根据初治及复治阶段、病理类型、联合化疗方案类型、肿瘤分期及手术情况,对两组患者进一步分组以评估临床疗效。

结果

NDP组的总有效率(ORR)和疾病控制率(DCR)分别为48.6%和95.2%,显著高于DDP组的35.1%和89.2%(P < 0.01)。在初治、鳞癌及Ⅲ期的非小细胞肺癌患者中,两组的ORR和DCR存在显著差异(P < 0.05),而腺癌、GP/TP方案及Ⅲa期患者的ORR差异有统计学意义(P < 0.05)。Ⅲb期患者的DCR也存在显著差异(P < 0.05)。根据所有患者及临床Ⅲ期患者生存时间的统计分析,NDP组的生存时间显著长于DDP组(P < 0.01)。NDP组血红蛋白降低、肌酐升高、恶心呕吐的发生率明显低于DDP组(P < 0.05)。

结论

NDP联合其他化疗药物治疗非小细胞肺癌有效,临床疗效高于DDP联合化疗,在延长生存时间及降低毒副反应方面具有优势。

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