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单药高剂量顺铂与分割剂量顺铂一线治疗初治中国晚期非小细胞肺癌患者的疗效比较研究。

Comparative effectiveness study of single high-dose cisplatin with fractionated doses cisplatin in first-line therapy for treatment-naive Chinese patients with advanced non-small-cell lung cancer.

机构信息

Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, PR China.

Department of Medical Oncology, First People's Hospital of Yancheng, Fourth Affiliated Hospital of Nantong University, Yancheng, PR China.

出版信息

Curr Probl Cancer. 2019 Dec;43(6):100466. doi: 10.1016/j.currproblcancer.2019.01.007. Epub 2019 Feb 13.

DOI:10.1016/j.currproblcancer.2019.01.007
PMID:30777344
Abstract

BACKGROUND

Cisplatin is one of the most effective chemotherapeutic drugs for patients with advanced non-small-cell lung cancer (NSCLC). Single high-dose cisplatin is a commonly used chemotherapy regimen in the world. At present, fractionated doses cisplatin is used in most hospitals in China. Although many doctors have begun to try a single dose of cisplatin, there are still few studies on the comparison of the 2 regimens. This study describes the efficacy and side effects of cisplatin single-dose administration and fractionated doses regimen in the treatment of advanced NSCLC.

METHODS

A retrospective study was conducted on 219 patients with advanced NSCLC who received chemotherapy with DDP were divided into 2 groups according to the single dose of cisplatin from January 2014 to December 2017. For experimental group, 108 patients were enrolled and received DDP at a dose of 75 mg/m on day 1. A total of 111 patients were enrolled in the control group, and DDP was administrated at 25 mg/m on days 1-3. The efficacy, toxicity, and progression-free survival of the 2 groups were observed and analyzed.

RESULTS

In the experimental group, the numbers of patients who received PR, SD, and PD were 66, 34, and 8 respectively. In the control group, the numbers of patients who received PR, SD, and PD were 18, 77, and 16 respectively. The percentages of patients with a objective response rate response in the experimental group were significantly higher than that in the control group (61.11% vs 16.22%, P < 0.0001). The incidence of III-IV vomiting in the experimental group was lower than that in the control group (11.11% vs 26.13%). The incidence of I-II hiccups in the experimental group was higher than that in the control group (15.74% vs 10.81%). None of the patients had III-IV degree nephrotoxicity. Myelosuppression mainly manifested as leukopenia. In the experimental group, the incidence of I-II degree of leukopenia was 71.30%, and the III-IV degree was 7.41%, which was 74.77% and 11.71 respectively in the control group. A small number of patients have a decrease in mild platelets and hemoglobin.

CONCLUSION

For patients with advanced NSCLC who require chemotherapy with DDP regimen, the short-term effect of single-dose administration of DDP is better than that of fractional small-dose administration. Toxicity can be tolerated and it is worth promoting clinically.

摘要

背景

顺铂是治疗晚期非小细胞肺癌(NSCLC)患者最有效的化疗药物之一。单剂高剂量顺铂是目前世界上常用的化疗方案。目前,中国大多数医院使用的是分割剂量顺铂。尽管许多医生已经开始尝试单剂量顺铂,但对于这两种方案的比较研究仍然很少。本研究描述了单剂量顺铂和分割剂量方案治疗晚期 NSCLC 的疗效和副作用。

方法

对 2014 年 1 月至 2017 年 12 月接受 DDP 化疗的 219 例晚期 NSCLC 患者进行回顾性研究,根据单剂顺铂将患者分为两组。实验组 108 例,DDP 剂量为 75mg/m2,于第 1 天给药。对照组共 111 例,DDP 剂量为 25mg/m2,于第 1-3 天给药。观察并分析两组的疗效、毒性和无进展生存期。

结果

实验组患者 PR、SD 和 PD 的例数分别为 66、34 和 8 例。对照组患者 PR、SD 和 PD 的例数分别为 18、77 和 16 例。实验组患者客观缓解率的百分比明显高于对照组(61.11% vs 16.22%,P<0.0001)。实验组 III-IV 级呕吐发生率低于对照组(11.11% vs 26.13%)。实验组 I-II 级呃逆发生率高于对照组(15.74% vs 10.81%)。无患者发生 III-IV 度肾毒性。骨髓抑制主要表现为白细胞减少。实验组白细胞 I-II 度发生率为 71.30%,III-IV 度发生率为 7.41%,对照组分别为 74.77%和 11.71%。少数患者血小板和血红蛋白轻度下降。

结论

对于需要 DDP 方案化疗的晚期 NSCLC 患者,DDP 单剂给药的短期疗效优于小剂量分割给药。毒性可以耐受,值得临床推广。

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