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顺铂联合吉西他滨或联合白蛋白结合型紫杉醇作为Ⅲ/Ⅳ期非小细胞肺癌一线化疗的疗效与毒性的临床对比研究

Clinical comparative investigation of efficacy and toxicity of cisplatin plus gemcitabine or plus Abraxane as first-line chemotherapy for stage III/IV non-small-cell lung cancer.

作者信息

Ai Dan, Guan Yan, Liu Xiu-Ju, Zhang Chu-Feng, Wang Peng, Liang Hong-Lu, Guo Qi-Sen

机构信息

School of Medicine and Life Sciences, University of Jinan-Shandong Academy of Medical Sciences, China; Shandong Cancer Hospital affiliated to Shandong University, Shandong Academy of Medical Sciences, Jinan, Shandong, China.

Shandong Cancer Hospital affiliated to Shandong University, Shandong Academy of Medical Sciences, Jinan, Shandong, China.

出版信息

Onco Targets Ther. 2016 Sep 16;9:5693-5698. doi: 10.2147/OTT.S109683. eCollection 2016.

Abstract

PURPOSE

The purpose of this study was to observe the clinical efficacy and toxicity of cisplatin in combination with gemcitabine or Abraxane as first-line chemotherapy for stage III/IV non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS

A total of 200 patients with advanced NSCLC, which was confirmed by pathology or cytology, were enrolled into our research by reviewing previous complete and retrievable medical records data of our hospital. A total of 100 patients were treated with gemcitabine (1,000 mg/m, day 1 and day 8) in combination with cisplatin (75 mg/m, days 1-3; GP group) and another 100 patients were treated with Abraxane (260 mg/m, day 1) in combination with cisplatin (75 mg/m, days 1-3; TP group). Twenty-one days were required to complete one cycle; at least two cycles were completed by each group.

RESULTS

For the 100 patients in the GP group, the effective response rate (RR) was 27%, the disease control rate (DCR) was 63%, and the median progression-free survival (PFS) time was 8 months. For the 100 patients in the TP group, the RR was 52%, the DCR was 75%, and the median PFS was 20 months. There was significant difference in RR (<0.001), but no significant difference in DSR and PFS (>0.05). Common treatment-related adverse events were hematologic toxicity and gastrointestinal reaction. Hematologic toxicity mainly included decreased white blood cells and platelets. The differences between the two groups were statistically significant (<0.05). Gastrointestinal reaction mainly included nausea and vomiting. There was no statistical significance between them (=0.805). For the 85 patients with squamous carcinoma in the TP group, the RR was 60%, the DCR was 78%, and the median PFS was 7.5 months. For the 85 patients with squamous carcinoma in the GP group, the RR was 36%, the DCR was 62%, and the median PFS was 18.5 months. There was significant difference in RR (=0.024), but no significant difference in DSR and PFS (>0.05). For the 115 patients with adenocarcinoma in the TP group, the RR was 47%, the DCR was 73%, and the median PFS was 8 months. For the 115 patients with adenocarcinoma in the GP group, the RR was 20%, the DCR was 64%, and the median PFS was 20.5 months. There was significant difference in RR (=0.003), but no significant difference in DCR and PFS (>0.05).

CONCLUSION

The efficacy of cisplatin in combination with Abraxane is better than that with gemcitabine in the treatment of NSCLC, and the treatment has less risk of hematologic toxicity.

摘要

目的

本研究旨在观察顺铂联合吉西他滨或白蛋白结合型紫杉醇作为Ⅲ/Ⅳ期非小细胞肺癌(NSCLC)一线化疗的临床疗效及毒性。

患者与方法

通过回顾我院既往完整且可检索的病历资料,共纳入200例经病理或细胞学确诊的晚期NSCLC患者。其中100例患者接受吉西他滨(1000mg/m²,第1天和第8天)联合顺铂(75mg/m²,第1 - 3天;GP组)治疗,另外100例患者接受白蛋白结合型紫杉醇(260mg/m²,第1天)联合顺铂(75mg/m²,第1 - 3天;TP组)治疗。完成一个周期需要21天;每组至少完成两个周期。

结果

GP组100例患者中,有效缓解率(RR)为27%,疾病控制率(DCR)为63%,中位无进展生存期(PFS)为8个月。TP组100例患者中,RR为52%,DCR为75%,中位PFS为20个月。RR差异有统计学意义(<0.001),但疾病稳定率(DSR)和PFS差异无统计学意义(>0.05)。常见的治疗相关不良事件为血液学毒性和胃肠道反应。血液学毒性主要包括白细胞和血小板减少。两组间差异有统计学意义(<0.05)。胃肠道反应主要包括恶心和呕吐。两组间无统计学意义(=0.805)。TP组85例鳞状细胞癌患者中,RR为60%,DCR为78%,中位PFS为7.5个月。GP组85例鳞状细胞癌患者中,RR为36%,DCR为62%,中位PFS为18.5个月。RR差异有统计学意义(=0.024),但DSR和PFS差异无统计学意义(>0.05)。TP组115例腺癌患者中,RR为47%,DCR为73%,中位PFS为8个月。GP组115例腺癌患者中,RR为20%,DCR为64%,中位PFS为20.5个月。RR差异有统计学意义(=0.003),但DCR和PFS差异无统计学意义(>0.05)。

结论

顺铂联合白蛋白结合型紫杉醇治疗NSCLC的疗效优于联合吉西他滨,且血液学毒性风险较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74c1/5033500/e4b8a3771fd6/ott-9-5693Fig1.jpg

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