多西他赛单药每周方案与每三周方案二线治疗晚期非小细胞肺癌疗效观察

The second-line chemotherapy of advanced non-small cell lung cancer with weekly or 3-weekly docetaxel monotherapy

目的对比观察单药多西他赛每周方案与每3周方案二线治疗晚期非小细胞肺癌（NSCLC）的临床疗效？毒副反应及生活质量。方法每周方案组（A组）：多西他赛35 mg/m^2,静滴,第1、8、15天,每4周重复;三周方案组（B组）：多西他赛75 mg/m^2,静滴,第1天,每3～4周重复,治疗2个周期评价疗效,每周期评价毒性。采用欧洲癌症研究和治疗组织（EORTC）简体中文版的生活质量调查核心问卷（QLQ-C30）和肺癌专用问卷（QLQ-LC13）评价患者生活质量,化疗前及治疗2个周期后给予评价生活质量。结果A组32例,B组35例,67例均无完全缓解（CR）;部分缓解（PR）：A组3例,B组4例;稳定（SD）A组5例,B组6例;有效率（RR）：A组9.4%,B组11.4%（P=1.000）;临床获益率：A组25.0%,B组28.6%（P=0.742）。中位生存期：A组9.2个月,B组6.3个月（P=0.07）。1年生存率：A组31.3%,B组28.6%（P=0.811）。两组Ⅲ/Ⅳ度粒细胞减少分别为15.6%和48.6%（P=0.004）。化疗后两组患者在气促、咳嗽、咯血、疼痛方面症状明显减轻,A组与B组比较,在疼痛（P=0.040）、咳嗽（P=0.045）两方面分值降低明显,差异有显著性。结论单药多西他赛二线治疗晚期非小细胞肺癌,每周方案与三周方案有效率相似,每周方案血液学毒性明显下降,临床症状明显改善,耐受性更好。

Objective To compare the efficacy, toxicity and quality-of-life （QOL） between weekly and 3-weekly docetaxel monotherapy in the second-line chemotherapy of patients with advanced non-small cell lung cancer（NSCLC）. Methods Group A： docetaxel 35 mg/m^2 iv d1,d8,d15,q4w; Group B： docetaxel 75 mg,/m^2 iv dl, q3-4w. The clinical response was assessed after two bycles. Toxicity was assessed every cycle. QOL was evaluated with the Chinese version of quality of life questionnaire core-30 （ QLQ - c30） of European Organization for Research and Treatment of Cancer（EORTC） and quality of life questionnaire lung cancer （ QLQ -LC13） at baseline and after two cycles. Results There was no complete remission （CR） in all 67 cases. There were 3 partial response （PR） and 5 stable disease（SD） in group A ; 4 PR and 6 SD in group B. The overall response rates（RR） were 9.4% and 11.4% in groups A and B（ P = 1. 000） respectively. The clinical benefit rates were 25.0% and 28. 6% in groups A and B （P = 0. 742） respectively. The median survival time was 9.2 months and 6. 3 months respectively in groups A and B （P =0. 070）. In groups A and B the 1-year survival rates were respectively 31.3% and 28. 6% （P =0. 811 ）. The grades- Ⅲ/Ⅳnentropenia were lower significantly in group A compared with group B （ 15. 6% vs 48. 6% , P = 0. 004）. Symptoms such as dyspnea, cough, hemoptysis and pain were relieved after the chemotherapy in both groups. The mean scores of the symptoms decreased significantly, especially the pain （ P = 0. 04） and cough（P =0. 045） in group A compared with gorup B with statistically significant differences. Conclusion Docetaxel as second -line treatment of advanced NSCLC, the overall response rates were similar between groups A and B. The occurrence of hematologic toxicity was lower, symptoms were palliated significantly and the tolerance was better in weekly regimen.