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前瞻性研究多西紫杉醇和顺铂经动脉灌注治疗不适合标准化疗的非小细胞肺癌患者。

Prospective study of transarterial infusion of docetaxel and cisplatin to treat non-small-cell lung cancer in patients contraindicated for standard chemotherapy.

机构信息

Departments of Respiratory Medicine, Shinseikai Toyama Hospital, 89-10 Shimowaka, Imizu City, Toyama 939-0243, Japan.

出版信息

Lung Cancer. 2012 Aug;77(2):353-8. doi: 10.1016/j.lungcan.2012.04.006. Epub 2012 Apr 25.

DOI:10.1016/j.lungcan.2012.04.006
PMID:22537620
Abstract

Our previous retrospective study indicated a good response rate of non-small-cell lung carcinoma (NSCLC) to transarterial infusion chemotherapy, but the precise effect remains unresolved. This prospective study enrolled 25 patients with stage III or IV or recurrent NSCLC without distant metastasis (M1b) who were not candidates for either standard chemotherapy or chemoradiotherapy. The feeding arteries of each tumor detected by angiography were recorded and tumor staining was visually graded on a scale of I-IV. Docetaxel and cisplatin (25 and 25 mg/m(2), respectively) were administered by arterial infusion. The total dose of each was divided among feeding arteries according to the degree of tumor staining. The end points included response rate, progression-free survival (PFS), overall survival (OS) and toxicity. Correlations between effects and some clinical aspects were investigated. Of 25 patients enrolled between May 2007 and April 2011, 24 of them were evaluable. One complete response and 12 partial responses were achieved for an overall response rate of 52% (95% confidence interval [CI]: 35-69%). The median progression-free survival and overall survival periods were 6.5 (95% CI: 5.4-7.6) and 17.4 (95% CI: 14.2-20.6) months, respectively. The 1- and 2-year survival rates were 81% and 32%, respectively. Grade 3-4 hematological toxicity was not evident. Grade 3 general fatigue or appetite loss developed in patients with performance status (PS) ≥3. Neither grade 4 non-hematological toxicity nor treatment-related death occurred. Among various clinical aspects, ECOG PS significantly correlated with PFS and OS, whereas tumor staining significantly correlated with response. Survival was significantly better for patients with good PS (0 or 1) than poor PS (≥2) and those with, than without grade IV tumor staining. If a sufficient number of feeding arteries are detected and the tumor is appropriately stained, then arterial infusion chemotherapy has favorable response rates with less toxicity for patients with stage III or IV or recurrent NSCLC without distant metastasis (M1b) who cannot tolerate standard chemotherapy.

摘要

我们之前的回顾性研究表明,非小细胞肺癌(NSCLC)对经动脉灌注化疗有较好的反应率,但确切疗效仍未确定。本前瞻性研究纳入了 25 例无远处转移(M1b)的 III 期或 IV 期或复发性 NSCLC 患者,这些患者不符合标准化疗或放化疗标准。通过血管造影记录每个肿瘤的供血动脉,并对肿瘤染色进行视觉分级(I-IV 级)。多西紫杉醇和顺铂(分别为 25 和 25mg/m2)经动脉输注给药。根据肿瘤染色程度,将每种药物的总剂量分配到供血动脉中。终点包括反应率、无进展生存期(PFS)、总生存期(OS)和毒性。研究了疗效与某些临床方面的关系。2007 年 5 月至 2011 年 4 月期间,共纳入 25 例患者,其中 24 例可评估。总缓解率为 52%(95%可信区间[CI]:35-69%),其中完全缓解 1 例,部分缓解 12 例。中位无进展生存期和总生存期分别为 6.5 个月(95%CI:5.4-7.6)和 17.4 个月(95%CI:14.2-20.6)。1 年和 2 年生存率分别为 81%和 32%。未出现 3-4 级血液学毒性。PS 评分≥3 的患者出现 3-4 级一般疲劳或食欲下降。未发生 4 级非血液学毒性或与治疗相关的死亡。在各种临床方面中,ECOG PS 与 PFS 和 OS 显著相关,而肿瘤染色与反应显著相关。PS 评分良好(0 或 1)的患者的生存明显优于 PS 评分差(≥2)的患者,且有 IV 级肿瘤染色的患者优于无 IV 级肿瘤染色的患者。如果能够检测到足够数量的供血动脉,并且肿瘤染色适当,那么对于不能耐受标准化疗的 III 期或 IV 期或复发性无远处转移(M1b)NSCLC 患者,动脉灌注化疗具有较好的反应率,且毒性较小。

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