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多中心 II 期研究:III 期 NSCLC 患者行每周紫杉醇/顺铂同步放化疗后手术。

Weekly chemoradiation (docetaxel/cisplatin) followed by surgery in stage III NSCLC; a multicentre phase II study.

机构信息

Department of Pulmonary Diseases, St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands.

出版信息

Anticancer Res. 2010 Oct;30(10):4237-43.

Abstract

BACKGROUND

This prospective study analyzed the feasibility and efficacy of weekly concurrent chemoradiation (docetaxel/cisplatin) followed by surgery. The primary endpoint was radiological response.

PATIENTS AND METHODS

Six chemotherapy (docetaxel/cisplatin) cycles were administered on days 1, 8, 15, 22, 29 and 36 with concurrent thoracic radiotherapy in fractions of 1.8 Gy, to a total dose of 45 Gy. Patients underwent surgery depending on results of invasive mediastinal re-staging.

RESULTS

Forty-two out of 45 NSCLC stage III patients were evaluable. Nineteen patients showed partial/complete response (46%), 14 stable disease (34%) and eight (20%) progressive disease. Toxicity was mild. The 30-day postoperative mortality was 4.2%. Twenty-four patients (59%) proceeded to surgery and 20 (49%) underwent a complete resection (R0).

CONCLUSION

Weekly concurrent chemoradiation (docetaxel/cisplatin) in stage III NSCLC results in a radiological response rate of 46% and mediastinal downstaging in 56%. Complete resection in downstaged patients was achieved in 49% of all patients.

摘要

背景

本前瞻性研究分析了每周同步放化疗(多西他赛/顺铂)联合手术的可行性和疗效。主要终点是影像学反应。

患者和方法

在第 1、8、15、22、29 和 36 天给予 6 个周期的化疗(多西他赛/顺铂),同时给予胸部放疗,每次 1.8 Gy,总剂量为 45 Gy。根据侵袭性纵隔重新分期的结果,患者进行手术。

结果

45 例 III 期 NSCLC 患者中,42 例可评估。19 例患者显示部分/完全缓解(46%),14 例稳定疾病(34%),8 例进展疾病(20%)。毒性轻微。术后 30 天死亡率为 4.2%。24 例(59%)患者进行了手术,20 例(49%)患者行完全切除术(R0)。

结论

III 期 NSCLC 中每周同步放化疗(多西他赛/顺铂)可产生 46%的影像学反应率和 56%的纵隔降期。降期患者的完全切除率为 49%。

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