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紫杉醇和顺铂联合放疗治疗 III 期非小细胞肺癌的 I 期研究,以确定最大耐受剂量。

Phase I Study to Determine MTD of Docetaxel and Cisplatin with Concurrent Radiation Therapy for Stage III Non-Small Cell Lung Cancer.

机构信息

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100142, China.

出版信息

Chin J Cancer Res. 2011 Jun;23(2):129-33. doi: 10.1007/s11670-011-0129-9.

DOI:10.1007/s11670-011-0129-9
PMID:23482452
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3587537/
Abstract

OBJECTIVE

To evaluate the maximum tolerated dose (MTD) of docetaxel (DCT) and cisplatin (DDP) concurrently with three dimensional (3D) conformal radiotherapy or IMRT for patients with locally advanced non-small cell lung cancer (stage IIIa and IIIb) after 2-4 cycles of induction chemotherapy.

METHODS

Fourteen patients with histological/cytological proven stage III non-small-cell lung cancer were eligible. 3D or IMRT radiotherapy (60-70Gy in 30-35 fractions, 6-7weeks, 2 Gy/fraction) was delivered concurrently with cisplatin and docetaxel, 2 cycles during concurrent chemoradiotherapy (CCRT). The level I dosage was composed of 56 mg/m(2) DCT, on day 1 and 28mg/m(2) DDP, on day 1 and day 2. The level II was composed of 60 mg/m(2) DCT, on day 1 and 30 mg/ m(2) DDP, on day 1 and day 2. The level III was composed of 64 mg/m(2) DCT, on day 1 and 32 mg/ m(2) DDP, on day 1 and day 2.

RESULTS

Fourteen patients were allocated and finished concurrent chemoradiotherapy. The dose-limiting neutropenia was at the dose Level III (64 mg/m(2)) and occurred in 2 of 5 patients. No dose limiting non-hematologic or hematologic toxicity occurred in the other patients.

CONCLUSIONS

Patients with locally advanced non-small cell lung cancer may tolerate 60mg/m(2) docetaxel and 60mg/m(2) cisplatin for 2 cycles during concurrent radiotherapy after 2-3 cycles of induction chemotherapy.

摘要

目的

评估多西他赛(DCT)和顺铂(DDP)与三维适形放疗或调强放疗同时应用于 2-4 周期诱导化疗后局部晚期非小细胞肺癌(IIIa 和 IIIb 期)患者的最大耐受剂量(MTD)。

方法

14 例经组织学/细胞学证实的 III 期非小细胞肺癌患者符合条件。在同期放化疗(CCRT)期间,3D 或调强放疗(60-70Gy,30-35 个分次,6-7 周,2Gy/分次)与顺铂和多西他赛同时给予,共 2 个周期。I 级剂量组为 56mg/m2DCT,第 1 天和第 28 天;28mg/m2DDP,第 1 天和第 2 天。II 级剂量组为 60mg/m2DCT,第 1 天和第 30 天;30mg/m2DDP,第 1 天和第 2 天。III 级剂量组为 64mg/m2DCT,第 1 天和第 32 天;32mg/m2DDP,第 1 天和第 2 天。

结果

14 例患者被分配并完成了同期放化疗。剂量限制中性粒细胞减少症发生在 III 级剂量(64mg/m2),5 例中有 2 例。其他患者没有发生剂量限制的非血液学或血液学毒性。

结论

在 2-3 周期诱导化疗后,局部晚期非小细胞肺癌患者在同期放疗期间可能耐受 60mg/m2多西他赛和 60mg/m2顺铂,共 2 个周期。

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