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不可切除非小细胞肺癌同步化疗及递增剂量放疗的I期试验结果

Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer.

作者信息

Schild Steven E, McGinnis William L, Graham David, Hillman Shauna, Fitch Tom R, Northfelt Donald, Garces Yolanda I, Shahidi Homayoon, Tschetter Loren K, Schaefer Paul L, Adjei Alex, Jett James

机构信息

Mayo Clinic and Mayo Foundation, Rochester, MN, USA.

出版信息

Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26.


DOI:10.1016/j.ijrobp.2006.02.046
PMID:16730134
Abstract

PURPOSE: This trial was performed to determine the maximum tolerated dose (MTD) of radiation that can be administered with carboplatin and paclitaxel. METHODS AND MATERIALS: This trial included 15 patients with unresectable non-small-cell lung cancer. Paclitaxel (50 mg/m2) and carboplatin (area under the curve=2) were given weekly during radiation therapy (RT). The RT included 2 Gy daily to an initial dose of 70 Gy, and the dose was increased in 4 Gy increments until determining the MTD. The MTD was defined as the highest safely tolerated dose where at most 1 patient of 6 experienced dose-limiting toxicity (DLT) with the next higher dose having at least 2 of 6 patients experiencing DLT. Three-dimensional treatment planning techniques were used without prophylactic nodal RT. RESULTS: Two patients were not evaluable because they did not receive therapy according to the protocol. No DLTs occurred in the 3 patients who received 70 Gy, 1 DLT occurred in the 6 patients who received 74 Gy, and 2 DLTs occurred in the 4 patients who received 78 Gy. The DLTs included Grade 3 pneumonitis (n=2) and Grade 4 pneumonitis (n=1). There have been 3 deaths during follow-up ranging from 14 to 38 months (median, 28 months). CONCLUSIONS: The MTD of the RT was 74 Gy with weekly carboplatin and paclitaxel. The Phase II portion of this trial is currently under way. The goal is to improve local control and survival with higher doses of RT delivered with this combined modality approach.

摘要

目的:本试验旨在确定与卡铂和紫杉醇联合使用时可给予的最大耐受辐射剂量(MTD)。 方法与材料:本试验纳入了15例不可切除的非小细胞肺癌患者。在放射治疗(RT)期间每周给予紫杉醇(50mg/m²)和卡铂(曲线下面积=2)。RT包括每日2Gy,初始剂量为70Gy,剂量以4Gy增量增加,直至确定MTD。MTD定义为最高安全耐受剂量,即6名患者中最多1名出现剂量限制性毒性(DLT),而下一个更高剂量至少有2名患者出现DLT。使用三维治疗计划技术,不进行预防性淋巴结放疗。 结果:2例患者因未按方案接受治疗而无法评估。接受70Gy的3例患者未出现DLT,接受74Gy的6例患者出现1例DLT,接受78Gy的4例患者出现2例DLT。DLT包括3级肺炎(n=2)和4级肺炎(n=1)。随访期间有3例死亡,随访时间为14至38个月(中位数为28个月)。 结论:联合每周使用卡铂和紫杉醇时,RT的MTD为74Gy。本试验的II期部分目前正在进行。目标是通过这种联合治疗方法给予更高剂量的RT来改善局部控制和生存率。

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