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同步放化疗后双周多西他赛和卡铂巩固化疗治疗不可切除 III 期非小细胞肺癌:一项在前期 II 期研究中使用方案的临床应用。

Concurrent chemoradiotherapy followed by consolidation chemotherapy with bi-weekly docetaxel and carboplatin for stage III unresectable, non-small-cell lung cancer: clinical application of a protocol used in a previous phase II study.

机构信息

Division of Radiation Oncology, Saitama Cancer Center, Saitama, Japan.

出版信息

Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1791-6. doi: 10.1016/j.ijrobp.2011.03.007. Epub 2011 May 19.

Abstract

PURPOSE

To assess the clinical applicability of a protocol evaluated in a previously reported phase II study of concurrent chemoradiotherapy followed by consolidation chemotherapy with bi-weekly docetaxel and carboplatin in patients with stage III, unresectable, non-small-cell lung cancer (NSCLC).

METHODS AND MATERIALS

Between January 2000 and March 2006, 116 previously untreated patients with histologically proven, stage III NSCLC were treated with concurrent chemoradiotherapy. Radiation therapy was administered in 2-Gy daily fractions to a total dose of 60 Gy in combination with docetaxel, 30 mg/m(2), and carboplatin at an area under the curve value of 3 every 2 weeks during and after radiation therapy.

RESULTS

The median survival time for the entire group was 25.5 months. The actuarial 2-year and 5-year overall survival rates were 53% and 31%, respectively. The 3-year cause-specific survival rate was 60% in patients with stage IIIA disease, whereas it was 35% in patients with stage IIIB disease (p = 0.007). The actuarial 2-year and 5-year local control rates were 62% and 55%, respectively. Acute hematologic toxicities of Grade ≥3 severity were observed in 20.7% of patients, while radiation pneumonitis and esophagitis of Grade ≥3 severity were observed in 2.6% and 1.7% of patients, respectively.

CONCLUSIONS

The feasibility of the protocol used in the previous phase II study was reconfirmed in this series, and excellent treatment results were achieved.

摘要

目的

评估在先前报道的 II 期研究中评估的方案的临床适用性,该方案在 III 期不可切除的非小细胞肺癌(NSCLC)患者中进行了同步放化疗后巩固化疗,每周用紫杉醇和卡铂治疗。

方法和材料

2000 年 1 月至 2006 年 3 月,116 例未经治疗的组织学证实的 III 期 NSCLC 患者接受了同步放化疗。放射治疗以 2Gy 的每日剂量分剂量进行,总剂量为 60Gy,同时给予多西紫杉醇 30mg/m2,卡铂在放射治疗期间和之后每 2 周进行一次,AUC 值为 3。

结果

全组患者中位生存时间为 25.5 个月。2 年和 5 年总生存率分别为 53%和 31%。III 期疾病患者的 3 年特异性生存率为 60%,而 IIIB 期疾病患者的 3 年特异性生存率为 35%(p=0.007)。2 年和 5 年局部控制率分别为 62%和 55%。20.7%的患者出现 3 级及以上严重程度的急性血液学毒性,2.6%和 1.7%的患者分别出现 3 级及以上严重程度的放射性肺炎和食管炎。

结论

本系列研究再次证实了先前 II 期研究中使用的方案的可行性,并取得了优异的治疗效果。

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