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一项前瞻性、多机构 II 期研究,旨在评估诱导化疗放疗后手术治疗累及胸壁的非小细胞肺癌患者(CJLSG0801)。

A prospective, multi-institutional phase II study of induction chemoradiotherapy followed by surgery in patients with non-small cell lung cancer involving the chest wall (CJLSG0801).

机构信息

Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

出版信息

Lung Cancer. 2017 Feb;104:79-84. doi: 10.1016/j.lungcan.2016.12.011. Epub 2016 Dec 21.

DOI:10.1016/j.lungcan.2016.12.011
PMID:28213006
Abstract

OBJECTIVES

The standard therapy for patients with T3N0-1M0 non-small cell lung cancer (NSCLC) involving the chest wall is considered surgical resection and adjuvant therapy. However, the compliance of adjuvant therapy is relatively low, and the prognosis for those patients has been unsatisfactory. Therefore, we conducted a phase II study of induction chemoradiotherapy followed by surgery with the aim of improving the survival.

PATIENTS AND METHODS

This treatment strategy consisted of induction chemotherapy (two cycles of cisplatin at 80mg/m on Day 1 and vinorelbine at 20mg/m on Days 1 and 8) concurrent with radiotherapy (40Gy in 20 fractions) followed by surgery. The inclusion criteria were patients with resectable T3N0-1M0 NSCLC involving the chest wall who were 20-70 years of age. The primary end point was the 3-year survival, assuming an expected rate of 67%.

RESULTS

From January 2009 to November 2012, 51 eligible patients were enrolled. Induction therapy was completed as planned in 49 (96%) patients without treatment-related death, and 25 (51%) had a partial response. Complete resection combined with the involved chest wall was achieved in 46 (92%) patients, and a pathologic complete response was seen in 13 (26%) patients. Five patients experienced major postoperative complications, and 1 patient died of acute exacerbation of interstitial pneumonia. With a median follow-up period of 42 months, the 3- and 5-year overall survivals of all registered patients were 77% and 63%, respectively. There was a significant difference in the survival rate between patients with a pathologic complete response and those with a residual tumor (p=0.039).

CONCLUSION

The mature results of this study in a multi-institutional setting showed the treatment strategy to be safe and effective with a high rate of pathologic response for patients with NSCLC involving the chest wall.

摘要

目的

对于累及胸壁的 T3N0-1M0 非小细胞肺癌(NSCLC)患者,标准治疗方法被认为是手术切除和辅助治疗。然而,辅助治疗的依从性相对较低,且这些患者的预后一直不尽如人意。因此,我们开展了一项 II 期研究,采用诱导化疗和放疗联合治疗,随后进行手术,旨在改善生存。

患者和方法

该治疗策略包括诱导化疗(顺铂 80mg/m2,第 1 天;长春瑞滨 20mg/m2,第 1 天和第 8 天,共 2 个周期)联合放疗(40Gy/20 次),随后进行手术。纳入标准为年龄在 20-70 岁、可切除累及胸壁的 T3N0-1M0 NSCLC 患者。主要终点为 3 年生存率,假设预期率为 67%。

结果

从 2009 年 1 月至 2012 年 11 月,共纳入 51 例符合条件的患者。49 例(96%)患者按计划完成了诱导治疗,无治疗相关死亡,25 例(51%)患者获得部分缓解。46 例(92%)患者达到完全切除联合累及胸壁,13 例(26%)患者获得病理完全缓解。5 例患者发生重大术后并发症,1 例患者死于间质性肺炎急性加重。中位随访时间为 42 个月,所有登记患者的 3 年和 5 年总生存率分别为 77%和 63%。病理完全缓解患者和有肿瘤残留患者的生存率有显著差异(p=0.039)。

结论

这项多中心研究的成熟结果表明,对于累及胸壁的 NSCLC 患者,该治疗策略安全有效,病理缓解率较高。

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