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诱导化疗三联顺铂/紫杉醇,随后同步放化疗顺铂/依托泊苷/45 Gy(1.5 Gy bid)加手术治疗局部晚期非小细胞肺癌(NSCLC)的 10 年长期生存(LTS):一项多中心 II 期试验(CISTAXOL)。

10-year long-term survival (LTS) of induction chemotherapy with three cycles cisplatin/paclitaxel followed by concurrent chemoradiation cisplatin/etoposide/45 Gy (1.5 Gy bid) plus surgery in locally advanced non-small-cell lung cancer (NSCLC)-a multicenter phase-II trial (CISTAXOL).

机构信息

West German Cancer Centre, Department of Medical Oncology, 45122 Essen, Germany.

出版信息

Lung Cancer. 2013 Oct;82(1):83-9. doi: 10.1016/j.lungcan.2013.06.007. Epub 2013 Aug 16.

DOI:10.1016/j.lungcan.2013.06.007
PMID:23957964
Abstract

BACKGROUND

Induction chemoradiotherapy plus surgery remains an option to study in IIIA(N2) and selected IIIB NSCLC. Here we report ten-year long-term survival of a prospective multicenter German-French phase-II trial with trimodality.

PATIENTS AND METHODS

Mediastinoscopically proven IIIA(N2)/selected IIIB NSCLC received three cycles cisplatin (50 mg/m(2) day 1+8) and paclitaxel (175 mg/m(2)d1) qd 22. Concurrent CTx/RTx followed: 45 Gy (1.5 Gy bid) with cisplatin 50 mg/m(2) day 2+9 and etoposide 100 mg/m(2) d 4-6. Surgery was planned three to five weeks after RTx. If evaluated inoperable/irresectable at the end of RTx, definitive RTx-boost (20 Gy; 2 Gy qd) followed. Here we report 10-year-LTS for this cohort.

RESULTS

All 64 patients were accrued 3/99 to 2/02. Patients characteristics: IIIA(N2)/IIIB 25/39; m/f 48/16; adeno/squamous/large-cell/adenosquamous/NOS 15/26/18/3/2; age: median 52.5 (range 33-69). 36 operated: R0 32/36 (89%); pCR 16/36 (44%). 10-year-LTS%; all 26.0; IIIA(N2) 37.1; IIIB 17.9; relevant prognostic factors (exploratory): pretreatment - histopathology (squamous/adeno) - age (<50/≥50) - Charlson-CI: 1/>1 - BMI (≥25/<25) - pack years smoking (≥10/<10); treatment-dependent - R0/no-R0.

CONCLUSIONS

This regimen achieves substantial LTS. Interestingly, adenocarcinomas, older patients, unfavorable comorbidity scores, higher BMI and light smokers demonstrate poor long-term outcome even with aggressive trimodality. This dataset defines the rationale for our ongoing randomized trial with surgery after induction therapy in IIIA(N2)/selected IIIB (ESPATÜ).

摘要

背景

诱导化疗联合放化疗加手术仍然是 IIIA(N2)和选定的 IIIB NSCLC 的研究选择。在此,我们报告了一项前瞻性多中心德法 II 期三联疗法试验的十年长期生存结果。

患者和方法

经纵隔镜证实的 IIIA(N2)/选定的 IIIB NSCLC 患者接受三个周期顺铂(50mg/m2,第 1 天和第 8 天)和紫杉醇(175mg/m2,第 1 天)qd 22。同时进行 CTx/RTx:45Gy(1.5Gybid),顺铂 50mg/m2,第 2 天和第 9 天,依托泊苷 100mg/m2,第 4-6 天。放射治疗后三至五周计划手术。如果在放射治疗结束时评估为不可手术/不可切除,则进行根治性放射治疗加量(20Gy;2Gyqd)。在此,我们报告了该队列的十年长期生存结果。

结果

所有 64 例患者于 99 年 3 月至 02 年 2 月入组。患者特征:IIIAN2/IIIB 25/39;男/女 48/16;腺癌/鳞癌/大细胞癌/腺鳞癌/NOS 15/26/18/3/2;年龄:中位数 52.5(范围 33-69)。36 例接受手术:R0 32/36(89%);pCR 16/36(44%)。10 年 LTS%;所有患者为 26.0%;IIIAN2 为 37.1%;IIIB 为 17.9%;相关预后因素(探索性):治疗前-组织病理学(鳞癌/腺癌)-年龄(<50/≥50)-Charlson-CI:1/>1-BMI(≥25/<25)-吸烟包年(≥10/<10);治疗相关-R0/非 R0。

结论

该方案实现了显著的长期生存。有趣的是,腺癌、老年患者、不良合并症评分、较高的 BMI 和轻度吸烟者即使采用积极的三联疗法,也表现出较差的长期预后。该数据集为我们正在进行的 IIIA(N2)/选定的 IIIB(ESPATÜ)诱导治疗后手术的随机试验提供了依据。

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