Flentje Michael, Huber Rudolf M, Engel-Riedel Walburga, Andreas Stefan, Kollmeier Jens, Staar Susanne, Dickgreber Nicolas, Vaissiere Nathalie, De Almeida Cecilia, Edlich Birgit, Fietkau Rainer
Dept. of Radiotherapy, University hospital Wuerzburg, Josef-Schneiderstr.11, 97084, Wuerzburg, Germany.
Member of the German Center for Lung Research (DZL CPC-M), University hospital Munich, Munich, Germany.
Strahlenther Onkol. 2016 Apr;192(4):216-22. doi: 10.1007/s00066-016-0941-8. Epub 2016 Jan 25.
Concurrent chemoradiotherapy (CRT) is considered standard for inoperable stage III non-small cell lung cancer (NSCLC). Consolidation chemotherapy (CC) following CRT is intended to further improve outcomes, yet studies have shown discordant results. This phase III study assessed CRT followed by best supportive care (BSC) or consolidation with oral vinorelbine and cisplatin.
Patients received two cycles of oral vinorelbine (50 mg/m(2) days 1, 8 and 15) + cisplatin (20 mg/m(2) days 1-4) q4w + radiotherapy (RT; 66 Gy). Patients with at least stable disease (SD) were randomised to either two cycles oral vinorelbine (60-80 mg/m(2) days 1 and 8) + cisplatin (80 mg/m(2) day 1) q3w + BSC or BSC alone. Primary endpoint was progression-free survival (PFS).
A total of 279 patients were enrolled for CRT and 201 patients were randomised to CC or BSC. Both CRT and CC were well tolerated, with limited radiation-mediated grade 3/4 toxicities (CRT/CC/BSC: oesophagitis-related events 12.9 %/3.1 %/0 %; grade 3 pneumonitis 0 %/0 %/2 %) and chemotherapy-mediated grade 3/4 toxicities (CRT/CC: neutropenia 11.2 %/22.1 %; leukopenia 18.3 %/26.7 %; grade 3 nausea 5.0 %/2.3 %, grade 3 vomiting 3.2 %/3.5 %). Median PFS from randomisation was 6.4 (5.0-8.7) and 5.5 (3.8-7.4) months in the CC and BSC arms (hazard ratio, HR = 0.93 [0.69-1.26]; p = 0.63), respectively; median overall survival (OS) 20.8 (13.5-25.3) and 18.5 (13.6-24.7) months, respectively.
Consolidation chemotherapy after concurrent CRT did not prolong PFS or OS. Concurrent RT with oral vinorelbine and cisplatin demonstrated a favourable safety profile and represents a suitable treatment regimen for inoperable stage III NSCLC.
同步放化疗（CRT）被认为是不可切除的III期非小细胞肺癌（NSCLC）的标准治疗方法。CRT后的巩固化疗（CC）旨在进一步改善疗效，但研究结果并不一致。这项III期研究评估了CRT后给予最佳支持治疗（BSC）或口服长春瑞滨和顺铂进行巩固治疗的效果。
患者接受两个周期的口服长春瑞滨（50mg/m²，第1、8和15天）+顺铂（20mg/m²，第1 - 4天），每4周重复一次，同时进行放疗（RT；66Gy）。疾病至少稳定（SD）的患者被随机分为两组，一组接受两个周期的口服长春瑞滨（60 - 80mg/m²，第1和8天）+顺铂（80mg/m²，第1天），每3周重复一次，同时给予BSC；另一组仅给予BSC。主要终点是无进展生存期（PFS）。
共有279例患者接受了CRT，201例患者被随机分为CC组或BSC组。CRT和CC的耐受性均良好，放疗介导的3/4级毒性有限（CRT/CC/BSC：食管炎相关事件12.9%/3.1%/0%；3级肺炎0%/0%/2%），化疗介导的3/4级毒性（CRT/CC：中性粒细胞减少11.2%/22.1%；白细胞减少18.3%/26.7%；3级恶心5.0%/2.3%，3级呕吐3.2%/3.5%）。随机分组后的中位PFS在CC组和BSC组分别为6.4（5.0 - 8.7）个月和5.5（3.8 - 7.4）个月（风险比，HR = 0.93 [0.69 - 1.26]；p = 0.63）；中位总生存期（OS）分别为20.8（13.5 - 25.3）个月和18.5（13.6 - 24.7）个月。
同步CRT后的巩固化疗并未延长PFS或OS。口服长春瑞滨和顺铂同步放疗显示出良好的安全性，是不可切除的III期NSCLC的合适治疗方案。
