Liu Yang, Cheng Ying, Li Kai, Shi Jianhua, Liu Ying, Wu Lin, Han Baohui, Chen Gongyan, He Jianxing, Wang Jie, Qin Haifeng, Li Xiaoling, Hamaji Masatsugu, Park Henry S
Department of Radiotherapy, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Jilin Cancer Hospital, Changchun, China.
Transl Lung Cancer Res. 2021 Sep;10(9):3793-3806. doi: 10.21037/tlcr-21-632.
In ALTER 1202, anlotinib prolonged the progression-free survival (PFS) and overall survival (OS) of patients with relapsed small cell lung cancer (SCLC). The aim of this study was to explore the effect of front-line thoracic radiotherapy (RT) on the benefits of anlotinib as a third-line-or-beyond treatment.
This was a subgroup analysis of a multicenter, randomized, double-blind, placebo-controlled phase 2 trial (ALTER 1202). The participants were divided into RT (previous thoracic RT) and non-RT subgroups. The outcomes included PFS, OS, objective response rate (ORR), disease control rate (DCR), and safety.
In the ALTER 1202 trial, 68 participants (anlotinib, n=46; placebo, n=22) received RT and 51 participants (anlotinib, n=35; placebo, n=16) did not. PFS was longer for anlotinib versus placebo in both the RT (5.49 0.69 months; P<0.001) and non-RT (2.83 0.76 months; P<0.001) subgroups. In the RT subgroup, the OS was longer for anlotinib placebo (9.49 4.90 months; P=0.039). No differences were found in the ORR, but the DCR was higher in the anlotinib arm of the RT subgroup compared with the placebo arm (73.9% 9.1%, P<0.001) and the non-RT subgroup (68.6% 18.8%; P=0.002).
In relapsed SCLC patients with previous thoracic RT, anlotinib might have DCR, PFS, and OS benefits compared with placebo. In those without previous thoracic RT patients, anlotinib might have DCR and PFS benefits compared with placebo. The safety was similar between anlotinib and placebo groups.
在ALTER 1202试验中，安罗替尼延长了复发小细胞肺癌（SCLC）患者的无进展生存期（PFS）和总生存期（OS）。本研究的目的是探讨一线胸部放疗（RT）对安罗替尼作为三线及以上治疗疗效的影响。
这是一项对多中心、随机、双盲、安慰剂对照的2期试验（ALTER 1202）的亚组分析。参与者被分为放疗组（既往接受过胸部放疗）和非放疗组。观察指标包括PFS、OS、客观缓解率（ORR）、疾病控制率（DCR）和安全性。
在ALTER 1202试验中，68名参与者（安罗替尼组n = 46；安慰剂组n = 22）接受了放疗，51名参与者（安罗替尼组n = 35；安慰剂组n = 16）未接受放疗。在放疗组（5.49±0.69个月；P<0.001）和非放疗组（2.83±0.76个月；P<0.001）中，安罗替尼组的PFS均长于安慰剂组。在放疗亚组中，安罗替尼组的OS长于安慰剂组（9.49±4.90个月；P = 0.039）。ORR未发现差异，但放疗亚组中安罗替尼组的DCR高于安慰剂组（73.9%±9.1%，P<0.001）和非放疗亚组（68.6%±18.8%；P = 0.002）。
在既往接受过胸部放疗的复发SCLC患者中，与安慰剂相比，安罗替尼可能在DCR、PFS和OS方面具有优势。在未接受过胸部放疗的患者中，与安慰剂相比，安罗替尼可能在DCR和PFS方面具有优势。安罗替尼组和安慰剂组的安全性相似。
