Chemoradiation ± Atezolizumab in Limited-Stage Small Cell Lung Cancer: Results of NRG Oncology/Alliance LU005.

Methods

Patients with limited-stage small cell lung cancer (LS-SCLC), stage Tx-IV, N0-3, and M0 with Eastern Cooperative Group performance status (PS) 0-2 received one cycle of chemotherapy (platinum/etoposide) before study registration and were randomly assigned to CRT alone versus CRT plus concurrent and adjuvant atezolizumab, 1,200 mg once daily, every 3 weeks until investigator-assessed progression or intolerable side effects for a maximum of 17 cycles.

在研究注册前接受了一轮化疗（铂类/依托泊苷）的局限期小细胞肺癌（LS-SCLC）患者，分期为Tx-IV，N0-3，M0，以及东部肿瘤协作组表现状态（PS）为0-2，被随机分配接受仅CRT治疗与CRT联合同步和辅助阿替利珠单抗治疗，剂量为每日1,200毫克，每3周一次，直至研究者评估的疾病进展或不可耐受的副作用，最多进行17个周期。

Patients were stratified by choice of chemotherapy (cisplatin v carboplatin), radiation fractionation schedule (66 Gy once daily v 45 Gy twice daily), sex, and PS (0/1 v 2).

患者根据化疗选择（顺铂对比卡铂）、放疗分割方案（单次66 Gy对比每日两次45 Gy）、性别和PS评分（0/1对比2）进行分层。

The primary end point was overall survival(OS).

主要终点是总生存（OS）。

Secondary end points included investigator-assessed progression-free survival(PFS), objective response rate, local control, and distant-metastasis-free survival (DMFS).

次要终点包括研究者评估的无进展生存期（PFS）、客观缓解率、局部控制率和无远处转移生存期（DMFS）。

Results

patients were randomly assigned from May 2019 to December 2023.

患者从2019年5月到2023年12月被随机分配。

The median OS was 36.1 months (95% CI, 28.1 to 42.5) for the CRT-alone arm and 31.1 months (95% CI, 28.5 to 44.7) for the CRT + atezolizumab arm, respectively (hazard ratio[HR], 1.03 [95% CI, 0.80 to 1.32]).

单纯放化疗组的中位总生存期为36.1个月（95%置信区间，28.1至42.5个月），而放化疗联合阿替利珠单抗组的中位总生存期为31.1个月（95%置信区间，28.5至44.7个月），两组的危险比为1.03（95%置信区间，0.80至1.32）。

The median PFS was 11.4 months (95% CI, 10.3 to 13.2) for the CRT-alone arm and 12.1 months (95% CI, 10.9 to 15.2) for the CRT + atezolizumab arm, respectively (HR, 0.98 [95% CI, 0.79 to 1.22]).

单纯放化疗组的中位无进展生存期为11.4个月（95%置信区间，10.3至13.2个月），而放化疗联合阿替利珠单抗组的中位无进展生存期为12.1个月（95%置信区间，10.9至15.2个月），两组的危险比为0.98（95%置信区间，0.79至1.22）。

The median DMFS was 13.0 months (95% CI, 11.3 to 18.2) for the CRT-alone arm and 16.8 months (95% CI, 12.1 to 21.6) for the CRT + atezolizumab arm (HR, 0.96 [95% CI, 0.76 to 1.21]).

单纯放化疗组的中位无病生存期为13.0个月（95%置信区间，11.3至18.2个月），而放化疗加用阿替利珠单抗组的中位无病生存期为16.8个月（95%置信区间，12.1至21.6个月）（风险比，0.96 [95%置信区间，0.76至1.21]）。

No unexpected safety signals with concurrent atezolizumab were observed.

在同时使用阿替利珠单抗的情况下，未观察到意外的安全信号。

Conclusions

Concurrent and adjuvant atezolizumab with chemoradiation did not improve survival in patients with LS-SCLC.

在LS-SCLC患者中，阿替利珠单抗与同步和辅助化疗放疗联合并未改善生存期。