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NRG/Alliance LU005：局限期小细胞肺癌同步放化疗VS同步放化疗联合阿替利珠单抗+辅助 NRG LU005：局限期小细胞肺癌同步放化疗联合阿替利珠单抗并后续巩固治疗 在局限期小细胞肺癌的标准治疗中，同步放化疗后巩固性免疫治疗已被证明可改善广泛期患者生存，但其在局限期患者与放化疗同步应用的价值尚不明确。评估免疫检查点抑制剂阿替利珠单抗与同步放化疗联合使用的疗效与安全性，对于优化局限期小细胞肺癌的治疗策略至关重要。 Higgins KA, Hu C, Ross HJ, Jabbour SK, Kozono DE, Owonikoko TK, Ritter TA, Williams TM, Welsh J, Simko JP, Movsas B, Xiao C, Kaira K, Gupta AK, Mohindra P, Dib EG, Brownstein J, Chun S, Kuzma CS, Kotecha R, Onitilo AA, Chen Y, Stinchcombe TE, Wang X, Paulus R, Bradley JD. Chemoradiation ± Atezolizumab in Limited-Stage Small Cell Lung Cancer: Results of NRG Oncology/Alliance LU005. J Clin Oncol. 2026 Jan 13:JCO2501569. doi: 10.1200/JCO-25-01569. Epub ahead of print. PMID: 41529214.
Purpose: NRG Oncology/Alliance LU005 (ClinicalTrials.gov identifier: NCT03811002) tested the addition of atezolizumab to concurrent chemoradiation (CRT) in this open-label, phase III international trial.
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. 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). The primary end point was overall survival (OS). Secondary end points included investigator-assessed progression-free survival (PFS), objective response rate, local control, and distant-metastasis-free survival (DMFS).
Results: patients were randomly assigned from May 2019 to December 2023. 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]). 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]). 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]). No unexpected safety signals with concurrent atezolizumab were observed.
Conclusion: Concurrent and adjuvant atezolizumab with chemoradiation did not improve survival in patients with LS-SCLC.
该研究是一项国际性开放标签III期临床试验。
局限期小细胞肺癌患者在接受一个周期铂类/依托泊苷化疗后，被随机分配至同步放化疗组或同步放化疗联合阿替利珠单抗组。联合组的患者接受同步及后续最长17个周期的阿替利珠单抗辅助治疗。
主要研究终点为总生存期。结果显示，同步放化疗组的中位总生存期为36.1个月，而联合阿替利珠单抗组为31.1个月，两组间风险比为1.03，无统计学差异。在无进展生存期方面，两组中位数分别为11.4个月与12.1个月，风险比为0.98。联合组在无远处转移生存期上略有数值提升，其中位数分别为16.8个月与13.0个月，风险比为0.96，但同样未达到统计学显著性。
该研究未观察到阿替利珠单抗与放化疗同步应用带来的预期外安全信号。该研究结论表明，在同步放化疗基础上增加同步及辅助性阿替利珠单抗治疗，未能改善局限期小细胞肺癌患者的总生存期。
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