Singh Ajaykumar, Kapoor Akhil, Noronha Vanita, Patil Vijay, Menon Nandini, Mahajan Abhishek, Janu Amit, Purandare Nilendru, Kaushal Rajiv, Prabhash Kumar
Medical Oncology, Tata Memorial Centre, Mumbai 400012, India.
Medical Oncology, Homi Bhabha Cancer Hospital, Varanasi 221001, Uttar Pradesh, India.
Ecancermedicalscience. 2022 Jun 7;16:1407. doi: 10.3332/ecancer.2022.1407. eCollection 2022.
Anaplastic lymphoma kinase (ALK) inhibitors have shown significant efficacy in ALK -rearranged non-small cell lung cancer (NSCLC) patients with good performance status (PS) in multiple randomised studies. However, there is limited data on patients with poor performance status.
We carried out a retrospective analysis of prospectively collected data of patients with ALK-rearranged NSCLC and Eastern Cooperative Oncology Group (ECOG) PS of 2-4 treated at a single academic cancer centre from January 2013 to November 2018. The outcomes, progression-free survival (PFS) and overall survival (OS) were calculated from the date of diagnosis. SPSS version 20 was used for all statistical calculations.
Out of the total 441 ALK-positive patients, 97 (21.9%) had ECOG PS 2-4 (poor PS). The median PFS was 9.3 months (95% CI = 6.6-12.0) as compared to 14.9 months (95% CI = 13.4-16.4) for patients with a PS of 0-1 (HR = 1.38, 95% CI = 1.04-1.84, = 0.027). The corresponding median OS were 17.9 months (95% CI = 12.8-23.1) and 33.5 months (95% CI = 28.6-38.4), respectively (HR = 1.89, 95% CI = 1.36-2.62, < 0.001). Among poor PS patients, a subgroup of patients with PS 2 had median OS of 20.6 months (95% CI = 10.8-47.3) as compared to 8.6 months for PS 3-4 (95% CI = 7.8-27.8) (HR = 1.79, 95% CI = 1.01-3.20, = 0.047). The patients treated with upfront ALK inhibitors had better survival as opposed to those treated with chemotherapy. On multivariate analysis, PS 3-4, smoking, stage 4 and not using ALK inhibitors as first-line therapy were associated significantly with poor outcomes.
The ALK-rearranged NSCLC patients with poor PS derived significant benefits with ALK inhibitors. The outcomes were significantly poorer as compared to patients with PS 0-1; the subgroup of patients with PS 2 had better outcomes as compared to patients with PS 3-4.
在多项随机研究中,间变性淋巴瘤激酶(ALK)抑制剂已在体能状态(PS)良好的ALK重排非小细胞肺癌(NSCLC)患者中显示出显著疗效。然而,关于体能状态较差患者的数据有限。
我们对2013年1月至2018年11月在单个学术癌症中心接受治疗的ALK重排NSCLC且东部肿瘤协作组(ECOG)体能状态为2 - 4级的患者的前瞻性收集数据进行了回顾性分析。从诊断日期计算无进展生存期(PFS)和总生存期(OS)等结局。所有统计计算均使用SPSS 20版。
在总共441例ALK阳性患者中,97例(21.9%)的ECOG体能状态为2 - 4级(体能状态差)。体能状态为2 - 4级患者的中位PFS为9.3个月(95%置信区间 = 6.6 - 12.0),而体能状态为0 - 1级的患者为14.9个月(95%置信区间 = 13.4 - 16.4)(风险比[HR] = 1.38,95%置信区间 = 1.04 - 1.84,P = 0.027)。相应的中位OS分别为17.9个月(95%置信区间 = 12.8 - 23.1)和33.5个月(95%置信区间 = 28.6 - 38.4)(HR = 1.89,95%置信区间 = 1.36 - 2.62,P < 0.001)。在体能状态差的患者中,体能状态为2级的患者亚组中位OS为20.6个月(95%置信区间 = 10.8 - 47.3),而体能状态为3 - 4级的患者为8.6个月(95%置信区间 = 7.8 - 27.8)(HR = 1.79,95%置信区间 = 1.01 - 3.20,P = 0.047)。与接受化疗的患者相比,一线使用ALK抑制剂治疗的患者生存期更好。多因素分析显示,体能状态为3 - 4级、吸烟、IV期以及未将ALK抑制剂作为一线治疗与不良结局显著相关。
体能状态差的ALK重排NSCLC患者使用ALK抑制剂可获得显著益处。与体能状态为0 - 1级的患者相比结局明显更差;体能状态为2级的患者亚组与体能状态为3 - 4级的患者相比结局更好。