First-Line Lorlatinib Versus Crizotinib in Asian Patients With Advanced ALK-Positive NSCLC: Five-Year Outcomes From the CROWN Study.

Efficacy was similar in the Asian subgroup.

在亚洲亚组中，疗效相似。

We present an updated subgroup analysis in Asian patients after five years of follow-up.

我们在亚洲患者中提供了五年随访后的最新亚组分析。

Methods

Patients were randomly (1:1) assigned to receive lorlatinib 100 mg once daily (n = 59) or crizotinib 250 mg twice daily (n = 61).

患者被随机（1:1）分配，每天一次接受100毫克洛拉替尼（n = 59）或每天两次接受250毫克克唑替尼（n = 61）。

This post hoc analysis presents updated investigator-assessed efficacy outcomes, safety, and biomarker analyses.

这项事后分析呈现了研究者评估的最新疗效结果、安全性以及生物标志物分析。

Results

After a median follow-up of 62.4 months for lorlatinib and 55.1 months for crizotinib, median PFS was not reached (NR, 95% confidence interval[CI]: 64.3‒NR) and 9.2 months (95% CI: 7.2‒12.7), respectively (hazard ratio[HR] = 0.22, 95% CI: 0.13‒0.37); the five-year PFS was 63% (95% CI: 49-74) and 7% (95% CI: 2-17).

在中位随访62.4个月后，洛拉替尼的中位无进展生存期（PFS）未达到（NR，95%置信区间[CI]：64.3‒NR），而克唑替尼为9.2个月（95% CI: 7.2‒12.7）（风险比[HR] = 0.22, 95% CI: 0.13‒0.37）；五年PFS分别为63%（95% CI: 49-74）和7%（95% CI: 2-17）。

The objective response ratewas 81% (95% CI: 69-90) with lorlatinib and 59% (95% CI: 46‒71) with crizotinib.

使用洛拉替尼的客观缓解率为81%（95%置信区间：69-90），而使用克唑替尼的为59%（95%置信区间：46-71）。

In patients with baseline brain metastases, the intracranial objective response ratewas 69% (95% CI: 39‒91) with lorlatinib and 6% (95% CI: <1‒30) with crizotinib.

对于基线时已有脑转移的患者，使用洛拉替尼的颅内客观缓解率为69%（95%置信区间：39-91），而使用克唑替尼的为6%（95%置信区间：<1-30）。

The median time to intracranial progression was NR (95% CI: NR‒NR) and 14.6 months (95% CI: 9.2‒27.4), respectively (HR = 0.01, 95% CI: <0.01‒0.11).

颅内进展的中位时间分别为NR（95%置信区间：NR‒NR）和14.6个月（95%置信区间：9.2‒27.4），分别（风险比=0.01，95%置信区间：<0.01‒0.11）。

Safety profiles were consistent with the entire population.

安全性特征与整个人群一致。

Conclusions

After five years of follow-up, lorlatinib efficacy and safety in the Asian subgroup of CROWN continue to be consistent with those in the overall population, with PFS remaining unreached with lorlatinib.

经过五年的随访，CROWN研究中亚洲亚组的洛拉替尼疗效和安全性与整体人群保持一致，无进展生存期（PFS）在使用洛拉替尼的情况下仍未达到。

trial_registration

ClinicalTrials.gov identifier: NCT03052608.

ClinicalTrials.gov注册号：NCT03052608。