Long-term outcomes of durvalumab after chemoradiotherapy in locally advanced non-small cell lung cancer in Russia

D. Yudin, К. Laktionov, F. Moiseenko, D. М. Ponomarenko, M. V. Сhernykh, V. Chubenko, N. Levchenko, V. V. Kozlov, E. О. Stepanova, M. N. Khagazheeva, D. Yukalchuk
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Abstract

Introduction. The results of the PACIFIC trial have changed the standards of care for the patients with unresectable stage III nonsmall cell lung cancer (NSCLC). However, many patients in our clinical practice do not meet the inclusion criteria of PACIFIC trial.Aim. To evaluate the long-term outcomes for this approach in real clinical practice in Russia.Materials and мethods. This real-world observational retrospective multicenter study analyzed clinical outcomes in 100 patients with unresectable stage III NSCLC after concurrent or sequential chemoradiotherapy (CRT). The overall survival (OS) and progression-free survival (PFS) were evaluated by the Kaplan-Meyer method. Multivariate subgroups analysis was performed as well. The median follow-up time was 22.7 months.Results. There were 96% patients with ECOG/WHO performance status 0 or 1 in our study. Most of the patients were treated by sequential CRT (76%). Median time of durvalumab start from the end of CRT was 34 days. Patients received durvalumab for a median 10 months. The estimated median progression-free survival (PFS) and overall survival (OS) were 14.3 months (11.8–16.7, 95% CI) and 29 months (18.7–39.2, 95% CI), respectively. The estimated 1-year and 2-year rates for OS and for PFS were 90.4%, 62.8% and 59.1%, 35%, respectively. In multivariate analysis, a smoking history (HR = 0.21 (0.10–0.45; 95% CI) and concurrent CRT (HR = 0.3 (0.12–0.74; 95%CI) were associated with better PFS. The smoking history was significantly associated with a better OS (HR = 0.29 (0.10–0.76; 95% CI)) as well.Conclusions. There is a difference between the real-world outcomes for patients with unresectable stage III NSCLC in Russia and the PACIFIC trial. Sequential CRT is the most frequent treatment option for locally advanced unresectable NSCLC in Russia, and estimated OS and PFS are shorter than in the PACIFIC clinical trial. A paradigm shift in chemoradiotherapy to the concurrent and personalized approach could change the current situation.
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俄罗斯局部晚期非小细胞肺癌化疗后使用杜伐单抗的长期疗效
简介PACIFIC 试验的结果改变了不可切除的 III 期非小细胞肺癌(NSCLC)患者的治疗标准。然而,在我们的临床实践中,许多患者并不符合 PACIFIC 试验的纳入标准。评估这种方法在俄罗斯实际临床实践中的长期疗效。这项真实世界观察性回顾性多中心研究分析了100例不可切除的III期NSCLC患者在接受同期或序贯化疗(CRT)后的临床疗效。研究采用Kaplan-Meyer法评估了总生存期(OS)和无进展生存期(PFS)。同时还进行了多变量亚组分析。中位随访时间为22.7个月。在我们的研究中,96%的患者 ECOG/WHO 表现为 0 或 1。大多数患者接受了序贯 CRT 治疗(76%)。从CRT结束到开始使用度伐卢单抗的中位时间为34天。患者接受杜伐单抗治疗的中位时间为10个月。估计中位无进展生存期(PFS)和总生存期(OS)分别为14.3个月(11.8-16.7,95% CI)和29个月(18.7-39.2,95% CI)。估计1年和2年的OS率和PFS率分别为90.4%、62.8%和59.1%、35%。在多变量分析中,吸烟史(HR = 0.21 (0.10-0.45; 95% CI))和同时进行 CRT(HR = 0.3 (0.12-0.74; 95%CI))与较好的 PFS 相关。吸烟史也与较好的OS(HR = 0.29 (0.10-0.76; 95% CI))明显相关。俄罗斯不可切除的 III 期 NSCLC 患者的实际治疗结果与 PACIFIC 试验结果存在差异。在俄罗斯,序贯 CRT 是局部晚期不可切除 NSCLC 最常见的治疗方案,但估计的 OS 和 PFS 短于 PACIFIC 临床试验。化放疗模式向同期和个性化方法转变可能会改变目前的状况。
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