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非小细胞肺癌手术切除后辅助化疗的时机:一项使用瑞典全国登记数据的目标试验模拟研究

Timing of Adjuvant Chemotherapy After Surgical Resection for Non-small Cell Lung Cancer: A Target Trial Emulation Using Nationwide Swedish Registry Data.

作者信息

Lampa Erik, Boros Miklos, Berglund Anders, Wagenius Gunnar, Oskarsdottir Gudrun N

机构信息

Epistat AB, Uppsala, Sweden.

Linköping University Hospital, Linköping, Sweden.

出版信息

Ann Surg Oncol. 2025 Mar 19. doi: 10.1245/s10434-025-17193-0.

DOI:10.1245/s10434-025-17193-0
PMID:40106109
Abstract

BACKGROUND

We investigated the impact of time to adjuvant chemotherapy (AC) on survival after surgical resection (<8 weeks or 8-16 weeks) for patients with non-small cell lung cancer (NSCLC) by applying a target-trial emulation.

MATERIAL AND METHODS

We used Swedish population-based healthcare registries to emulate a hypothetical target trial, with treatment arms of 'initiate AC <8 weeks postoperatively' and 'initiate AC 8-16 weeks postoperatively'. The clone-censor-weight approach was used in which all patients were cloned and all clones were assigned to each treatment arm. Clones were then censored when the assigned treatment was no longer compatible with the actual treatment.

RESULTS

We included 510 patients in the hypothetical target trial, of whom 51% received AC and 150 (57%) started AC within 8 weeks. More than half of the patients were female (52.5%) and the mean age was 69 years. The 5-year disease-free survival (DFS) in the emulated trial for the group who initiated AC <8 weeks postoperatively was 50.3% and the 5-year overall survival (OS) was 58.1%. For the group who initiated AC 8-16 weeks postoperatively, the emulated trial showed a 5-year DFS and OS of 49.1% and 57.1%, respectively.

CONCLUSION

By using target trial emulation, our study supports earlier data on timing for AC after surgical resection for NSCLC. However, further research is needed and our data indicate that a randomized controlled trial could be conducted without major harm to the experimental group (>8 weeks).

摘要

背景

我们通过应用目标试验模拟方法,研究了非小细胞肺癌(NSCLC)患者手术切除后辅助化疗(AC)时间(<8周或8 - 16周)对生存的影响。

材料与方法

我们使用瑞典基于人群的医疗保健登记系统来模拟一项假设的目标试验,治疗组分为“术后<8周开始AC”和“术后8 - 16周开始AC”。采用克隆删失加权法,即对所有患者进行克隆,并将所有克隆分配到每个治疗组。当分配的治疗与实际治疗不再相符时,对克隆进行删失。

结果

我们在假设的目标试验中纳入了510例患者,其中51%接受了AC,150例(57%)在8周内开始AC。超过一半的患者为女性(52.5%),平均年龄为69岁。在模拟试验中,术后<8周开始AC的组5年无病生存率(DFS)为50.3%,5年总生存率(OS)为58.1%。对于术后8 - 16周开始AC的组,模拟试验显示5年DFS和OS分别为49.1%和57.1%。

结论

通过使用目标试验模拟,我们的研究支持了关于NSCLC手术切除后AC时机的早期数据。然而,仍需要进一步研究,并且我们的数据表明可以进行一项对实验组(>8周)无重大危害的随机对照试验。

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