立體定向消融放療（SAbR）可提高非小細胞肺癌患者生存期達三倍！

編譯：腫瘤資訊-小編 來源：腫瘤資訊

2017年的美國放射治療年會在聖地亞哥舉行，維持化學療法之前立體定向消融放療（SAbR）的固化治療與單純維持化療相比，局限期的非小細胞肺癌（NSCLC）患者的無進展生存期（PFS）幾乎翻了三倍。該文章也發表在JAMA Oncology上。

一項II期研究表明在維持化學療法之前使用立體定向消融放療（SAbR）的治療方法與單純維持化療相比，可使局限期非小細胞肺癌（NSCLC）患者的無進展生存期（PFS）幾乎翻了三倍。

該研究的作者Iyengar博士是得克薩斯大學達拉斯西南醫學中心放射腫瘤學教授和助理教授，在美國輻射腫瘤學會（ASTRO）2017年會議的全體會議上介紹了改研究的結果。

該研究顯示，在局限性性NSCLC患者的患者中，SAbR組的PFS增加從3.5到9.7個月有統計學意義的改善， 0.113-0.815; P = 0.01）。

主要作者Puneeth Iyengar博士說：「PFS幾乎增加了三倍，我們希望它與整體生存相關，但在分析時，總體生存期尚未達到。」。

摘要：

Consolidative Radiotherapy for Limited Metastatic Non–Small-Cell Lung Cancer：A Phase 2 Randomized Clinical Trial

Puneeth Iyengar, MD, PhD1; Zabi Wardak, MD1; David E. Gerber, MD2; et al Vasu Tumati, MD1; Chul Ahn, PhD3; Randall S. Hughes, MD2; Jonathan E. Dowell, MD2; Naga Cheedella, MD2; Lucien Nedzi, MD1; Kenneth D. Westover, MD, PhD1; Suprabha Pulipparacharuvil, PhD1; Hak Choy, MD1; Robert D. Timmerman, MD1

Author Affiliations

JAMA Oncol. Published online September 24, 2017. doi:10.1001/jamaoncol.2017.3501

Importance Patterns-of-failure studies suggest that in metastatic non–small-cell lung cancer (NSCLC) sites of gross disease at presentation are the first to progress when treated with chemotherapy. This knowledge has led to increased adoption of local ablative radiation therapy in patients with stage IV NSCLC, though prospective randomized evidence is limited.

Objective To determine if intervening with noninvasive stereotactic ablative radiotherapy (SAbR) prior to maintenance chemotherapy in patients with non–progressive limited metastatic NSCLC after induction therapy led to significant improvements in progression-free survival (PFS).

Design, Setting, and Participants This is a single-institution randomized phase 2 study of maintenance chemotherapy alone vs SAbR followed by maintenance chemotherapy for patients with limited metastatic NSCLC (primary plus up to 5 metastatic sites) whose tumors did not possess EGFR-targetable or ALK-targetable mutations but did achieve a partial response or stable disease after induction chemotherapy.

Interventions Maintenance chemotherapy or SAbR to all sites of gross disease (including SAbR or hypofractionated radiation to the primary) followed by maintenance chemotherapy.

Main Outcomes and Measures The primary end point was PFS; secondary end points included toxic effects, local and distant tumor control, patterns of failure, and overall survival.

Results A total of 29 patients (9 women and 20 men) were enrolled; 14 patients (median [range] age, 63.5 [51.0-78.0] years) were allocated to the SAbR-plus-maintenance chemotherapy arm, and 15 patients (median [range] age, 70.0 [51.0-79.0] years) were allocated to the maintenance chemotherapy–alone arm. The trial was stopped to accrual early after an interim analysis found a significant improvement in PFS in the SAbR-plus-maintenance chemotherapy arm of 9.7 months vs 3.5 months in the maintenance chemotherapy–alone arm (P = .01). Toxic effects were similar in both arms. There were no in-field failures with fewer overall recurrences in the SAbR arm while those patients receiving maintenance therapy alone had progression at existing sites of disease and distantly.

Conclusions and Relevance Consolidative SAbR prior to maintenance chemotherapy appeared beneficial, nearly tripling PFS in patients with limited metastatic NSCLC compared with maintenance chemotherapy alone, with no difference in toxic effects. The irradiation prevented local failures in original disease, the most likely sites of first recurrence. Furthermore, PFS for patients with limited metastatic disease appeared similar to those patients with a greater metastatic burden, further arguing for the potential benefits of local therapy in limited metastatic settings.

Trial Registration clinicaltrials.gov Identifier: NCT02045446

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