Genomically matched therapy in advanced solid tumors: the randomized phase 2 ROME trial.

The ROME trial was a multicenter, randomized, open-label phase 2 study comparing tailored treatment (TT) to standard of care (SoC) in patients with advanced solid tumors progressing after one or two lines of therapy.

ROMETrial是一项多中心、随机、开放标签的2期研究，比较了在一线或二线治疗后疾病进展的晚期实体瘤患者中，个体化治疗（TT）与标准治疗（SoC）的差异。

Comprehensive genomic profiling on tissue and blood was performed to identify actionable alterations.

对组织和血液进行了全面的基因组分析，以识别可采取行动的改变。

Overall response rate (ORR) was the primary endpoint, and progression-free survival(PFS), overall survival(OS), time to treatment failure (TTF), time to next treatment (TTNT) and safety were the secondary endpoints.

主要终点是总缓解率（ORR），次要终点包括无进展生存期（PFS）、总生存（OS）、治疗失败时间（TTF）、下一次治疗时间（TTNT）和安全性。

Between November 2020 and August 2023, 1,794 patients were screened, 897 were evaluated by the molecular tumor board (MTB) and 400 were randomized to TT or SoC.

在2020年11月至2023年8月期间，共筛查了1,794名患者，897名患者由分子肿瘤委员会（MTB）评估，并有400名患者被随机分配至TT或SoC。

TT achieved a significantly higher ORR (17.5% versus 10%; P = 0.0294) and improved median PFS (3.5 months versus 2.8 months; hazard ratio= 0.66 (0.53-0.82), P = 0.0002).

TT实现了显著更高的客观缓解率（ORR）（17.5%对比10%；P = 0.0294），并改善了中位无进展生存期（PFS）（3.5个月对比2.8个月；风险比=0.66（0.53-0.82），P = 0.0002）。

TT also showed superior 12-month PFS rates (22.0% versus 8.3%).

TT还显示出更优越的12个月无进展生存（PFS）率（22.0%对比8.3%）。

Median OS was similar, with a 52% crossover rate.

中位总生存（OS）相似，有52%的交叉率。

Grade 3/4 adverse events were also similar (40% TT versus 52% SoC).

3级/4级不良事件的发生率也相似（TT组为40%，SoC组为52%）。

These results highlight the potential of TT to improve outcomes for patients with diverse actionable genomic alterations.

这些结果强调了TT在改善具有多种可操作基因组改变患者预后方面的潜力。

These results also provide relevant evidence supporting a tumor-agnostic precision oncology strategy and highlight the potential of TTs, guided by genomic profiling and MTB recommendations, to significantly improve outcomes for patients with diverse actionable genomic alterations.

这些结果还提供了支持肿瘤不拘一格的精准肿瘤学策略的相关证据，并突显了基于基因组分析和MTB建议指导下的TTs（治疗策略），对于具有多种可操作基因组改变的患者显著改善预后的潜力。

ClinicalTrials.gov identifier: NCT04591431 .

ClinicalTrials.gov注册号：NCT04591431。