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Relationship Between Fluoropyrimidine (FPD) Exposure and Outcomes in Patients with Metastatic Colorectal Cancer (mcrc) Receiving Trifluridine/tipiracil (FTD/TPI) with or Without Bevacizumab (BEV) in the Phase 3 SUNLIGHT Trial.

Journal of Clinical Oncology(2024)

City of Hope | Medical University of Vienna | Hôpital Européen Georges-Pompidou | Taiho Oncology (United States) | Institut des Hautes Études Scientifiques | Vall d'Hebron Hospital Universitari

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Abstract
114 Background: Standard first- and second-line chemotherapy regimens for mCRC are FPD-based. In the phase 3 SUNLIGHT trial, the addition of BEV to FTD/TPI significantly improved overall survival (OS) compared with FTD/TPI alone in patients with mCRC who had received no more than two prior chemotherapy regimens. Here, we assessed the effect of timing of prior exposure to FPD on efficacy outcomes among patients treated in SUNLIGHT. Methods: In this post-hoc analysis, OS, progression-free survival (PFS), and disease control rate (DCR) were assessed in patients treated with FPD within 2 months of enrollment (<2 months FPD-free exposure) and patients who had not received FPD for ≥2 months prior to enrollment (≥2 months FPD-free exposure). Differences in OS between FTD/TPI + BEV and FTD/TPI alone were assessed in each subgroup. The Kaplan-Meier method and log-rank test were used to compare differences in OS/PFS; DCR was compared using Fisher's exact tests. The hazard ratio (HR) for OS was estimated using a Cox proportional hazards model. Results: Of 246 patients randomized to FTD/TPI + BEV, 79 had ≥2 months FPD-free exposure and 167 had <2 months FPD-free exposure. Median OS (95% CI) was 11.8 months (9.4–not estimable) for patients with ≥2 months FPD-free exposure and 10.5 months (8.6–11.3) for patients with <2 months FPD-free exposure ( P=0.095); median PFS was 6.7 months (4.6–7.5) and 5.2 months (4.2–5.7), respectively ( P=0.043). The DCR among patients treated with FTD/TPI + BEV was 79.8% for patients with ≥2 months FPD-free exposure and 64.7% for patients with <2 months FPD-free exposure, with a between-group difference of 15.1% (95% CI: 3.6%–26.5%; P=0.018). Of 246 patients randomized to FTD/TPI alone, 91 had ≥2 months FPD-free exposure and 155 had <2 months FPD-free exposure. Median OS was 9.3 months (6.7–10.9) and 6.8 months (6.0–7.8) for patients with ≥2 and <2 months FPD-free exposure, respectively ( P=0.106) and median PFS was 3.6 months (2.1–3.9) and 2.1 months (2.0–2.7) ( P=0.002). The between-group difference in the DCR was 13.8% (50.6% vs. 36.7% for ≥2 and <2 months FPD-free exposure; 95% CI: 1.0%–26.6%; P=0.044). Compared with FTD/TPI alone, FTD/TPI + BEV resulted in longer OS in both the ≥2-month (HR 0.61, 95% CI: 0.41–0.93) and <2-month (HR 0.59, 95% CI: 0.45–0.78) groups, respectively. Conclusions: Owing to imbalances between the ≥2- and <2-month FPD-free exposure groups, the data need to be interpreted with caution. However, with both FTD/TPI + BEV and FTD/TPI alone, OS, PFS, and DCR were numerically higher in patients with ≥2 months FPD-free exposure than in those with <2 months FU-free exposure, potentially reflecting the better prognosis of the former group. The survival benefits of adding BEV to FTD/TPI were maintained regardless of the timing of exposure to FPD prior to enrollment. Clinical trial information: NCT04737187 .
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要点】:本研究通过分析SUNLIGHT试验的数据,探讨了在转移性结直肠癌患者中,先前氟嘧啶类药物暴露时间对三氟尿苷/替加氟(FTD/TPI)联合或不联合贝伐珠单抗(BEV)治疗效果的影响,发现无论先前暴露时间长短,添加BEV均能提高总生存期。

方法】:采用回顾性分析,将患者分为先前氟嘧啶类药物暴露时间小于2个月和大于等于2个月两组,比较两组患者的总生存期(OS)、无进展生存期(PFS)和疾病控制率(DCR)。

实验】:在SUNLIGHT试验中,共246名患者被随机分配至FTD/TPI+BEV组,其中79名患者有大于等于2个月的氟嘧啶类药物暴露间隔,167名患者有小于2个月的暴露间隔。结果显示,对于有大于等于2个月暴露间隔的患者,中位OS为11.8个月,中位PFS为6.7个月,DCR为79.8%;对于有小于2个月暴露间隔的患者,中位OS为10.5个月,中位PFS为5.2个月,DCR为64.7%。在FTD/TPI单独治疗组中,有大于等于2个月和小于2个月暴露间隔的患者的中位OS分别为9.3个月和6.8个月,中位PFS分别为3.6个月和2.1个月,DCR分别为50.6%和36.7%。无论先前暴露时间长短,添加BEV均能显著提高OS。临床试验信息:NCT04737187。