Ka-On Lam, Karen Hoi-Lam Li, Roland Ching-Yu Leung, Vikki Tang, Thomas Yau
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引用次数: 0
Abstract
Randomized phase III trials showed that using trifluridine/tipiracil (FTD/TPI) in patients with pre-treated metastatic colorectal cancer (mCRC) conferred survival benefit versus placebo. Here, we investigated the effectiveness and safety of FTD/TPI and sought to identify prognostic factors among the mCRC population in Hong Kong.
A non-interventional, retrospective, multicenter cohort study enrolled patients with mCRC who received FTD/TPI in seven public hospitals in Hong Kong between 2016 and 2020. Overall survival (OS) was the primary endpoint; treatment duration and occurrence of neutropenia were secondary endpoints. We also performed a post hoc analysis to identify factors influencing OS and treatment duration.
Overall, 456 patients were included (median age, 64.0 years; 57.5% men). Approximately half (225/456; 49.3%) had RAS wild-type tumors; the median treatment duration was 12.4 weeks (95% confidence interval [CI] 11.1–13.1). Median OS was 7.59 months (95% CI 7.00–8.21). Overall, 289 (63.4%) patients developed neutropenia of any grade and 159 (34.9%) developed grade ≥ 3 neutropenia. Neutropenia at 1 month occurred in 193 (43.1%) patients. The use of granulocyte colony-stimulating factor for neutropenia was reported for 42 (9.2%) patients. The development of neutropenia, absolute neutrophil count decrease of ≥ 2 grades in 1 month, absence of liver metastasis, and RAS wild-type status were associated with significantly longer OS and, except for RAS wild-type status (not analyzed), longer treatment duration (p < 0.05 for all comparisons).
Our data show that treatment with FTD/TPI offers survival benefits in patients with refractory mCRC in Hong Kong consistent with randomized controlled trials and other real-world studies. Furthermore, the prognosis in patients receiving FTD/TPI appears to be significantly better in those who develop neutropenia, with RAS wild-type status, or those without liver metastases, despite a higher rate of dose reduction in the real-world setting.
随机III期试验表明，与安慰剂相比，在治疗前转移性结直肠癌（mCRC）患者中使用trifluridine/tipiracil （FTD/TPI）可提高生存期。在这里，我们调查了FTD/TPI的有效性和安全性，并试图确定香港mCRC人群的预后因素。方法：一项非介入性、回顾性、多中心队列研究纳入了2016年至2020年间在香港7家公立医院接受FTD/TPI治疗的mCRC患者。总生存期（OS）是主要终点；治疗时间和中性粒细胞减少的发生是次要终点。我们还进行了事后分析，以确定影响OS和治疗时间的因素。结果：共纳入456例患者(中位年龄64.0岁；57.5%的男性)。大约一半(225/456；49.3%)为RAS野生型肿瘤；中位治疗持续时间为12.4周（95%可信区间[CI] 11.1-13.1）。中位OS为7.59个月（95% CI 7.00-8.21）。总体而言，289例（63.4%）患者出现任何级别的中性粒细胞减少症，159例（34.9%）患者出现≥3级中性粒细胞减少症。1个月中性粒细胞减少193例（43.1%）。42例（9.2%）患者报告使用粒细胞集落刺激因子治疗中性粒细胞减少症。中性粒细胞减少症的发生、中性粒细胞绝对计数在1个月内下降≥2级、无肝转移和RAS野生型状态与更长的生存期相关，并且除了RAS野生型状态（未分析）外，更长的治疗时间(p)结论：我们的数据显示，在香港的随机对照试验和其他现实世界的研究中，FTD/TPI治疗为难治性mCRC患者提供了生存益处。此外，接受FTD/TPI治疗的中性粒细胞减少症患者、RAS野生型患者或无肝转移患者的预后似乎明显更好，尽管在现实环境中剂量减少率更高。
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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