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培美曲塞与铂类化疗联用肿瘤治疗电场用于不可切除恶性胸膜间皮瘤的可行性:单中心真实世界数据

Feasibility of Tumor Treating Fields with Pemetrexed and Platinum-Based Chemotherapy for Unresectable Malignant Pleural Mesothelioma: Single-Center, Real-World Data.

作者信息

Kutuk Tugce, Appel Haley, Avendano Maria Carolina, Albrecht Federico, Kaywin Paul, Ramos Suyen, Suarez-Murias Melanie E, Mehta Minesh P, Kotecha Rupesh

机构信息

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL 33176, USA.

Department of Medical Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL 33176, USA.

出版信息

Cancers (Basel). 2022 Apr 16;14(8):2020. doi: 10.3390/cancers14082020.

Abstract

PURPOSE

The objectives of this study were to evaluate the implementation, device usage rates, clinical outcomes, and treatment-related toxicities associated with TTFields and pemetrexed plus platinum-based chemotherapy in patients with unresectable MPM, outside the initial trial results.

METHODS

Consecutive patients with unresectable MPM were enrolled onto an FDA-required HDE protocol from 2019 to 2021. All patients were treated with a protocol-defined regimen of continuous TTFields (150 kHz) and pemetrexed plus platinum-based chemotherapy.

RESULTS

Five patients with unresectable MPM were enrolled. The median number of 4-week TTFields cycles was 5 (range: 2-7 cycles). Median TTFields device usage in the first 3 months was 12.5 h per day (range: 5-16.8 h), representing 52% (21-70%) of the potential daily duration. The median follow-up was 5.4 months (range: 1.1-20.9 months). Treatment-related dermatitis was the only side effect associated with TTFields and was reported as grade 1-2 in all patients; no patient had grade 3+ device-related toxicities.

CONCLUSIONS

This study represents the first results of real-world implementation of TTFields for MPM. In comparison to the initial clinical trial (STELLAR), compliance rates were lower, although skin-related toxicities appeared similar. Further initiatives and guidelines should be developed to manage treatment-related dermatitis and improve device usage.

摘要

目的

本研究的目的是在初始试验结果之外,评估与肿瘤治疗电场(TTFields)以及培美曲塞加铂类化疗相关的不可切除恶性胸膜间皮瘤(MPM)患者的实施情况、设备使用率、临床结果和治疗相关毒性。

方法

2019年至2021年,连续的不可切除MPM患者被纳入美国食品药品监督管理局(FDA)要求的人道主义设备豁免(HDE)方案。所有患者均接受了方案定义的连续TTFields(150kHz)以及培美曲塞加铂类化疗方案的治疗。

结果

纳入了5例不可切除MPM患者。4周TTFields周期的中位数为5(范围:2 - 7个周期)。前3个月TTFields设备的中位使用时间为每天12.5小时(范围:5 - 16.8小时),占潜在每日时长的52%(21% - 70%)。中位随访时间为5.4个月(范围:1.1 - 20.9个月)。与TTFields相关的唯一副作用是治疗相关的皮炎,所有患者报告为1 - 2级;没有患者出现3级及以上与设备相关的毒性。

结论

本研究代表了TTFields在MPM实际应用中的首批结果。与初始临床试验(STELLAR)相比,依从率较低,尽管皮肤相关毒性似乎相似。应制定进一步的倡议和指南来管理治疗相关的皮炎并提高设备使用率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d78/9032984/6b1586ea273f/cancers-14-02020-g001.jpg

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