nab -紫杉醇和吉西他滨作为不适合顺铂化疗(NACHO)的胆管癌患者一线治疗的II期研究

IF 2 4区 医学 Q3 ONCOLOGY Oncology Research and Treatment Pub Date : 2023-01-01 DOI:10.1159/000529012
Isabel Virchow, Jürgen-Walter Treckmann, Nicole Prasnikar, Gabriele Linden, Peter Markus, Brigitte Schumacher, David Albers, Thomas Herold, Saskia Ting, Hartmut Schmidt, Sonja Radunz, Marcel Wiesweg, Jens Siveke, Martin Schuler, Stefan Kasper
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引用次数: 0

摘要

吉西他滨和顺铂是晚期胆管癌(CCA)患者的标准一线全身治疗。然而,由于合并症或表现不佳,大量患者不符合顺铂治疗的条件。NACHO II期试点研究评估了nab-紫杉醇(125 mg/m2)和吉西他滨(1000 mg/m2)作为不适合顺铂化疗的晚期CCA患者的一线治疗,每4周给药1、8和15天。方法:有任何排除顺铂治疗的合并症的患者,如肾脏损害、听力受损、血栓栓塞事件风险增加或病史、广泛水合不耐受或显著心血管疾病的患者均符合条件。主要终点是RECIST 1.1的总缓解率(ORR)。次要终点是无进展生存期(PFS)、总生存期(OS)、安全性和患者报告的结果。结果:2016年12月至2017年7月,前瞻性纳入治疗10例患者。nab-紫杉醇/吉西他滨的ORR为50%,疾病控制率(DCR)为90%。中位PFS为5.7个月(95% CI: 5.3-6.1),中位OS为7.8个月(95% CI: 5.4-10.2)。总共记录了13例sae,没有任何新的安全信号。ITT人群中10例患者出现14例3-4级治疗相关不良事件(TRAEs)。进行探索性亚组分析,包括已知的预后指标。结论:NACHO试验支持nab-紫杉醇和吉西他滨治疗晚期CCA患者的安全性和有效性,不适合顺铂为基础的治疗,应在更大的前瞻性试验中进一步评估。
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A Phase II Study of Nab-Paclitaxel and Gemcitabine as First-Line Therapy in Patients with Cholangiocarcinoma Ineligible for Cisplatin-Based Chemotherapy (NACHO).

Introduction: Gemcitabine and cisplatin is the standard first-line systemic treatment in patients with advanced cholangiocarcinoma (CCA). However, a substantial number of patients do not qualify for cisplatin due to comorbidities or poor performance status. The phase II pilot study NACHO evaluated the efficacy of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) given on days 1, 8, and 15 every 4 weeks as first-line therapy in patients with advanced CCA ineligible for cisplatin-based chemotherapy.

Methods: Patients with any comorbidity precluding cisplatin therapy, such as renal impairment, impaired hearing, increased risk or history for thromboembolic events, intolerance of extensive hydration, or significant cardiovascular disease were eligible. Primary endpoint was overall response rate (ORR) per RECIST 1.1. Secondary endpoints were progression-free survival (PFS), overall survival (OS), safety, and patient reported outcome.

Results: From December 2016 to July 2017, 10 patients were prospectively enrolled and treated. The ORR with nab-paclitaxel/gemcitabine was 50%, the disease control rate (DCR) was 90%. Median PFS was 5.7 months (95% CI: 5.3-6.1), and median OS was 7.8 months (95% CI: 5.4-10.2). In total, 13 SAEs were documented without any new safety signals. There were 14 grade 3-4 treatment-related adverse events (TRAEs) in 10 patients of the ITT population. Exploratory subgroup analyses including known prognostic markers were performed.

Conclusions: The NACHO trial supports safety and efficacy of nab-paclitaxel and gemcitabine in patients with advanced CCA ineligible for cisplatin-based therapy and should be further evaluated in a larger prospective trial.

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来源期刊
CiteScore
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0.00%
发文量
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期刊介绍: With the first issue in 2014, the journal ''Onkologie'' has changed its title to ''Oncology Research and Treatment''. By this change, publisher and editor set the scene for the further development of this interdisciplinary journal. The English title makes it clear that the articles are published in English – a logical step for the journal, which is listed in all relevant international databases. For excellent manuscripts, a ''Fast Track'' was introduced: The review is carried out within 2 weeks; after acceptance the papers are published online within 14 days and immediately released as ''Editor’s Choice'' to provide the authors with maximum visibility of their results. Interesting case reports are published in the section ''Novel Insights from Clinical Practice'' which clearly highlights the scientific advances which the report presents.
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