Impact of age and sex on the efficacy and safety of ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy: a subgroup analysis of the ARMANI phase III trial

IF 7.1 2区医学 Q1 ONCOLOGY

ESMO Open Pub Date : 2025-06-19 DOI:10.1016/j.esmoop.2025.105329

R. Fazio , G. Randon , F. Bergamo , F. Palermo , S. Tamberi , E. Giommoni , S. Di Donato , L. Fornaro , O. Brunetti , F. De Vita , M. Valgiusti , S.M. Gobba , A. Spallanzani , S. Murgioni , V. Bethaz , A. Strippoli , T.P. Latiano , G.G. Cardellino , C. Ceccon , A. Raimondi , F. Pietrantonio

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引用次数: 0

Abstract

Background

There is a growing interest in optimizing the therapeutic management of older cancer patients as well as understanding the sex-specific differences in terms of efficacy and safety of cancer treatments. However, limited data are available on the initial therapy of patients with advanced gastro-oesophageal cancer.

Materials and methods

The ARMANI phase III trial showed progression-free survival (PFS) and overall survival (OS) benefit with paclitaxel plus ramucirumab switch maintenance (arm A) versus the continuation of first-line oxaliplatin and fluoropyrimidine (arm B) in patients with advanced human epidermal growth factor receptor 2-negative gastric or gastro-oesophageal junction cancer. We conducted a subgroup analysis aimed at assessing the differences in efficacy, safety and quality of life (QoL) according to age (<70 versus ≥70 years) and sex.

Results

No significant differences in terms of PFS (P = 0.757), OS (P = 0.588) and overall response rates (ORRs) (P = 0.238) were observed between older and younger patients. No significant differences in PFS (P = 0.646), OS (P = 0.858) and ORRs (P = 0.649) were observed between females and males. The effect of treatment arm on survival outcomes was similar across age (P = 0.094) and sex groups (P = 0.469). Looking at specific adverse events, peripheral neuropathy occurred more frequently in younger patients (P = 0.020), anaemia in older patients (P = 0.044) and hand-foot syndrome in women (P = 0.021). Older patients were less likely to receive a post-discontinuation treatment (P = 0.010), especially in arm B (P = 0.026). The impact on QoL was better in arm A, irrespective of age and sex.

Conclusion

The ARMANI trial supported the benefit of the investigated switch maintenance strategy irrespective of age and sex.

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年龄和性别对ramucirumab +紫杉醇作为切换维持与继续一线奥沙利铂化疗的有效性和安全性的影响：ARMANI III期试验的亚组分析

背景：人们对老年癌症患者的治疗管理优化以及癌症治疗在疗效和安全性方面的性别差异越来越感兴趣。然而，关于晚期胃食管癌患者的初始治疗的数据有限。材料和方法ARMANI III期试验显示，紫杉醇加ramucirumab切换维持（A组）与继续使用奥沙利铂和氟嘧啶（B组）治疗晚期人表皮生长因子受体2阴性胃癌或胃食管结癌患者的无进展生存期（PFS）和总生存期（OS）获益。我们进行了一项亚组分析，旨在根据年龄（70岁vs≥70岁）和性别评估疗效、安全性和生活质量（QoL）的差异。结果两组患者在PFS （P = 0.757）、OS （P = 0.588）和总有效率（ORRs）（P = 0.238）方面均无显著差异。男女患者PFS （P = 0.646）、OS （P = 0.858）、orr （P = 0.649）差异均无统计学意义。治疗组对生存结局的影响在不同年龄组（P = 0.094）和性别组（P = 0.469）相似。观察特定不良事件，年轻患者周围神经病变发生率更高（P = 0.020），老年患者贫血发生率更高（P = 0.044），女性手足综合征发生率更高（P = 0.021）。老年患者接受停药后治疗的可能性较小（P = 0.010），特别是在B组（P = 0.026）。无论年龄和性别，A组对生活质量的影响都更好。结论ARMANI试验支持所研究的开关维护策略的益处，无论年龄和性别如何。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

ESMO Open Medicine-Oncology

CiteScore

11.70

自引率

2.70%

发文量

255

审稿时长

10 weeks

期刊介绍： ESMO Open is the online-only, open access journal of the European Society for Medical Oncology (ESMO). It is a peer-reviewed publication dedicated to sharing high-quality medical research and educational materials from various fields of oncology. The journal specifically focuses on showcasing innovative clinical and translational cancer research. ESMO Open aims to publish a wide range of research articles covering all aspects of oncology, including experimental studies, translational research, diagnostic advancements, and therapeutic approaches. The content of the journal includes original research articles, insightful reviews, thought-provoking editorials, and correspondence. Moreover, the journal warmly welcomes the submission of phase I trials and meta-analyses. It also showcases reviews from significant ESMO conferences and meetings, as well as publishes important position statements on behalf of ESMO. Overall, ESMO Open offers a platform for scientists, clinicians, and researchers in the field of oncology to share their valuable insights and contribute to advancing the understanding and treatment of cancer. The journal serves as a source of up-to-date information and fosters collaboration within the oncology community.