Shi Yan, Han Quanli, Yan Huan, Lv Yao, Yuan Jing, Li Jie, Guan Shasha, Wang Zhikuan, Huang Lei, Dai Guanghai
Department of Oncology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Department of Medical Oncology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Front Oncol. 2022 May 13;12:865404. doi: 10.3389/fonc.2022.865404. eCollection 2022.
In our previous phase II study, nab-paclitaxel plus S-1 (NPS) showed encouraging objective response rate (ORR) as first-line treatment for advanced pancreatic adenocarcinoma (APAC). This study aimed to evaluate the effectiveness and safety of S-1 maintenance after NPS in APAC and to explore factors predicting survival benefits when using S-1 maintenance.
Between 2014 and 2018 a total of 182 patients with APAC, who were primarily treated with NPS, were included. For patients without progression or with treatment discontinuation due to any reasons within 4 months during NPS treatment, S-1 monotherapy was administrable as maintenance therapy at the physicians' discretion based on the patients' preference and performance status. Efficacy and safety of S-1 maintenance were investigated.
In 123 patients without progression within 4 months during NPS treatment, 74 received S-1 maintenance and had median progression-free survival of 9.6 months and median overall survival of 16.7 months. Multivariable analysis showed that in patients receiving S-1 maintenance after first-line NPS therapy, an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, non-metastatic disease, and complete or partial response as best response to NPS chemotherapy were independently associated with better survival. The most common all-grade hematological and non-hematological adverse events were neutropenia (82.4%) and peripheral neurotoxicity (66.2%), respectively, and the most common ≥Grade 3 hematological and non-hematological adverse events were neutropenia (40.5%) and peripheral neurotoxicity (6.8%), respectively in patients who received S-1 maintenance.
Our real-world study showed that S-1 maintenance after tumor response or stable disease induced by first-line NPS treatment was effective and well-tolerated for some patients with APAC, which offers a promising alternative treatment strategy with encouraging survival for APAC.
在我们之前的II期研究中,纳武单抗联合S-1(NPS)作为晚期胰腺腺癌(APAC)的一线治疗显示出令人鼓舞的客观缓解率(ORR)。本研究旨在评估NPS后S-1维持治疗在APAC中的有效性和安全性,并探索使用S-1维持治疗时预测生存获益的因素。
2014年至2018年期间,共纳入182例主要接受NPS治疗的APAC患者。对于在NPS治疗期间4个月内无进展或因任何原因中断治疗的患者,可根据医生的判断,基于患者的偏好和体能状态,酌情给予S-1单药作为维持治疗。研究了S-1维持治疗的疗效和安全性。
在123例NPS治疗期间4个月内无进展的患者中,74例接受了S-1维持治疗,无进展生存期的中位数为9.6个月,总生存期的中位数为16.7个月。多变量分析显示,在一线NPS治疗后接受S-1维持治疗的患者中,东部肿瘤协作组(ECOG)体能状态评分为0、无转移性疾病以及对NPS化疗的最佳反应为完全或部分缓解与更好的生存独立相关。接受S-1维持治疗的患者中,最常见的所有级别的血液学和非血液学不良事件分别为中性粒细胞减少(82.4%)和外周神经毒性(66.2%),最常见的≥3级血液学和非血液学不良事件分别为中性粒细胞减少(40.5%)和外周神经毒性(6.8%)。
我们的真实世界研究表明,对于一些APAC患者,一线NPS治疗诱导肿瘤反应或病情稳定后使用S-1维持治疗是有效的,且耐受性良好,这为APAC提供了一种有前景的替代治疗策略,其生存结果令人鼓舞。