Takumoto Yuki, Ohba Akihiro, Terashima Takeshi, Ueno Makoto, Ikezawa Kenji, Okano Naohiro, Okusaka Takuji, Morizane Chigusa, Ikeda Masafumi, Ozaka Masato, Narimatsu Hiroto, Akazawa Manabu, Shiroiwa Takeru, Furuse Junji
Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Saitama, Japan.
Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, Japan.
Cancer Med. 2025 Sep;14(17):e71161. doi: 10.1002/cam4.71161.
Patients' QoL scores during chemotherapy are generally measured during hospital visits. However, patients frequently recover from AEs before hospital arrival. This study continuously assessed each chemotherapy's impact on patients' QoL scores during hospital visits and at home using an electronic device (ePRO).
This multicenter, prospective observational study was conducted in 29 Japanese hospitals. Patients were treated with liposomal irinotecan, fluorouracil, and levoleucovorin (Nal-IRI + 5-FU/LV), gemcitabine and nab-paclitaxel (GnP), or gemcitabine (GEM) as second-line chemotherapy for unresectable pancreatic cancer. All respondents used ePRO to answer several QoL questionnaires on Days 1, 2, 4, 6, 8, and 11 following chemotherapy administration. The primary endpoint was the EQ-5D-5L index value, and the secondary endpoints were AE frequency and the EORTC QLQ-C30.
The analysis included 67 participants. The mean ± SD QoL scores of the Nal-IRI + 5-FU/LV and GnP arms varied from 0.803 ± 0.142 to 0.678 ± 0.247 and 0.872 ± 0.077 to 0.726 ± 0.185, respectively, over the evaluation period. The highest and lowest QoL scores were observed around the chemotherapy administration and approximately 1 week after the chemotherapy administration, respectively, in both arms.
Patients' QoL score assessment over time by ePRO revealed QoL score trends, which emphasized the importance of QoL management outside of hospital visits for each chemotherapy.
化疗期间患者的生活质量(QoL)评分通常在医院就诊时进行测量。然而,患者在到达医院之前经常已从不良事件(AE)中恢复。本研究使用电子设备(电子患者报告结局,ePRO)持续评估每次化疗对患者在医院就诊期间及在家中的QoL评分的影响。
本多中心前瞻性观察性研究在29家日本医院进行。患者接受脂质体伊立替康、氟尿嘧啶和亚叶酸钙(Nal-IRI + 5-FU/LV)、吉西他滨和纳米白蛋白结合型紫杉醇(GnP)或吉西他滨(GEM)作为不可切除胰腺癌的二线化疗。所有受访者在化疗给药后的第1、2、4、6、8和11天使用ePRO回答几份QoL问卷。主要终点是EQ-5D-5L指数值,次要终点是AE发生率和欧洲癌症研究与治疗组织核心生活质量问卷(EORTC QLQ-C30)。
分析纳入了67名参与者。在评估期内,Nal-IRI + 5-FU/LV组和GnP组的平均±标准差QoL评分分别从0.803±0.142变化至0.678±0.247以及从0.872±0.077变化至0.726±0.185。在两组中,最高和最低QoL评分分别在化疗给药前后以及化疗给药后约1周时观察到。
通过ePRO对患者QoL评分进行长期评估揭示了QoL评分趋势,这强调了每次化疗在医院就诊之外进行QoL管理的重要性。