Electronic patient-reported outcomes with vital sign monitoring versus usual care during trastuzumab deruxtecan treatment for metastatic breast cancer: Updated results from the PRO-DUCE study.

• DOI: 10.1200/jco.2025.43.16_suppl.1545
• Publication Date: 2025-05-28T16:48:40Z
• Authors: Yuichiro Kikawa; Yukari Uemura; Tetsuhiko Taira; Chiyoe Kitagawa; Hideki Maeda; Hiroaki Kato; Naoki Hashimoto; Mitsuchika Hosoda; Yohei Hamanaka; Yuko Tanabe; Tatsuya Yoshida; Kaori Tane; Daisuke Takabatake; Takashi Ishikawa; Takayuki Iwamoto; Takeshi Yamaguchi; Daisuke Takiguchi; Hirofumi Mukai; Naruto Taira; Takafumi Sangai

1545 Background: The PRO-DUCE study (jRCTs031200387), a multicenter, randomized controlled study, evaluated the impact of ePRO plus body temperature (BT)/SpO 2 monitoring (ePROm) vs.usual care (UC) on quality life (QoL) for patients (pts) with HER2-positive metastatic breast cancer (MBC) treated T-DXd. primary results presented at ASCO 2024 showed that week 24, ePROm demonstrated better global health status (GHS) vs. UC. Based recent studies showing symptom and alert notifications via ePROs could improve pt QoL overall survival (OS), we consider effects long-term scores OS. Methods: pts population was observed from March 1, 2021, to February 29, (data cutoff date: May 20, 2024). We MBC eligible T-DXd or UC group. involved weekly reporting symptoms based PRO-CTCAE daily BT SpO reports smartphone home. If any reported exceeded predetermined thresholds, an email sent medical staff; data were then reviewed, and, if necessary, phone consultation provided. Endpoints in this updated analysis included cancer-related fatigue beyond 24 using EORTC QLQ-C30 (C30) QLQ-FA12 (FA12), OS, safety. Results: Between 2021 January 2023, 111 enrolled (ePROm: 56; UC: 55). Throughout observation period, 1045 generated, which 279 considered necessary contact 231 telephone counseling conducted by healthcare providers (response rate: 82.8%). 48 weeks, response rate > 89% number evaluable weeks 37 41 At 48, changes GHS baseline groups -3.7±18.6 -12.7±23.8, those FA12 total score -4.9±14.3 8.1±16.4, respectively. median OS 24.5 months (95% CI: 21.8, not reached) group follow-up duration 18.3 months, whereas group, reached 20.7, 18.1 [HR = 1.39; 95% 0.75, 2.59]. majority any-grade treatment-emergent adverse event CTCAE higher proportion than during period. Interstitial lung disease incidence similar both (7.4% 9.3% group), all cases being grade 1. Conclusions: Long-term findings maintained over time. While there no difference these might support integration clinical practice optimize receiving Clinical trial information: jRCTs031200387 .