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Randomized Controlled Trial
. 2025 Aug 1;8(8):e2527403.
doi: 10.1001/jamanetworkopen.2025.27403.

Electronic Patient-Reported Outcomes With Vital Sign Monitoring During Trastuzumab Deruxtecan Therapy: The PRO-DUCE Randomized Clinical Trial

Yuichiro Kikawa  1 , Yukari Uemura  2 , Tetsuhiko Taira  3 , Chiyoe Kitagawa  4 , Hideki Maeda  5 , Hiroaki Kato  6 , Naoki Hashimoto  7 , Mitsuchika Hosoda  8 , Yohei Hamanaka  9 , Yuko Tanabe  10 , Tatsuya Yoshida  11 , Kaori Tane  12 , Daisuke Takabatake  13 , Takashi Ishikawa  14 , Takayuki Iwamoto  15 , Takeshi Yamaguchi  10 , Daisuke Takiguchi  16 , Hirofumi Mukai  17 , Naruto Taira  15 , Takafumi Sangai  18
Affiliations
Randomized Controlled Trial

Electronic Patient-Reported Outcomes With Vital Sign Monitoring During Trastuzumab Deruxtecan Therapy: The PRO-DUCE Randomized Clinical Trial

Yuichiro Kikawa et al. JAMA Netw Open. .

Abstract

Importance: Patients with ERBB2 (formerly HER2 or HER2/neu)-positive metastatic breast cancer (MBC) receiving trastuzumab deruxtecan (T-DXd), a new standard of care, may experience specific adverse events affecting their quality of life (QOL). Monitoring electronic patient-reported outcomes alongside vital signs may help improve their QOL through early detection and management of these symptoms.

Objective: To assess whether symptom tracking and vital sign monitoring improve QOL compared with usual care in patients receiving T-DXd.

Design, setting, and participants: This multicenter randomized clinical trial conducted at 38 Japanese hospitals from March 1, 2021, to December 31, 2024, assigned patients with ERBB2-positive MBC eligible for T-DXd to either a monitoring or usual care group.

Intervention: Randomization was 1:1 for the monitoring and usual care groups. Patients in the monitoring group recorded weekly symptom reports and daily body temperature and percutaneous oxygen saturation data using a smartphone or tablet. Alerts were sent to medical staff when symptom or vital sign thresholds were exceeded.

Main outcomes and measures: The primary outcome was the change from baseline in global health status scores at week 24, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (scores range from 0 to 100, in which higher scores indicate a better quality of life and level of functioning). For symptom scales, however, higher scores indicate a worse symptom burden. Secondary outcomes included changes in functional and symptom scales, as well as survival outcomes.

Results: Of 111 female patients enrolled (mean [SD] age, 57.1 [11.0] years), 56 (50.5%) were randomized to the monitoring group and 55 (49.5%) to the usual care group. Baseline patient characteristics and QOL scores were comparable between the 2 groups. At week 24, the mean change in the global health status score from baseline was higher in the monitoring group compared with the usual care group (mean difference, 8.0 [90% CI, 0.2-15.8]; P = .09). Improvements in functional scales were noted in the monitoring group for role (mean difference, 10.0 [95% CI, 1.1-18.9]), cognitive (6.3 [95% CI, 1.1-11.5]), and social (10.9 [95% CI, 3.9-18.0]) functioning. Fatigue scores were lower in the monitoring group (mean difference, -8.4 [95% CI, -16.1 to -0.6]), although nausea or vomiting scores were similar between the groups (mean difference, 0.5 [95% CI, -6.2 to 7.1]). No significant differences were observed in survival outcomes.

Conclusions and relevance: In this randomized clinical trial of patients with ERBB2-positive MBC receiving T-DXd, the findings suggest that electronic symptom and vital sign tracking may help maintain QOL or prevented its deterioration. While survival outcomes were unaffected, this monitoring strategy has potential to enhance patient-centered care.

Trial registration: jRCT identifier: jRCTs031200387.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kikawa reported receiving honoraria for lectures from Daiichi Sankyo, Eisai, Chugai Pharma, Pfizer, Lilly, Taiho, and AstraZeneca outside the submitted work. Dr Uemura reported receiving personal fees from Chugai Pharma, Eli Lilly, and Pfizer during the conduct of the study. Dr T. Taira reported receiving honoraria for lectures from Daiichi Sankyo during the conduct of the study and reported receiving honoraria for lectures from Kyowa-Kirin, MSD, Chugai, Eli Lilly, Taiho, and Pfizer outside the submitted work. Dr Kitagawa reported receiving speakers honoraria from Daiichi Sankyo, Chugai Pharma, Eisai, MSD, Ono Yakuhin, and Taiho and grants for research from Daiichi Sankyo, AbbVie, ALX Oncolo, MSD, Ono Yakuhin, and Sanofi outside the submitted work. Dr Maeda reported receiving personal fees from AstraZeneca, Lilly Japan, PDRadiopharma, and Pfizer outside the submitted work. Dr Kato reported receiving honoraria for lectures from Daiichi Sankyo outside the submitted work. Dr Hashimoto reported receiving honoraria for lectures from Daiichi Sankyo during the conduct of the study and outside the submitted work. Dr Tanabe reported receiving grants from Daiichi Sankyo during the conduct of the study and reported receiving grants from Daiichi Sankyo, MSD, and Eli Lilly outside the submitted work. Dr Yoshida reported receiving honoraria for lectures from AstraZeneca, Chugai Pharma, Daiichi Sankyo, Lilly Japan, Pfizer, and Taiho Pharmaceutical outside the submitted work. Dr Tane reported receiving honoraria for lectures, consulting, or advising from Daiichi Sankyo and Chugai Pharma and honoraria for lectures from Pfizer, Lilly, and Eisai outside the submitted work. Dr Ishikawa reported receiving honoraria for lectures from AstraZeneca, Chugai Pharma, Daiichi Sankyo, Eisai, Kyowa Kirin, Lilly, MSD, and Pfizer and grants from Chugai Pharma, Lilly, and Nihonkayaku outside the submitted work. Dr Iwamoto reported receiving honoraria for lectures from Daiichi Sankyo during the conduct of the study and reported receiving honoraria for lectures from Kyowa Kirin, Chugai, Takeda, and MSD and honoraria for advising from Hitachi High-Tech outside the submitted work. Dr Takiguchi reported being an employee of Daiichi Sankyo. Dr Mukai reported receiving honoraria for lectures from Takeda and Taiho outside the submitted work. Dr N. Taira reported receiving honoraria for lectures from Daiichi Sankyo and grants for research from Daiichi Sankyo and AstraZeneca during the conduct of the study and reported receiving honoraria for lectures from Pfizer, Eisai, Chugai Pharma, Kirin Pharmaceuticals, MSD, Eli Lilly, Boehringer Ingelheim, Takeda, and AstraZeneca and grants for research from Chugai Pharma, Kirin Pharmaceuticals, Taiho Pharmaceutical, Lilly, and Eisai outside the submitted work. Prof Sangai reported receiving honoraria for lectures from Daiichi Sankyo during the conduct of the study and reported receiving honoraria for lectures from Daiichi Sankyo, Chugai Pharma, Eisai, Kaken, Kyowa Hakko Kirin, Maruho, Miyarisan Pharmaceutical, MSD, Nihonkayaku, Novartis, PDRadiopharma, Pfizer, and Taiho Pharmaceutical and grants from Chugai Pharma, Eisai, Kyowa Hakko Kirin, and Taiho Pharmaceutical outside the submitted work. No other conflicts were disclosed.

Figures

Figure 1.
Figure 1.. Patient Flow Diagram
EORTC QLQ-C30 indicates European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; m-ITT, modified intention-to-treat; QOL, quality of life; T-DXd, trastuzumab deruxtecan. aThe number of patients assessed for eligibility was not available.
Figure 2.
Figure 2.. Change in Global Quality of Life From Baseline
Measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores (ranging from 0 to 100, in which higher scores indicate a better quality of life and level of functioning) indicate worsened (<0) and improved (>0) changes in quality of life between the monitoring and usual care groups.
Figure 3.
Figure 3.. Estimated Baseline-Adjusted Scores and Differences Between Groups for Survey Points in Functional and Symptom Scales, Measured Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
EORTC QLQ-C30 scores range from 0 to 100, where higher scores indicate better quality of life and level of functioning for functional scales but worse symptom burden for symptom scales. A mixed-effects model for repeated measures was used. LS indicates least-squares.
Figure 4.
Figure 4.. Kaplan-Meier Analyses of Survival
NE indicates not evaluable; NR, not reached; OS, overall survival; PFS, progression-free survival; TTF, time-to-treatment failure.
See this image and copyright information in PMC

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