Kaoru Kubota

Background: Diuretics are commonly used to reduce renal dysfunction during cisplatin-based chemotherapy; however, reports suggest that renal function is unaffected when diuretics are not administered. This phase II trial evaluated the effectiveness and safety of a short hydration method without diuretics. Methods: Patients were included if they were aged 20-74 years, had a thoracic malignancy for which a cisplatin-based regimen (dose: ≥60 mg/m2) was indicated, and had adequate renal function. All patients received cisplatin-based chemotherapy using a short hydration method without diuretics. The primary endpoint was the proportion of patients without grade 2 or higher elevations in creatinine levels during the first cycle of cisplatin. Results: Forty-six patients were enrolled between June 2019 and April 2022. The patients included 38 men and 8 women with a median age of 64 years (range: 45-74 years). Of these, 13 patients received adjuvant chemotherapy, 19 received chemoradiotherapy, 1 received chemotherapy for post-surgical recurrence, and 13 received chemotherapy for advanced disease. The median number of chemotherapy cycles was 3 (range: 1-4). A total of 93.5% (43/46) of the patients completed cisplatin-based chemotherapy without grade 2 or higher creatinine elevation during the first cycle, and 84.8% (39/46) of participants, including those who discontinued treatment, did not show grade 2 or higher creatinine elevation after all cycles of cisplatin-based chemotherapy. Conclusions: Short hydration without diuretics is safe for patients receiving cisplatin-containing chemotherapy. Randomized trials with or without diuretics in this setting are warranted.

Electronic patient-reported outcome (ePRO) monitoring for patients undergoing cancer chemotherapy may provide qualified and early detection of adverse events or disease-related symptoms, leading to improved patient care. The aim of this study is to examine whether addition of ePRO monitoring to routine medical care contributes to improved overall survival and quality of life of cancer patients undergoing chemotherapy. Patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic chemotherapy will be randomized to an ePRO monitoring group and a usual care group. The ePRO group will conduct weekly symptom monitoring using an electronic device after study enrollment until the end of the study. Monitoring results will be returned to medical personnel and used as information for patient care. The primary endpoints are overall survival and health related quality of life. The initial target sample size for the study was 1500 patients. However, due to delays in enrollment, the target was readjusted to 500 patients. Enrollment has been completed, and the study is now in the follow-up phase.

Comparison of the background between this study and the PACIFIC study

Onset and grade of pneumonitis

Summary of the efficacy and safety between this study and the previous studies

Summary of the efficacy and safety between this study and the previous studies

Phase III clinical trials with a combination of immunotherapy and radiotherapy

Representativeness of Study Participants