Amrubicin in previously treated patients with malignant pleural mesothelioma: A phase II study Journal Article

Authors: Ikeda, T.; Takemoto, S.; Senju, H.; Gyotoku, H.; Taniguchi, H.; Shimada, M.; Dotsu, Y.; Umeyama, Y.; Tomono, H.; Kitazaki, T.; Fukuda, M.; Soda, H.; Yamaguchi, H.; Fukuda, M.; Mukae, H.
Article Title: Amrubicin in previously treated patients with malignant pleural mesothelioma: A phase II study
Abstract: Background: The aim of this study was to assess the efficacy and safety of amrubicin for previously treated malignant pleural mesothelioma. Methods: The eligibility criteria were: previously treated unresectable malignant pleural mesothelioma; performance status 0–1; age ≤ 75; adequate hematological, hepatic, and renal function. The patients were injected with 35 mg/m2 amrubicin on days one, two, and three every 3–4 weeks. The planned number of patients was 32. Results: The study was terminated due to delay in enrollment and 10 patients were subsequently enrolled (nine males and one female; median age 67 [range 49–73]), of which four had epithelioid tumors, three had sarcomatoid tumors and three had biphasic tumors, respectively. According to the International Mesothelioma Interest Group (IMIG), one, four, and four patients had stage II, III, and IV, respectively, and one had postoperative recurrence. There was one (10%) partial response, four (40%) had stable disease, and five (50%) patients exhibited disease progression. The overall response and disease control rates were 10% (95% CI: 0.3–44.5%) and 60% (95% CI: 26.2–87.8%), respectively. The median progression-free survival time was 1.6 months. The median overall survival time was 6.6 months, and the one-, two-, and three-year survival rates were 23%, 23%, and 0%, respectively. The observed grade 3 or 4 toxicities included neutropenia in six (60%) patients; leukopenia in five (50%) patients; and febrile neutropenia, thrombocytopenia, anemia, and pneumonia in one (10%) patient each. Conclusions: There was not enough data to evaluate the efficacy because the study was terminated early. However, amrubicin showed limited activity and. acceptable toxicities when used in previously treated malignant pleural mesothelioma patients. © 2020 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd
Keywords: adult; clinical article; controlled study; treatment response; aged; middle aged; survival rate; overall survival; disease course; fatigue; neutropenia; cancer recurrence; postoperative period; drug efficacy; drug safety; liver function; chemotherapy; cancer staging; anorexia; progression free survival; multiple cycle treatment; phase 2 clinical trial; anemia; leukopenia; nausea; thrombocytopenia; vomiting; dizziness; febrile neutropenia; pneumonia; kidney function; pleura mesothelioma; mesothelioma; sarcomatoid carcinoma; cancer control; lung infection; epithelium tumor; amrubicin; human; male; female; priority journal; article; loss of appetite
Journal Title: Thoracic Cancer
Volume: 11
Issue: 7
ISSN: 1759-7706
Publisher: Wiley-Blackwell Publishing Asia  
Date Published: 2020-07-01
Start Page: 1972
End Page: 1978
Language: English
DOI: 10.1111/1759-7714.13490
PUBMED: 32462731
PROVIDER: scopus
PMCID: PMC7327919
Notes: Article -- Export Date: 3 August 2020 -- Source: Scopus
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