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

Our plain-English summary of Amrubicin in previously treated patients with malignant pleural mesothelioma: A phase II study, by T. Ikeda, S. Takemoto, H. Senju, et al (Thoracic Cancer, 2020).

The study

• Authors: T. Ikeda, S. Takemoto, H. Senju, H. Gyotoku, H. Taniguchi, M. Shimada, Y. Dotsu, Y. Umeyama, H. Tomono, T. Kitazaki, M. Fukuda, H. Soda, H. Yamaguchi, M. Fukuda, H. Mukae
• Journal: Thoracic Cancer
• Published: 2020;11(7):1972-1978
• Cited by: 6 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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.

In plain English

This phase II trial tested the chemotherapy drug amrubicin in people with previously treated malignant pleural mesothelioma that could not be removed by surgery. The authors planned to enroll 32 patients. Enrollment was slow, so the trial stopped after enrolling 10 patients (nine men, one woman) at three institutions between December 2009 and January 2017. Nine of the 10 were recorded as having asbestos exposure. Each cycle was 35 mg/m2 of amrubicin given by vein on days 1, 2 and 3. One patient's tumor shrank (a partial response) and four had stable disease. The response rate was 10.0% (95% confidence interval 0.3 to 44.5%), and the main results section gives a disease control rate of 50.0% (95% confidence interval 18.7 to 81.3%). Median progression-free time was 1.6 months; median overall survival was 6.6 months. Seven patients had grade 3 or 4 blood-related side effects, most often neutropenia (six patients). There were no treatment-related deaths. The authors concluded that early termination left too little data to judge efficacy, but that amrubicin showed limited activity and acceptable toxicity.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Phase II, single-arm, multi-institution clinical trial (unsponsored group study), stopped early because enrollment was slow
• Who was studied: 10 patients with previously treated, unresectable malignant pleural mesothelioma, enrolled at three institutions between December 2009 and January 2017 (planned number 32). There were 9 men and 1 woman, median age 67 (range 49 to 73). Four had epithelioid tumors, three sarcomatoid and three biphasic.
• Exposure: Treatment with amrubicin, 35 mg/m2 by intravenous injection on days 1, 2 and 3 of each cycle, repeated until disease progression or unacceptable side effects. Asbestos exposure was recorded as yes for 9 of the 10 patients (Table 1).
• Main results:
  • Table 1 lists asbestos exposure as yes for 9 patients and no for 1 patient, out of 10.
  • One of 10 patients had a partial response (tumor shrinkage) and four had stable disease. Five had progressive disease, and there were no complete responses.
  • Among the 10 patients, the overall response rate was 10.0% (95% CI: 0.3 to 44.5%).
  • The results section gives a disease control rate of 50.0% (95% CI: 18.7 to 81.3%). The abstract gives 60% (95% CI: 26.2 to 87.8%).
  • Median progression-free survival among the 10 patients was 1.6 months.
  • Median overall survival was 6.6 months. One-, two- and three-year survival rates were 23%, 23% and 0%.
  • Seven of 10 patients (70%) had grade 3 or 4 blood-related (hematological) side effects. The most common was neutropenia, in 6 patients (60%).
  • One patient (10%) had grade 3 pneumonitis. There were no treatment-related deaths.
• The authors' conclusion: The authors concluded that, because the study was stopped early, there was not enough data to evaluate efficacy, but that single-agent amrubicin showed limited activity and an acceptable toxicity profile in previously treated malignant pleural mesothelioma.
• Limitations the authors state:
  • Enrollment was slow and the trial was stopped with 10 of the planned 32 patients.
  • Because of the early stop, the authors state there was not enough data to evaluate efficacy.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Mesothelioma.

Medical terms in this study, explained in our Lexicon: Pleural Mesothelioma, Unresectable, Performance Status, Epithelioid, Sarcomatoid, Biphasic Mesothelioma, Mesothelioma, IMIG.

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• Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial — L. Calabrò, A. Morra, et al. (2013)
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