Combined epirubicin and interleukin-2 regimen in the treatment of malignant mesothelioma: a multicenter phase II study of the Italian Group on Rare Tumors

Our plain-English summary of Combined epirubicin and interleukin-2 regimen in the treatment of malignant mesothelioma: a multicenter phase II study of the Italian Group on Rare Tumors, by S. Bretti, A. Berruti, L. Dogliotti, et al (Tumori, 1998).

The study

• Authors: S. Bretti, A. Berruti, L. Dogliotti, B. Castagneto, R. Bertulli, P. Spadaro, G. Toscano, P. Astorre, C. Verusio, R. Lionetto, P. Bruzzi, A. Santoro
• Journal: Tumori
• Published: 1998;84(5):558-61
• Cited by: 14 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

The Italian Group on Rare Tumors undertook a phase II study of a combination of epirubicin and interleukin-2 in 21 chemotherapy-naive patients with malignant mesothelioma. All patients had bidimensionally measurable disease at CT scan. Treatment included Intravenous administration of epirubicin at a dose of 110 mg/m2 i.v. on day 1, and interleukin-2 at a dose of 9 MU subcutaneously from day 8 to day 12 and from day 15 to day 19. Cycles were repeated every three weeks, up to six times in the absence of progressive disease. Treatment response was evaluated after two cycles of therapy. Only one patient achieved a partial response, resulting in an overall response rate of 5% (1/21) with a median progression-free and overall survival of 5 and 10 months, respectively. Toxicity was relevant and caused treatment discontinuation in many patients. These results do not support the use of such a combination in the management of malignant mesothelioma.

In plain English

The Italian Group on Rare Tumors ran a multicenter phase II trial of a drug combination for malignant mesothelioma. Between May 1994 and March 1996, 21 patients (17 men and 4 women) who had not had chemotherapy before were enrolled at seven Italian institutions. They received epirubicin (110 mg/m2 into a vein on day 1) and interleukin-2 (9 MU injected under the skin on days 8 to 12 and 15 to 19), with cycles every three weeks. Patients received a median of 4 cycles. One of the 21 patients had a partial remission, a response rate of 5% (95% confidence interval 0 to 26%), and 7 had stable disease. Because of this low response rate, enrollment was stopped as the study design required. Median overall survival was 10 months and median progression-free survival was 5 months. Among assessable patients, 20% had grade 3 fever and 10% had grade 3 asthenia (weakness). One patient died of respiratory failure after the first cycle, and treatment was interrupted in 13 patients. The authors concluded that further testing of this combination is not warranted.

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: multicenter phase II clinical trial (single treatment arm, two-stage design)
• Who was studied: 21 chemotherapy-naive patients with malignant mesothelioma (17 males, 4 females) from seven Italian institutions, enrolled May 1994 to March 1996
• Exposure: Treatment, not asbestos exposure: epirubicin 110 mg/m2 intravenously on day 1 plus interleukin-2 9 MU subcutaneously on days 8 to 12 and 15 to 19, with cycles repeated every three weeks
• Main results:
  • Patients received a median of 4 cycles (range 1 to 6), 82 cycles in total
  • Of all 21 patients enrolled, one had a partial remission (5% response rate)
  • 95% confidence interval for the response rate was 0 to 26%; 7 patients had stable disease
  • Because of the low response rate, enrollment was stopped as the study design required
  • Median overall survival was 10 months and median progression-free survival was 5 months
  • At the time of the report, one patient was still alive without evidence of disease progression after more than two years
  • Of the 20 patients assessable for toxicity, 10% had grade 3 asthenia and 20% had grade 3 fever
  • One patient was not assessable for toxicity because the patient died of respiratory failure after the first cycle
  • One patient developed septic peritonitis
  • Treatment was interrupted in 13 of the 21 patients for medical reasons, including progressive disease during therapy (3 patients) and death (2 patients)
  • The authors described the toxicity as relevant, although reversible and manageable, and a frequent cause of stopping treatment
• The authors' conclusion: The authors concluded that the potential role of combining anthracyclines and interleukin-2 was not confirmed and that further testing of this combination is not warranted

Topics

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

Medical terms in this study, explained in our Lexicon: Mesothelioma, Chemotherapy, CT Scan, Overall Survival.

Related studies

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• Treatment of malignant mesothelioma with epirubicin and ifosfamide: a phase II cooperative study — M.D. Magri, S. Foladore, et al. (1992)
• Epirubicin in malignant mesothelioma: a phase II study of the European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group — K. Mattson, G. Giaccone, et al. (1992)
• A phase II study of combined intravenous and subcutaneous interleukin-2 in malignant pleural mesothelioma — C.W. Mulatero, R.T. Penson, et al. (2001)
• Mesothelioma in children and adolescents: the European Cooperative Study Group for Pediatric Rare Tumors (EXPeRT) contribution — D. Orbach, N. André, et al. (2020)
• Combination chemotherapy with mitoxantrone, methotrexate, and mitomycin (MMM regimen) in malignant pleural mesothelioma: a phase II study — C. Pinto, A. Marino, et al. (2001)

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