Combined regimen of cisplatin, doxorubicin, and α-2b interferon in the treatment of advanced malignant pleural mesothelioma: A phase II multicenter trial of the Italian Group on Rare Tumors (GITR) and the Italian Lung Cancer Task Force (FONICAP)

Héctor Soto Parra, Lucia Tixi, Fiorenza Latteri, Sergio Bretti, Marco Alloisio, Adriano Gravina, Rita Lionetto, Paolo Bruzzi, Carla Dani, Riccardo Rosso, Maurizio Cosso, Luca Balzarini, Armando Santoro, Andrea Ardizzoni

Research output: Contribution to journalArticle

Abstract

BACKGROUND. The cisplatin-doxorubicin combination has shown moderate activity in malignant pleural mesothelioma (MPM; objective response, 25%), and preclinical studies suggest that interferons (IFNs) may have an antiproliferative effect on mesothelioma cell lines with a marked increase in cisplatin cytotoxicity. Therefore, the combined chemoimmunotherapy regimen is an worthwhile approach to evaluate in a Phase II trial. METHODS. From December 1995 to June 1999, 37 previously untreated patients with MPM were treated with cisplatin 60 mg/m2 intravenously on Day 1 plus doxorubicin 60 mg/m2, recycled every 3-4 weeks and IFN-α-2b, 3 × 106 international units subcutaneously 3 times a week for a total of 6 courses or until progression. Inclusion criteria were histologic diagnosis of MPM and measurable disease defined by computed tomography scan or magnetic resonance imaging. RESULTS. Thirty-four patients were assessable for toxicity and 35 for efficacy according to World Health Organization criteria. One hundred thirty-five courses were administered with a median of 4 cycles per patients. Seventy-six percent of patient presented at least 1 episode of severe myelosuppresion (Grade 3 and 4). Severe anemia and thrombocytopenia occurred in 30% and 24% of patients, respectively. Sixty percent of patients presented constitutional symptoms. In the 35 patients assessable for response, the overall response rate was 29% (95% confidence interval, 15-47%). The median duration of response was 8.4 months. With a median follow-up of 19.6 months, the median survival was 9.3 months. One- and 2-year survival was 45% and 34%, respectively. CONCLUSIONS. This combined regimen has definite activity in MPM. However, toxicity, particularly myelosuppression and fatigue, is not negligible and may limit its application.

Original languageEnglish
Pages (from-to)650-656
Number of pages7
JournalCancer
Volume92
Issue number3
DOIs
Publication statusPublished - Aug 1 2001

Keywords

  • Chemotherapy
  • Cisplatin
  • Combined modalities
  • Doxorubicin
  • Immunotherapy
  • Interferon
  • Malignant mesothelioma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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