Sequential chemotherapy with cisplatin/gemcitabine (CG) followed by mitoxantrone/methotrexate/mitomycin (MMM) in patients with malignant pleural mesothelioma. A multicenter Italian Phase II Study (SITMP1)

Carmine Pinto, Antonella Marino, Vincenzo De Pangher Manzini, Giovanni Benedetti, Domenico Galetta, Paola Mazzanti, Guido Del Conte, Davide dell'Amore, Edera Piana, Stefania Giaquinta, Massimo Lopez, Andrea Martoni

Research output: Contribution to journalArticle

Abstract

Purpose: We performed a multicenter phase II trial to evaluate the impact on the activity, efficacy, symptom control and safety of using two active regimens in a sequential schedule (cisplatin/gemcitabine followed by mitoxantrone/methotrexate/mitomycin) as first-line chemotherapy for unresectable malignant pleural mesothelioma (MPM). Patients and methods: A total of 54 patients received cisplatin 75 mg/m2 on day 1 and gemcitabine 1200 mg/m2 on days 1 and 8, every 3 weeks for four courses (CG regimen) followed by mitoxantrone 10 mg/m2 on day 1, methotrexate 35 mg/m2 on day 1 and mitomycin 7 mg/m2 on day 1, every 3 weeks with mitomycin in alternate cycles for four courses (MMM regimen). Results: We observed 3 complete responses (CRs) (5.6%) and 13 partial responses (PRs) (24.0%), with an overall response rate (ORR) of 29.6% (95% confidence interval, 17-42%), 33 stable disease (SD) (61.1%) and 5 progressive disease (PD) (9.2%). Median time to progression (TTP) was 9.5 months (range, 2-23). Median overall survival (OS) was 13 months (range, 3-33); 1-year survival rate was 63%. The treatment produced a good symptom control, with an improvement during chemotherapy in dyspnea and pain in 52.9 and 48.3% of patients, respectively. The major toxicity observed was hematological. Grades 3-4 NCI-CTC v 2.0 toxicity with the CG regimen included: neutropenia (11.1%), anemia (1.9%), thrombocytopenia (7.4%), vomiting (11.1%) and with the MMM regimen: neutropenia (35.2%), anemia (5.5%), thrombocytopenia (7.4%) and stomatitis (1.9%). Conclusion: This phase II study with the sequential approach of two active regimens showed a good disease control in MPM, with symptom improvement and only mild toxicity.

Original languageEnglish
Pages (from-to)199-206
Number of pages8
JournalLung Cancer
Volume52
Issue number2
DOIs
Publication statusPublished - May 2006

Keywords

  • Cisplatin/gemcitabine
  • Mitoxantrone/methotrexate/mitomycin
  • Phase II study

ASJC Scopus subject areas

  • Oncology

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