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).

• 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/m(2) on day 1 and gemcitabine 1,200 mg/m(2) on days 1 and 8, every 3 weeks for four courses (CG regimen) followed by mitoxantrone 10 mg/m(2) on day 1, methotrexate 35 mg/m(2) on day 1 and mitomycin 7 mg/m(2) 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.
• Authors: 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 (Affiliation: Unit of Medical Oncology, S. Orsola-Malpighi Hospital, Via Albertoni 15, 40138 Bologna, Italy. cpinto at aosp.bo.it)
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 52 Issue 2 Pg. 199-206 (May 2006) ISSN: 0169-5002 [Print] Ireland
• PMID: 16542747 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• MMM protocol 2
• gemcitabine
• Cisplatin
• Mitomycin
• Methotrexate
• Mitoxantrone
• Deoxycytidine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Cisplatin (therapeutic use)
• Deoxycytidine (analogs & derivatives, therapeutic use)
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• Italy
• Male
• Mesothelioma (drug therapy, pathology)
• Methotrexate (therapeutic use)
• Middle Aged
• Mitomycin (therapeutic use)
• Mitoxantrone (therapeutic use)
• Neoplasm Staging
• Pleural Neoplasms (drug therapy, pathology)
• Retrospective Studies
• Treatment Outcome