Combined cisplatin, doxorubicin, and mitomycin for the treatment of advanced pleural mesothelioma (original) (raw)
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Japanese Journal of Clinical Oncology, 2008
Background: Pemetrexed in combination with cisplatin (Pem/Cis) is used globally for the treatment of malignant pleural mesothelioma (MPM). This Phase I/II study was conducted to determine the recommended dose (RD) (Phase I) of Pem/Cis, and evaluate the efficacy and safety (Phase II) in Japanese MPM patients. Methods: Key eligibility criteria were histologic diagnosis of MPM incurable by surgery, no prior chemotherapy, and a performance status 0-1. Under full vitamin supplementation, pemetrexed was intravenously administered on Day 1 of a 21-day cycle, followed by cisplatin. A cohort of six patients, starting from pemetrexed 500 mg/m 2 and cisplatin 75 mg/m 2 (Level 1), were studied in the dose-escalation Phase I (Step 1). The RD determined in Step 1 was carried forward into Phase II (Step 2). Planned number of patients treated with Pem/Cis was 18-38. Results: In Step 1, 13 patients were enrolled: seven in Level 1 and six in Level 21 (pemetrexed 500 mg/m 2 , cisplatin 60 mg/m 2 ). Two of six evaluable patients had dose-limiting toxicities (pneumonitis and neutropenia) in Level 1, establishing Level 1 as the RD. In Step 2, 12 patients were enrolled, for a total of 19 patients treated at the RD. Seven patients achieved a partial response among these patients, for a response rate of 36.8% (95% confidence interval: 16.3-61.6); overall survival was 7.3 months. One drug-related death occurred due to worsening of a pre-existing pneumonia. Common grade 3/4 toxicities were neutropenia and decreased-hemoglobin. Conclusion: The Pem/Cis combination provides promising activity and an acceptable safety profile for chemonaive Japanese MPM patients with the same recommend dosage and schedule used in rest of the world. Downloaded from *Not calculated. NA, not assessed. Level 1: pemetrexed 500 mg/m 2 þ cisplatin 75 mg/m 2 . Level 21: pemetrexed 500 mg/m 2 þ cisplatin 60 mg/m 2 . CI, confidence interval. Jpn J Clin Oncol 2008;38(5) 343 by guest on January 8, 2016 http://jjco.oxfordjournals.org/ Downloaded from Level 1: pemetrexed 500 mg/m 2 þ cisplatin 75 mg/m 2. M, months. QOL, quality of life.
Phase II Trial of Cisplatin and Vinorelbine as First-line Therapy in Malignant Pleural Mesothelioma
Research in Oncology
The aim of the current study is to focus on treatment response in patients with malignant pleural mesothelioma (mPm) treated with combination chemotherapy using cisplatin plus vinorelbine. Secondary endpoints included, toxicity, progression-free and overall survival. Patients and Methods: This prospective study included 26 patients with histologically proven unresectable mPm treated at Kasr El-Aini Center of Clinical Oncology and Nuclear medicine (NEmROCK) from march 2003 to August 2004. Patients were assigned to receive cisplatin 75mg/m 2 on day one and vinorelbine 25mg/m 2 on days one and 8 every three weeks. Results: All 26 patients had measurable disease and were assessed for response. Six patients had partial response (23%), 14 patients had stable disease (54%), and six patients had disease progression on therapy (23%). Toxicity was acceptable and no treatment-related deaths occurred. The median progression-free survival was 5.15 months and the median overall survival for was 10.3 months, with a 42.3% one-year survival. Conclusion: Cisplatin-vinorelbine combination is an effectve regimen for management of malignant pleural mesothelioma with a tolerable toxicity profile. Further studies with a larger number of patients is necessary.
Cancer, 1991
Twenty-six symptomatic patients with diffuse malignant pleural mesothelioma (DMPM) were enrolled in a Phase I1 Italian Lung Cancer Task Force (FONICAP) study to assess the activity and toxicity of doxorubicin and cisplatin combination chemotherapy. The drug schedule was as follows: 60 mg/mz of doxorubicin and 60 mg/mz of cisplatin both given intravenously (IV) on day 1 every 3 to 4 weeks. Of the 24 evaluable patients, 6 objective partial responses (25%; 95% confidence limits, 9.77% to 46.71%) were observed. Twelve of 24 patients (Soyo), including 6 with no radiologic evidence of response, had a clinical improvement as demonstrated by an objective reduction of symptom or performance status scores along treatment. The overall median survival time was 10 months. Toxicity was mild and dose reductions or suspensions were not required. The combination of doxorubicin and cisplatin is effective and well tolerated. It might be considered for palliation of symptomatic patients with DMPM. Cancer 672984-2987,1991.
Chemotherapy for malignant pleural mesothelioma: past results and recent developments
Lung Cancer, 2004
This review summarises the results of previously conducted clinical trials, and subsequently presents data arising from all phase II-III studies on chemotherapy of malignant pleural mesothelioma (MPM) published since the last relevant overview. While response rates exceeding 30% have barely been achieved with established cytotoxic drugs in MPM therapy, novel chemotherapeutic agents and their combinations appear more promising. This applies especially to the antimetabolites, and in particular to pemetrexed that produced response rates of up to 45% in combination with platinum compounds. Raltitrexed combined with oxaliplatin has also been shown to be effective, and gemcitabine-applied as a single agent or in combination with cisplatin-as well as vinorelbine appear to improve the quality of life in patients presenting with MPM. Data can now be more precisely analysed by increasingly implemented randomised studies, applying a standardised staging system, and distinguishing prognostic groups. While chemotherapy for MPM remains a challenging task, important steps have clearly been made in the past years to combat this aggressive disease. The publication of pemetrexed with cisplatin phase III results in a peer-reviewed journal may soon establish a standard of care.