Article
First- and Secondline chemotherapy with Pemetrexed alone or in combination with Carboplatin in malignant pleural mesothelioma
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Published: | March 20, 2006 |
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Background: Malignant pleural mesothelioma represents a highly aggressive tumor that has become considerably more prevalent in recent decades and is expected to increase further until the year 2020 due to the lag phase of 20-50 years after exposure to asbestos. Pemetrexed (Alimta®), a novel multitargeted antifolate, has demonstreted significant efficacy in randomized trials. We report the results of a non-randomized phase II trial of Pemetrexed with or without Carboplatin given as first or secondline treatment of malignant mesothelioma.
Patients and Methods: From february 2003 to december 2004, 87 patients with advanced non-resective malignant mesothelioma were included in the trial. Patients recieved as first or secondline therapy Pemetrexed 500mg/m² as a single-agent or Pemetrexed 500mg/m² in combination with Carboplatin AUC 5. Both regimens were given intravenously at day 1 every 21 days with vitamin supplementation. Toxicity, response rates and epidemiologic factors were evaluated.
Results: The majority of patients were male (n = 76), had a Karnofsky performance status of 80 or more (n = 74) and had a known (n = 68) oder possible (n = 6) asbest exposure. Median age was 63 years. 55 patients were chemotherapy-naive, 32 patients were previously treated.
Histologically 52 epithelial, 5 sarcomatous, 11 mixed and 13 other mesothelioma were found. 6 Patients had peritoneal mesothelioma.
Monotherapy was given to 45, combination therapy to 42 patients with a median of 6 cycles (range 1 to 12). Tumor control rate was 75%. Median survival time was 11.4 month (range 0.2 to 30.4 month), median time to progression 5 month.
Main toxic effects were skin reactions (n = 48), ophthalmologic toxicity (n = 39) and abdominal symptoms (n = 34) with moderate hematologic toxicity and hepatic toxicity (n = 24).
Conclusions: This non-randomized trial also showed effectiveness of pemetrexed as single agend and in combination with Carboplatin in the management of malignant mesothelioma as first- and secondline therapy.