Phase II Trial of Pralatrexate (10-Propargyl-10-deazaaminopterin, PDX) in Patients with Unresectable Malignant Pleural Mesothelioma
Autor: | Lee M. Krug, Francis M. Sirotnak, Ennapadam Venkatraman, Robert T. Heelan, Mark G. Kris |
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Rok vydání: | 2007 |
Předmět: |
Male
Mesothelioma Pulmonary and Respiratory Medicine 10-Propargyl-10-deazaaminopterin medicine.medical_specialty Pralatrexate Maximum Tolerated Dose Pleural Neoplasms Phases of clinical research Risk Assessment Gastroenterology Drug Administration Schedule chemistry.chemical_compound Internal medicine Confidence Intervals medicine Humans Terminally Ill Stomatitis PDX Aged Neoplasm Staging Probability Aged 80 and over Dose-Response Relationship Drug business.industry Antifolate Palliative Care Middle Aged Prognosis medicine.disease Survival Analysis Confidence interval Dihydrofolate reductase inhibitor Aminopterin Surgery Clinical trial chemistry Oncology Female business medicine.drug |
Zdroj: | Journal of Thoracic Oncology. 2(4):317-320 |
ISSN: | 1556-0864 |
DOI: | 10.1097/01.jto.0000263715.84567.5f |
Popis: | Background: Several previous clinical trials have shown that malignant pleural mesothelioma is responsive to antifolates. The dihydrofolate reductase inhibitor, pralatrexate, has a favorable toxicity profile, primarily limited to stomatitis, and has demonstrated activity in patients with non-small cell lung cancer. In mesothelioma cell lines and xenografts, pralatrexate demonstrated significant antitumor activity. Methods: We conducted this phase II study to determine the response rate of malignant pleural mesothelioma to pralatrexate at a dose of 135 mg/m 2 IV every 2 weeks. After a protocol amendment, patients were supplemented with vitamin B 12 and folic acid at the time of starting therapy. Results: A total of 16 assessable patients were enrolled. No complete or partial responses were observed. Two patients with epithelioid histology had minor responses. Three other patients remained on study with stable disease for 9, 9, and 48 months. The median time to progression was 3 months. The overall median survival time was 7 months (95% confidence interval: 3.2–16.2 months) and the one-year survival was 31% (95% confidence interval: 15%–65%). Three patients (19%) had grade 2 stomatitis, eight (50%) had grade 3, and one (6%) had grade 4. Conclusions: With this particular dose and schedule, pralatrexate as a single agent had no activity in malignant pleural mesothelioma. |
Databáze: | OpenAIRE |
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