Mitoguazone therapy in patients with refractory or relapsed AIDS-related lymphoma: results from a multicenter phase II trial
| Autor: | B D Luskey, Byron M. Espina, F Giles, D. Tessman, Anil Tulpule, D. H. Von Hoff, Lee M. Kaplan, David T. Scadden, I Silverberg, J Wernz, Alexandra M. Levine, D W Northfelt |
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| Rok vydání: | 1997 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Mitoguazone Neutropenia medicine.medical_treatment Antineoplastic Agents Gastroenterology AIDS-related lymphoma Drug Administration Schedule Extranodal Disease Refractory Recurrence Internal medicine Immunopathology Antineoplastic Combined Chemotherapy Protocols Medicine Humans Sida Infusions Intravenous Aged Lymphoma AIDS-Related Chemotherapy biology business.industry Remission Induction Middle Aged medicine.disease biology.organism_classification Survival Analysis Thrombocytopenia Surgery Lymphoma Oncology Drug Resistance Neoplasm Female business |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 15(3) |
| ISSN: | 0732-183X |
| Popis: | PURPOSE Patients with AIDS-related lymphoma usually have extensive lymphomatous disease, with relatively frequent involvement of the CNS. Approximately half may achieve complete remission after chemotherapy. Mitoguazone, an inhibitor of polyamine biosynthesis, has demonstrated efficacy in patients with de novo recurrent lymphoma. The drug is relatively nonmyelotoxic and may cross the blood-brain barrier. The current study was designed to assess the safety and potential efficacy of mitoguazone in patients with relapsed or refractory AIDS-lymphoma. PATIENTS AND METHODS Thirty-five patients were accrued, all of whom had failed one (51%) or multiple (two to six) prior regimens. Mitoguazone (600 mg/m2) was given intravenously on days 1 and 8, and then every 2 weeks, until best response, progression, or toxicity. RESULTS The median age was 39 years. High-grade lymphoma was diagnosed in 29 patients (83%). Extranodal disease was present in 30 patients (86%), with multiple extranodal sites (two to seven) in 18 (51%). The median CD4 cell count at study entry was 66/dL (range, zero to 549). Twenty-six patients were assessable for response. The objective response rate was 23% (95% confidence interval [CI], 6.9 to 39.3), with complete remission in three patients (11.5%), and partial remission (PR) in three patients (11.5%). Six patients experienced stable disease. Median survival from study entry was 2.6 months for the group as a whole; 21.5 months (range, 3.8 to 29.1) in complete responders, 5.6 months (range, 3.8 to 34.8) in partial responders. The most common toxicities occurred solely during drug infusion and included vasodilation (63%), paresthesia (86%), and somnolence (17%). Fourteen patients (40%) experienced nausea and 16 (46%) vomiting (grade 3 in one). Ten patients (29%) developed stomatitis, including grade 3 in two and grade 4 in one. Seven patients (20%) developed neutropenia, with grade 4 in one. Thrombocytopenia occurred in nine patients (26%). While on study, three patients developed sepsis, four had pneumonia, and two developed opportunistic infections. CONCLUSION Mitoguazone is an effective agent in patients with multiply relapsed or refractory AIDS-related lymphoma, with acceptable toxicity. Further study in patients with newly diagnosed disease is warranted. |
| Databáze: | OpenAIRE |
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