ABSTRACT
A randomized trial was conducted by the Southwest Oncology Group (SWOG) in advanced carcinoma of the stomach and pancreas. Patients were assigned to receive monthly 5-fluorouracil 96-hour continuous infusions with either bolus mitomycin-C or oral methyl-CCNU. Mitomycin-C and methyl-CCNU were administered every eight weeks. The 5 FU-mitomycin combination produced a 14% and 22% response rate in disseminated stomach and pancreatic carcinoma, respectively. The combination of infusion 5 FU and methyl-CCNU achieved responses in 9% and 5% of stomach and pancreatic tumors, respectively. There was no significant difference in survival between limbs for either tumor. Median survival in gastric carcinoma on the 5 FU-mitomycin regimen was 25 weeks vs. 18 weeks on the 5 FU-METHYL-CCNU arm. In pancreatic carcinoma median survival on the mitomycin limb was 19 weeks as compared to 17 weeks on the methyl-CCNU program. Leukopenia was greater for the first course on the mitomycin limb. Regression analysis demonstrated that performance status was the most important pretreatment characteristic for predicting survival in both tumors. Neither 5 FU infusion combination appears to significantly alter the dismal prognosis of advanced upper gastrointestinal neoplasms.
Subject(s)
Fluorouracil/administration & dosage , Mitomycins/administration & dosage , Nitrosourea Compounds/administration & dosage , Pancreatic Neoplasms/drug therapy , Semustine/administration & dosage , Stomach Neoplasms/drug therapy , Antineoplastic Agents/adverse effects , Bone Marrow/drug effects , Clinical Trials as Topic , Drug Therapy, Combination , Female , Humans , Infusions, Parenteral , Male , Remission, Spontaneous , Time FactorsABSTRACT
101 patients with acute leukemia in relapse were treated with 5-azacytidine according to three schedules: Regimen A--300 mg/m2(day divided intravenously at 8 hour intervals for 5 days; Regimen B--750 mg/m2 as a single iv pulse dose administered at 2 to 3 weeks intervals; and Regimen C--300 mg/m2/day by continuous infusion daily for 5 days. Twelve patients achieved a complete remission (CR) and six achieved a partial remission (PR) for an overall 18% response rate. Of 78 patients receiving an adequate trial the response rate was 23%. An average of 1.5 courses and a median of 5 weeks were necessary to achieve a response. The median duration of CR patients was 21 weeks and for PR patients it was 5 weeks. Response rates were 24% for Regimen A, 0 for Regimen B, and 1 of 8 for Regimen C. The CR rate for AML and AMML was 13%. Two of eight AMoL patients achieved a CR. Only 2 of 23 ALL patients responded, one of whom achieved a CR. Toxicity included moderate to severe nausea and vomiting, diarrhea, stomatitis, skin rash, and prolonged myelosuppression. 5-azacytidine has significant activity in the acute nonlymphoblastic leukemias.
Subject(s)
Azacitidine/therapeutic use , Leukemia/drug therapy , Acute Disease , Adult , Azacitidine/administration & dosage , Azacitidine/adverse effects , Bone Marrow/drug effects , Central Nervous System/drug effects , Female , Humans , Leukemia, Lymphoid/drug therapy , Leukemia, Myeloid, Acute/drug therapy , Male , Remission, Spontaneous , Time FactorsABSTRACT
Twenty-nine patients with metastatic malignant melanoma were treated with cyclocytidine, 240 mg/m2/day sc for 10 days. All partients had received extensive prior chemotherapy. Only one patient achieved a partial remission; the overall response rate (complete plus partial) was 4%. Unusual toxic effects associated with cyclocytidine chemotherapy included the delayed onset of thrombocytopenia, orthostatic hypotension, and jaw pain.
Subject(s)
Ancitabine/therapeutic use , Cytarabine/analogs & derivatives , Melanoma/drug therapy , Ancitabine/adverse effects , Clinical Trials as Topic , Humans , Neoplasm MetastasisABSTRACT
Of 41 adults with a diagnosis of acute leukemia that were randomized for induction therapy in combination with methotrexate, 6-MP, vincristine and prednisone (POMP) versus a combination of cytosine arabinoside, cytoxan, vincristine and prednisone (COAP), 23 (56%) patients achieved a complete remission. During remission, patients received consolidation therapy with the three courses of remission induction regimen that they had not received initially. They then received daunomycin (three courses) and L-asparaginase and were then maintained for two years with their induction therapy. The median duration of survival for all patients was 40 weeks; the median duration of survival of those patients that responded to chemotherapy was 80 weeks. There was no significant difference between the two induction regimens with regard to complete remission more than four and one half years from diagnosis and two and one half years from discontinuation of all therapy.
Subject(s)
Antineoplastic Agents/administration & dosage , Leukemia/drug therapy , Acute Disease , Adolescent , Adult , Aged , Antineoplastic Agents/therapeutic use , Child , Child, Preschool , Cyclophosphamide/administration & dosage , Cytarabine/administration & dosage , Drug Administration Schedule , Female , Humans , Infant , Infant, Newborn , Male , Mercaptopurine/administration & dosage , Methotrexate/administration & dosage , Middle Aged , Prednisone/administration & dosage , Remission, Spontaneous , Vincristine/administration & dosageABSTRACT
Beta-thioguanine deoxyriboside (betaTGdR) is a purine nucleoside derivative which was studied alone or in combination with arabinosyl cytosine (Ara-C) in patients with solid tumors and acute leukemia. No significant responses were observed in 22 patients with solid tumors. The response rate with betaTGdR alone in acute leukemia was 26% and in combination with Ara-C was 24%. Responses were generally of short duration. Toxicity included myelosuppression, nausea, stomatitis, hyperpigmentation, photosensitivity, and liver function abnormalities.
