ABSTRACT
A combination regimen consisting of cisplatin, bleomycin, and vinblastine was evaluated in 86 patients with metastatic testicular tumors. Prior therapy included surgical resection of primary tumor (84 patients), radiotheapy (21 patients), chemotherapy (33 patients). Thirteen patients received prior bleomycin and vincristine or vinblastine. Of 80 evaluable patients 51 achieved complete response (CR) and 26 achieved partial response (PR), for an overall response rate 96.5%. There was no significant difference in response rates or survival with respect to prior therapy, sites of metastatic lesions, and tumor histology. The median survival time was not reached in an observation period of 44+ months. Sixty patients were alive 11+--44+ months, and 57 of these were free of disease. Thirty-two of the 60 patients (53%) had a survival time greater than 20 months. Toxicities included nephrotoxicity (18 patients) leukopenia, (69 patients), thrombocytopenia (nine patients), and anemia (56 patients). Bleomycin-induced pulmonary toxicity was fatal in one patient. Other toxicities included nausea and vomiting, stomatitis, fever, alopecia, and neurological effects.
Subject(s)
Antineoplastic Agents/administration & dosage , Teratoma/drug therapy , Testicular Neoplasms/drug therapy , Adolescent , Adult , Anemia/chemically induced , Antineoplastic Agents/adverse effects , Bleomycin/administration & dosage , Cisplatin/administration & dosage , Drug Administration Schedule , Drug Evaluation , Drug Therapy, Combination , Dysgerminoma/drug therapy , Humans , Kidney/drug effects , Leukopenia/chemically induced , Lung/drug effects , Male , Middle Aged , Neoplasm Metastasis , Prognosis , Testicular Neoplasms/mortality , Thrombocytopenia/chemically induced , Vinblastine/administration & dosageABSTRACT
An oral butorphanol/acetaminophen (4 mg/650 mg) combination product was evaluated for analgesic activity in 120 postoperative patients employing a double-blind experimental design. The combination product was significantly (p less than 0.05) superior to either butorphanol (4 mg) or acetaminophen (650 mg) as well as placebo. Except for acetaminophen which was only significantly different (p less than 0.05) from placebo at 2 hours according to pain relief, all other treatments were superior to placebo over the entire 4 hour observation period. The data demonstrate that butorphanol and acetaminophen have at least additive analgesic activity with a suggestion of synergism. A single tablet dose of the combination product (butorphanol 2 mg/acetaminophen 325 mg) was evaluated in a second study involving 60 patients and was significantly (p less than 0.05) superior to placebo. Both studies demonstrate that the butorphanol/acetaminophen combination product has potent analgesic activity with a minimal side effect profile.
