ABSTRACT
BACKGROUND: Treatment of patients with metastatic melanoma with either dacarbazine or recombinant interleukin-2 (rIL-2) resulted in a response rate of approximately 15%. This study investigates the possible synergism of this chemoimmunotherapy combination. METHODS: Fifty-seven patients with metastatic malignant melanoma received 135 treatment cycles. Treatment consisted of dacarbazine (Days 1-5) at 250 mg/m2 by a 30-minute slow infusion, and interleukin-2 by constant intravenous infusion (Days 21-25 and 28-32) at 18 x 10(6) IU/m2/24 hours. After this treatment cycle, a 1-week rest was scheduled, and in the absence of undue toxicity or tumor progression, patients received a second cycle as described. Maximum treatment consisted of two induction and four maintenance cycles. In a subgroup of patients, immunoparameters were analyzed to identify prognostic factors. Standard supportive care was given. RESULTS: Common toxicities included fever, hypotension, nausea/vomiting, anemia, leukopenia, thrombocytopenia, an increase in serum lactic dehydrogenase levels and diarrhea. The objective response rate was 15.8% (one complete response and eight partial responses). In 14 patients, the disease stabilized. For patients who had an objective response, median response duration was 13.9 months (6.3-39.0+), and median survival was 19.0 months (6.3-39.0+); overall survival was 9.3 months (0.8-39.0+). Immunomonitoring did not reveal any relevant prognostic factors for overall response. CONCLUSIONS: Sequential treatment with dacarbazine and rIL-2 is feasible and produces long-lasting responses in a minority of patients.
Subject(s)
Dacarbazine/therapeutic use , Interleukin-2/administration & dosage , Melanoma/secondary , Melanoma/therapy , Skin Neoplasms/therapy , Adult , Aged , Combined Modality Therapy , Drug Administration Schedule , Female , Humans , Infusions, Intravenous , Interleukin-2/adverse effects , Male , Melanoma/mortality , Middle Aged , Prognosis , Regression Analysis , Remission Induction , Skin Neoplasms/mortality , Skin Neoplasms/pathology , Survival Analysis , Treatment OutcomeABSTRACT
Between March 1989 and June 1990, 133 patients were treated with interleukin 2 (rIL-2) for metastatic renal cell carcinoma (RCC) in a multicentre open non-randomised study. The results show an objective response rate of 14% (95% confidence interval 8-21) with 4 patients achieving a complete remission. This is in keeping with the data from previous studies using rIL-2 by continuous infusion. It is of interest that 87% of objective responses occurred in hospitals that entered 5 or more patients.
Subject(s)
Carcinoma, Renal Cell/drug therapy , Interleukin-2/administration & dosage , Kidney Neoplasms/drug therapy , Adult , Aged , Female , Humans , Infusions, Intravenous , Interleukin-2/adverse effects , Male , Middle Aged , Neoplasm Metastasis , Recombinant Proteins/administration & dosage , Remission InductionABSTRACT
In this study valtrate and isovaltrate, two isomeric valepotriates present in various Valeriana species, were separated on a preparative scale with a Waters preparative Liquid Chromatography/500 A system. A rapid separation was achieved with the solvent methylene chloride-n-propanol-acetone (99 + 0.5 + 0.5). Extensive use of the recycle mode of the instrument resulted in a considerable reduction of the amount of solvent used, without affecting the purity and the recovery (greater than 90%) of the separated components. With the method presented in this communication 1 gram of a mixture of valtrate and isovaltrate was separated in 20 minutes using 2.1 liters of solvent.