In a paper by Ziegler et al (Ann Intern Med 116: 821-828, 1992), total parenteral nutrition supplemented with L-glutamine (TPN/GLN) was reported beneficial in patients receiving bone marrow transplantation (BMT) for hematologic malignancies. By using a similar protocol, we studied 29 patients with both hematologic malignancies and solid tumors, and with both allogeneic and autologous BMTs. In a double-blind, randomized approach, patients were given isocaloric, isonitrogenous TPN after BMT until they consumed 50% of their required diet orally. Total body water and extracellular water were measured before and after TPN in 10 patients. Total body water increased in patients receiving standard TPN and decreased significantly in patients receiving TPN/GLN. Length of hospital stay after BMT was significantly (5.8 days) less in patients receiving TPN/GLN. Incidence of positive bacterial cultures, clinical infections, and mortality did not differ significantly between the two groups. When the groups were subdivided into patients with hematologic malignancies and those with solid tumors, there were no significant differences in the above variables associated with TPN/GLN. In 17 of 30 additional hospitalized patients receiving standard TPN, substitution of TPN/GLN did not have discernible clinical or laboratory effects but appeared to be safe. Inclusion of patients with solid tumors and a higher mortality in our patients may have obscured beneficial effects of TPN/GLN observed by others.
Previously untreated patients with multiple myeloma were entered on a randomized clinical trial to determine whether the use of alternating combination chemotherapy, including vincristine, doxorubicin, alkylating agents, and prednisone (160 patients) was more effective than conventional chemotherapy with melphalan and prednisone (77 patients), and whether the addition of the immunomodulating agent levamisole to maintenance chemotherapy enhanced the survival of patients achieving remission. The treatment groups were well matched for all major factors. The more aggressive chemotherapy was more effective at inducing remission, with a significantly higher proportion of patients achieving at least 75% tumor mass regression (53% with alternating combinations versus 32% with melphalan-prednisone, p = 0.002). Furthermore, the median survival was increased to 43 months with alternating combination chemotherapy as compared to 23 months with melphalan-prednisone (p = 0.004). After six to 12 months of induction therapy, 84 patients achieving remission were rerandomized to receive maintenance chemotherapy alone or with the addition of levamisole. The survival from the start of maintenance therapy was longer in patients receiving the added levamisole than with chemotherapy alone (p = 0.01). These findings support the use of aggressive multiagent chemotherapy for remission induction in patients with advanced-stage multiple myeloma.
One-hundred-fifty-four patients with acute leukemia and extensive prior chemotherapy were treated with 5-Azacytidine and evaluated according to five different schedules. One-hundred-twenty patients received adequate trials; 34 patients died within 14 days of onset of treatment. Nine patients achieved a complete remission (CR) and two achieved a partial remission. Although two of the treatments have a higher remission rate, the data were not statistically significant. The median time to CR was 48 days (range 21-173). The median duration of CR was 65 days (range 39-369). There was no difference in response rate according to cell type. The median age of responders was 31 years, and 39 years for nonresponders. Proportionately there were more women among responders (5M/6F) and more men (70M/39F) among nonresponders. At onset of therapy the median leukocyte counts were similar between responding (5.4 X 10(3)) and nonresponding (5.7 X 10(3)) patients, but the proportion of leukemic cells was significantly higher among nonresponding patients (46% vs. 7%). Toxicities included nausea, vomiting, diarrhea, skin rash, myalgias, prolonged myelosuppression, hypotension, and central nervous system stupor and/or coma. Lower dose continuous infusion schedules of five-, seven-, and ten-days duration appear effective and were associated with less toxicity.
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