Eighty-five adult patients under the age of 50 years with acute myeloid leukaemia (AML) were entered into a prospective controlled study conducted to compare the effectiveness of allogeneic or autologous bone marrow transplantation and intensive chemotherapy for patients in first complete remission. Sixty-one patients (72%) achieved complete remission then received a consolidation treatment. After consolidation, 58 patients who were still in remission were assigned to three different therapeutic modalities. Fifty-two patients were evaluable: 20 patients who had an HLA-identical sibling donor underwent allogeneic bone marrow transplantation within 3 months after achievement of complete remission; the other 32 patients were randomized to receive autologous bone marrow transplantation or intensive sequential chemotherapy. The actuarial risk of relapse at 3 years was 18% for the allogeneic patients, 50% for the autologous patients and 83% in the chemotherapy group. The difference was highly significant (P less than 0.0002). The disease-free survival was respectively 66% (95% confidence interval 41-85%), 41% (95% confidence interval 16-66%) and 16% (95% confidence interval 0-31%) (P less than 0.004). We conclude that allogeneic bone marrow transplantation is presently the best therapeutic approach for patients with AML in first complete remission.
Between 1 January 1980 and 31 July 1988, 62 patients with chronic lymphocytic leukaemia (CLL) or malignant non-Hodgkin's lymphoma (NHL) were splenectomized for splenomegaly and presumed hypersplenism. All patients except one had splenomegaly (mean (s.d.) weight 1585(872) g, range 150-4300 g) and 34 had massive splenomegaly (greater than 1500 g). Forty-nine patients had platelet counts less than 100 x 10(9)/l and 16 patients had anaemia with haemoglobin levels less than 10 g/dl. White cell counts were less than 3 x 10(9)/l in six NHL patients. Fifteen patients had bicytopenia, and three NHL patients had tricytopenia. The selected group of 62 patients underwent splenectomy largely because of failure to respond to medical therapy (39 patients) or inability to tolerate or start adequate chemotherapy because of very low blood counts (11 patients). There was one postoperative death, and a 29 per cent morbidity rate. The response rate was 89 per cent in the first month after splenectomy and 39 patients (63 per cent) had a continuing complete response with a median follow-up of 26 months (range 3-96 months). Twelve patients (10 with CLL) received no further therapy after splenectomy. Seven patients failed to respond and 15 relapsed after splenectomy. These 22 patients could be distinguished on the basis of: (1) lower average preoperative platelet counts (P less than 0.007), postoperative platelet counts (P less than 0.001), and postoperative rise in platelets (P less than 0.004); (2) lower average spleen weight (P less than 0.052); (3) preoperative chemotherapy (P less than 0.044). However preoperative and postoperative platelet counts were the only two variables selected by stepwise regression analysis (P less than 0.05 and P less than 0.01, respectively). Bone marrow failure did not preclude complete response after splenectomy. Long-term survivors emerged from the group of patients with continuing complete response. Of the seven patients who failed to respond, five died with a median survival of 4 months, and of the 15 patients who relapsed after splenectomy, 13 died, with a median survival of 6 months after relapse and 18 months after splenectomy. Thus, splenectomy may be an effective palliation for both CLL and NHL patients with splenomegaly and hypersplenism.
Adriamycin was administered by IV injection to seven patients with various solid tumors at a dose of 30 mg/m2 during successive courses. Extraction was carried out by the SEP-PAK method for plasma and by solvents for urine. Plasma and urinary levels of adriamycin and adriamycinol were determined by high-performance liquid chromatography over 72-h period after injection. Pharmacokinetic parameters for adriamycin and adriamycinol were calculated for each course of treatment. The results show significant inter- and intra-individual variations in the kinetics and elimination of both compounds. The analysis of pharmacokinetic data reveals a wide variability in the fluctuations observed during the successive courses in different patients. This study confirms the time-dependency of ADR kinetics.
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