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A randomized clinical trial of combination chemotherapy for adult acute lymphoblastic leukemia (ALL) with doxorubicin, vincristine and prednisolone with and without L-asparaginase (AdVP vs L-AdVP) was conducted, involving 58 institutions throughout Japan. After reaching complete remission (CR), patients were treated with the same regimen for more than 2 years. Among 166 evaluable cases of the 198 cases enrolled, CR rates were 63.1% (53/84) with AdVP and 64.6% (53/82) with L-AdVP (P = 0.837). Median survival times and 7-year survival rates were 12.7 months and 21.2% with AdVP, and 16.0 months and 22.3% with L-AdVP (P = 0.955 by generalized Wilcoxon test [GW], P = 0.952 by log-rank test [LR]). Median disease-free survival times and 7-year survival rates were 13.5 months and 23.8% with AdVP and 17.0 months and 30.6% with L-AdVP, showing some increments for L-AdVP but no statistical significance (P = 0.141 by GW, P = 0.300 by LR). Among the cases of extramurally confirmed FAB subtypes, CR rates were 75.9% (63/83) for the L1 subtype and 51.3% (39/76) for the L2 subtype (P = 0.001). As to adverse effects, pancreatitis was complicated more frequently in L-AdVP than in AdVP (P = 0.039). Other side effects such as hyperbilirubinemia, diabetes mellitus, diarrhea and hypofibrinogenemia were observed more frequently with L-AdVP, but with no statistical significance. Thus, addition of a single course of L-asparaginase in the induction phase of combination chemotherapy with doxorubicin, vincristine and prednisolone did not significantly enhance the effect of antileukemic treatment of adult ALL. [ABSTRACT FROM AUTHOR]

UFT is a compound in which futraful (FT) and uracil are combined at a ratio of 1:4. UFT was given orally at a daily dose of 300-600 mg in a phase II study. Pooled data on a UFT phase II study of 438 evaluable patients, at 104 institutions revealed a response in carcinoma of the stomach (27.7%), pancreas (25.0%), gallbladder and bile duct (25.0%), liver (19.2%), colon and rectum (25.0%), breast (32.0%), and lung (7.0%). The mainly gastrointestinal toxicity resulted in anorexia (24.3%), nausea and vomiting (12.5%), and diarrhea (11.8%). On the other hand, hematological toxicity was rare and mild. To analyze the life-prolonging effect of the therapy, a cohort study was carried out in 438 cases collected in the UFT phase II study 5 years after the commencement of the therapy. The 50% survival time for 185 patients with gastric cancer was 185 days. The corresponding times in 54 patients with colorectal cancer and 49 with breast cancer were 227 and 505 days, respectively. A historical comparative study of UFT and FT, which was administered in the same institutions for equal evaluation, revealed that UFT had a significantly better effect than FT without more pronounced side effects with the equivalent dose schedule. In conclusion, UFT can be considered a useful against cancers over a broad spectrum, especially in gastrointestinal cancer. [ABSTRACT FROM AUTHOR]

A phase I clinical and pharmacokinetic study of recombinant human tumor necrosis factor (rH-TNF) was conducted in a single dose schedule in 33 patients with advanced cancer. rH-TNF was given by i.v. infusion over 30 min with a starting dose of 1 x 10(5) units/m2. The dose was escalated up to 16 x 10(5) units/m2 according to the modified Fibonacci scheme. Toxic effects were similar but not identical to those reported with interferons and interleukin-2, and included fever, rigors, nausea and vomiting and anorexia in a non-dose-dependent manner, and hypotension, leukocytosis, thrombocytopenia and transient elevation of transaminases (SGOT and SGPT) in an approximately dose-dependent manner. DIC syndrome was observed in one patient who had received 16 x 10(5) units/m2. The dose-limiting toxicities were hypotension, thrombocytopenia and hepatotoxicity, and the maximum tolerated dose in a single i.v. infusion of rH-TNF appeared to be 12 x 10(5) units/m2 when thrombocytopenia and elevation of SGOT and SGPT were taken as the dose-limiting toxicities. However, if hypotension was included, the maximum safely tolerated dose appeared to be 5 x 10(5) units/m2. [ABSTRACT FROM AUTHOR]