Potassium para-aminobenzoate and liver function test findings

Risk of hepatotoxicity has been raised with respect to potassium para-aminobenzoate (Potaba) therapy. In this regard relevant clinical and laboratory hepatic findings in the hospital records of 390 scleroderma patients were analyzed. There were 274 patients who had received potassium para-aminobenzoate at some time and 116 who never received it. No instance was found in which potassium para-aminobenzoate was the cause of an acute hepatic hypersensitivity reaction. There were random or intercurrent abnormalities in hepatic test findings over time, but these actually occurred more often in the group of patients never treated with potassium para-aminobenzoate. Further, there was no evidence that long-term potassium para-aminobenzoate therapy is hepatotoxic. These findings suggest that acute hepatic reaction to potassium para-aminobenzoate is at least uncommon if not rare.     

Phase II evaluation of aclarubicin in refractory adult acute leukemia: a Southwest Oncology Group Study

Aclarubicin, a new anthracycline antibiotic, was used to treat 24 adult patients with refractory adult leukemia, using a total dose of 300 mg/m2 (75 mg/m2/day X 4). There were 20 patients with acute myelogenous and four with acute lymphoblastic leukemia. Approximately two-thirds of the patients had a Karnofsky score of less than or equal to 2, and two-thirds had received two or more previous induction programs. Interim bone marrow evaluation was obtained in 18 of 30 remission induction courses and revealed marked hypocellularity in 14, inadequate specimens in three, and persistent disease in one. Seven patients received more than one course. Two patients refused further therapy. In patients with myelogenous leukemia, there were two complete remissions lasting 10 and 16 months and one partial remission lasting 4 1/2 months. There were no responders in patients with lymphoblastic leukemia. Toxicity included profound leukopenia and thrombocytopenia, moderate nausea and vomiting, diarrhea, and mucositis. There were no cardiac symptoms associated with the drug infusion, but there were three late events possibly associated with anthracycline cardiotoxicity. Used in this dosage schedule, aclarubicin is an active, but toxic, agent in the acute myelogenous leukemias.     

Barrett's esophagus complicating scleroderma

Two patients with scleroderma whose esophageal involvement was associated with longstanding reflux esophagitis were found to also have Barrett's esophagus. Since Barrett's esophagus is a premalignant condition, these patients with scleroderma should be considered at high risk for the development of adenocarcinoma of the esophagus.     

Retrospective studies in scleroderma: skin response to potassium para-aminobenzoate therapy

Analyses were made of University of Michigan Hospital records of 467 patients diagnosed during the period 1948 - July 1980 as having scleroderma (390) or scleroderma associated with manifestations of other collagen disease (77). In all, there were coded 4733 visits or admissions. Demographic characteristics are detailed for the 390 patients with clinical features of scleroderma alone. The principal focus of this report is on degree and extent of skin involvement and response to therapy with potassium para-aminobenzoate (Potaba, KPAB). Ninety percent of 224 patients treated with KPAB experienced mild, moderate, or marked skin softening. Among a parallel group of 96 evaluable patients who did not receive KPAB, less than 20% were noted to have mild or moderate skin improvement at the end of follow-up. The difference in skin softening attained by patients treated with KPAB compared to that of patients who did not receive this medication was significant (p less than 0.0001).     

Improved survival duration with combination chemotherapy induction for multiple myeloma: a Southwest Oncology Group Study

Four hundred forty previously untreated patients with active multiple myeloma were entered into a randomized trial (Southwest Oncology Group [SWOG] study 7927/28) comparing vincristine, melphalan, Cytoxan (Mead Johnson & Company, Evansville, Ind), and prednisone (VMCP) alternating with vincristine, BCNU, Adriamycin (Adria Laboratories, Columbus, Ohio) and prednisone (VBAP) with or without levamisole with vincristine, Cytoxan, and prednisone (VCP) with or without levamisole for induction therapy. The treatment groups were well balanced for all of the known major prognostic factors. Patients receiving VMCP-VBAP responded (greater than or equal to 75% regression) more frequently to induction therapy, both without (54%) and with (44%) levamisole v VCP without (28%) or with (28%) levamisole (P less than .001). In addition, patients receiving VMCP-VBAP (+/- levamisole) had a survival duration determined to be significantly increased by all forms of analysis: 48 and 33 months for VMCP-VBAP without and with levamisole v 29 and 26 months for VCP without and with levamisole (P = .011 overall). Levamisole did not improve response rates or survival duration (P greater than or equal to .1), nor did it prolong remission in the maintenance phase (P = .85). Analysis of SWOG study 7704/05 (updated April 1985) confirmed improved survival for combination therapy v MP, but no benefit for levamisole. The overall findings support the use of VMCP-VBAP as an excellent treatment option for remission induction in patients with active myeloma of all stages and prognostic categories.     

Alternated Versus Syncopated CHOP-PVB: Two Studies for the Treatment of Non-Hodgkin's Lymphoma by the Southwest Oncology Group

Based on a preliminary trial that suggested that CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), and PVB (cisplatinum, vinblastine, bleomycin), are at least partially non-cross-resistant, the Southwest Oncology Group treated patients with unfavorable histology, non-Hodgkin's lymphoma with CHOP and PVB. In the first study, 76 eligible patients were given three courses of CHOP, with complete or partial responders receiving three courses of PVB followed by three further courses of CHOP. Nonresponders after the initial three cycles of CHOP, received six courses of PVB. In the second study, 154 eligible patients were treated with alternating cycles of the two drug regimens. The overall objective antitumor response (CR+PR) was 77% for the first study and 58% for the second. The complete remission rates were 48% and 38%, respectively. The overall survival for both studies is similar. These results are interpreted in terms of the Goldie-Coldman hypothesis.