aclarubicin and Leukopenia

Aclacinomycin-A (ACLA-A), the new anthracycline antibiotic that produces substantially less cardiotoxicity relative to doxorubicin, was evaluated in a phase II trial for advanced large cell and adenocarcinoma of the lung patients. Twenty-three patients with measurable disease were entered into the trial and received ACLA-A in doses of a weekly infusion of 65 mg/m2 and 85 mg/m2. Eighteen patients were evaluable for response and toxicity. Two patients were evaluable for toxicity only, one died before completion of a full course of therapy, and two did not receive the drug. There were no complete or partial remissions in this study. Three patients had disease stabilization for a median of 10 weeks (range 6-17). Toxicity was mainly hematologic. Nausea and vomiting were moderate. ACLA-A, in the dose schedules used, appears to have no activity in large cell and adenocarcinoma of the lung.

Topics: Aclarubicin; Adenocarcinoma; Adult; Aged; Carcinoma, Small Cell; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Infusions, Parenteral; Leukopenia; Lung Neoplasms; Male; Middle Aged; Naphthacenes; Nausea; Thrombocytopenia; Vomiting

The purpose of the study was to evaluate the effect of a mouthrinse regimen comprising both chemical plaque control and mechanical plaque removal. 20 adult patients with acute myeloid leukaemia were assigned to one of the following 2 regimens: (1) (group 1) mouthrinse twice daily with a 0.1% chlorhexidine solution; or (2) (group 2) the same regimen, but preceded by mechanical removal of plaque and calculus on day 1. All patients were followed for 28 days from the initiation of remission-induction therapy. In group 2, the plaque scores remained lower than those of group 1 throughout the study, although only 3 patients remained completely free of plaque after 28 days. Gingival inflammation as judged by bleeding scores remained unchanged in group 1, whereas in group 2, the degree of inflammation was reduced from 52% (median value) on day 1 to 31% (median value) on day 28. The bleeding scores were also lower in group 2 (31%) than in group 1 (60%) on day 28. No differences were found between the 2 groups with respect to the occurrence of other oral infections. It is concluded that chemical plaque control with chlorhexidine should be preceded by mechanical removal of plaque and calculus, when used in patients with acute myeloid leukaemia and thrombocytopenia.

Topics: Aclarubicin; Acute Disease; Adolescent; Aged; Antineoplastic Combined Chemotherapy Protocols; Bacterial Infections; Chlorhexidine; Cytarabine; Dental Calculus; Dental Plaque; Dental Scaling; Female; Gingival Hemorrhage; Gingivitis; Humans; Leukemia, Myeloid; Leukopenia; Male; Middle Aged; Mouthwashes; Netilmicin; Piperacillin; Premedication; Thrombocytopenia

Six patients with recurrent ovarian cancer who had prior chemotherapy were studied for the clinical efficacy of CDDP-ACR treatment. Five out of the 6 had received CDDP a total doses of 1,320, 780, 750, 475, and 340 mg. CDDP-ACR therapy consisted of continuous infusion of CDDP at a daily dose of 10 mg/m2 over 14 days (total CDDP doses; 140 mg/m2) and of intermittent infusion of ACR (aclarubicin) at a dose of 20 mg/body every other day (total ACR doses: 140 mg). There were one CR and five PR and a response rate up to 100% was noted. Toxicity was manifested in slight nausea or vomiting, but there was no nephrotoxicity. However bone marrow was severe. Thrombocytopenia less than 50,000/mcl in 4 pts (67%) and leukopenia less than 1,000 mcl in 3 pts (50%). The mean filterable platinum exposure measured by area under the concentration-time curve (AUC) was as high as 19.7 +/- 6/0 mg.hr/ml. In conclusion the bone marrow toxicity in this regimen was severe, but the therapeutic efficacy was promising. Further studies on the appropriate infusion time and the minimum effective dose of CDDP are needed.

Topics: Abdominal Neoplasms; Aclarubicin; Adult; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Cystadenocarcinoma; Drug Administration Schedule; Female; Humans; Infusions, Intravenous; Leukopenia; Lymphatic Metastasis; Middle Aged; Ovarian Neoplasms; Platinum; Recurrence; Remission Induction; Thrombocytopenia

Nineteen patients with refractory non-Hodgkin's lymphoma were treated with a combination of N4-behenoyl-1-beta-D-arabinofuranosylcytosine (150-200 mg/m2), aclacinomycin (15 mg/m2), etoposide (70 mg/m2 i.v. or 100 mg/m2 p.o) and prednisolone (20 mg/m2) (ABEP regimen). Patients who achieved complete remission (CR) received 10 courses of consolidation therapy with ACOP-E chemotherapy (adriamycin, cyclophosphamide, vincristine, prednisolone and etoposide). Seven patients achieved CR and three partial remission. Twelve patients with fresh non-Hodgkin's lymphoma stage IV were treated with ABEP regimen. CR was obtained in eight patients (66.7%). The median duration of CR was 11+ alpha months. Hematological toxicity was a dose-limiting factor but this was manageable.

Topics: Aclarubicin; Adult; Aged; Alopecia; Anorexia; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Cytarabine; Doxorubicin; Drug Administration Schedule; Etoposide; Female; Humans; Leukopenia; Lymphoma; Male; Middle Aged; Naphthacenes; Prednisolone; Thrombocytopenia; Vincristine

Aclarubicin (ACR) was administered in a prospective cooperative phase II trial to 44 patients with possibly refractory acute nonlymphocytic leukemia who were previously treated with daunorubicin and cytarabine. Induction treatment consisted of 80 mg/m2 of ACR iv daily for 3 days, followed by 80 mg/m2 iv daily for 2 days in patients not obtaining a complete remission (CR) after 2-4 weeks. CR was observed in eight patients (18%) and partial remission was observed in six (14%). On monthly maintenance chemotherapy with ACR and cytarabine, the duration of CRs varied between 10 and 58 weeks. Achievement of remission was not related to age, presence or absence of Auer bodies, cytogenetic characteristics, or previous response to daunorubicin and cytarabine. Side effects were nausea and vomiting observed in 86% and diarrhea in 34% of the patients, whereas mucositis and alopecia were uncommon. Disturbances of cardiac function arousing suspicion of acute ACR toxicity were observed in seven patients. No case of chronic cardiotoxicity was observed, despite the fact that 20 patients received ACR doses greater than 400 mg/m2, with seven of the 20 having had a previous daunorubicin dose greater than 400 mg/m2. As CR was obtained in four of 14 patients with primary therapy-resistant leukemia and in two of 16 patients with relapse and no response to re-treatment with daunorubicin and cytarabine, ACR does not seem to show clinical cross-resistance to daunorubicin. Evaluation of ACR in first-line chemotherapy of acute nonlymphocytic leukemia appears justified.

Topics: Aclarubicin; Acute Disease; Adult; Aged; Antibiotics, Antineoplastic; Cytarabine; Daunorubicin; Drug Evaluation; Heart; Humans; Leukemia; Leukopenia; Middle Aged; Naphthacenes; Prospective Studies; Thrombocytopenia

Aclacinomycin A (ACM) is a new anthracycline antibiotic with a reduced cardiac toxicity in animal models. A phase II study was performed in a total of 25 patients, 23 of whom are evaluable for response. All suffered from recurrent and advanced tumors. Pretreatment consisted of at least four different chemotherapeutic agents (range: 4-9). Lung cancer patients (3/9) were irradiated to the mediastinum. Eighteen patients were pretreated with doxo- or daunomycin. The dose for solid tumors was 2-3 mg/kg given on 3 consecutive days every 3 weeks. Leukemia patients received a daily dose of 20 mg/m2, and standard response criteria were used. Marked reductions of leukocyte counts were achieved in leukemia patients. The overall response rate was about 15% in solid tumors, but major objective responses (CR + PR) have not been observed. Myelosuppression was commonly moderate in solid tumor patients, nausea and vomiting were rare, and alopecia was not induced. Cumulative cardiotoxicity was not evaluated in this trial. Treatment with ACM requires further investigation in acute leukemias and solid tumors, not pretreated with anthracycline antibiotics.

Topics: Aclarubicin; Adolescent; Adult; Aged; Antibiotics, Antineoplastic; Drug Evaluation; Female; Humans; Leukemia; Leukopenia; Lung Neoplasms; Male; Middle Aged; Naphthacenes; Nausea; Thrombocytopenia

Topics: Aclarubicin; Adult; Aged; Breast Neoplasms; Drug Evaluation; Female; Gastrointestinal Diseases; Humans; Leukopenia; Middle Aged; Naphthacenes; Thrombocytopenia