Out-patient management of acute myeloid leukemia after consolidation chemotherapy. Role of a hematologic emergency unit.

BACKGROUND AND OBJECTIVE: Increasing attention to quality of life and to health care costs has recently induced several cancer centers to change in-patient management into an out-patient setting even during high risk phases of disease. The aim of this prospective study was to evaluate feasibility and safety, as well as clinical characteristics, of out-hospital management of AML patients during their post-consolidation phase. DESIGN AND METHODS: All patients who were treated over a three year period by the three following protocols were included in the study: AML10 EORTC/GIMEMA for patients with AML, except for APL, aged 60 years; AIDA GIMEMA for APL patients. All patients submitted to the AML10 and AML13 protocols and those patients submitted to the AIDA protocol with difficult peripheral vein access had a central venous catheter (CVC) sited. Patients treated as in-patients were discharged at the end of consolidation chemotherapy provided they were in a good clinical condition. They were routinely evaluated on an out-patient basis twice weekly. In the event of any complication they were referred to the Emergency Unit of our Department dedicated to out-patients with hematologic diseases. RESULTS: One hundred and eleven patients with AML were eligible for intensive chemotherapy. After achievement of complete remission they received a total of 133 consolidation courses and in 127 instances they were followed on an out-patient basis during the aplastic phase. There were 69 cases (54%) of rehospitalization, 68 because of fever and only one because of severe anemia. Rehospitalization occurred in 90%,70% and 38% of courses in AML10, AML13 and AIDA protocols, respectively. Only one patient died: the cause of death was a brain hemorrhage. Coagulase negative staphylococci and viridans streptococci were the organisms most frequently isolated from blood. Most coagulase negative staphylococci were isolated in patients submitted to AML10 and AML13 protocols, who had an indwelling CVC. Empiric once-a-day antibacterial therapy with ceftriaxone and amikacin was effective in 75% of the cases and made early discharge possible in 28% of the cases with antibiotic therapy continued in an out-patient setting. Overall, patients were managed out of the hospital for 66% of the period of post-consolidation neutropenia (77%, 48% and 50% of the post-consolidation neutropenia period in patients treated with AIDA, AML10 and AML13 protocols, respectively). INTERPRETATION AND CONCLUSIONS: Thanks to the availability of an emergency unit specifically dedicated to out-patients with hematologic diseases, selected out-hospital management of AML patients during post-consolidation cytopenia is a feasible, well accepted and cost-saving option, and can contribute to lower the risk of developing severe nosocomial infections. The empiric therapy with once-a-day ceftriaxone plus amikacin was effective, with the exception of staphylococcal infections, and made it possible to discharge patients early to continue treatment in an out-patient setting.

Outpatient management of acute promyelocytic leukemia after consolidation chemotherapy.

The feasibility and safety of outpatient management of acute promyelocytic leukemia (APL) during the aplastic phase after intensive consolidation chemotherapy, the incidence and types of complications requiring readmission to hospital, and the number of hospital days spared by this policy have been prospectively evaluated. After chemotherapy administration, patients were evaluated on an ambulatory basis. In the event of any complication they referred to the Emergency Unit (EU) of our Department dedicated to outpatients with hematologic diseases. Forty patients with APL observed over a 4 year period were eligible for intensive chemotherapy. After the achievement of complete remission they received a total of 104 consolidation courses and in 98 instances they were followed on an ambulatory basis. There were 41 cases (42%) of rehospitalization for fever (40 cases) or severe anemia (one case). Only one patient died due to a brain hemorrhage. Streptococcus viridans was the organism most frequently isolated from blood. Empiric once-a-day antibacterial therapy with ceftriaxone and amikacin was effective in 87% of the cases and made possible early discharge in 28% of the cases to continue the antibiotic therapy on an outpatient setting. Patients were managed out of the hospital for 76% of the post-consolidation neutropenia period. Thanks to the availability of an EU specifically dedicated to outpatients with hematologic diseases, out-hospital management of APL patients after consolidation therapy appeared to be safe, well accepted, potentially cost-saving, and contributed to saving the risk of developing severe nosocomial infections.

Etoposide, intermediate-dose cytarabine and carboplatin (VAC): a combination therapy for the blastic phase of chronic myelogenous leukemia.

BACKGROUND: Carboplatin is a second-generation platinum compound that in combination with etoposide and intermediate doses of cytarabine, in early clinical trials has demonstrated high efficacy in refractory acute myelogenous leukemia and the blastic phase of CML. PATIENTS AND METHODS: Starting in April 1992, 17 consecutive patients with the blastic phase (BP) of chronic myelogenous leukemia (CML) and a median age of 33 years (range 10 to 45) received a new treatment regimen consisting of etoposide (100 mg/m2/d i.v. over one hour), intermediate-dose cytarabine (500 mg/m2/d i.v. over one hour, q12 hours) and carboplatin (150 mg/m2/d continuous infusion) on days 1 3 and 8 10 (VAC regimen). The BP phenotype was myeloid in 16 patients and hybrid in one. At the time of their BP diagnoses, two patients showed extramedullary involvement, in eight patients the BP was preceded by an accelerated phase. RESULTS: Overall, 11 of 17 patients (65%) achieved complete remission and 7 of 11 responding patients (64%) manifested a cytogenetic conversion ranging from 38% to 100% Ph-negative metaphases: one patient died in CR of hemothorax, three died of sepsis during induction therapy and three patients (17.5%) had resistant disease. As of April 1996, four patients are alive, three of them in first remission at +7, +10, +16 months after CR, and one in BP at +38 months after the start of VAC therapy. Profound myelosuppression was observed in all patients; extrahematologic toxicity, especially involved the gastro-intestinal tract, with grade > 2 mucositis in five patients (29.5%) and liver dysfunction in five (29.5%). No renal toxicity or ototoxicity was observed. CONCLUSIONS: Despite the brief relapse-free duration, the high remission rate and tolerable toxicity indicate that the VAC combination chemotherapy has a high antileukemic efficacy, and warrants further evaluation for the treatment of CML in acute phase, provided a post-remission BMT strategy is feasible.