Optimizing clinical care in patients with advanced soft tissue sarcoma: a phase II study of a new schedule of high-dose continuous infusion ifosfamide and doxorubicin combination.

BACKGROUND: Ifosfamide and doxorubicin combination is an active regimen for patients with advanced soft tissue sarcomas (STS) but is burdened by high toxicity. A phase II trial was designed to assess the activity of continuous infusion ifosfamide and doxorubicin combination. PATIENTS AND METHODS: Thirty-four chemotherapy-naive patients with advanced STS were treated with ifosfamide (13 g/m(2)/12 days as continuous infusion) and doxorubicin (75 mg/m(2) on day 8) every 28 days with granulocyte colony-stimulating factor. RESULTS: The major toxicity was hematological: grade 3/4 neutropenia, anemia and thrombocytopenia occurred in 63, 30 and 12% of patients, respectively. The disease control rate was 68% and the median time to progression was 7.1 months. Among leiomyosarcomas, 2 partial responses and 4 stable diseases were observed. CONCLUSIONS: Our study confirms that the ifosfamide and doxorubicin combination has a very low non-hematological toxicity profile. This regimen attained a high disease control rate with moderate activity. Further investigation into leiomyosarcoma is warranted.

UFT as maintenance therapy in patients with advanced colorectal cancer responsive to the FOLFOX4 regimen.

BACKGROUND: In advanced colorectal cancer (ACC), FOLFOX4 has been accepted as a standard chemotherapeutic regimen. Due to the neurotoxicity induced by oxaliplatin, which occurs in about 50% of patients during the 6-month FOLFOX4 regimen, and the frequent need for hospitalization, alternative regimens may be required. We aimed to determine whether a 'maintenance' therapy with oral UFT (uracil-tegafur) in patients responding to FOLFOX4 is able to maintain the response and improve the quality of life (QoL) as a result of the outpatient regimen and lower psychological distress. METHODS: Untreated patients with ACC who did not progress after 6 months of FOLFOX4 received oral UFT until disease progression or unacceptable toxicity. The aim of the study was to maintain the response obtained with the FOLFOX4 regimen for at least 6 months. The secondary objective was to evaluate QoL during the two different treatment regimens utilizing the 36-item Short Form Health Survey (SF-36). RESULTS: From January 2003 to August 2004, out of the enrolled 30 patients [22 males and 8 females; 2 patients with a complete response (CR), 14 patients with a partial response (PR) and 6 patients in stable disease (SD) after 6 months of FOLFOX4] 22 continued therapy with UFT until progression without significant toxicity; the remaining 8 patients (27%) had progressive disease (PD) during or at the end of FOLFOX4 and were treated with other regimen. After 6 months of UFT, 4 patients (13%) had CR, 6 patients (20%) PR and 4 patients (13%) SD; 16 patients (53%) progressed. Median follow-up was 31 months [interquartile range (IQR): 20-31 months]; 14 patients died of PD. The median time to progression was 13.9 (IQR: 7.7-20.1) months and the median survival time was 31 months (IQR: 20-31 months). Evaluation of QoL demonstrated a trend towards better QoL during UFT treatment. CONCLUSIONS: These results support the feasibility of maintaining good response and improving QoL (measured by SF-36) with an oral fluoropyrimidine after combination chemotherapy in ACC patients; moreover, since UFT can be used orally, patient compliance is increased and the duration of hospitalization can be decreased.

Autotransfusion program: integrated use of different techniques.

A successful autologous program should enroll all appropriate patients, conserve homologous blood and minimise the exposure to the risks of donor blood. A program of autotransfusion and proper use of blood has been implemented since 1980 with the objectives to include all eligible patients and to transfuse autologous blood only. The following strategies were adopted: critical review of transfusion indications; control of overtransfusion; avoidance of waste; systematic and integrated use of all autotransfusion techniques currently available. Results in 1992 in elective surgery: 98% enrollment, 75% blood conservation. Exposure to homologous blood was completely avoided in 53% of the cases.

One-year use of the Bloodloc system in an orthopedic institute.

UNLABELLED: Human error in patient or specimen identification due to fatigue, stress and lack of attention by technologists, nurses, interns, and physicians, can cause routinely safety procedures to be circumvented. Clerical errors may occur during the specimen collection, the issue of blood unit and the transfusion of blood. The introduction in an increasing number of hospital of preoperative autologous blood donation programs further increases the chance of error, because a single patient can predeposit multiple units of blood. In this cases there is a greater commitment not only to transfuse any blood unit that is ABO compatible but to transfuse the specific units the patient previously donated for his own use. Human error has been recognized as a significant cause of transfusion-associated fatalities. The persistence of the frequency and type of errors observed in spite of extensive efforts to eradicate them, suggests that errors are inevitable as long as large number of repetitive procedures are performed unless major system changes are adopted. A system (Bloodloc System) that physically prevents the possibility of error was adopted since January 1993 and cuncurrently a quality improvement program (QI) was implemented specifically designed to monitor: 1. the absence of the code on the blood samples, 2. the blood bank error in setting the Bloodloc, 3. the misidentification of blood samples, 4. any attempt to transfuse the wrong blood unit, 5. any attempt to transfuse, the wrong patients. RESULTS: 4895 blood units (2469 autologous and 2426 allogeneic units) were transfused to 1478 patients (849 predeposited an average of 3.3 +/- 2.0 units). The methodological errors (absence of three-letter code on the patient's specimen tube, wrong transcription of the code on the blood sample, wrong setting of the Bloodloc in the blood bank)--41 cases--were limited at the first four months of implementation of the system. In the same period however have been reported 3 potentially fatal errors which have been avoided by the Bloodloc. Two cases of misidentification of blood samples at the moment of the specimen collection, and one attempt to transfuse the wrong units to the wrong patients. CONCLUSIONS: The Bloodloc system is effective in preventing potential transfusion-associated fatalities caused by units or recipients misidentification.

The potential role of oxygen-carrying products in autologous blood transfusion protocols.

For surgical patients transfusion of autologous blood (AB) is the most useful of measures to reduce patient's exposure to homologous blood (HB). In our Institute an autotransfusion program was started in 1982 utilizing all the autotransfusion techniques currently available. The integrated use of the techniques offered to the majority of the patients the possibility of receiving AB (98% of the elective surgery patients) and a consistent conservation of HB has been achieved (60-70%). However 42% are still exposed to some HB. Critical parameters that render the patients unable to fulfill the anticipated transfusion needs with the current AB transfusion techniques are: the patient's ability to predonate sufficient AB prior to surgery and the amount of blood transfused intraoperatively that in turn depends on different "transfusion trigger". In our Institute over 50% of all the blood units are transfused the day of operation (60% being AB, 40% HB) and 50% postoperatively (only 33% being AB). For this reason, a clinical application for the oxygen-carrying products can be the replacement of the blood lost during, or immediately after the operation permitting the surgeon to operate safely at a lower Hct levels, thereby delaying the transfusion of blood and saving the AB obtained.

Autologous blood pre-deposit and cell salvage in orthopedic surgery.

A successful autologous blood program should enrol all appropriate patients, conserve homologous blood and minimize the exposure to the risks of donor blood. A program of autotransfusion and proper use of blood has been implemented since 1980 with the objectives of including all eligible patients and to transfuse autologous blood only. The following strategies were adopted: critical review of transfusion indications; control of over-transfusion; avoidance of waste; systematic and integrated use of all autotransfusion techniques currently available. Results in 1992 in elective surgery: 98% enrolment, 75% blood conservation. Exposure to homologous blood was completely avoided in 53% of the cases.

Bedside transfusion errors: analysis of 2 years' use of a system to monitor and prevent transfusion errors.

Clerical errors occurring during specimen collection, issue and transfusion of blood are the most common cause of AB0 incompatible transfusions. 40-50% of the transfusion fatalities result from errors in properly identifying the patient or the blood components. The frequency and type of errors observed, despite the implementation of measures to prevent them, suggests that errors are inevitable unless major changes in procedures are adopted. A fail-safe system, which physically prevents the possibility of error, was adopted in January 1993 and concurrently a quality improvement program was implemented to monitor any transfusion errors. Up to December 1994, 10,995 blood units (5,057 autologous and 5,938 allogeneic) were transfused to 3,231 patients. Seventy-one methodological errors(1/155 units) were observed, half of which were concentrated during the first 4 months of introducing the system. However the system detected and avoided four potentially fatal errors (1/2,748 units). Two cases involved the interchanging of recipient sample tubes, 1 case was due to patient misidentification and the other involved misidentification of blood units. In conclusion the system is effective in detecting otherwise undiscovered errors in transfusion practice and can prevent potential transfusion-associated fatalities caused by misidentification of blood units or recipients.