The objective of the study was to evaluate the incidence, characteristics, treatment and outcome of acute megakaryoblastic leukemia (AMeL) in patients enrolled in GIMEMA trials. Between 1982 and ...1999, 3603 new consecutive cases of AML aged over 15 years were admitted to GIMEMA trials. Of them, 24 were AMeL. The incidence of AMeL among AML patients enrolled in GIMEMA trials was 0.6% (24/3603). Diagnosis was based on morphological criteria. Out of 11 cytogenetic studies performed two presented chromosome 3 abnormalities. Twelve patients (50%) reached a CR, five (21%) died in induction and seven (27%) were unresponsive. The median duration of CR was 35 weeks (range 10-441). Seven patients underwent transplantation procedures (1 BMT, 4 aBMT, 2 aPBSCT). Four patients died in CR due to chemotherapy-related complications. Comparing the CR rate between AMeL and the other cases of AML enrolled in GIMEMA trials, no differences were observed. These results were mirrored for different age groups. The median survival was 40 weeks. At present, after a follow-up of a minimum of 2 years, only two patients are alive in CR, all the others having died. A 5-year Kaplan-Meier curve shows a disease-free survival of 17% and an actuarial overall survival of 10%. AMeL is a rare form of AML. The CR duration and the overall survival in this group of patients are very poor, even if similar to those observed in other AML. Furthermore, a high number of deaths in CR were observed. On the basis of these data, a specific therapeutic approach, possibly with innovative treatments, should be evaluated.
Abstract
Background
Crohn’s disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Telemedicine (TM) is particularly useful in patients with chronic diseases who need ...frequent monitoring to achieve therapeutic outcomes and improve their quality of life. We examined the differences in patient satisfaction comparing telemedicine versus traditional in-person visits. We also examined the potential cost savings benefits of utilizing telemedicine.
Methods
All consecutive patients with IBD in clinical remission evaluated by Partial Mayo Score (PMS) for UC and Harvey Bradshaw Index (HBI) for CD were considered eligible (PMS<2 or HBI<5). Patients were randomized into two arms: telemedicine or in-person visits after a questionnaire investigating the Information and communication technology (ICT) skills . All patients were asked to respond to an 11-items survey investigating their trust in telemedicine at first in-person visit. Enrolled patients performed after 3 months a telehealth or an in-person visit. All patients answered a standard questionnaire to evaluate the indirect costs of managing their disease. Patients randomized into telemedicine arm answered a specific 28-item survey investigating their degree of satisfaction.
Results
We enrolled 30 patients with IBD randomized to telemedicine (n. 22; 11 CD; 13 female; mean age 45 years) or in-person visits (n. 8; 5 CD; 3 female; mean age 52 years). All patients randomized in TM (100 %) showed interest in this new clinical practice and were satisfied of the received information about telemedicine management. No patients thought that telemedicine would have no positive effects on their health status. Regarding demographic data, 6 out of 22 patients randomized to TM (27.2%) lived in a different province than our hospital’s and16 patients (72.7%) had high school diploma or degree. All TM patients (100%) were satisfied of the televisit and considered clear the information received during conversation with physician. From a technical point of view, only one patient had problems of connection and three patients needed the support of a caregiver. Eighteen patients (81.8 %) thought that the efficacy of the televisit was equivalent to the in-person visit. Nineteen patients (86.3 %) were convinced that televisit is a tool to be promoted for future clinical practice. Patients randomized to telemedicine had an average saving of 125 €. Data shown are illustrated in the figure 1.
Conclusion
In patients with IBD in remission, telemedicine is feasible and effective in the majority of patients. In addition, TM has allowed a significant cost savings without reducing the quality of the health assistance.
The incidence of chronic myeloid leukemia (CML) increases with age, but it is unclear how the characteristics of the disease vary with age. In children, where CML is very rare, it presents with more ...aggressive features, including huge splenomegaly, higher cell count and higher blast cell percentage.
To investigate if after childhood the disease maintains or loses these characteristics of aggressiveness, we analyzed 2784 adult patients, at least 18 years old, registered by GIMEMA CML WP over a 40-year period.
Young adults (YAs: 18–29 years old) significantly differed from adults (30–59 years old) and elderly patients (at least 60 years old) particularly for the frequency of splenomegaly (71%, 63% and 55%, P < 0.001), and the greater spleen size (median value: 4.5, 3.0 and 1.0cm, P < 0.001). According to the EUTOS score, that is age-independent, high-risk patients were more frequent among YAs, than among adult and elderly patients (18%, 9% and 6%, P < 0.001). In tyrosine kinase inhibitors-treated patients, the rates of complete cytogenetic and major molecular response were lower in YAs, and the probability of transformation was higher (16%, 5% and 7%, P = 0.011).
The characteristics of CML or the host response to leukemia differ with age. The knowledge of these differences and of their causes may help to refine the treatment and to improve the outcome.
NCT00510926, NCT00514488, NCT00769327, NCT00481052.
A retrospective study of 37 patients with haematological malignancy (21 acute myeloid leukaemia, 11 acute lymphoid leukaemia, two lymphoma, two hairy cell leukaemia, one Hodgkin's disease) and ...histologically documented mucormycosis was conducted to evaluate the clinical characteristics and ascertain the factors which influenced the outcome from mycotic infection. Patients were admitted to 18 haematology divisions in tertiary care or university hospitals in Italy between 1987 and 1995.
Fever, thoracic pain, dyspnoea and cough were the most frequent presenting symptoms. At the onset, 89% patients were neutropenic (neutrophil counts < 0.5 × 109/l) with a median duration of previous neutropenia of 14 d (range 6–60). The most frequent sites of infection were lungs (81%), CNS (27%), sinus (16%), liver (16%) and orbital space (10%). Only three patients were asymptomatic. A correct in vivo diagnosis was made in only 13 (35%) patients. When performed, thoracic and cranial CT scan were the most useful diagnostic investigations. Despite the fact that 26 febrile patients were treated with empirical antifungal treatment, 28 of the 37 patients (76%) died from fungal infection at a median time of 17 d from the onset of clinical symptoms. Nine patients were cured by antifungal therapy plus, in five cases, radical surgery procedures.
An analysis of factors influencing outcome demonstrated that the resolution of chemotherapy‐induced neutropenia and prolonged treatment with amphotericin B and, if feasible, radical surgical debridement treatment, were significantly correlated with recovery from infection.
Mucormycosis, a rare filamentous fungal infection that occurs most frequently in neutropenic acute leukaemia patients, is characterized by a high mortality rate. Extensive and aggressive diagnostic and therapeutic procedures are essential to improve the prognosis in these patients.
Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality after allogeneic bone marrow transplantation (BMT). Our aim was to study the prophylactic effect of high-dose intravenous ...acyclovir given around the time of BMT followed by oral acyclovir on CMV infection and survival. 310 BMT recipients at risk of developing CMV infection were randomised to one of three regimens in a double-blind and double-dummy design: intravenous acyclovir (500 mg/m2, three times a day) for 1 month followed by oral acyclovir (800 mg four times a day for a further 6 months) (intravenous/oral group); intravenous acyclovir followed by oral placebo (intermediate group); or low-dose oral acyclovir (200 or 400 mg, four times a day) followed by placebo ("controls"). Analysis was by intention-to-treat. Intravenous acyclovir significantly reduced the probability of and delayed the onset of CMV infection. There was no further reduction in infection risk with the addition of long-term oral acyclovir. Time to CMV viraemia was delayed in the intravenous/oral acyclovir group compared with controls. Extending the prophylaxis with oral acyclovir significantly improved survival: 79 of 105 recipients were still alive at 7 months compared with 60 of 102 controls (p=0·012). Although the intravenous/oral acyclovir group did significantly better than controls in terms of survival, the difference between the intravenous/oral acyclovir group and the intermediate group was of borderline statistical significance (p=0·054). Adverse events that were possibly treatment related were similar in all three groups. The most commonly reported events were nausea, vomiting, elevated creatinine, and renal failure. High-dose intravenous followed by oral acyclovir improved survival and was of benefit in prophylaxis against the effects of CMV after BMT. Interpretation of CMV infection was made difficult because an intermediate treatment (intravenous acyclovir followed by oral placebo) was as effective as high-dose intravenous/oral acyclovir.
Objective: To analyze determinants/risk factors for uterine prolapse in a population of women around menopause.
Methods: Between 1997 and 1999, we conducted a large cross sectional study on the ...characteristics of women around menopause attending a network of first level outpatients menopause clinics in Italy for general counselling about menopause or treatment of menopausal symptoms. Eligible for the study were women consecutively observed during the study period. All women underwent a gynecological examination.
Results: Considering the 21 449 non-hysterectomized women, uterine prolapse was diagnosed in 1182 cases (5.5%). Of those, 772 (65.3%) had prolapse degree I and 410 (34.7%) degree II or III. The frequency of uterine prolapse increases with age: In comparison with women aged ≤51 years, the odds ratio
OR of uterine prolapse was 1.3 and 1.7 respectively for women aged 52–55 and ≥56 years. In comparison with women with none/primary education, the
OR of uterine prolapse was 0.8 (95% confidential interval
CI 0.7–0.9) and 0.8 (95%
CI 0.6–0.9), respectively, for women with intermediate or high school/university degree. The risk of uterine prolapse increased with body mass index (
BMI; kg/m
2) value: In comparison with women with
BMI<23.8, the
OR was 1.4 (95%
CI 1.2–1.7) and 1.6 (95%
CI 1.3–1.9) for women with
BMI 23.8–27.2 and >27.2. In comparison with nulliparae, the
OR of uterine prolapse increased with number of births, being 3.0 (95%
CI 2.1–4.3) in women reporting ≥3 births. A history of caesarean section or of a delivery of a fetus weighing >4500 g were not associated with increased risk of uterine prolapse. When the analysis was conducted separately in strata of grade of uterine prolapse (I and ≥II), no marked differences emerged in the
OR estimates.
Conclusions: This study indicates that, in this population, the risk of uterovaginal prolapse increase with the number of vaginal births and was higher in overweight women, offering some quantitative estimates of the role of these factors on the risk of the condition.
To compare the efficacy and tolerability of fluconazole and oral amphotericin B in preventing fungal infection in neutropenic patients with acute leukemia.
A randomized, controlled, multicenter ...trial.
30 hematologic units in tertiary care or university hospitals.
820 consecutive, afebrile, adult patients with acute leukemia and chemotherapy-induced neutropenia.
Patients were randomly assigned to receive fluconazole, 150 mg, as a once-daily capsule, or amphotericin B suspension, 500 mg every 6 hours.
An intention-to-treat analysis was done for 820 patients: 420 treated with fluconazole and 400 treated with oral amphotericin B.
Definite systemic fungal infection occurred in 2.6% of fluconazole recipients and 2.5% of amphotericin B recipients; suspected systemic fungal infection requiring the empiric use of intravenous amphotericin B occurred in 16% of fluconazole recipients and 21% of oral amphotericin B recipients, a difference of 5 percentage points (95% CI for difference, -0.02% to 10%; P = 0.07). Superficial fungal infection was documented in 1.7% of fluconazole recipients compared with 2.7% of amphotericin B recipients, a difference of one percentage point (CI of difference, -0.9% to 3%; P > 0.2). The distribution of fungal isolates in systemic and superficial fungal infection was similar in both groups. The overall mortality rate accounted for 10% in both groups. An excellent compliance was documented for 90% of patients treated with fluconazole compared with 72% of those treated with amphotericin B suspension, a difference of 18 percentage points (CI for difference, 13% to 23%). Side effects were documented less frequently in fluconazole than in amphotericin B recipients (1.4% compared with 7%, a difference of 5.6 percentage points; CI for difference, 2% to 8%; P < 0.01).
Fluconazole was at least as effective as oral amphotericin B in preventing systemic and superficial fungal infection and the empiric use of amphotericin B in neutropenic patients with acute leukemia but was better tolerated.
The objective of the study was to analyze medical and general factors associated with hormone replacement therapy (HRT) use in women attending a network of menopause clinics in Italy.
Between 1997 ...and 1999, we conducted a large cross-sectional study on the characteristics of women around menopause attending a network of first level outpatient menopause clinics for general counseling about menopause or treatment of menopausal symptoms. All women consecutively observed during the study period at the participating centers were eligible for the study. A total of 42,464 women (mean age 54 years) entered the study. The characteristics of women who had at some time used HRT were compared with those of women who were never users.
Of the 42,464 women considered, 4,909 (11.6%) reported having used HRT at some time. In comparison with premenopausal women, the odds ratio (OR) of HRT use was 2.1 and 4.0, respectively, in women with natural and surgical menopause; the frequency of use tends to be lower in women with later age at menopause. In comparison with women reporting primary school education, the OR was 1.4 in women with a secondary or university degree. In comparison with nulliparity, the OR of HRT use was 0.7 (95% confidence interval CI 0.6-0.7) in women with two or more births. HRT use was less frequent in women reporting a history of diabetes (OR 0.7, in comparison with women with no history, 95% CI 0.5-0.9) and cardiovascular diseases (OR 0.8, 95% CI 0.7-0.8) and more frequent in women with a history of osteopenia/osteoporosis (OR 1.2, 95% CI 1.0-1.5), but the latter finding was not statistically significant.
The results of the study indicate that HRT use is more common in this population in women of higher education with early age at menopause and with a history of osteoporosis/osteopenia and less frequent in women with a history of cardiovascular disease and diabetes.
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