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Biomedical subjects

G Mele

Publications and source records attributed to G Mele.

At least 19 recordsLinked to original sources
PubMed1999

Fludarabine, cytarabine, and granulocyte-colony stimulating factor for the treatment of high risk myelodysplastic syndromes.

BACKGROUND: The prognosis of patients with high risk myelodysplastic syndromes (MDS) (i.e., refractory anemia with excess of blasts [RAEB] and refractory anemia with excess of blasts in transformation [RAEB-t]) usually is poor. The combination of fludarabine, cytarabine, and granulocyte-colony stimulating factor (G-CSF) (FLAG regimen) has been reported to be effective in patients with these diseases. METHODS: Forty-two patients (32 with RAEB-t and 10 with RAEB) were treated with the FLAG regimen. The median age was 61 years (range, 27-74 years). Forty patients were diagnosed with primary MDS and 2 patients had treatment-related MDS. Induction therapy was comprised of the FLAG regimen, whereas consolidation therapy included idarubicin and cytarabine. Patients with a compatible donor and who were age < 50 years were scheduled to undergo an allogeneic bone marrow transplantation (BMT), whereas for those patients without a donor and who were age < 60 years autologous BMT with peripheral blood stem cells mobilized by the consolidation regimen plus G-CSF was planned. RESULTS: Complete remission (CR) was achieved in 31 of 42 patients (74%; 95% confidence interval, 60-87%). Death during induction therapy occurred in 4 patients (9%) whereas 7 patients (17%) were resistant to the FLAG regimen. Toxicity from the consolidation regimen was negligible. All patients age < 50 years and achieving CR were eligible for allogeneic BMT procedures, with early recurrence being the only reason for exclusion. The median overall survival and disease free survival were 13 months and 18 months, respectively. Patients with favorable cytogenetics had a significantly better outcome compared with those patients with an adverse karyotype. CONCLUSIONS: The FLAG regimen is effective in patients with high risk MDS as well as in patients age > 60 years. The toxicity of the regimen is low and the majority of patients are eligible to undergo allogeneic BMT procedures after induction/consolidation therapy.

Aged↗
PubMed1999

Fludarabine, cytarabine, and G-CSF (FLAG) for the treatment of acute myeloid leukemia relapsing after autologous stem cell transplantation.

Twenty-six patients affected by acute myeloid leukemia (AML) who relapsed after autologous stem cell transplantation (ASCT) were treated with the FLAG regimen (fludarabine, cytarabine, and G-CSF). Their median age was 39 years (range 14-59). The median interval from achievement of CR to ASCT was 4 months (2-8). The conditioning regimen was BAVC (BCNU, amsacrine, VP-16, cytarabine) in eight patients, BuCy (busulfan, cyclophosphamide) in 13, and TBI-Cy (total body irradiation, cyclophosphamide) in five. Relapse occurred after a median of 7 months (2-18). ASCT had been performed in CR1 for 23 patients and in CR2 for three. Nineteen patients had been given bone marrow, seven peripheral blood stem cells collected following consolidation plus G-CSF. Overall, CR was obtained by 13 patients (50%), all remitters requiring a single course. The median time for hematological recovery of neutrophils >500/microl and platelets >20,000/microl was 24 and 30 days, respectively. The median duration of G-CSF administration was 25 days, while the median hospitalization was 31 days. There were four deaths in induction (15%), while nine patients (35%) were resistant. After achieving CR, two patients received allogeneic BMT, five a second ASCT, and four were consolidated with HD-ARA-C. Only two patients were judged unable to receive any further therapy. There were 14 documented infections, while nine patients experienced fever of unknown origin. WHO >2 nonhematological toxicity consisted of stomatitis (50%), hepatic dysfunction (11%), diarrhea (11%), and lethargy (4%). Median overall survival and disease-free survival were 6 and 13 months, respectively. Six patients are in CCR at present. We conclude that FLAG is effective in patients with AML who are relapsing after ASCT. The toxicity is acceptable, enabling most patients to receive further treatment, including second transplantation procedures.

Acute Disease↗
PubMed1999

Vincristine as salvage treatment for refractory thrombotic thrombocytopenic purpura.

Vincristine (1.4 mg/m(2) on day 1, followed by 1 mg on days 4 and 7) was given to eight patients with thrombotic thrombocytopenic purpura (TTP) who were refractory to plasma exchange (n=4) or plasma infusion (n=4). Seven of eight patients (87%) achieved a complete response; one was refractory to treatment and died within a few weeks. After a median follow-up of 50 months, all responding patients are alive and well. Two patients relapsed and were successfully retreated with vincristine. Toxicity was mild, consisting of two episodes of leukopenia and one of autonomic neuropathy leading to paralytic ileus in a patient aged 70 years. We conclude that vincristine is highly effective in the treatment of patients suffering from refractory TTP, with negligible toxicity.

Adult↗
PubMed1999

MsJ1, an alfalfa DnaJ-like gene, is tissue-specific and transcriptionally regulated during cell cycle.

DnaJ-like proteins are molecular chaperones that regulate Hsp70 ATPase activity both in protein folding, assembly and disassembly of protein complexes. Here we report the isolation of MsJ1, an alfalfa gene encoding a protein homologous to cytosolic DnaJ-like proteins. MsJ1 was induced under heat-shock treatment in both leaves and stems of adult plants. In the absence of heat shock MsJ1 expression was tissue-specific with the highest levels of mRNA in roots and in embryonal structures. High levels of transcript were also detected in cotyledons where active degradation of storage protein occurs. In synchronized alfalfa suspension-cultured cells the MsJ1 transcript was actively expressed and showed a phase-specific modulation during cell cycle with a 2-fold induction in G2/M. These findings suggest that DnaJ-like proteins play an active role in regulating normal cellular events like protein degradation, morphogenesis and cell cycle progression.

Amino Acid Sequence↗
PubMed1998

Fludarabine, cytarabine, and G-CSF (FLAG) for the treatment of poor risk acute myeloid leukemia.

Thirty-eight patients with primary resistant or relapsing acute myeloid leukemia (AML) were treated with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). Median age was 41 (range 11-70). Sixteen patients had AML that was primary resistant to induction treatment, while 22 were relapsed, 11 after autologous bone marrow transplant (AuBMT), 8 less than 6 months from complete remission (CR) achievement, and 3 were second relapse from chemotherapy alone. Overall, 21 of 38 patients (55%) obtained CR. Age, sex, length of CR, and interval between autoBMT and FLAG administration did not significantly influence the CR rate. On the contrary, a normal karyotype at diagnosis was significantly related to a better outcome. There were 4 induction deaths (10%), due to fungal infection in 2 patients and hemorrhagic complications in the remaining two. All patients experienced profound cytopenia. Median time to neutrophil (>500/microl) recovery was 21 days, while a platelet count >20,000/microl was reached after 23 days. The median period of hospitalization was 31 days. The nonhematological toxicity was mild, mainly consisting of mucositis. There were 17 documented infections and 17 episodes of fever of unknown origin. Following CR achievement, 6 patients received autoBMT, 3 alloBMT, 2 high-dose arabinosil-cytosine, and 2 are on a waiting list for transplantation procedure. We conclude that FLAG is an effective and well-tolerated regimen for refractory or recurrent AML, mainly useful for patients to be admitted to bone marrow transplantation.

Acute Disease↗
PubMed1998

Spontaneous splenic rupture in a patient with acute lymphoblastic leukemia of Burkitt type.

We describe a case of spontaneous splenic rupture occurred in a patient with acute lymphoblastic leukemia of Burkitt type before starting cytotoxic chemotherapy. Left hypochondrial pain radiating to the homolateral shoulder was the only clinical symptom. Emergency computed tomography showed splenic laceration and hemoperitoneum. The patient underwent immediate laparatomy with splenectomy and experienced an uneventful postoperative recovery. Eight days after surgery, chemotherapy could be administered and complete remission was achieved. Although spontaneous rupture of the spleen is rare in leukemia and related disorders, this diagnosis should be taken in account also when clinical symptoms are mild. Following immediate operative management, patients may completely recover and receive cytotoxic chemotherapy with substantial possibilities of achieving complete remission.

Abdominal Pain↗
PubMed1998

Therapeutic options and treatment results for patients over 75 years of age with acute myeloid leukemia.

BACKGROUND AND OBJECTIVE: Acute myeloid leukemia (AML) is a prevalent disease of the elderly. Given the progressive aging of the general population, the frequency of the disease will further increase, especially in very old individuals. In a cohort of 70 consecutive AML patients aged over 75 years, we investigated the clinico-hematological characteristics and treatment results. DESIGN AND METHODS: Seventy patients aged > 75 were diagnosed at our institutions as having AML between January 1987 and December 1996. This figure represents 8% of the whole AML patient population observed during the same period. These patients were studied concerning the main clinical and hematological features at presentation, therapeutic approach and clinical outcome. RESULTS: A myelodysplastic syndrome preceded the onset of AML in 10 patients (14%). Trilinear myelodysplasia was present in 28 patients (40%). Hypocellular leukemia was diagnosed in 12 cases (17%). An active infection was found in 12 patients (17%). Aggressive chemotherapy was given to 22 patients (31%), low-dose ARA-C (LDARA-C) to 7 patients (10%), while 41 (58%) were managed with supportive care and/or hydroxyurea (HU). Therapeutic choice was significantly influenced by performance status (p = .03), infections (p = .0001), severe co-morbid disease (p = .0001), and hypocellular AML diagnosis (p = .0001). Complete remission (CR) was obtained in 7/22 patients aggressively treated (32%), 0/7 in the LD-ARA-C group, and in one patient treated with HU. The median survival for the whole patient population was 18 weeks. There was no significant difference among the three treatment groups. However, patients achieving CR experienced significantly longer survival as did those with hypocellular leukemia. INTERPRETATION AND CONCLUSIONS: In spite of a relevant selection at diagnosis, intensive chemotherapy is not appropriate for the majority of very old patients with AML. However, since a minority of patients takes substantial advantage from an aggressive approach, any effort should be made to preliminarily identify this subset at diagnosis.

Acute Disease↗
PubMed1997

Circadian performance of suprachiasmatic nuclei (SCN)-lesioned antelope ground squirrels in a desert enclosure.

Circadian activity parameters of 53 white-tailed antelope ground squirrels, Ammospermophilus leucurus, were measured to determine the role of the suprachiasmatic nuclei (SCN) pacemaker in their health and survival. Wheel-running activity was monitored in the laboratory with 44 individuals to document the presence of free-running circadian rhythms and ability to entrain to light-dark cycles. Twenty-two individuals were returned to the desert site of origin, including 12 intact control animals and 10 animals whose circadian timing had been disrupted by SCN-lesioning. Time of activity was recorded continuously for 15 days in a large outdoor enclosure by a motion detector, a microchip transponder detector, and video surveillance. An unplanned nighttime attack by a feral cat resulted in the death of 60% of the SCN-lesioned animals and 29% of the control animals in the enclosure. Surface activity of SCN-lesioned animals at the food cache occurred both in daytime and at night, ranging from 16.0% nighttime activity for one partially lesioned individual to 52.1% for one completely lesioned animal. Controls were strongly day-active, with nighttime surface trips constituting only 0-1.3% of all excursions to the cache. Nine wild free-ranging individuals, including one with a radiotransmitter collar, were exclusively day-active. One of the functions of the SCN in mammals may be to reduce activity of animals during times that are unfavorable for activity.

Animals↗
PubMed1993

Recombinant interferon alpha-2b in the treatment of polycythemia vera.

We studied the effects of recombinant alpha 2-b interferon (alpha 2-b IFN) in a dose of 3 x 10(6)U intramuscularly three times a week for 1 year in 13 patients affected by polycythemia vera (PV) previously treated with phlebotomy only. Response to treatment was evaluated by reduction of the number of phlebotomies required to retain normal hematocrit value. Ten out of 13 patients (77%) responded to treatment; in 4 of them the exigency of phlebotomy was completely eliminated. In all responders a concomitant decrease of platelet count and splenomegaly was obtained. Treatment was well tolerated and side effects were easily controlled. We conclude that alpha-IFN may represent an attractive therapeutic option in the management of the proliferative stages of PV.

Adult↗
PubMed1992

Clinical relevance of immunological dissection in T-ALL: a report on 20 cases with stem cell (CD7+, CD4-, CD8-, CD1-) phenotype.

In a prospective study on 44 cases of T-cell origin acute lymphoblastic leukemia, 20 patients were found to display an immature immunophenotype (CD7+, CD4-, CD8-, CD1-) and were classified as T-stem cell leukemia (T-SCL). Twenty-four patients expressed CD4 and/or CD8 antigens on their blast cells, designated T acute lymphoblastic leukemia (T-ALL). The T-SCL subset showed a significantly higher median age, a more frequent incidence of extramedullary leukemia, a morphology L1 in most cases, and a poor response to treatment in terms of either complete remission rate or median survival duration. In addition, significant differences between the two groups were found in evaluating the number of days of blast disappearance from peripheral blood, of CR achievement, and of neutrophils and platelets recovery. We conclude that T-SCL represents a distinct clinical entity, characterized by a poor response to ALL conventional chemotherapy. Alternative therapeutic approaches should be developed for patients suffering from this form of leukemia, to modify its severe prognosis.

Adult↗
PubMed1992

Recombinant interferon-alpha 2A as maintenance treatment for patients with advanced stage chronic lymphocytic leukemia responding to chemotherapy.

Forty-five patients suffering from advanced B-CLL were randomized to receive interferon-alpha (IFN alpha) or no treatment after achieving complete remission or partial response, following a chemotherapy protocol called MiNa. The two groups were fully comparable in terms of clinical characteristics and level of response obtained by chemotherapy. IFN alpha was given at a dose of 3 megaunits three times a week intramuscularly for 1 year. The IFN-treated patient group showed a significantly longer duration of response and a less frequent incidence of infections as compared to the no treatment group. A minority of patients who had had partial response to chemotherapy obtained complete remission while on therapy with IFN alpha. Toxicity was mild and patient compliance was excellent. We conclude that IFN alpha may have a role as maintenance therapy in CLL for patients responding to chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

Post-marketing survey of nimesulide in the short-term treatment of osteoarthritis.

A multicentric trial was carried out to assess the therapeutic efficacy and tolerability of nimesulide in the treatment of patients with osteoarthritis. The trial involved 1600 general practitioners, 80 orthopedists and 88 specialists in internal medicine. A total of 22,938 ambulatory patients was admitted to the trial. Patients were given nimesulide tablets (40%) or granules (60%) from 100 to 400 mg/day for a length of time ranging from 1 to 3 weeks. The treatment was effective in relieving spontaneous pain and morning stiffness. The level of patients with adverse reactions, presumably related to nimesulide and mostly involving the gastro-intestinal tract, was 8%. The results of this study suggest that nimesulide is effective and well tolerated in the short-term treatment of a large number of patients with osteoarthritis.

Adult↗
PubMed1990

Myeloid antigen expression in adult acute lymphoblastic leukemia: clinicohematological correlations and prognostic relevance.

Fifty adult patients with acute lymphoblastic leukemia (ALL) were prospectively studied to determine the clinical and hematological relevance of surface immunophenotypes. Before treatment, blast cells were assayed for reactivity to monoclonal antibodies to B-cell, T-cell, and myeloid (My) antigens. My antigens (CD13, CD33, and VIM2, singly or in combination) were demonstrated in 16 cases (32%) along with lymphoid specificities. Bone marrow and peripheral blood stains were classified according to French-American-British (FAB) Cooperative Group criteria and evaluated for myelodysplastic changes and azurophilic granules. Mean age of My+ patients was significantly higher. Furthermore, a greater number of My+ cases showed azurophilic cytoplasmic granules and acid ANAE positivity. FAB subtypes and myelodysplastic features did not significantly differ in the two groups analyzed, but patients with myelodysplastic abnormalities represented a significantly older age group. Response to treatment was comparable in My+ and My- cases, in terms of either complete remission rate or median survival duration.

Adult↗
PubMed1989

A new combination chemotherapy for advanced chronic lymphocytic leukemia (vincristine, cyclophosphamide, melphalan, peptichemio, and prednisone protocol).

The MiNa protocol (vincristine, cyclophosphamide, melphalan, peptichemio, and prednisone) was given to 20 patients with advanced B-cell chronic lymphocytic leukemia. Complete remission (absence of all clinical and bone marrow evidence of leukemia) was obtained in 35% of cases; partial response (greater than 50% reduction in organ enlargement and decreasement of lymphocyte count to less than 15(9) X 10/l) was observed in 35% of patients. Of 12 patients (60%) previously treated with chlorambucil and corticosteroids, nine responded to treatment. Toxicity was mild and the relapse rate particularly low. It was concluded that the MiNa protocol represents an effective chemotherapy for advanced and/or progressive CLL.

Aged↗
PubMed1988

Antibiotic prophylaxis for abdominal hysterectomy.

Three different regimens of antibiotic treatment have been employed in order to evaluate their efficacy as a profilaxis for abdominal hysterectomy. Two short term administrations (Cephtriaxone and Cephamandole plus Tobramycine) and a conventional full dose treatment (Cephazoline) have been compared over a group of homogeneous patients. No significant differences, except a reduction in postoperative time spent in hospital, have been found among the groups. A reduction in urinary tract infection has also been reported with a single-dose antibiotic prophylaxis.

Anti-Bacterial Agents↗
PubMed1987

[Diacereine: an original approach in the treatment of degenerative and/or extra-articular rheumatism].

71 patients with variously located osteoarthrosis or primary fibromyalgic syndrome were treated with oral diacereine (DAR). The case series was accumulated in successive periods and may be divided into three groups. An "open" test on DAR (100 mg/die for 4 weeks) was conducted on the first group of 31 arthrosis patients. On the second group of 20 other arthrosis patients a "double-blind, cross-over" test was carried out using DAR (100 mg/die) and naproxene (500 mg/die) both for 2 weeks. The third group of 20 patients with fibromyalgia was treated with DAR alone: 100 mg/die 5 days a week for 12 weeks. The efficacy of the treatment was judged on the basis of the following parameters: rest pain, pressure pain, pain on active and passive movement, and functional limitation. In the first group a positive therapeutic effect was noted in 20 cases (68.9%). There were side effects (moderate diarrhea) in 3 patients 2 of whom suspended treatment. In the second group, DAR and naproxene had an almost identical effect. However 7 patients (36.8%) expressed a preference for DAR, 9 (47.4%) expressed no preference and only 3 (15.8%) preferred naproxene. Side effects were encountered in 3 patients treated with naproxene (2 cases of epigastralgia and pyrosis and 1 case of dyspnea so marked as to require suspension of treatment) and in 3 treated with DAR (modest diarrhea). In the third group, a positive therapeutic effect was noted in 68.4% of the patients with fibromyalgia with a 15% incidence of side effects consisting of slight abdominal pain (diarrhea caused suspension of treatment in 1 case only). Blood chemical parameters were studied in all three groups and no alterations attributable to the treatment were found. The obtained result suggests that the new drug is effective and well tolerated in the envisaged indications.

Administration, Oral↗