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M Algara

Publications and source records attributed to M Algara.

At least 19 recordsLinked to original sources
PubMed1999

[Multicenter double-blind clinical trial comparing sucralfate vs placebo in the prevention of diarrhea secondary to pelvic irradiation].

BACKGROUND: Sucralfate has been used in the prophylaxis of acute enteric toxicity induced by radiation therapy of pelvic organs. The aim of the study was to demonstrate the efficacy of sucralfate in the prevention of the acute enteric toxicity induced by pelvic irradiation in cancer patients, compared with placebo, in a multicentric double-blind randomised clinical trial. PATIENTS AND METHOD: One hundred and twenty patients, with a localised pelvic cancer, 18 to 80 years old, with a Karnofsky index of 80% or more, and "normal" defecation habits (3-10 defecations/week), undergoing whole pelvic irradiation, were included. The duration of the study was 7 weeks, with weekly controls. The first week all patients received placebo. In the second week the patients were randomised into two groups: sucralfate (61 patients, 2 g/tid p.o. before meals) and placebo (59 patients). Radiotherapy started at the beginning of the third week and lasted until the end of the study. All patients received 45-50 Gy total dose (1.8-2 Gy/day, 5 days/week) with the "box technique". The main variables were the number of stools per week and the number of loperamide pills per week. RESULTS: The number of stools per week showed no differences between groups. By the contrary in the group intention to treat (120 patients) and per protocol (100 cases) the percentage of diarrhoeal stools per week showed a statistical significance in favour of sucralfate: (p < 0.05) and (p < 0.03) respectively, concerning the evolution of this variable from the baseline (first week) to the end of the pelvic radiotherapy (seventh week). Furthermore, the consumption of loperamide was significantly lower in the sucralfate group (p < 0.001). CONCLUSION: Sucralfate is effective in the preparation of acute enteric toxicity induced by pelvic irradiation.

Adolescent↗
PubMed1995

[Allogenic bone marrow transplantation in multiple myeloma. Analysis of 12 consecutive cases].

BACKGROUND: Allogeneic bone marrow transplantation (BMT) is the only potentially curative treatment in multiple myeloma (MM). METHODS: From january 1986 to december 1993, 12 cases (10 males and 2 females) underwent BMT in the authors' institution. The mean age of the series was 39 years (range 23-49). The situation of the myeloma on initiation of the conditioning was: complete remission (CR) in 2 cases, objective response in 5 cases, partial response in 1 case and treatment resistance in 4 cases. The conditioning schedule included cyclophosphamide (120 mg/kg) and total body irradiation (10-14 Gy) with or without melfalan at high doses in 11 patients and busulfan (16 mg/kg) and cyclophosphamide (120 mg/kg) in 1 case. The prophylaxis of graft versus host disease (GVHD) was carried out with methotrexate and cyclosporine A (CsA) in 7 cases, CsA plus prednisone in 2 cases and 3 patients received CsA plus bone marrow partially depleted of T lymphocytes by elutriation. RESULTS: The situation of the myeloma with regard to response following transplantation was: unevaluable in 1 case, resistant in 1 case, objective response in 2 cases and CR in 8 cases. Seven out of the 10 patients at risk presented grades II-IV GVHD. Four of the 8 patients who were in CR following transplantation died due to post transplant complications and 2 out of the 6 relapsed 9 months after the transplant while 2 remain in CR at 5 and 8 years after the transplant, respectively. Nine patients died due to infection in 2 cases, GVHD and infection in 4 cases, GVHD and hemorrhage in 1 case and progression and infection in 2 cases. Of the 3 surviving patients, 1 relapsed at 14 months after the transplant and two remain in CR at 5 and 8 years post transplantation. CONCLUSIONS: Bone marrow transplantation conditioning gives place to a high number of complete remission in multiple myeloma. However, the incidence of acute grade II-IV graft versus host disease and mortality due to complications related to the transplantation are very high. Nonetheless, a proportion of patients may achieve curation with bone marrow transplantation.

Adult↗
PubMed1995

[Bone marrow transplantation from unrelated donors in chronic myeloid leukemia: the results in 15 patients].

BACKGROUND: Bone marrow transplantation (BMT) from a histocompatible donor is the only curative treatment in chronic myeloid leukemia (CML). Only a minority of patients dispose of an adequate donor from among his/her relatives. The remaining transplant receptors must look to unrelated donors (URD). The experience of the Escuela de Hematología Farreras Valentí (Farreras Valentí School of Hematology, Barcelona, Spain) in BMT from URD in CML in the first chronic phase is herein reported. METHODS: Fifteen patients (9 males and 6 females, median age 33 years; range 14-48 years) were transplanted from October 1988 to May 1994. Serologic identity was expressed in the A, B and D loci in 9 cases and minor incompatibility in 6. Conditioning included total body irradiation and cyclophosphamide in 14 patients and busulphan plus cyclophosphamide in 1. Partial and selective T lymphocyte depletion was performed by elutriation in 7 cases. RESULTS: Primary implant failure was detected in 2 out of 14 risk patients (14%) and secondary failure was observed in 3 out of 12 cases (25%). The actuarial probability of acute graft versus host disease (GVHD) was 55 +/- 15% at 7 weeks with a probability of appearance with an intensity of II-IV of 31 +/- 13%. Five out of 7 patients with a survival of greater than 100 days, developed chronic GVHD (71%). Ten presented fatal complications. In 5 cases, death was due to pulmonary problems. Recurrence of CML was not observed in any of the patients in the series. The probability of disease free survival at 2 years was 30 +/- 12%. CONCLUSIONS: Bone marrow transplantation from an unrelated donor is an effective treatment for a proportion of patients with chronic myeloid leukemia although severe complications are frequent and originate a high mortality.

Adolescent↗
PubMed1994

[Half-body irradiation. Palliative efficacy and predictive factors of response in 78 procedures].

BACKGROUND: Assessment of palliative effect of hemibody irradiation (HBI) and response-related factors. METHODS: Analysis of prospective collected data of 78 procedures on 71 patients with multiple symptomatic bone metastases, treated with 6 Gy (upper half-body) or 8 Gy (lower half-body) HBI in single fraction. Clinical improvement was quantified by self-evaluation on a visual analogic scale (SVAS) before HBI, and at 24, 48 and 72 hours, at 7 days, and at each monthly control until patient's death. Univariate analysis included: sex, Karnofsky's index, tumor origin, histology, HBI dose, and SVAS before treatment. For statistical purposes the significance level was 0.05. RESULTS: Complete (37.5%) or partial responses were observed in 72/78 (92.3%) procedures, 80% appearing during the first 72 hours. Difference between mean SVAS, before and after treatment (7.7 +/- 1.5 vs 2.8 +/- 2.5), was statistically significant (p < 0.001). A mean response duration of 101 days over a mean overall survival of 141 days implies the 70% of expected patient's life span. Any analyzed prognostic factor does not correlate significantly with HBI response. CONCLUSIONS: HBI is a powerful palliative treatment in patients with multiple symptomatic bone metastasis.

Aged↗
PubMed1994

[The prognostic factors of early mortality in bone marrow transplantation in patients with chronic myeloid leukemia].

INTRODUCTION: The use of bone marrow transplantation (BMT) in leukemia treatment is associated with high early morbid-mortality rates. Therefore, to identify morbid-mortality risk factors in this setting can be useful to improve therapeutic ratio. METHODS: We studied 15 variables in 46 patients with chronic myeloid leukemia (CML) treated with cyclophosphamide, total body irradiation (TBI) and allogeneic BMT. A multivariant analysis with an unconditional logistic regression model was used. RESULTS: Variables found to be related with early mortality included general state of health and acute graft versus host disease. Patients with a Karnofsky index (KI) between 60% and 80% had a higher risk of early death than those with a KI between 90 and 100%. Patients who developed severe (grade II-IV) acute graft versus host disease (AGVHD), had a relative risk of 15.62 (IC 95%: 3.16-77.34) compared with those who do not. Time between diagnosis and BMT contributed to the creation of the mathematical model without reaching statistical significance. CONCLUSIONS: In this series and in the range of the parameters analysed, general state of health according to KI, and the appearance of severe AGVHD are the variables related with a higher risk of early mortality.

Acute Disease↗
PubMed1994

Outpatient total body irradiation for bone marrow transplantation.

Five selected patients entering a BMT program were included in a prospective feasibility study to evaluate the tolerance to total body irradiation (TBI) on an outpatient basis. Four fractions of 3 Gy in 4 consecutive days (8 Gy lung total dose) were given. Ondansetron 8 mg/8 h orally was used without sedation as anti-emetic regimen. After each treatment dose, patients went home where they remained in close telephone contact with the BMT team. After the last TBI fraction, patients were hospitalized and treated with cyclophosphamide 60 mg/g/day for 2 consecutive days. The outpatient TBI regimen was well tolerated in four cases. Only one patient presented with nausea and vomiting after the second treatment day. She was admitted to the hospital and treated with chlorpromazine. During the conditioning and hematological recovery period, no complications related to the outpatient TBI could be identified. We conclude that TBI can be given on an outpatient basis with safety. Additionally, it represents a cost saving of US$ 1160 per patient.

Adult↗
PubMed1993

Risk factors for early mortality in allogeneic bone marrow transplantation. A multivariate analysis on 174 leukaemia patients.

Allogeneic bone marrow transplantation in patients with leukaemia is an aggressive therapeutic procedure which implies high early mortality. Current opinion trends attribute the greater part of the procedure toxicity to the preparative regimen. The results of a multivariate analysis on data of 174 leukaemia patients conditioned with total body irradiation (TBI), 10-12 Gy, single dose or fractionated, and lung shielding at 8 Gy, plus chemotherapy: cyclophosphamide 120 mg/kg, before or after TBI, are presented. The variables statistically related with early mortality are age, Karnofsky index (KI) and acute graft-versus-host disease (GvHD). No variable depending on radiotherapy reached the significance level. The relative risk of early mortality for patients older than 26 years, in bad general condition (KI < 90%), or developing acute severe (grades II-IV)GvHD, is 3.99, 5.68, and 6.71, respectively. We conclude that in the range of TBI schedules analysed, radiation therapy is not an important factor in early death, but acute severe GvHD, or recipient's bad general condition are factors to be improved by bone marrow transplantation teams if they want to improve the therapeutic index of the procedure.

Adolescent↗
PubMed1993

A single dose of granulocyte colony-stimulating factor modifies radiation-induced death in B6D2F1 mice.

Granulocyte colony stimulating factor (G-CSF) stimulates the proliferation of progenitor cells committed to myeloid differentiation. In animal models, G-CSF is able to stimulate granulocyte recovery and promote survival after lethal or sublethal irradiation when administered as daily injections, suggesting an influence on the residual hematopoietic primitive precursors surviving irradiation. In this study, we clearly demonstrate that a single dose of G-CSF (1 mg/kg) administered to B6D2F1 mice 2 hours after a lethal dose 95/30 irradiation achieves a 78% survival at day +30 after irradiation. Survival of G-CSF treated mice compares favourably with that of syngenic bone marrow transplantation recipients (78% vs 90%, ns).

Animals↗
PubMed1993

Autologous bone marrow transplantation for acute leukemia: results and prognostic factors in 90 consecutive patients.

The results of autologous bone marrow transplantation (ABMT) in acute leukemia (AL) and the prognostic factors for outcome were analyzed in a series of 90 consecutive patients treated at a single institution (mean +/- SD age: 25 +/- 11 years). Diagnosis was: AML (n = 43), ALL (n = 44), acute undifferentiated leukemia (n = 2) and acute bilineage (n = 1). Disease stage at ABMT was: first complete remission (CR1) 46 cases, CR2 33, other stages 11. Conditioning consisted of cyclophosphamide and total body irradiation in 88 patients. The 3 year probability of disease-free survival (DFS) was influenced by disease stage at ABMT: CR1 48%, CR2 28%, CR3 plus CR4 15%. The characteristics associated with a high probability of relapse were: in AML a FAB subtype other than M1 or M3 (p = 0.01) and in ALL an interval between CR1 and ABMT of < 3 months (p = 0.002). A WBC > 15 x 10(9)/l at diagnosis (p = 0.01), splenomegaly at diagnosis (p = 0.002) and time to CR1 > 4 weeks (p = 0.06) increased the risk of relapse in the entire group in CR1. In multivariate analysis, WBC at diagnosis (p = 0.006) and disease stage at ABMT (p = 0.03) independently influenced DFS. This study confirms the encouraging results of ABMT in CR1 but further antileukemia measures are necessary in patients with adverse prognostic features.

Acute Disease↗
PubMed1993

Interstitial pneumonitis after BMT: 15 years experience in a single institution.

Data from 311 patients with hematological malignancies who received an autologous, allogeneic or syngeneic BMT in a single institution were analyzed. Interstitial pneumonia (IPn) was observed in 58 patients. Two years actuarial probability of IPn was 26.8%. In 50% of cases CMV was detected. In 23 patients (39.7%) IPn was considered idiopathic. The median time from BMT to IPn was 63.5 (range 7-720) days. Patients submitted to allogeneic BMT had a significantly higher risk of developing IPn than patients receiving syngeneic or autologous BMT (34.1% vs 16.7% and 4.9%, respectively; p = 0.0006). Among 230 patients receiving allogeneic transplant, factors with a higher risk for IPn in univariate analysis were: age over 20 years, CML, alloimmunized donor, previous splenectomy, acute and chronic GVHD. When the analysis was restricted to patients with a CMV-associated IPn, all factors except alloimmunization maintained their significance. Multivariate analysis showed that only acute GVHD (p < 0.0001) and a diagnosis of CML (p < 0.001) in the whole group of allogeneic transplants, and acute GVHD (p < 0.001) and splenectomy (p < 0.003) in CMV-associated IPn, maintained their significance. These results are discussed within the frame work of the clinical application of BMT.

Adolescent↗
PubMed1991

[Efficacy of sucralfate in the prophylaxis of diarrhea secondary to acute radiation-induced enteritis. Preliminary results of a double-blind randomized trial].

BACKGROUND: Pelvic radiation therapy is usually associated with intestinal symptoms, especially diarrhea. Sucralfate has been demonstrated to be effective in peptic ulcers, and seems to provide some benefits in chemotherapy induced mucositis and radiogenic rectitis and enteritis. METHODS: Thirty-four patients between 20-80 years of age, without diarrea and with a Karnofsky index greater than 60%, undergoing whole pelvic irradiation (46 Gy total dose, 2 Gy/day, 5 days/week) have been randomized to receive: sucralfate (1g/6h) (18 patients) or placebo (16 patients) during the treatment period and 3 weeks later. RESULTS: The statistical analysis of the clinical records show that patients receiving sucralfate do better during the whole treatment period (p = 0.03), and they need other complementary measures against diarrhea, as diet (p = 0.03) or pharmacologic support (p = 0.002), later in the course of the radiotherapy. Nevertheless, the incidence and severity of diarrea and other associated simptoms show no differences between both groups. CONCLUSIONS: Sucralfate increases the enteric tolerance during pelvic irradiation in cancer patients.

Acute Disease↗
PubMed1991

Dosimetry and use of an immobilization system for head and neck radiotherapy treatments.

The day-to-day reproducibility of planned radiotherapy treatment is an important precondition for achieving good clinical results and reducing toxic effects. This reproducibility is difficult to achieve in the irradiation of head and neck malignancies because of the mobility of this anatomical area. This paper presents a dosimetric study and analysis of the utility of a facial mask immobilization system prepared from an orthopedic glass-fiber bandage. The dosimetric study conducted on a lucite phantom shows that the interposition of one, two, or three layers of the bandage reduces the deep absorbed dose by about 1% at 0.5 cm2, while increasing the absorbed surface dose by 12% (for a field of 15 X 15 cm2 and one layer of bandage) to 46% (for a field of 5 X 5 cm and three layers of bandage). The dosimetric study conducted on a Rando Anderson manikin shows an average increase in the skin dose of about 8% and a maximum increase of about 20%. The good dosimetric results and the practicality of this system of immobilization have persuaded us to propose it as an alternative to the systems currently on the market, which, although rather more sophisticated, are also more expensive.

Head and Neck Neoplasms↗
PubMed1990

Fractionated total body irradiation for bone marrow transplantation: clinical results on 66 patients.

Short term clinical results of bone marrow transplantation on 66 patients conditioned with fractionated total body irradiation (12 Gy in 6 fractions and 3 days) are presented here. An acute toxic effects incident, similar to that obtained previously, a 27.6% interstitial pneumonitis associated with acute severe graft versus host disease in 77% of cases, 19.2% relapses, and 41% total crude survival with an actuarial probability of surviving for more than two years of 46% for ALL, 64% for AML and 28% for CML, are the results obtained since now.

Adolescent↗