Martha Gonzalez - Academia.edu (original) (raw)
Books by Martha Gonzalez
Papers by Martha Gonzalez
Colombian Applied Linguistics Journal, 2010
Investigational New Drugs, Oct 1, 2005
Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a ... more Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level < 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients > 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity. We developed an new, not-cytotoxic regimen with dexamethasone 30 mg/m(2), iv, days 1 to 4, all trans retinoic acid 45 mg/m(2), po, days 5 to 14 and interferon alfa 2a 4.5 MU, sc, daily, days 5 to 14 (DAI regimen) administered every 28 days in number of 6 cycles, at this point patients were restaging, if they showed complete response, objective response or partial response they were conducted to received thalidomide 100-200 mg po, daily and dexamethasone 10 mg/2, po days 1 to 4 at monthly intervals, for 18 months. Forty one patients were enrolled in an Phase II study. In an intent to treat analysis all patients were evaluable. Complete response was observed in 18 cases (43%), objective response in 10 patients (24%) and partial response in 5 patients (12%), overall response rate was 80%. Eight patients were considered failures. At an median of 36 months, no relapse of progression disease has been observed, thus actuarial curves at 3-years showed that event free survival is 100% and overall survival is 91%. Toxicity was mild, all patients received the planned dose in time. This regimen appear to be useful in older patients with multiple myeloma, the response rate is higher and toxicity was mild. Controlled clinical trials comparing with conventional chemotherapy will be conducted to define the role of this therapeutic approach.
Rev Invest Clin, Mar 1, 1992
... grupo IV, subgrupo C-2, que contempla "otras infecciones secunda... more ... grupo IV, subgrupo C-2, que contempla "otras infecciones secundarias"; lo cual si bien no indica que sean pacientes con SIDA si enfatiza la ... 9. Morfeldt-Manson L, Julander I, Nilsson B. Dermatitis of the face, yellow toe nail changes, hairy leukoplakia and oral candidiasis are ...
Tropical gastroenterology : official journal of the Digestive Diseases Foundation
was observed in only 53% of the patients with GERD.
Journal of the American Board of Family Medicine : JABFM
In 2003, the National Institutes of Health (NIH) created a translational science funding stream t... more In 2003, the National Institutes of Health (NIH) created a translational science funding stream to foster widespread, practice-based dissemination of scientific evidence. A decade later, our study of a national cohort of innovative practices suggests that effective dissemination continues to be prevented by the limited biomedical focus of funded research, conventional research strategies, and failure to report contextual factors.
Transactions of the Royal Society of Tropical Medicine and Hygiene, 1999
Studies on the protective efficacy of insecticide-treated materials (ITMs) in Plasmodium vivax en... more Studies on the protective efficacy of insecticide-treated materials (ITMs) in Plasmodium vivax endemic areas of Latin America have not yielded sufficient evidence for recommendation of their extensive use in the region. Therefore 2 randomized community trials have been conducted on the Pacific Coast of Nicaragua which analysed the minimum coverage of ITMs needed to be effective against malaria. For the characterization of the study area, epidemiological and entomological baseline surveys and household interview surveys were undertaken. Thereafter the communities were paired (6 pairs in the 1st year and 13 pairs in the 2nd year) according to 4-monthly reported malaria incidence rates, population size and bednet coverage, and then randomly allocated to intervention and control groups. In the intervention groups, bednets were impregnated with lambdacyhalothrin; in the control groups, people received general health education. Anopheles albimanus was found to be the main vector with marked indoor biting behaviour late in the evening. P. vivax (99%) clearly outweighed P. falciparum (1%) with low parasite prevalence rates in the asymptomatic general population (8%) and low parasite densities. The protective efficacy of ITMs varied according to the coverage achieved: protective efficacy was 68% in communities with an average ITM coverage of 50% (10 pairs); 31% in communities with an ITM coverage of 16-30% (4 pairs); and no protective efficacy in communities with ITM coverage below 16% (5 pairs). The comparison with other P. vivax endemic areas in Latin America showed that the vector's late biting behaviour and the indoor preference (where ITMs have a repellent effect) probably led to the favourable results in the study. In malaria endemic areas of Latin America, where P. vivax is predominant, studies on vector behaviour should be conducted in order to predict the impact of ITMs on malaria transmission.
Medical Oncology, 2008
We performed a controlled clinical trial to define the use of a brief therapy: CMED (cyclophospha... more We performed a controlled clinical trial to define the use of a brief therapy: CMED (cyclophosphamide, etoposide, methotrexate, and dexamethasone) compared with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in the treatment of peripheral T-cell lymphoma unspecific (PTCLu). The end point to the study was to assess efficacy, measured from complete response rate (CRR), progression-free survival (PFS), and overall survival in 217 previously untreated patients with PTCLu. In an intent-to treat analysis all patients were evaluable. CRR was 76% in CMED regimen and 57% in CHOP arm (P \ 0.05); actuarial curves at 10 years showed that PFS was 70% and 43%, respectively (P \ 0.01); overall survival was 60% and 34%, respectively (P \ 0.01). Adjuvant radiotherapy was employed in 48 cases (54% of patients who achieve CR in CMED arm) and 30 patients (47% of patients who achieve CR in CHOP arm). Acute toxicity was mild and well tolerated. Our results showed that the CMED regimen is feasible and effective in PTCLu.
Medical Oncology, 2007
To assess efficacy and toxicity of rituximab and dose chemotherapy in high-risk diffuse large cel... more To assess efficacy and toxicity of rituximab and dose chemotherapy in high-risk diffuse large cell lymphoma, we conducted a controlled clinical trial to assess efficacy and toxicity of a dose-dense regimen CEOP- 14 (cyclophosphamide, epirubicin, vincristine, and prednisone every 14 d) compared to CEOP-14 plus rituximab. One hundred and ninety-six patients were randomized to received CEOP-rituximab (cyclophosphamide 1500 mg/m2, epirubicin 120 mg/m2, vincristine, and prednisone at standard dose and rituximab at 375 mg/m2) compared with the same chemotherapy administered every 14 d (CEOP-14). In an intent-to-treat analysis all patients were available for efficacy and toxicity. Complete response in CEOP-14 was observed in 73 cases (74%) and in 75 patients (76%) in the CEOP-R regimen (76%) (p = 0.8). With a median follow-up of 53.4 mo, median has not been reached in time to tumor-progression (TTP) and overall survival (OS). Actuarial curves at 5 yr showed that TTP and OS in patients treated with CEOP-R were 74% and 67%, respectively, that were not statistical different when compared to CEOP-14, 72% and 65%, respectively (p = 0.8). Acute toxicity was mild and well tolerated. The use of a dense-dose regimen is useful and well tolerated in patients with very high risk diffuse large cell lymphoma. The addition of rituximab did not improve outcome in these setting of patients.
Here we report, for the first time in Cuba, the evaluation of the positive therapeutic action and... more Here we report, for the first time in Cuba, the evaluation of the positive therapeutic action and safety in a pilot clinical trial for ischemic cardiac arrhythmia, of a gene therapy using a plasmid expressing the vascular endothelial growth factor isoform 121 gene (pVEGF121). Six patients irrespective of sex or race, with ages between 49 and 71, were included. They
Tropical Medicine & International Health, 2007
A malaria study was undertaken in 98 rural communities of the Pacific coast of Ecuador (n= 14), C... more A malaria study was undertaken in 98 rural communities of the Pacific coast of Ecuador (n= 14), Colombia ( n = z z ) and Nicaragua (n=62). In-depth interviews on people's knowledge and practice regarding malaria aetiology, symptoms and treatment were conducted and complemented by formal household interviews. On the basis of this information, an educational programme was set up which included the training of village health promoters and community workshops organized by the health workers and used a set of methods of interactive learning. After the baseline survey the communities were paired and randomly allocated to the intervention and control groups. Malaria education took place only in the intervention communities.
Leukemia & Lymphoma, 2003
We start a controlled clinical trial to assess efficacy and toxicity of EBVD (epirubicin, bleomyc... more We start a controlled clinical trial to assess efficacy and toxicity of EBVD (epirubicin, bleomycin, vinblastine and dacarbazine) with an intensive and brief program of seven drugs administered weekly for 12 weeks in previously untreated patients with advanced Hodgkin's disease. Two hundred and sixty four patients were randomized to receive EBVD chemotherapy (134 cases) or intensive chemotherapy (130 cases). Eligible patients were either previously untreated stages III or IV. Patients with bulky disease received adjuvant radiotherapy. In an intent to treat analysis, all patients were evaluable for efficacy and toxicity. Complete response rate to the two regimens were similar (88 and 84%, respectively). However, actuarial 5 years overall survival rates were 87% (95% confidence interval (CI): 78-94%) for the EBVD regimen, which is statistically different to 59% (95% CI: 48-66%) for the intensive program (p < 0.01). Event-free survival were 83% (95% CI: 74-89%) for EBVD and 65% (95% CI: 58-71%) for the intensive program (p < 0.01). Significantly, more episodes of granulocytopenia grade III-IV, infection-related granulocytopenia, death-related infection even early hematological support with granulocyte colony stimulating factor were seen with the intensive, program. In the present single center trial, intensive chemotherapy did not appear to have better results when compared with standard chemotherapy in patients with advanced Hodgkin's disease.
Leukemia & Lymphoma, 2004
ABSTRACT The role of adjuvant radiotherapy to sites of nodal bulky disease in patients with aggre... more ABSTRACT The role of adjuvant radiotherapy to sites of nodal bulky disease in patients with aggressive diffuse large cell lymphoma (DLCL), and stage IV remain undefined. We began a prospective controlled clinical trial to evaluate impact in event free survival (EFS) and overall survival (OS) in a large cohort of patients with a longer follow-up. Between 1989 and 1995; 341 patients with aggressive DLCL and presence of nodal bulky disease (tumor mass > 10 cm) in pathological proven complete response after intensive chemotherapy were randomized to received either radiotherapy (involved fields, 40 Gy) or not. The 5-year EFS and OS in radiated patients were respectively: 82% (95% Confidence interval (CI): 70-89%) and 87% (95% 80-99%), that were statistically significant to control group: 55% (41-64%) (P < 0.001) and 66% (95% CI: 51-73%) (P < 0.01) respectively. Radiotherapy was well tolerated, acute toxicity was mild and until now late toxicity did not appear. The use of adjuvant radiotherapy improve EFS and OS and probably the possibility of cure in patients diffuse large cell lymphoma with worse prognostic factors. Thus, we felt that adjuvant radiotherapy will be considered as part of the initial treatment in this setting of patients.
Journal of Oral Pathology and Medicine, 1993
Oral findings of 42 Mexican AIDS patients with cancer were reviewed. Kaposi&amp;amp;amp;a... more Oral findings of 42 Mexican AIDS patients with cancer were reviewed. Kaposi&amp;amp;amp;amp;amp;amp;amp;#39;s sarcoma (KS) was the most frequent malignancy (81%) followed by non-Hodgkin&amp;amp;amp;amp;amp;amp;amp;#39;s lymphoma (NHL) (12%). All cases of NHL were of high or intermediate grade and most of them were extranodal. Out of the 34 individuals with KS, 22 (65%) showed oral KS and in 21 of them the palate was involved. The clinical features of oral KS including site, appearance and size are described. Pseudomembranous candidosis (PC), hairy leukoplakia (HL) and exfoliative cheilitis (ECh) were also found in these patients. There was no association of these lesions with any type of cancer. A strong association of oral candidosis and history of this infection was found, RR = 7.0 (1.3-4.1). There was evidence of severe immunosuppression in most patients, with mean average CD4 counts of 116 mm3 (range 4-841/mm3). Oral KS, ECh, PC and HL were more common in patients with lower CD4 counts. Our findings illustrate the most frequent oral lesions associated with HIV-1 infection in patients with AIDS and cancer, and further support the importance of oral examination in HIV infected patients.
Investigational New Drugs, 2005
Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a ... more Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity. We developed an new, not-cytotoxic regimen with dexamethasone 30 mg/m(2), iv, days 1 to 4, all trans retinoic acid 45 mg/m(2), po, days 5 to 14 and interferon alfa 2a 4.5 MU, sc, daily, days 5 to 14 (DAI regimen) administered every 28 days in number of 6 cycles, at this point patients were restaging, if they showed complete response, objective response or partial response they were conducted to received thalidomide 100-200 mg po, daily and dexamethasone 10 mg/2, po days 1 to 4 at monthly intervals, for 18 months. Forty one patients were enrolled in an Phase II study. In an intent to treat analysis all patients were evaluable. Complete response was observed in 18 cases (43%), objective response in 10 patients (24%) and partial response in 5 patients (12%), overall response rate was 80%. Eight patients were considered failures. At an median of 36 months, no relapse of progression disease has been observed, thus actuarial curves at 3-years showed that event free survival is 100% and overall survival is 91%. Toxicity was mild, all patients received the planned dose in time. This regimen appear to be useful in older patients with multiple myeloma, the response rate is higher and toxicity was mild. Controlled clinical trials comparing with conventional chemotherapy will be conducted to define the role of this therapeutic approach.
Cancer Biotherapy & Radiopharmaceuticals, 2007
Treatment of refractory mycosis fungoides and Sézary syndrome remain unsatisfactory. In this stud... more Treatment of refractory mycosis fungoides and Sézary syndrome remain unsatisfactory. In this study, we assessed the efficacy and toxicity of low-dose methotrexate (10 mg/m(2), biweekly) and interferon (9.0 MU, three times a week) as induction therapy by 6 or 12 months, followed, if patients achieved a complete remission, by interferon maintenance until toxicity or relapse. In an intent-to-treat analysis, 158 patients were considered evaluable. Complete response (biopsy proven) was observed in 112 patients (49 [31%] at 6 months and 63 [49%] at 12 months); thus, the complete response rate was 74%. With a median follow-up of 155 months (range, 62-181), progression-free disease was 71% and overall survival was 69%. Acute toxicity was mild, treatment was well tolerated, and to date no late toxicity has been observed. We conclude that this regimen is a benefit to this setting of patients, with excellent outcome and mild toxicity.
Cancer Biotherapy & Radiopharmaceuticals, 2009
We performed a phase II clinical trial to assess the efficacy and toxicity of the addition of rit... more We performed a phase II clinical trial to assess the efficacy and toxicity of the addition of rituximab and conventional chemotherapy in primary gastric lymphoma (PGL). Forty-two (42) patients with PGL, stage IE and IIE, and with low- or low-intermediate clinical risk were treated in a prospective longitudinal study with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy and rituximab (375 mg/m2, intravenously) on day 1 of each cycle administered every 21 days, for 6 cycles. The endpoint was to assess improvement in outcome measured by prolongation in event-free survival (EFS) and overall survival (OS). Complete response was achieved in 40 cases (95%) (95% confidence interval [CI]: 88%-102%). Relapse was observed in 2 cases. Two (2) patients died secondary to tumor progression. Thus, actuarial 5-year EFS was 95% (95 % CI: 87%-104%) and OS was 95% (95% CI: 88%-101%), which was not statistically different to historic controls. Acute toxicity was minimal and well tolerated, 4 cases developed late toxicity, 2 cases of herpes zoster infection, and 2 cases with granulocytopenia; in 1 case, the patient continued with mild granulocytopenia 3 years after treatment. The addition of rituximab to CHOP chemotherapy did not improve outcome in early-stage PGL.
Annals of Oncology, 2005
Background: High dose chemotherapy with supporting autologous stem cell transplantation is now co... more Background: High dose chemotherapy with supporting autologous stem cell transplantation is now considered the treatment of choice in patients with multiple myeloma <65 years old. The best regimen appears to be VAD (vincristine, doxorubicin and dexamethasone), but acute and late toxicity can limit the use of this combination. The use of biological modifiers has not been considered in this situation. We developed a new cytoreductive regimen, in an attempt to retain clinical efficacy but reduce toxicity. Patients and methods: Thirty-six patients, previously untreated with diagnosis of multiple myeloma were enrolled to received the DAI regimen (dexamethasone 30 mg/m 2 , i.v., days 1 -4, all-transretinoic acid 45 mg/m 2 , p.o., days 5 -14 and interferon alpha 2a, 4.5 MU s.c., days 5 -14) administered every 28 days for six cycles before high-dose chemotherapy (melphalan 200 g/m 2 ) and autologous stem cell transplantation. Results: Overall response was observed in 29 cases (80%), complete response in 19 and partial response in 10 patients. Five patients were >65 years old and were treated with dexamethasone/thalidomide. Twenty-four patients underwent transplants. At a median follow-up of 31.6 months, no relapse or disease progression was observed, thus actuarial curves at 3-years showed that event-free survival was 86% and overall survival was 94%. Toxicity was mild.
Annals of Hematology, 2011
... 20.↵: Papaldo P.,; Fabi A.,; Ferreti G.,; et al. . A phase II study on metastatic breast canc... more ... 20.↵: Papaldo P.,; Fabi A.,; Ferreti G.,; et al. . A phase II study on metastatic breast cancer patients treated with weekly vinorelbine with or without trastuzumab according to HER2 expression: changing the natural history of HER2-positive disease. Ann Oncol 2006;17:630-636. ...
Colombian Applied Linguistics Journal, 2010
Investigational New Drugs, Oct 1, 2005
Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a ... more Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity. We developed an new, not-cytotoxic regimen with dexamethasone 30 mg/m(2), iv, days 1 to 4, all trans retinoic acid 45 mg/m(2), po, days 5 to 14 and interferon alfa 2a 4.5 MU, sc, daily, days 5 to 14 (DAI regimen) administered every 28 days in number of 6 cycles, at this point patients were restaging, if they showed complete response, objective response or partial response they were conducted to received thalidomide 100-200 mg po, daily and dexamethasone 10 mg/2, po days 1 to 4 at monthly intervals, for 18 months. Forty one patients were enrolled in an Phase II study. In an intent to treat analysis all patients were evaluable. Complete response was observed in 18 cases (43%), objective response in 10 patients (24%) and partial response in 5 patients (12%), overall response rate was 80%. Eight patients were considered failures. At an median of 36 months, no relapse of progression disease has been observed, thus actuarial curves at 3-years showed that event free survival is 100% and overall survival is 91%. Toxicity was mild, all patients received the planned dose in time. This regimen appear to be useful in older patients with multiple myeloma, the response rate is higher and toxicity was mild. Controlled clinical trials comparing with conventional chemotherapy will be conducted to define the role of this therapeutic approach.
Rev Invest Clin, Mar 1, 1992
... grupo IV, subgrupo C-2, que contempla &amp;amp;amp;amp;quot;otras infecciones secunda... more ... grupo IV, subgrupo C-2, que contempla &amp;amp;amp;amp;quot;otras infecciones secundarias&amp;amp;amp;amp;quot;; lo cual si bien no indica que sean pacientes con SIDA si enfatiza la ... 9. Morfeldt-Manson L, Julander I, Nilsson B. Dermatitis of the face, yellow toe nail changes, hairy leukoplakia and oral candidiasis are ...
Tropical gastroenterology : official journal of the Digestive Diseases Foundation
was observed in only 53% of the patients with GERD.
Journal of the American Board of Family Medicine : JABFM
In 2003, the National Institutes of Health (NIH) created a translational science funding stream t... more In 2003, the National Institutes of Health (NIH) created a translational science funding stream to foster widespread, practice-based dissemination of scientific evidence. A decade later, our study of a national cohort of innovative practices suggests that effective dissemination continues to be prevented by the limited biomedical focus of funded research, conventional research strategies, and failure to report contextual factors.
Transactions of the Royal Society of Tropical Medicine and Hygiene, 1999
Studies on the protective efficacy of insecticide-treated materials (ITMs) in Plasmodium vivax en... more Studies on the protective efficacy of insecticide-treated materials (ITMs) in Plasmodium vivax endemic areas of Latin America have not yielded sufficient evidence for recommendation of their extensive use in the region. Therefore 2 randomized community trials have been conducted on the Pacific Coast of Nicaragua which analysed the minimum coverage of ITMs needed to be effective against malaria. For the characterization of the study area, epidemiological and entomological baseline surveys and household interview surveys were undertaken. Thereafter the communities were paired (6 pairs in the 1st year and 13 pairs in the 2nd year) according to 4-monthly reported malaria incidence rates, population size and bednet coverage, and then randomly allocated to intervention and control groups. In the intervention groups, bednets were impregnated with lambdacyhalothrin; in the control groups, people received general health education. Anopheles albimanus was found to be the main vector with marked indoor biting behaviour late in the evening. P. vivax (99%) clearly outweighed P. falciparum (1%) with low parasite prevalence rates in the asymptomatic general population (8%) and low parasite densities. The protective efficacy of ITMs varied according to the coverage achieved: protective efficacy was 68% in communities with an average ITM coverage of 50% (10 pairs); 31% in communities with an ITM coverage of 16-30% (4 pairs); and no protective efficacy in communities with ITM coverage below 16% (5 pairs). The comparison with other P. vivax endemic areas in Latin America showed that the vector's late biting behaviour and the indoor preference (where ITMs have a repellent effect) probably led to the favourable results in the study. In malaria endemic areas of Latin America, where P. vivax is predominant, studies on vector behaviour should be conducted in order to predict the impact of ITMs on malaria transmission.
Medical Oncology, 2008
We performed a controlled clinical trial to define the use of a brief therapy: CMED (cyclophospha... more We performed a controlled clinical trial to define the use of a brief therapy: CMED (cyclophosphamide, etoposide, methotrexate, and dexamethasone) compared with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in the treatment of peripheral T-cell lymphoma unspecific (PTCLu). The end point to the study was to assess efficacy, measured from complete response rate (CRR), progression-free survival (PFS), and overall survival in 217 previously untreated patients with PTCLu. In an intent-to treat analysis all patients were evaluable. CRR was 76% in CMED regimen and 57% in CHOP arm (P \ 0.05); actuarial curves at 10 years showed that PFS was 70% and 43%, respectively (P \ 0.01); overall survival was 60% and 34%, respectively (P \ 0.01). Adjuvant radiotherapy was employed in 48 cases (54% of patients who achieve CR in CMED arm) and 30 patients (47% of patients who achieve CR in CHOP arm). Acute toxicity was mild and well tolerated. Our results showed that the CMED regimen is feasible and effective in PTCLu.
Medical Oncology, 2007
To assess efficacy and toxicity of rituximab and dose chemotherapy in high-risk diffuse large cel... more To assess efficacy and toxicity of rituximab and dose chemotherapy in high-risk diffuse large cell lymphoma, we conducted a controlled clinical trial to assess efficacy and toxicity of a dose-dense regimen CEOP- 14 (cyclophosphamide, epirubicin, vincristine, and prednisone every 14 d) compared to CEOP-14 plus rituximab. One hundred and ninety-six patients were randomized to received CEOP-rituximab (cyclophosphamide 1500 mg/m2, epirubicin 120 mg/m2, vincristine, and prednisone at standard dose and rituximab at 375 mg/m2) compared with the same chemotherapy administered every 14 d (CEOP-14). In an intent-to-treat analysis all patients were available for efficacy and toxicity. Complete response in CEOP-14 was observed in 73 cases (74%) and in 75 patients (76%) in the CEOP-R regimen (76%) (p = 0.8). With a median follow-up of 53.4 mo, median has not been reached in time to tumor-progression (TTP) and overall survival (OS). Actuarial curves at 5 yr showed that TTP and OS in patients treated with CEOP-R were 74% and 67%, respectively, that were not statistical different when compared to CEOP-14, 72% and 65%, respectively (p = 0.8). Acute toxicity was mild and well tolerated. The use of a dense-dose regimen is useful and well tolerated in patients with very high risk diffuse large cell lymphoma. The addition of rituximab did not improve outcome in these setting of patients.
Here we report, for the first time in Cuba, the evaluation of the positive therapeutic action and... more Here we report, for the first time in Cuba, the evaluation of the positive therapeutic action and safety in a pilot clinical trial for ischemic cardiac arrhythmia, of a gene therapy using a plasmid expressing the vascular endothelial growth factor isoform 121 gene (pVEGF121). Six patients irrespective of sex or race, with ages between 49 and 71, were included. They
Tropical Medicine & International Health, 2007
A malaria study was undertaken in 98 rural communities of the Pacific coast of Ecuador (n= 14), C... more A malaria study was undertaken in 98 rural communities of the Pacific coast of Ecuador (n= 14), Colombia ( n = z z ) and Nicaragua (n=62). In-depth interviews on people's knowledge and practice regarding malaria aetiology, symptoms and treatment were conducted and complemented by formal household interviews. On the basis of this information, an educational programme was set up which included the training of village health promoters and community workshops organized by the health workers and used a set of methods of interactive learning. After the baseline survey the communities were paired and randomly allocated to the intervention and control groups. Malaria education took place only in the intervention communities.
Leukemia & Lymphoma, 2003
We start a controlled clinical trial to assess efficacy and toxicity of EBVD (epirubicin, bleomyc... more We start a controlled clinical trial to assess efficacy and toxicity of EBVD (epirubicin, bleomycin, vinblastine and dacarbazine) with an intensive and brief program of seven drugs administered weekly for 12 weeks in previously untreated patients with advanced Hodgkin&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease. Two hundred and sixty four patients were randomized to receive EBVD chemotherapy (134 cases) or intensive chemotherapy (130 cases). Eligible patients were either previously untreated stages III or IV. Patients with bulky disease received adjuvant radiotherapy. In an intent to treat analysis, all patients were evaluable for efficacy and toxicity. Complete response rate to the two regimens were similar (88 and 84%, respectively). However, actuarial 5 years overall survival rates were 87% (95% confidence interval (CI): 78-94%) for the EBVD regimen, which is statistically different to 59% (95% CI: 48-66%) for the intensive program (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.01). Event-free survival were 83% (95% CI: 74-89%) for EBVD and 65% (95% CI: 58-71%) for the intensive program (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.01). Significantly, more episodes of granulocytopenia grade III-IV, infection-related granulocytopenia, death-related infection even early hematological support with granulocyte colony stimulating factor were seen with the intensive, program. In the present single center trial, intensive chemotherapy did not appear to have better results when compared with standard chemotherapy in patients with advanced Hodgkin&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease.
Leukemia & Lymphoma, 2004
ABSTRACT The role of adjuvant radiotherapy to sites of nodal bulky disease in patients with aggre... more ABSTRACT The role of adjuvant radiotherapy to sites of nodal bulky disease in patients with aggressive diffuse large cell lymphoma (DLCL), and stage IV remain undefined. We began a prospective controlled clinical trial to evaluate impact in event free survival (EFS) and overall survival (OS) in a large cohort of patients with a longer follow-up. Between 1989 and 1995; 341 patients with aggressive DLCL and presence of nodal bulky disease (tumor mass > 10 cm) in pathological proven complete response after intensive chemotherapy were randomized to received either radiotherapy (involved fields, 40 Gy) or not. The 5-year EFS and OS in radiated patients were respectively: 82% (95% Confidence interval (CI): 70-89%) and 87% (95% 80-99%), that were statistically significant to control group: 55% (41-64%) (P < 0.001) and 66% (95% CI: 51-73%) (P < 0.01) respectively. Radiotherapy was well tolerated, acute toxicity was mild and until now late toxicity did not appear. The use of adjuvant radiotherapy improve EFS and OS and probably the possibility of cure in patients diffuse large cell lymphoma with worse prognostic factors. Thus, we felt that adjuvant radiotherapy will be considered as part of the initial treatment in this setting of patients.
Journal of Oral Pathology and Medicine, 1993
Oral findings of 42 Mexican AIDS patients with cancer were reviewed. Kaposi&amp;amp;amp;a... more Oral findings of 42 Mexican AIDS patients with cancer were reviewed. Kaposi&amp;amp;amp;amp;amp;amp;amp;#39;s sarcoma (KS) was the most frequent malignancy (81%) followed by non-Hodgkin&amp;amp;amp;amp;amp;amp;amp;#39;s lymphoma (NHL) (12%). All cases of NHL were of high or intermediate grade and most of them were extranodal. Out of the 34 individuals with KS, 22 (65%) showed oral KS and in 21 of them the palate was involved. The clinical features of oral KS including site, appearance and size are described. Pseudomembranous candidosis (PC), hairy leukoplakia (HL) and exfoliative cheilitis (ECh) were also found in these patients. There was no association of these lesions with any type of cancer. A strong association of oral candidosis and history of this infection was found, RR = 7.0 (1.3-4.1). There was evidence of severe immunosuppression in most patients, with mean average CD4 counts of 116 mm3 (range 4-841/mm3). Oral KS, ECh, PC and HL were more common in patients with lower CD4 counts. Our findings illustrate the most frequent oral lesions associated with HIV-1 infection in patients with AIDS and cancer, and further support the importance of oral examination in HIV infected patients.
Investigational New Drugs, 2005
Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a ... more Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity. We developed an new, not-cytotoxic regimen with dexamethasone 30 mg/m(2), iv, days 1 to 4, all trans retinoic acid 45 mg/m(2), po, days 5 to 14 and interferon alfa 2a 4.5 MU, sc, daily, days 5 to 14 (DAI regimen) administered every 28 days in number of 6 cycles, at this point patients were restaging, if they showed complete response, objective response or partial response they were conducted to received thalidomide 100-200 mg po, daily and dexamethasone 10 mg/2, po days 1 to 4 at monthly intervals, for 18 months. Forty one patients were enrolled in an Phase II study. In an intent to treat analysis all patients were evaluable. Complete response was observed in 18 cases (43%), objective response in 10 patients (24%) and partial response in 5 patients (12%), overall response rate was 80%. Eight patients were considered failures. At an median of 36 months, no relapse of progression disease has been observed, thus actuarial curves at 3-years showed that event free survival is 100% and overall survival is 91%. Toxicity was mild, all patients received the planned dose in time. This regimen appear to be useful in older patients with multiple myeloma, the response rate is higher and toxicity was mild. Controlled clinical trials comparing with conventional chemotherapy will be conducted to define the role of this therapeutic approach.
Cancer Biotherapy & Radiopharmaceuticals, 2007
Treatment of refractory mycosis fungoides and Sézary syndrome remain unsatisfactory. In this stud... more Treatment of refractory mycosis fungoides and Sézary syndrome remain unsatisfactory. In this study, we assessed the efficacy and toxicity of low-dose methotrexate (10 mg/m(2), biweekly) and interferon (9.0 MU, three times a week) as induction therapy by 6 or 12 months, followed, if patients achieved a complete remission, by interferon maintenance until toxicity or relapse. In an intent-to-treat analysis, 158 patients were considered evaluable. Complete response (biopsy proven) was observed in 112 patients (49 [31%] at 6 months and 63 [49%] at 12 months); thus, the complete response rate was 74%. With a median follow-up of 155 months (range, 62-181), progression-free disease was 71% and overall survival was 69%. Acute toxicity was mild, treatment was well tolerated, and to date no late toxicity has been observed. We conclude that this regimen is a benefit to this setting of patients, with excellent outcome and mild toxicity.
Cancer Biotherapy & Radiopharmaceuticals, 2009
We performed a phase II clinical trial to assess the efficacy and toxicity of the addition of rit... more We performed a phase II clinical trial to assess the efficacy and toxicity of the addition of rituximab and conventional chemotherapy in primary gastric lymphoma (PGL). Forty-two (42) patients with PGL, stage IE and IIE, and with low- or low-intermediate clinical risk were treated in a prospective longitudinal study with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy and rituximab (375 mg/m2, intravenously) on day 1 of each cycle administered every 21 days, for 6 cycles. The endpoint was to assess improvement in outcome measured by prolongation in event-free survival (EFS) and overall survival (OS). Complete response was achieved in 40 cases (95%) (95% confidence interval [CI]: 88%-102%). Relapse was observed in 2 cases. Two (2) patients died secondary to tumor progression. Thus, actuarial 5-year EFS was 95% (95 % CI: 87%-104%) and OS was 95% (95% CI: 88%-101%), which was not statistically different to historic controls. Acute toxicity was minimal and well tolerated, 4 cases developed late toxicity, 2 cases of herpes zoster infection, and 2 cases with granulocytopenia; in 1 case, the patient continued with mild granulocytopenia 3 years after treatment. The addition of rituximab to CHOP chemotherapy did not improve outcome in early-stage PGL.
Annals of Oncology, 2005
Background: High dose chemotherapy with supporting autologous stem cell transplantation is now co... more Background: High dose chemotherapy with supporting autologous stem cell transplantation is now considered the treatment of choice in patients with multiple myeloma <65 years old. The best regimen appears to be VAD (vincristine, doxorubicin and dexamethasone), but acute and late toxicity can limit the use of this combination. The use of biological modifiers has not been considered in this situation. We developed a new cytoreductive regimen, in an attempt to retain clinical efficacy but reduce toxicity. Patients and methods: Thirty-six patients, previously untreated with diagnosis of multiple myeloma were enrolled to received the DAI regimen (dexamethasone 30 mg/m 2 , i.v., days 1 -4, all-transretinoic acid 45 mg/m 2 , p.o., days 5 -14 and interferon alpha 2a, 4.5 MU s.c., days 5 -14) administered every 28 days for six cycles before high-dose chemotherapy (melphalan 200 g/m 2 ) and autologous stem cell transplantation. Results: Overall response was observed in 29 cases (80%), complete response in 19 and partial response in 10 patients. Five patients were >65 years old and were treated with dexamethasone/thalidomide. Twenty-four patients underwent transplants. At a median follow-up of 31.6 months, no relapse or disease progression was observed, thus actuarial curves at 3-years showed that event-free survival was 86% and overall survival was 94%. Toxicity was mild.
Annals of Hematology, 2011
... 20.↵: Papaldo P.,; Fabi A.,; Ferreti G.,; et al. . A phase II study on metastatic breast canc... more ... 20.↵: Papaldo P.,; Fabi A.,; Ferreti G.,; et al. . A phase II study on metastatic breast cancer patients treated with weekly vinorelbine with or without trastuzumab according to HER2 expression: changing the natural history of HER2-positive disease. Ann Oncol 2006;17:630-636. ...