ABSTRACT
STUDY DESIGN: Cross sectional. OBJECTIVES: To determine the inter-rater and intra-rater reliability of the Spanish version of the Berg Balance Scale with incomplete spinal cord injured subjects. SETTING: CINER Rehabilitation Center. METHODS: We administered and video recorded the Spanish version of the Berg Balance Scale to 20 incomplete SCI patients. Two raters scored the videos on two different occasions at least three weeks apart. We used intraclass correlation coefficient (ICC) and a confidence interval (CI) of 95% to evaluate the inter-rater and intra-rater (test-retest) reliability of the BBS total scores. RESULTS: ICC values for inter-rater reliability at first and second observation were 0.99 (95% CI 0.97-1.00) and 0.99 (95% CI 0.99-1.00), respectively. Intra-rater ICC for rater 1 was 1.00 (95% CI 1.00-1.00) and for rater 2 was 1.00 (95% CI 0.99-1.00). All of them were excellent. CONCLUSIONS: The results indicate that the Spanish version of the Berg Balance Scale is a reliable tool to evaluate spinal cord injured patients' balance.
Subject(s)
Disability Evaluation , Postural Balance/physiology , Spinal Cord Injuries/diagnosis , Spinal Cord Injuries/rehabilitation , Translating , Adult , Aged , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Observer Variation , Reproducibility of Results , Young AdultABSTRACT
The purpose of this study was to evaluate the trends in complete remission (CR) rate, disease-free survival (DFS), and overall survival (OS) through 35 years of Grupo Argentino de Tratamiento de la Leucemia Aguda (GATLA) clinical trials. A total of 1,254 adult patients with Hodgkin's Lymphoma were evaluated according to seven consecutive protocols. This 35-year study was divided into three phases. The patients in the first phase (1968-1985) were treated with CVPP (cyclophosphamide/vinblastine/procarbazine/prednisone) plus involved-field radiotherapy (IFRT). In the CVPP regimen, cyclophosphamide and vinblastine were administered intravenously on day 1 and prednisone and procarbazine were administered orally on days 1-14 every 28 days. The second phase (1986-1996) used mainly reinforced CVPP with cyclophosphamide and vinblastine on days 1-8 plus IFRT. The third phase (1997-2003) used ABVD(doxorubicin/bleomycin/vinblastine/dacarbazine) plus IFRT. In clinical stage I/II, the CR rate was 86% in 252 patients treated in the first phase and DFS and OS were 57% and 78% at 5 years and 50% and 71% at 10 years. The second phase had 148 patients with clinical stage I/II disease, and the CR rate was 91%, 5-year DFS and OS were 78% and 90%, and 10-year DFS and OS were 70% and 83%. The third phase had 182 patients with clinical stage I/II disease, and the CR rate was 95%, 5-year DFS and OS were 87% and 96%, and 10-year DFS and OS were not reached. The statistical difference was P = 0.016 in terms of CR and P < 0.001 in terms of DFS and OS. In the first phase of 394 patients with clinical stage III/IV disease, the CR rate was 71%, DFS and OS at 5 years were 37% and 62%, and DFS and OS at 10 years were 32% and 53%. In the second phase of 164 patients with clinical stage III/IV disease, the CR rate was 84%, DFS and OS at 5 years were 66% and 80%, and DFS and OS at 10 years were 60% and 75%. In the third phase of 114 patients with clinical stage III/IV disease, the CR rate was 88% and DFS and OS at 5 years were 60% and 90%. The DFS and OS were not reached at 10 years. The differences among the 3 phases in CR, DFS and OS were highly significant (P < 0.001).
Subject(s)
Hodgkin Disease/therapy , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Argentina , Clinical Trials as Topic , Combined Modality Therapy , Cyclophosphamide/administration & dosage , Disease-Free Survival , Hodgkin Disease/diagnosis , Hodgkin Disease/mortality , Humans , Middle Aged , Prednisolone/administration & dosage , Procarbazine/administration & dosage , Prognosis , Radiotherapy , Remission Induction , Time Factors , Treatment Outcome , Vinblastine/administration & dosageABSTRACT
BACKGROUND: Monitoring minimal residual disease (MRD) by real-time quantitative polymerase chain reaction (RT-PCR) in chronic myeloid leukemia (CML) patients is mandatory in the era of tyrosine kinase inhibitors. Achieving a major molecular response (MMR) at 12 and 18 months predicts a better progression and event-free survival. PATIENTS AND METHODS: The objective of this prospective, multicentric study was to evaluate MRD by standardized RT-PCR in 178 patients with chronic-phase CML who were treated with imatinib at different institutions in Argentina and Uruguay and to determine if achievement of a stable MMR (BCR-ABL transcript levels < 0.1%) identifies a low-risk cytogenetic relapse group. The median age of the patients was 50 years, and 55% of them had received imatinib as first-line therapy. BCR-ABL transcript levels were measured after achievement of complete cytogenetic remission (CCyR) and at 6-month intervals. RESULTS: MMR was detected in 44% patients at the start of the study. This value increased to 79% at month 36 of evaluation. Complete molecular response (CMR) also increased from 24% to 52% of patients. Not achieving a stable MMR determined a higher risk of cytogenetic relapse (9% of MMR patients not achieving an MMR vs. 1% of patients who achieved MMR). Patients with sustained MMR had a significantly better cytogenetic relapse-free survival at 48 months (97% vs. 87%; P = .008) but showed no differences in overall survival. Patients who did not remain in CCyR changed treatment. CONCLUSIONS: A stable MMR is a strong predictor for a durable CCyR. Standardized molecular monitoring could replace cytogenetic analysis once CCyR is obtained. These results emphasize the validity and feasibility of molecular monitoring in all standardized medical centers of the world.
Subject(s)
Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/genetics , Piperazines/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Pyrimidines/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Argentina , Benzamides , Female , Fusion Proteins, bcr-abl/genetics , Humans , Imatinib Mesylate , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/diagnosis , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/mortality , Male , Middle Aged , Neoplasm, Residual/diagnosis , Neoplasm, Residual/genetics , Prognosis , Remission Induction , Survival Analysis , Treatment Outcome , Uruguay , Young AdultABSTRACT
BACKGROUND: Doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD) plus involved-field radiation therapy (IFRT) is the gold-standard treatment for early and advanced stages of Hodgkin lymphoma (HL). We evaluated the outcomes of patients according to prognosis at diagnosis and over time to determine who achieved complete remission (CR). PATIENTS AND METHODS: Treatment-naive patients under the age of 75 years at all stages of HL were eligible. The favorable group (FG) contained patients with stage IA-IIIA disease without bulky areas who achieved CR after the third cycle of ABVD. They received only IFRT at 25 Gy. Patients in the unfavorable group (UG) exhibited stages IIIB and IV HL. The UG also included all patients with bulky disease and the subset of the FG without CR after 3 cycles of ABVD, ie, slow responders (FGSR). The UG received 6 cycles of ABVD plus IFRT at 30 Gy to bulky areas at diagnosis or to those areas remaining positive after the third cycle of ABVD. RESULTS: In total, 584 patients were evaluable: 285 of them belonged to the FG, and 299 to the UG. Rates of CR were 98% and 85% for the FG and the UG, respectively (P < .001). Sixty patients in the FG received 6 cycles of ABVD because they had not achieved CR after 3 cycles (ie, the FGSR subgroup). The 5-year event-free survival rate was 89% for the FG, 66% for the FGSR, and 72% for the UG (P < .001). The overall survival at 5 years was significantly better for the FG (98%) than for the FGSR (87%) and the UG (88%; P < .001). CONCLUSION: Patients from the FG demonstrated excellent outcomes compared with those from the FGSR and UG, despite receiving less chemotherapy and fewer doses of IFRT.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Hodgkin Disease/therapy , Adolescent , Adult , Aged , Bleomycin/administration & dosage , Child , Combined Modality Therapy , Dacarbazine/administration & dosage , Disease-Free Survival , Doxorubicin/administration & dosage , Drug Administration Schedule , Female , Hodgkin Disease/mortality , Hodgkin Disease/pathology , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Neoplasm Staging , Prognosis , Radiotherapy , Radiotherapy Dosage , Remission Induction , Risk Factors , Vinblastine/administration & dosage , Young AdultABSTRACT
BACKGROUND: The objective of this analysis was to evaluate the role of autologous stem cell transplantation (ASCT) in prolonging disease free survival (DFS) and overall survival (OS) in patients with chronic myeloid leukemia (CML) who received autografts of Philadelphia chromosome (Ph) positive or Ph negative cell harvests. METHODS: Over a 4-year period (1994-1999), 53 patients who underwent ASCT for CML were reported to the Argentine Group of Bone Marrow Transplantation (GATMO) Registry. RESULTS: Ph negative cell products were harvested in only 18 patients (34%). Comparison of disease status at the time of autograft, duration of neutropenia, thrombocytopenia, days of antibiotics, and transfusional requirements of red blood cells and platelets did not reveal statistical significant differences between the Ph positive group and the Ph negative group. Only days of hospitalization were increased significantly in patients who received Ph positive autografts. Although DFS at 36 months was significantly longer after infusion of Ph negative cell products (54% vs. 14%; P Subject(s)
Leukemia, Myelogenous, Chronic, BCR-ABL Positive/therapy
, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative/therapy
, Peripheral Blood Stem Cell Transplantation
, Adolescent
, Adult
, Disease-Free Survival
, Female
, Hospitalization
, Humans
, Length of Stay
, Leukemia, Myelogenous, Chronic, BCR-ABL Positive/pathology
, Male
, Middle Aged
, Retrospective Studies
, Transplantation, Autologous
, Treatment Outcome
ABSTRACT
BACKGROUND:Monitoring minimal residual disease (MRD) by real-time quantitative polymerase chain reaction (RT-PCR) in chronic myeloid leukemia (CML) patients is mandatory in the era of tyrosine kinase inhibitors. Achieving a major molecular response (MMR) at 12 and 18 months predicts a better progression and event-free survival.PATIENTS AND METHODS:The objective of this prospective, multicentric study was to evaluate MRD by standardized RT-PCR in 178 patients with chronic-phase CML who were treated with imatinib at different institutions in Argentina and Uruguay and to determine if achievement of a stable MMR (BCR-ABL transcript levels < 0.1%) identifies a low-risk cytogenetic relapse group. The median age of the patients was 50 years, and 55% of them had received imatinib as first-line therapy. BCR-ABL transcript levels were measured after achievement of complete cytogenetic remission (CCyR) and at 6-month intervals.RESULTS:MMR was detected in 44% patients at the start of the study. This value increased to 79% at month 36 of evaluation. Complete molecular response (CMR) also increased from 24% to 52% of patients. Not achieving a stable MMR determined a higher risk of cytogenetic relapse (9% of MMR patients not achieving an MMR vs. 1% of patients who achieved MMR). Patients with sustained MMR had a significantly better cytogenetic relapse-free survival at 48 months (97% vs. 87%; P = .008) but showed no differences in overall survival. Patients who did not remain in CCyR changed treatment.CONCLUSIONS:A stable MMR is a strong predictor for a durable CCyR. Standardized molecular monitoring could replace cytogenetic analysis once CCyR is obtained. These results emphasize the validity and feasibility of molecular monitoring in all standardized medical centers of the world(AU)
Subject(s)
Humans , Male , Female , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/diagnosis , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/genetics , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/therapy , Piperazines/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Pyrimidines/therapeutic use , Bibliography, National , UruguayABSTRACT
El control de calidad se efectuó sobre los valores obtenidos, relativos y absolutos, de linfocitos T y de sus subpoblaciones CD4+ y CD8+ en muestras de sangre de pacientes infectados con el virus de la inmunodeficiencia humana (HIV). El estudio incluyó dieciocho centros: diez utilizaron citómetros de flujo de Becton Dickinson, tres de Coulter y 5 de Ortho que representan a 17 laboratorios de Argentina y a uno de Uruguay. Los siguientes programas se utilizaron para analizar los datos : SimulSET, Paint a Gate (Becton Dickinson), Profile II, XL System (Coulter), ImmunoCount Trio y Combo Cytoron (Ortho). Se obtuvieron muestras de sangre periférica en horas de la mañana (8 a 10 hs) de 10 voluntarios normales (por serología y hemograma) y de 10 pacientes HIV positivos con valores previos de CD4 que variaron entre 200-350 células por microlito y fueron procesadas dentro de las 12 horas. Cada centro obtuvo los valores relativos con el procedimiento técnico habitual y el de los valores absolutos utilizando el hemograma propio. Además, en un contador hematológico Cell-Dyn 3500 se obtuvo para cada muestra el hemograma correspondiente considerado de referencia. Los valores absolutos medios, obtenidos en cada centro con el hemograma propio, para los linfocitos T y los de sus subpoblaciones fueron significativamente diferentes. No hubo diferencias significativas para los valores porcentuales entre los diferentes centros ni para los valores absolutos obtenidos con el hemograma de referencia. Concluimos que las diferencias en los valores absolutos de los linfocitos T y sus subpoblaciones dependen del recuento hematológico empleado. (AU)
Subject(s)
Humans , Male , Female , Adult , Flow Cytometry/methods , Multicenter Studies as Topic , Quality Control , Lymphocyte Subsets , CD4-Positive T-Lymphocytes , CD8-Positive T-Lymphocytes , HIV , Data Interpretation, Statistical , Blood Specimen Collection , CD4 Lymphocyte Count/methodsABSTRACT
El control de calidad se efectuó sobre los valores obtenidos, relativos y absolutos, de linfocitos T y de sus subpoblaciones CD4+ y CD8+ en muestras de sangre de pacientes infectados con el virus de la inmunodeficiencia humana (HIV). El estudio incluyó dieciocho centros: diez utilizaron citómetros de flujo de Becton Dickinson, tres de Coulter y 5 de Ortho que representan a 17 laboratorios de Argentina y a uno de Uruguay. Los siguientes programas se utilizaron para analizar los datos : SimulSET, Paint a Gate (Becton Dickinson), Profile II, XL System (Coulter), ImmunoCount Trio y Combo Cytoron (Ortho). Se obtuvieron muestras de sangre periférica en horas de la mañana (8 a 10 hs) de 10 voluntarios normales (por serología y hemograma) y de 10 pacientes HIV positivos con valores previos de CD4 que variaron entre 200-350 células por microlito y fueron procesadas dentro de las 12 horas. Cada centro obtuvo los valores relativos con el procedimiento técnico habitual y el de los valores absolutos utilizando el hemograma propio. Además, en un contador hematológico Cell-Dyn 3500 se obtuvo para cada muestra el hemograma correspondiente considerado de referencia. Los valores absolutos medios, obtenidos en cada centro con el hemograma propio, para los linfocitos T y los de sus subpoblaciones fueron significativamente diferentes. No hubo diferencias significativas para los valores porcentuales entre los diferentes centros ni para los valores absolutos obtenidos con el hemograma de referencia. Concluimos que las diferencias en los valores absolutos de los linfocitos T y sus subpoblaciones dependen del recuento hematológico empleado.