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1.
Cancer Treat Res Commun ; 27: 100358, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33957603

RESUMO

INTRODUCTION: Breast cancer is the tumor with highest incidence in women worldwide and adjuvant treatment is extremely important to achieve disease control. Given the relevance of systematic reviews, their rigor should be warranted to avoid biased conclusions. Our objective was to investigate the methodological quality of meta-analysis of early breast cancer adjuvant treatment. MATERIAL AND METHODS: Comprehensive searches were performed using electronic databases from 1/1/2007 to 11/12/2018. All studies identified as a systematic review with meta-analysis investigating the efficacy of breast cancer adjuvant treatments were included. Two reviewers independently assessed titles and abstracts, then full-texts for eligibility. Quality was assessed using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) version 2 tool. RESULTS: Of 950 citations retrieved, 66 studies (7.0%) were deemed eligible. Methodological quality was highly variable, median AMSTAR score 8.5 (IQR 7-9.5) and range 0-16. There was a weak positive correlation between journal impact factor and AMSTAR score (r = 0.17) and citation rate and AMSTAR score (r = 0.16). Cochrane Systematic Reviews were of higher quality than reviews from other journals. Overall confidence was critically low for 61 (92.4%) studies, and the least well-reported domains were the statement of conflict of interest and funding source for the included studies (4.6%), the report of a pre-defined study protocol (15.2%), and the description of details of excluded studies (6.1%). CONCLUSIONS: Our findings reinforce concerns about the design, conduction and interpretation of meta-analysis in current literature. Methodological quality should be carefully considered and journal editors, decision makers and readers in general, must follow a critical approach to this studies.

2.
Crit Rev Oncol Hematol ; 160: 103296, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33675904

RESUMO

We systematically reviewed the quality of AEs reports in published oncology trials analyzing also the bias in the attribution process. We searched MEDLINE, PubMed (2000-2019) selecting randomized, double-blind, placebo-controlled, and phase 3 cancer trials using exclusively targeted therapy or immunotherapy-related drugs. The proportion of publications with complete AE reports (including both all-cause and drug-related AE data) and the AEs attribution ratio (patients with drug-related over all-cause AE) were investigated. Among 60 trials (38,174 patients) included, 40 (66.6 %) presented an incomplete report of AEs attribution. Journals with the lowest impact factor were significantly associated with deficient reports of grade 3-4 AEs (p = 0.02). Under placebo administration, the median incidence of all-grade drug-related AEs was 49 % (IQR 39-56). The median attribution ratio for all-grade AEs in the active and placebo arms was 88.9 % (IQR 79.8-93) and 53.9 % (IQR 43.4-60.9), respectively. The AEs reporting and attribution process appear to be more unreliable than expected.


Assuntos
Neoplasias , Método Duplo-Cego , Humanos , Fatores Imunológicos , Imunoterapia , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Oncologist ; 25(10): e1562-e1573, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32888360

RESUMO

BACKGROUND: The COVID-19 outbreak has resulted in collision between patients infected with SARS-CoV-2 and those with cancer on different fronts. Patients with cancer have been impacted by deferral, modification, and even cessation of therapy. Adaptive measures to minimize hospital exposure, following the precautionary principle, have been proposed for cancer care during COVID-19 era. We present here a consensus on prioritizing recommendations across the continuum of sarcoma patient care. MATERIAL AND METHODS: A total of 125 recommendations were proposed in soft-tissue, bone, and visceral sarcoma care. Recommendations were assigned as higher or lower priority if they cannot or can be postponed at least 2-3 months, respectively. The consensus level for each recommendation was classified as "strongly recommended" (SR) if more than 90% of experts agreed, "recommended" (R) if 75%-90% of experts agreed and "no consensus" (NC) if fewer than 75% agreed. Sarcoma experts from 11 countries within the Sarcoma European-Latin American Network (SELNET) consortium participated, including countries in the Americas and Europe. The European Society for Medical Oncology-Magnitude of clinical benefit scale was applied to systemic-treatment recommendations to support prioritization. RESULTS: There were 80 SRs, 35 Rs, and 10 NCs among the 125 recommendations issued and completed by 31 multidisciplinary sarcoma experts. The consensus was higher among the 75 higher-priority recommendations (85%, 12%, and 3% for SR, R, and NC, respectively) than in the 50 lower-priority recommendations (32%, 52%, and 16% for SR, R, and NC, respectively). CONCLUSION: The consensus on 115 of 125 recommendations indicates a high-level of convergence among experts. The SELNET consensus provides a tool for sarcoma multidisciplinary treatment committees during the COVID-19 outbreak. IMPLICATIONS FOR PRACTICE: The Sarcoma European-Latin American Network (SELNET) consensus on sarcoma prioritization care during the COVID-19 era issued 125 pragmatical recommendations distributed as higher or lower priority to protect critical decisions on sarcoma care during the COVID-19 pandemic. A multidisciplinary team from 11 countries reached consensus on 115 recommendations. The consensus was lower among lower-priority recommendations, which shows reticence to postpone actions even in indolent tumors. The European Society for Medical Oncology-Magnitude of Clinical Benefit scale was applied as support for prioritizing systemic treatment. Consensus on 115 of 125 recommendations indicates a high level of convergence among experts. The SELNET consensus provides a practice tool for guidance in the decisions of sarcoma multidisciplinary treatment committees during the COVID-19 outbreak.


Assuntos
COVID-19/epidemiologia , Oncologia/organização & administração , Oncologia/normas , Sarcoma/terapia , COVID-19/prevenção & controle , Consenso , Europa (Continente)/epidemiologia , Humanos , América Latina/epidemiologia , Assistência ao Paciente/normas , Guias de Prática Clínica como Assunto , SARS-CoV-2 , Sarcoma/diagnóstico
6.
Cancers (Basel) ; 12(9)2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32825562

RESUMO

Malignant melanoma represents the most aggressive type of skin cancer. Modern therapies, including targeted agents and immune checkpoint inhibitors, have changed the dismal prognosis that characterized this disease. However, most evidence was obtained by studying patients with frequent subtypes of cutaneous melanoma (CM). Consequently, there is an emerging need to understand the molecular basis and treatment approaches for unusual melanoma subtypes. Even a standardized definition of infrequent or rare melanoma is not clearly established. For that reason, we reviewed this challenging topic considering clinical and molecular perspectives, including uncommon CMs-not associated with classical V600E/K BRAF mutations-malignant mucosal and uveal melanomas, and some unusual independent entities, such as amelanotic, desmoplastic, or spitzoid melanomas. Finally, we collected information regarding melanomas from non-traditional primary sites, which emerge from locations as unique as meninges, dermis, lymph nodes, the esophagus, and breasts. The aim of this review is to summarize and highlight the main scientific evidence regarding rare melanomas, with a particular focus on treatment perspectives.

7.
Ecancermedicalscience ; 14: 1058, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32582373

RESUMO

Background: In hormone receptor-positive, HER-2 negative (HR+/HER2-) advanced breast cancer (ABC) endocrine therapy (ET) plus cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in first and second line improved progression-free survival (PFS), overall response rate (ORR) and clinical benefit rate (CB) without deterioration in quality of life compared with ET alone. In addition, recent data showed improvement in overall survival (OS) for premenopausal women in first line setting and for different subgroups of patients in second line. Since 2015, in Argentina, the combination of ET with CDK4/6i is a standard of care in HR+/HER2- ABC. Methods: We carried out a prospective analysis of real-world use of palbociclib with ET in HR+/HER2- ABC patients who received treatment between October 2015 and August 2019 in two private institutes from Buenos Aires, Argentina. The aims of the study were to determine efficacy and safety of patients treated with ET and palbociclib, describe patient profile and treatment strategy beyond progression. Results: One-hundred and twenty-eight patients were included in the final analysis. Main baseline characteristics include, median age 57 years, 20% were premenopausal women, 44% had visceral metastasis and 26% bone only disease. More than half of patients had two or more metastatic sites, 44.4% had performance status 1, and most of them (59.4%) were treated with palbociclib in first-line setting. Palbociclib was preferentially associated with aromatase inhibitors in 63.9% of patients, and with fulvestrant in the remaining. All premenopausal women received ovarian suppression or ovarian ablation (OS/OA). The median PFS was 36.7 months in first line and 24.2 months in second line. The ORR was 45.3% and 25.0% in first and second line, respectively. The median OS in the entire population was not reached. Half of patients did not require dose interruption and/or delay, dose reduction was required in 15% of patients and almost no patients required drug discontinuation (2.0%). With regard to safety, 55% of patients developed grade 3-4 adverse events, 20% neutropenia grade 3-4, and 7% febrile neutropenia. Infections were presented in one out of three patients, mostly uncomplicated. Conclusions: This is the first prospective evidence of real-world use of palbociclib in a Latin American population. We found similar outcomes to the PALOMA-2 and PALOMA-3 randomised trials and Real-World Data already published, with lower incidence of side effects and treatment discontinuation, but with higher incidence of febrile neutropenia.

9.
Melanoma Manag ; 6(4): MMT33, 2019 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-31871622

RESUMO

Aim: To describe treatment patterns among patients with stage III melanoma who underwent surgical excision in years 2011-2016, and assess outcomes among patients who subsequently received systemic adjuvant therapy versus watch-and-wait. Methods: Chart review of 380 patients from 17 melanoma centers in North America, South America and Europe. Results: Of 129 (34%) patients treated with adjuvant therapy, 85% received interferon α-2b and 56% discontinued treatment (mostly due to adverse events). Relapse-free survival was significantly longer for patients treated with adjuvant therapy versus watch-and-wait (hazard ratio = 0.63; p < 0.05). There was considerable heterogeneity in adjuvant treatment schedules and doses. Similar results were found in patients who received interferon-based adjuvant therapy. Conclusion: Adjuvant therapies with better safety/efficacy profiles will improve clinical outcomes in patients with stage III melanoma.

10.
Adv Ther ; 36(12): 3446-3457, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31630333

RESUMO

INTRODUCTION: Pazopanib is approved in Latin America as first targeted therapy for patients with metastatic renal cell carcinoma (mRCC). METHODS: A retrospective chart review of adult patients with mRCC who initiated pazopanib as first targeted therapy between January 2011 and March 2016 was conducted among oncology care centers in Argentina, Brazil, Chile, Colombia, and Mexico. Patient characteristics, treatment patterns, overall survival (OS), progression-free survival (PFS), and adverse events were summarized. RESULTS: A total of 156 charts of patients with mRCC receiving first-line pazopanib were reviewed (29, 54, 27, 28, and 18 patients from Argentina, Brazil, Chile, Colombia, and Mexico, respectively). The mean age at initial mRCC diagnosis was 61.6 years, 73.7% were male, and 51.3% were Hispanic. The median dose of pazopanib was 800 mg and the median time from initial mRCC diagnosis to pazopanib start was 2.2 months. The median time on treatment was 10.0 months. At the time of data extraction, 16.7% of patients remained on pazopanib, with clinical progression listed as the main reason for discontinuation. Subsequent therapy was received by 25.6% of patients; the most common were everolimus (9.6%) and axitinib (5.8%). Overall, median PFS and OS were 10.8 and 16.9 months, respectively, and varied across countries. The most common all-grade adverse events were diarrhea (44.9%), asthenia/fatigue (43.6%), and nausea (28.8%). CONCLUSIONS: Pazopanib was used for first-line mRCC treatment in a clinically diverse patient population across Latin America. Real-world PFS and tolerability were similar to clinical studies of pazopanib. FUNDING: Novartis Pharmaceuticals Corporation, Inc.


Assuntos
Carcinoma de Células Renais/tratamento farmacológico , Neoplasias Renais/tratamento farmacológico , Pirimidinas/uso terapêutico , Sulfonamidas/uso terapêutico , Idoso , Carcinoma de Células Renais/mortalidade , Carcinoma de Células Renais/patologia , Progressão da Doença , Everolimo/uso terapêutico , Feminino , Humanos , Neoplasias Renais/mortalidade , Neoplasias Renais/patologia , América Latina , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Padrões de Prática Médica , Intervalo Livre de Progressão , Pirimidinas/administração & dosagem , Pirimidinas/efeitos adversos , Estudos Retrospectivos , Sulfonamidas/administração & dosagem , Sulfonamidas/efeitos adversos , Tempo para o Tratamento
11.
Pediatr Neurol Briefs ; 33: 5, 2019 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-31929716

RESUMO

A panel of experts representing academic centers, family foundations and pharmaceutical industry came together to formulate a treatment algorithm for infants diagnosed via newborn screening (NBS) with Spinal muscular atrophy (SMA).

12.
JAMA Netw Open ; 1(8): e185617, 2018 12 07.
Artigo em Inglês | MEDLINE | ID: mdl-30646278

RESUMO

Importance: Several reports have associated the placebo effect with objective response and improvement of a clinical condition in oncology, but only a few studies have analyzed the adverse events (AEs) in the placebo groups of the clinical trials. Objective: To determine the incidence of placebo AEs reported in randomized clinical trials of modern cancer drugs in the adjuvant setting. Data Sources: Based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline, a systematic literature search of English-language publications from January 1, 2000, through April 15, 2018, was performed using MEDLINE (PubMed). The following search terms were used to retrieve all trials from the PubMed library: adjuvant, maintenance, consolidation, and placebo, in addition to specific cancer type-related keywords. Study Selection: A double-blind, randomized, placebo-controlled, phase 3 design was mandatory for study inclusion. Only studies enrolling patients who had undergone macroscopically complete resections were included. No other anticancer treatments in addition to placebo were allowed in the control group. Only trials involving a targeted therapy (tyrosine kinase, BRAF, or MEK inhibitors) or immunotherapy-related drugs were included. Trials using chemotherapy, interferon, and endocrine therapy were excluded. Two authors (D.H.E. and F.D.W.) independently reviewed the studies for inclusion. Data Extraction and Synthesis: Data were extracted by investigators, and random-effects meta-analysis was performed to estimate the proportion of grade 3 to 4 placebo AEs in the included studies. Main Outcomes and Measures: Incidence of grade 3 to 4 placebo AEs in the placebo groups. Results: Of 731 studies screened, 10 eligible trials were found including 4 tumor types (melanoma, non-small cell lung cancer, gastrointestinal stromal tumor, and renal cell carcinoma). Overall, 11 143 patients (6270 [56.3%] in the treatment group with mean [SD] age of 55.6 [4.2] years and 4873 patients [43.7%] in the placebo group with mean [SD] age of 55.9 [4.3] years) were included. The mean incidence of any-grade placebo AEs was 85.1% (95% CI, 79.2%-91.0%). The most frequent (mean [SD]) grade 3 to 4 placebo AEs in patients were hypertension (2.8% [2.2%]), fatigue (1.0% [0.9%]), and diarrhea (0.8% [0.6%]). The overall, random-effects pooled incidence of grade 3 to 4 placebo AEs was 18% (95% CI, 15%-21%), with a high level of heterogeneity (I2 = 86%). Frequency of grade 3 to 4 placebo AEs was found to be correlated in the treatment and placebo groups (ρ = 0.7; P = .03). Mean study drug discontinuation owing to placebo AEs was 3.9% (95% CI, 2.7%-5.2%). Conclusions and Relevance: Placebo administration was associated with a substantial incidence of grade 3 to 4 placebo AEs in modern cancer adjuvant trials. This finding should be considered by investigators, sponsors, regulatory authorities, and patient support groups.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Imunoterapia , Neoplasias/tratamento farmacológico , Placebos/efeitos adversos , Antineoplásicos/uso terapêutico , Ensaios Clínicos Fase III como Assunto , Diarreia , Fadiga , Humanos , Hipertensão , Pessoa de Meia-Idade , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
Oncol. clín ; 22(3): 95-100, 2017. graf
Artigo em Espanhol | LILACS | ID: biblio-909375

RESUMO

El cáncer de cuello uterino (CCU) es la primera causa de muerte por cáncer en la provincia de Misiones. Objetivo primario: evaluación de las pacientes con CCU en estadios tempranos, sometidas a cirugía de Wertheim Meigs (WM). Objetivos secundarios: analizar las características clínico patológicas asociadas a los patrones de eficacia, en términos de SLR-SG y morbilidades. La búsqueda fue multidisciplinaria y activa, se seleccionaron mujeres con diagnóstico de CCU en estadios tempranos, tratadas con cirugía de WM, período 2010-2017. Se registraron datos clínico-patológicos y terapéuticos. Se calculó tasa de recurrencia local-sistémica, SLE y SG. Fuente de datos: RISMI (HC Informatizada), RITA (Registro de tumores), sub-registros de los servicios de ginecología y oncología. Se incluyeron 101 pacientes, edad promedio de 38 años. El 56% (57) se encontraba asintomático al momento del diagnóstico. La vía de abordaje fue laparotomía en el 97% (98), tiempo operatorio promedio 247 minutos. El promedio de días de internación post operatorio fue de 5.3. Ausencia de complicaciones post operatorias en 79% (80). Promedio de ganglios resecados 12, FIGO patológico IB en 42% (43). Realizaron adyuvancia 36% (35). Recurrencias loco-regionales y sistémicas 8% (5), tiempo medio a la recaída 37 meses. Mediana de seguimiento a 3 años: VSE 60% (35), PDSEG 27% (15), tasa de mortalidad específica 11% (6), VCE 6% (3). El CCU en estadios tempranos, diagnosticado y tratado por un grupo multidisciplinario en el Hospital Escuela de Agudos Dr. Ramón Madariaga, presentó patrones de eficacia y tasas de supervivencia enfermedad específica y de mortalidad, similar a las informadas en la literatura (AU)


Cervical cancer (CC) is the leading cause of cancer death in Misiones province. Primary objective: evaluation of patients with CCU in early stages submitted to Wertheim Meigs (WM) surgery. Secondary objectives: clinical pathological characteristics associated with efficacy patterns in terms of SLR-SG and morbidities. The research was multidisciplinary and active, we selected women with CC in early stages, treated with WM surgery, period 2010- 2017. Clinical-pathological and therapeutic data were recorded. Local-systemic recurrence rate, SLE, SG was calculated. Data source: RISMI (HC Computerized), RITA (Tumor Registry), subregistries of gynecology and oncology services. We included 101 patients, mean age 38 years. The 56% (57) were asymptomatic at the time of diagnosis. The approach was laparotomy in 97% (98), mean operative time 247 minutes. The mean number of days of post-operative hospitalization was 5.3. Absence of postoperative complications in 79% (80). Average resected nodes 12. Pathological IB in 42% (43). The 36% (35) performed adjuvancy). Locoregional and systemic recurrences 8% (5), mean time to relapse 37 months. Median followup at 3 years: VSE 60% (35), PDSEG 27% (15), specific mortality rate 11% (6), VCE 6% (3). The CC in early stages, diagnosed and treated by a multidisciplinary group in the Hospital Escuela de Agudos Dr. Ramón Madariaga, presents patterns of efficacy and survival rates, specific disease and mortality, similar to those reported in the literature (AU)


Assuntos
Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Adenocarcinoma , Carcinoma de Células Escamosas , Histerectomia/métodos , Neoplasias do Colo do Útero/cirurgia , Argentina , Carcinoma Adenoescamoso , Tratamento Farmacológico , Terapia Neoadjuvante , Complicações Pós-Operatórias
14.
Onco Targets Ther ; 9: 7309-7314, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27942224

RESUMO

OBJECTIVE: To describe the clinical characteristics of Latin American patients with metastatic renal cell carcinoma (mRCC) who experienced a progression-free survival (PFS) for at least 15 months following treatment with sunitinib. PATIENTS AND METHODS: In this retrospective analysis, mRCC patients in two institutions in Latin America received sunitinib at a starting dose of either 50 mg/day for 4 weeks followed by 2 weeks off treatment (Schedule 4/2) in repeated 6-week cycles or sunitinib 37.5 mg on a continuous daily dosing schedule. Clinical characteristics, tolerability, and PFS data were collected. RESULTS: Twenty-nine patients with long-term clinical benefit from sunitinib were identified between September 2005 and August 2009. Median PFS was 23 months (range: 15-54 months). Two of the 29 patients with prolonged PFS achieved a complete response and additional eleven had a partial response. Most patients were aged <60 years, had good performance status, favorable or intermediate Memorial Sloan Kettering Cancer Center prognostic risk, and disease limited to one or two sites. Dose reduction was necessary in all patients who started sunitinib at 50 mg/day administered on Schedule 4/2. Adverse events leading to dose reduction included grade 3 hand-foot syndrome, mucositis, fatigue, and hypertension. At the time of data cutoff, four patients were still receiving sunitinib treatment. CONCLUSION: Extended PFS can be achieved in Latin American patients with mRCC treated with sunitinib. Although the small sample size and retrospective nature of this evaluation preclude the identification of pretreatment predictive factors contributing to this benefit, the current analysis warrants further investigation using a larger data set in this population.

15.
Onco Targets Ther ; 9: 5839-5845, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27713637

RESUMO

BACKGROUND: Sunitinib is an approved treatment for metastatic renal cell carcinoma (mRCC). The safety profile and efficacy of sunitinib were confirmed in a global expanded access trial (ClinicalTrials.gov identifier: NCT00130897). This report presents a subanalysis of the final trial data from patients in Latin America. METHODS: Treatment-naïve or previously treated mRCC patients aged ≥18 years received oral sunitinib at a starting dose of 50 mg/day on a 4-weeks-on/2-weeks-off schedule. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. Safety was assessed regularly, and tumor measurements were scheduled per local practice (using Response Evaluation Criteria in Solid Tumors). RESULTS: In total, 348 patients from Latin America received sunitinib. Overall, 75% of patients had two or more sites of metastatic disease, 28% were aged ≥65 years, 14% had an Eastern Cooperative Oncology Group performance status ≥2, 9% had brain metastases, 9% had no prior nephrectomy, and 5% had non-clear cell RCC. Median treatment duration was 8 months, and median follow-up was 15.1 months. In total, 326 patients (94%) discontinued treatment, primarily due to death (41%) or lack of efficacy (22%). Most treatment-related adverse events were of mild to moderate severity (grade 1/2). Mucosal inflammation (reported in 54% of patients), diarrhea (53%), and asthenia (41%) were the most common any-grade treatment-related adverse events. Asthenia (12%), neutropenia (10%), and fatigue and thrombocytopenia (both 9%) were the most common grade 3/4 treatment-related adverse events. In total, 311 patients were included for tumor response, of whom eight (3%) had a complete response and 46 (15%) a partial response, yielding an objective response rate of 17%. Median duration of response, progression-free survival, and overall survival were 26.7, 12.1, and 16.9 months, respectively. CONCLUSION: The efficacy and safety profile of sunitinib in patients with mRCC from Latin America was comparable to that in the entire cohort of the global expanded access trial.

16.
Dig Liver Dis ; 48(11): 1372-1377, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27260329

RESUMO

BACKGROUND: The non-surgical management in a selected group of rectal cancer patients has shown promising results with adequate follow up. AIMS: describing the results of the non-surgical management in patients with complete clinical response, with a close follow up. METHODS: Between 2006 and 2015, patients with rectal cancer, stages I-III, without metastasis, treated with neoadjuvant CRT/CT, who had clinical complete response were included. CCR was defined through digital palpation, endoscopy-based criteria and MRI. Follow up was set according to institutional guidelines. RESULTS: 68 patients were included. Initial stage was assessed with MRI in 55/68 pts and EUS 11/68. Considering the recurrence risk factors 57.6% (29/68) were T2-3ab N0, 3.3% (2/68) were T4N0, 29% (20/68) were T3-4 N1-2, with 39.7% with positive MRC. Mean distance to the anal margin was 3cm. Chemoradiation included radiotherapy at 50.4cGy, and concurrent capecitabine. In 22% a fluoropirimidine and oxaliplatin-based schema was used as induction therapy. Median follow up was 37.5 months and response assessment time 9 weeks (5-19). Eleven patients recurred, 6 endoluminally, 3 developed mesorectal recurrence, and two distant failure. Five years DFS and OS were 76.3% and 93.8%. CONCLUSIONS: conservative management was feasible with close follow up in leading cancer centres. In this series, DFS and OS were comparable to the data already reported in the literature.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimiorradioterapia/métodos , Terapia Neoadjuvante/métodos , Recidiva Local de Neoplasia/terapia , Neoplasias Retais/terapia , Adulto , Idoso , Argentina , Intervalo Livre de Doença , Feminino , Fluoruracila/administração & dosagem , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Compostos Organoplatínicos/administração & dosagem , Oxaliplatina , Estudos Retrospectivos
17.
Oncol. clín ; 21(2): 34-43, 2016. tab, graf
Artigo em Espanhol | LILACS | ID: biblio-882186

RESUMO

El conocimiento en cáncer renal ha sido manifiesto en la última década, con adelantos que optimizan el abordaje diagnóstico, quirúrgico y terapéutico con agentes dirigidos contra blancos específicos. El objetivo del trabajo fue la evaluación retrospectiva de pacientes con cáncer de riñón, destacando los datos demográficos, patológicos, quirúrgicos, de recurrencia, así como las modalidades terapéuticas empleadas, y describir la evolución clínica a través de parámetros de eficacia y seguridad. Fueron incluidos 417 pacientes, analizándose los datos de 356. La edad mediana fue de 56 años y 68% eran hombres. El 14% presentó otro tumor primario no renal y 14 desarrollaron otro tumor renal. El diagnóstico fue incidental en el 28% de los casos, la histología más frecuente fue el carcinoma de células claras, el tamaño mediano fue 6.1 cm y en el 20% se observó infiltración capsular. De los 298 pacientes operados, 54% fueron a nefrectomía radical y 26% parcial. El 19% presentaba metástasis al diagnóstico. Recurrencia post-operatoria en 75 de los 298 operados. Los tratamientos más frecuentemente utilizados en primera línea fueron los inhibidores de tirosina-quinasa (55% de los casos) con remisiones del 43-50% y un tiempo a la progresión de 12.1 meses. La revisión retrospectiva de los datos en cáncer renal de una población académica que incorpora la metodología diagnóstica, quirúrgica y terapéutica en enfermedad localizada y avanzada, permite reproducir los datos que surgen de países centrales y de estudios clínicos aleatorizados (AU)


Improving knowledge in renal cancer has been successful in the last decade in terms of diagnosis, surgical and therapeutic approach with targeted agents. The objective of the study was the retrospective evaluation of patients with kidney cancer, emphasizing recurrence as well as therapeutic modalities, pathological and surgical, demographic data and to describe outcome through efficacy and safety parameters. There were included 417 patients. The median age was of 56 years and 68% were men. There was a 14% of patients with another non-renal primary tumor and 14 patients developed another kidney tumor. The diagnosis was incidental in 28% of cases. The most common histology was clear cell carcinoma, medium size was 6.1 cm and capsular infiltration was observed in 20%. Of the 298 patients operated, 54% were to radical nephrectomy and 26% partial. The 19% of the patients had metastases from diagnosis. Post-operative recurrence was developed in 75 of 298 surgical patients. The most frequent systemic first line therapy was tyrosine-kinase inhibitors (55% of cases) with remissions of 43-50% and time to progression was 12.1 months. The retrospective review in renal cancer of an academic population gives the rationale of data of the real world and to compare with those that arise from central countries and randomized clinical trials (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Carcinoma de Células Renais , Neoplasias Renais/tratamento farmacológico , Diagnóstico por Imagem , Nefrectomia , Análise Estatística
18.
Oncol. clín ; 21(3): 61-64, 2016. Tab, ilus
Artigo em Espanhol | LILACS | ID: biblio-882192

RESUMO

El cáncer de mama es una de las enfermedades más frecuentes en todo el mundo. La amplificación del proto-oncogén HER2 se presenta en 20-25% de los tumores de mama. TDM-1 es un conjugado anticuerpo-quimioterápico. Se realizó en forma retrospectiva, observacional y descriptiva un análisis de los datos de pacientes con diagnóstico de cáncer de mama metastásico HER2 positivo, que realizaban y/o habían realizado tratamiento con dicho fármaco. Se evaluaron 27 mujeres. La indicación de TDM-1 fue en 7.4% (2) en primera línea, 37% (10) en segunda línea, y 55.5% (15) en líneas posteriores, con un tiempo a la progresión de 7.44 meses (IC: 4.33-NC) para el global de pacientes, tasa de respuesta objetiva de 44% y se constataron 7 (26%) toxicidades G3-4 (AU)


Breast cancer is one of the most common diseases worldwide. HER2 proto-oncogene amplification occurs in 20-25% of breast tumors. TDM-1 is an antibody-chemotherapeutic conjugate. We performed a retrospective, observational and descriptive analysis of data from patients diagnosed with metastatic HER2 positive breast cancer who were and / or had been treated with this drug. Twenty-seven women were evaluated. The indication for TDM-1 was 7.4% (2) in the 1st line, 37% (10) in the 2nd line, and 55.5% (15) in later lines, with a time to progression of 7.44 months (CI:4.33-NC) for the global patient, objective response rate was 44% and 7 (26%) G3-4 toxicities were found (AU)


Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , Neoplasias da Mama , Metástase Neoplásica , Trastuzumab/uso terapêutico , Trombocitopenia
19.
Oncol. clín ; 21(3): 65-70, 2016. tab
Artigo em Espanhol | LILACS | ID: biblio-882193

RESUMO

El objetivo fue analizar retrospectivamente, en pacientes con cáncer de cuello uterino localmente avanzado tratados en nuestro centro, el perfil de toxicidad de la radioterapia concurrente con platinos mono droga o combinados con gemcitabine y su impacto en el tratamiento. Estudio descriptivo, retrospectivo y observacional de pacientes con cáncer de cuello uterino localmente avanzado (estadios IIa/IVa) desde marzo de 2011 a febrero de 2016. Se analizaron características patológicas, dosis de tratamiento radiante y quimioterápico, así como toxicidades graves (GIII/IV) y su impacto en el tratamiento, observado como reducción o suspensión de dosis y/o split de radioterapia (RT). Se evaluaron 60 pacientes, edad mediana 47 años (17-75), 93% PS0-1. Histología: escamoso (89%) y adenocarcinoma (8%). Estadio IIb 24 (40%) y IIIb 16 (27%). Dosis de RT utilizada 5040cGy; 35 (58%) realizaron boost y 47 (78%) braquiterapia posterior. Cuarenta y cinco realizaron tratamiento concurrente con PLA y 15 con platinos/gemcitabine (PLA/GEM). En el grupo que recibió PLA, uno requirió reducción de dosis de quimioterapia (QT), dos suspendieron algún ciclo por toxicidad y tres realizaron split de RT. El 100% completó el tratamiento de quimioradioterapia (QRT) concurrente. En el grupo que recibió PLA/GEM: 9 requirieron reducción de dosis de QT, 11 suspendieron algún ciclo y 4 no completaron el esquema por toxicidad; 4 hicieron split de RT, y 87% completó el tratamiento de RT. En este estudio, el esquema concurrente con quimioterapia combinada muestra mayor toxicidad que impacta en el cumplimiento del tratamiento, 15% no lo completó por toxicidades graves. No obstante, un correcto manejo institucional de toxicidades, permite utilizar la combinación de tratamiento para obtener potenciales beneficios (AU)


This is a retrospective analysis of profile toxicity and treatment impact of gemcitabine plus platinum radiotherapy in patients with locally advanced cervix cancer, treated at our Centre. Descriptive, retrospective and observational study of patients with locally advanced cervix cancer (Ila/IVa stages), since March 2011 until February 2016. The analysis included the pathological characteristics, chemo radiotherapy doses, as well as severs toxicity (GIII/V) and it impact in treatment observed as reduction or suspension of doses and/or radiotherapy (RT) split. There were evaluated 60 patients of 47 median age (17-75), 93-5 PS0-1. Histology: 89% of squamous cell carcinoma and 8% of adenocarcinoma. 40% of IIb 24 and 27% of IIIB 16 stages. RT doses used 5040cGy; 35 pts (58%) did boost and 47 pts (78%) followed with brachytherapy. 45pts took PLA concurrent treatment, 15pts gemcitabine plus platinum (PLA/GEM). Regarding PLA group, one required a doses reduction of chemotherapy (QT), 2pts suspended a cycle due to toxicity and 3pts did RT split. 100% pts completed chemo radiotherapy (QRT) concurrent treatment. Regarding PLA/GEM group: 9pts required QT doses reduction, 11pts suspended a cycle due to toxicity and 4 didn´t complete the cycle due to toxicity; 4 did RT split and 87% completed RT. The study shown that the scheme of concurrent combined chemotherapy presents higher toxicity that impacts in the fulfillment of treatment, 66 ONCOLOGÍA CLÍNICA - Vol. 21 Nº 3 - Diciembre 2016 15% couldn´t complete due to sever toxicity. However, a correct institutional manage of toxicities allows to use treatment combination to obtain potential benefits (AU)


Assuntos
Cisplatino/uso terapêutico , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/tratamento farmacológico , Imageamento por Ressonância Magnética , Radioterapia
20.
Eur J Cancer ; 51(16): 2423-33, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26248685

RESUMO

BACKGROUND: Gastrointestinal stromal tumours (GISTs) are the most common gastrointestinal sarcomas. This global, prospective registry followed patients with advanced or localised GIST (2007-2011). METHODS: Current and evolving diagnostics, treatments and outcome measures in patients with GIST were assessed. Eligible patients were diagnosed with advanced or localised GIST within 15months of registry entry. No treatment plan was prescribed, and no visit schedule was mandated. Treating physicians recorded patient information, including tumour response, diagnostic methods, medications, surgeries performed, mutation status and adverse events leading to dose/medication changes. Survival outcomes were estimated using the Kaplan-Meier method. Other data were analysed using descriptive statistics. RESULTS: The registry included 1663 patients (advanced GIST, n=1095; localised GIST, n=537). Medications (e.g. tyrosine kinase inhibitor use and dosing), disease progression or recurrence and physician assessment of response to treatment in registry patients were consistent with controlled trials and prevailing clinical recommendations. In advanced GIST, estimated 30-month progression-free survival (PFS) (59.8%) and overall survival (OS) (82.7%) were higher than results from previously reported trials (≈40% and ≈70%, respectively). Consistent with treatment guidelines, the most common initial treatments were imatinib for advanced GIST, and complete surgical resection for localised GIST. Computed tomography scans were the most common imaging technique used at diagnosis and follow-up. Mutation analysis was performed at diagnosis in only 15.3% and 14.5% of patients with advanced and localised GIST, respectively. CONCLUSIONS: In this real-world GIST registry, patients with advanced GIST were treated with imatinib and patients with localised GIST received surgical resection, in accordance with prevailing clinical recommendations.


Assuntos
Tumores do Estroma Gastrointestinal , Padrões de Prática Médica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ásia/epidemiologia , Biomarcadores Tumorais/genética , Canadá/epidemiologia , Análise Mutacional de DNA , Procedimentos Cirúrgicos do Sistema Digestório , Progressão da Doença , Europa (Continente)/epidemiologia , Feminino , Tumores do Estroma Gastrointestinal/genética , Tumores do Estroma Gastrointestinal/mortalidade , Tumores do Estroma Gastrointestinal/patologia , Tumores do Estroma Gastrointestinal/terapia , Humanos , Mesilato de Imatinib/uso terapêutico , Estimativa de Kaplan-Meier , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Mutação , Recidiva Local de Neoplasia , Valor Preditivo dos Testes , Estudos Prospectivos , Inibidores de Proteínas Quinases/uso terapêutico , Sistema de Registros , Fatores de Risco , América do Sul/epidemiologia , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Adulto Jovem
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