Purpose:The importance of gamma probe detection (GPD) combined with vital dye for sentinel node (SN) biopsy is well accepted. We evaluated the efficacy of patent blue dye (PBD) in identifying inguinal SN. Methods: Ninety-four cutaneous melanoma patients with inferior extremity lesions were submitted to SNB according to a established protocol. Patients were randomized in two groups: Blue group, where SN was identified by PPD and Probe group, where SN was identified by GPD. The median age was 44.2 years and median Breslow thickness was 2.1 mm. Preoperative lymphoscintigraphy, lymphatic mapping with PBD and intra-operative GPD was performed on all patients. Histological examination of SN consisted of hematoxylin-eosin and immunohistochemical staining. If micrometastases were present complete lymphadenectomy was performed. The SN was considered as identified by PBD if it was blue and identified by GPD if it demonstrated at least ten times greater radioactivity than background. Results: It was explored 94 inguinal lymphatic basins, 145 SN were excised (70 guided primarily by blue dye and 75 guided primarily by probe). All SN identified by preoperative lymphoscintigraphy were excised. In the Blue group PPD identified all SN and all of them were hot. In the Probe group all SN were identified by probe and were blue. The coincidence of PPD and GPD was 100%. Conclusion: Patent blue dye is enough to identify superficial inguinal SN in cutaneous melanoma. Key words: Dyes. Lymphatic Vessels. Probe. Lymph Nodes. Melanoma. RESUMOObjetivo: a importância da detecção gama intra-operatória combinada com corante vital para biópsia de linfonodo sentinela é bem aceita. Nós avaliamos a eficácia do azul patente V na identificação do linfonodo sentinela inguinal. Métodos: Noventa e quatro pacientes portadores de melanoma cutâneo de membro inferior foram submetidos a biópsia de linfonodo sentinela de acordo com protocolo estabelecido. Foram randomizados em dois grupos: Grupo Azul, onde o linfonodo sentinela foi identificado primariamente com o corante vital azul patente V (Guerbet) e o Grupo Sonda, onde o linfonodo sentinela foi identificado primariamente pela sonda de detecção gama (Neoprobe). A idade mediana foi de 44,2 anos e a espessura mediana de Breslow foi 2,1 mm. Linfocintilografia pré-operatória, mapeamento linfático com azul patente V e detecção gama intra-opertaória foram realizados em todos os pacientes. O exame histopatológico do linfonodo sentinela consistiu de hematoxilina-eosina e imunohistoquímica. Se micrometástase estivesse presente, linfadenectomia completa era realizada. O linfonodo sentinela era considerado como identificado pelo corante vital se estivesse azul e identificado pela sonda de detecção gama se demonstrasse pelo menos 10 vezes ou mais radioatividade do que o fundo. Vital dye is enough for inguinal sentinel lymph node biopsy in melanoma patients linfonodos sentinelas foram primariamente identificados pela sonda e estavam corados pelo azul. A coincidência da sonda com o corante vital foi de 100%. ...
CONTEXT: Cutaneous melanoma presents significant morbidity and mortality. Nowadays, about 90% of them are diagnosed by clinical examination and most are localized melanomas. Sentinel node biopsy has brought about a new and interesting approach towards localized cutaneous melanoma. The meaning of micrometastases in sentinel nodes diagnosed by the reverse transcriptase-polymerase chain reaction is not well established. OBJECTIVE: To define the real value of micrometastases diagnosed by the reverse transcriptase-polymerase chain reaction in relation to melanoma recurrence. METHODS: Systematic literature review and meta-analysis. The Cochrane Library, Medline, Embase and Lilacs were the databases searched. We used the following key words: sentinel node and melanoma; sentinel node and reverse transcriptase-polymerase chain reaction; melanoma and reverse transcriptase-polymerase chain reaction. Cohort studies enrolling localized cutaneous melanoma patients who underwent sentinel node biopsy were selected. Sentinel node evaluations included hematoxylin and eosin, immunohistochemistry and reverse transcriptase-polymerase chain reaction. RESULTS: Out of the 1,542 studies evaluated, four were eligible. The four studies, when combined, were statistically homogeneous. The sample totaled 450 patients grouped as follows: 163 with a sentinel node negative to hematoxylin eosin and immunohistochemistry and positive to the reverse transcriptase-polymerase chain reaction; 192 with a sentinel node negative to hematoxylin eosin, immunohistochemistry and the reverse transcriptase-polymerase chain reaction and 95 patients with a sentinel node positive to hematoxylin eosin and/or immunohistochemistry. We analyzed the first two groups. The meta-analysis for the random model showed an increased effect from a positive reverse transcriptase-polymerase chain reaction on the recurrence rate. A similar result occurred in the meta-analysis for the fixed effect model. CONCLUSION: Patients with a positive reverse transcriptase-polymerase chain reaction had a greater recurrence rate than those with a negative reverse transcriptase-polymerase chain reaction. This suggests an important role for the reverse transcriptase-polymerase chain reaction in sentinel node examinations. In view of the small sample, a clinical trial could better evaluate this question.
OBJETIVO: verificar se há alguma relação entre o estado histopatológico do linfonodo sentinela, a recorrência e a mortalidade decorrente do melanoma espesso em pacientes submetidos à BLS ao longo de um seguimento significante. MÉTODOS: Oitenta e seis pacientes portadores de melanoma espesso submetidos à BLS foram selecionados de um banco de dados prospectivo. A linfocintilografia, o mapeamento linfático e a detecção gama intraoperatória foram realizados em todos pacientes. O linfonodo sentinela (LS) foi analisado por HE e por imunoistoquímica. Linfadenectomia total foi indicada para os pacientes com LS positivo. O estado histopatológico do LS foi relacionado à taxa de recorrência e de mortalidade por melanoma. RESULTADOS: Cento e sessenta e seis LS foram retirados dos 86 pacientes. As idades variaram de 18 a 73 anos. Havia 47 mulheres e 39 homens. Micrometástases foram encontradas em 44 pacientes. Quarenta e dois pacientes foram submetidos à linfadenectomia total. Sete pacientes tiveram outro linfonodo positivo. Entre os 44 pacientes com LS positivo houve 20 recorrências e 15 mortes. Houve 18 recidivas e 12 mortes no grupo de LS negativo. A espessura de Breslow não apresentou correlação com o estado histopatológico do LS. O estado histopatológico do LS não interferiu nas taxas de recorrência e de mortalidade (teste de Fisher, p=1.00). A mediana de seguimento foi 69 meses. CONCLUSÃO: Considerando a falta de evidência de benefício, a BLS não deve ser indicada para pacientes com melanoma espesso fora de estudos clínicos.
OBJETIVO: A biópsia de linfonodo sentinela (BLS) representa um avanço na cirurgia oncológica para o microestadiamento do melanoma. Apresentamos nossa experiência dando ênfase para a recorrência. MÉTODO: A BLS foi realizada em 133 pacientes portadores de melanoma cutâneo localizado envolvendo linfocintilografia, mapeamento linfático e detecção gama intra-operatórios em todos os pacientes. O exame histopatológico foi realizado por HE e imunohistoquímica (IHC). RESULTADOS: Encontrou-se LS em 128 pacientes (96,2%). Micrometástase foi diagnosticada em 20 pacientes (15,6%). Houve nove recorrências, sendo quatro no grupo com LS negativo (108 pacientes). Neste grupo, houve uma recorrência sistêmica e três (2,8%) na região linfática de drenagem (falso negativo). No grupo com LS positivo (20 pacientes) ocorreram cinco recorrências. Houve diferença significativa de recorrência entre os grupos, tendo sido menor no grupo LS negativo (p=0,0048). Através de análise de regressão logística univariada a ulceração (p=0,029) e a positividade do LS (p=0,003) apresentaram significância estatística como fatores de risco. Porém, apenas a positividade do LS manteve singificância na análise multivariada (p=0,024). O seguimento mediano foi de 37 meses. CONCLUSÕES: Pacientes com LS positivo apresentam recorrência significativamente maior que pacientes com LS negativo. O índice de falso negativo foi de 2,8% e os pacientes não apresentaram seqüelas o que permite considerar a BLS como procedimento seguro para o microestadiamento do melanoma cutâneo.
e14504 Background: In 2017, biosimilar trastuzumab (Zedora) became the first biosimilar trastuzumab approved in Brazil. In May 2018 an active postmarketing surveillance program was instituted. Data from this program was presented in ASCO in 2019 and 2020. Now, with an extended follow up (May 2018 to December 2020) and more patients included, we present updated data from the surveillance program. Methods: This is a prospective observational study to evaluate data from the patient support program. Patients who received prescription for biosimilar trastuzumab were invited to participate. After agreement of informed consent, they were followed by periodical phone calls after each infusion and up to 3 months after the end of treatment. Treatment related data and adverse events (AEs) were collected. Results: A total of 74 reports containing 656 adverse events (AEs) were received from the active postmarketing surveillance program between May 2018 and December 2020. Of the 74 reports, 73 are female patients with HER2+ breast cancer (BC) and 1 is a male patient with gastric adenocarcinoma. The patients mean age was 52 years (31 to 79 years). Regarding to AEs severity and expectedness, 588 (89.63%) were non-serious AE (413 expected / 175 unexpected) and 68 (10.37%) were serious AE (51 expected / 17 unexpected). Considering all serious unexpected AEs (17), 13 were assessed as not related to trastuzumab therapy and 4 were assessed as related to therapy. For the 175 non-serious unexpected AEs, 56 were assessed as not related to therapy and 119 were assessed as related to therapy. The three most frequently reported AEs according to SOC (System Organ Classification) were general disorders and administration site conditions 111 (16.92%), gastrointestinal disorders 98 (14.93%) and nervous system disorders 88 (13.41%). The five most commonly reported adverse events (MedDRA PT - Preferred term) were diarrhea 27 (4.11%), fatigue 24 (3.66%), nausea 22 (3.35%), weight decreased 18 (2.74%) and infusion related reaction 17 (2.59%). Further monitoring is continued. Conclusions: Nature of AEs noted in patients with breast cancer and gastric cancer treated with biosimilar trastuzumab (Zedora) were consistent with the known safety profile of Trastuzumab. The risk benefit remains consistent with the reference safety information and no new safety signals were detected.[Table: see text]
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