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Author(s):  
Maureen M. O'Brien ◽  
Lingyun Ji ◽  
Nirali N. Shah ◽  
Susan R. Rheingold ◽  
Deepa Bhojwani ◽  
...  

PURPOSE Children's Oncology Group trial AALL1621 was conducted to prospectively determine the safety and efficacy of inotuzumab ozogamicin (InO) in pediatric and adolescent patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). PATIENTS AND METHODS This single-arm phase II trial enrolled patients age 1-21 years with R/R CD22-positive B-ALL. In cycle 1, InO dosing was 0.8 mg/m2 intravenously on day 1 and 0.5 mg/m2 on days 8 and 15 of a 28-day cycle with response evaluation at day 28. Using a two-stage design, the trial was continuously monitored for dose-limiting toxicities and sinusoidal obstruction syndrome (SOS). CD22 expression was retrospectively evaluated by central flow cytometry. RESULTS Forty-eight patients were evaluable for response and toxicity; 19 had complete response (CR) and nine CR with incomplete count recovery (CRi) after cycle 1 (CR/CRi rate: 58.3%; two-sided 90% CI, 46.5 to 69.3). Twenty-seven of 28 patients with CR or CRi had minimal residual disease measured by flow cytometry; 18 (66.7%) had minimal residual disease < 0.01%. Seven of 28 patients (25%) with CR or CRi had delayed count recovery past day 42 in cycle 1. Three (6.3%) patients had grade 3 ALT elevation and one patient had grade 3 hyperbilirubinemia in cycle 1. Of 21 patients undergoing hematopoietic stem-cell transplantation after InO, 6 (28.6%) developed grade 3 SOS. Partial CD22 expression and lower CD22 site density were associated with lower likelihood of response to InO. CONCLUSION InO is effective and well tolerated in heavily pretreated children and adolescents with R/R CD22-positive B-ALL. SOS after hematopoietic stem-cell transplantation and prolonged cytopenias were notable. CD22 modulation was identified as a mechanism of resistance. Expanded study of InO combined with chemotherapy is underway.


2022 ◽  
pp. 000313482110707
Author(s):  
Katlyn G. McKay ◽  
Muhammad O. Abdul Ghani ◽  
Gabriella L. Crane ◽  
Parker T. Evans ◽  
Shilin Zhao ◽  
...  

Background The Children's Oncology Group recommends upfront resection of Wilms tumor (WT), however, unique scenarios warrant neoadjuvant chemotherapy and delayed resection. We hypothesized that in the context of neoadjuvant chemotherapy, minimally invasive surgery (MIS) to resect WT achieves equivalent oncologic fidelity and better maintains therapy schedules. Methods A retrospective analysis of WT treated between 2010-2021 at a free-standing children's hospital was performed. Patient and disease specific characteristics were collected, and pre-resection tumor volumes (TV) were calculated. Impact of MIS or open resection on oncologic fidelity and time to resume chemotherapy was analyzed. Results For the study period, 62 patients were treated for 65 WT, and 14 patients (22.6%) received neoadjuvant chemotherapy to treat 17 WT (26.2%): 7 Stage I (all predisposition syndromes), 2 stage III, 7 stage IV, and 1 stage V (bilateral). MIS was utilized to resect 6 WT from 5 patients. For partial nephrectomy, pre-resection TV was 0.38 ml if MIS and 10.38 ml if open ( P = .025). For radical nephrectomy, pre-resection TV was 31.58 ml if MIS and 175.00 ml if open ( P = .101). No significant differences between surgical approach were detected regarding pathologic variables or survival. Epidural use was significantly greater with open procedures ( P = .001). Length of stay was 2.00 days after MIS compared to 6.00 for open resection ( P = .004). Time to resume chemotherapy was 7.00 days after MIS versus 27.00 for open ( P = .004). Conclusion After neoadjuvant chemotherapy for WT, MIS partial and radical nephrectomies achieved equivalent oncologic fidelity, reduced epidural use and post-operative stays, and better maintained adjuvant therapy timelines when compared to open resections.


2022 ◽  
Vol 9 (1) ◽  
pp. e49-e57 ◽  
Author(s):  
Justine M Kahn ◽  
Qinglin Pei ◽  
Debra L Friedman ◽  
Joel Kaplan ◽  
Frank G Keller ◽  
...  

2021 ◽  
Author(s):  
Wabison Júnior Fernandes dos Santos ◽  
Maria Aparecida A Machado ◽  
Natacha Silva Móz

Introdução: Segundo a Organização Mundial de Saúde (OMS) é considerado padrão ouro o tratamento oncológico em conjunto com Cuidados Paliativos (CP). Estes, por sua vez, “consistem na assistência promovida por uma equipe multidisciplinar, que objetiva a melhoria da qualidade de vida do paciente e seus familiares, diante de uma doença que ameace a vida, por meio da prevenção e alívio do sofrimento, por meio da identificação precoce, avaliação impecável e tratamento de dor e demais sintomas físicos, sociais, psicológicos e espirituais”. Objetivos: Identificar pacientes com critérios de fase avançada da neoplasia com ou sem proposta de terapia modificadora e atuar precocemente com abordagem multidisciplinar em CP. Material e métodos: Estudo realizado através de busca ativa em unidade de internação clínica oncológica é realizado a identificação de pacientes que preenchem critérios para serem acompanhados via interconsulta com equipe transdisciplinar de CP, sendo aplicado escalas específicas de funcionalidade “Eastern Cooperative Oncology Group” (ECOG Perfomance Status) e “Karnofsky Perfomance Status” (KPS) em conjunto com a correlação clínica. Resultados: Após dois meses de busca ativa, foram identificados mais de 230 pacientes com necessidade de avaliação pela equipe de CP. Por meio da avaliação do enfermeiro especialista, foi permitido que pacientes oncológicos pudessem ser encaminhados de forma mais precoce aos CP. Sendo um total de mais de 130 pacientes assistidos sob titularidade dos CP. Além disso, foi possível promover qualidade de vida mesmo no processo de finitude, com o controle adequado dos sintomas físicos e demais domínios, acolhimento de familiares e, inclusive, captação de córneas em paciente sob Cuidados Paliativos como potencial doador. Conclusão: É inegável as múltiplas vantagens que o paciente e familiares adquirem sendo assistidos pela equipe de CP. Tais benefícios são ainda melhores e mais garantidos quando iniciado o acompanhamento de forma precoce com tal equipe. Todavia, a identificação do paciente oncológico quanto ao risco paliativo, quando realizado por um enfermeiro especialista em Oncologia e Cuidados Paliativos, permite que o mesmo não seja submetido a tratamentos “fúteis” e desproporcionais em fim de vida.


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