[PMID]: | 28640389 |
[Au] Autor: | Wang FH; Wang Y; Sun GP; Chen JH; Lin YC; Liu W; Zheng RS; Chen J; Zhang HL; Lan HT; Qi J; Liu YQ; Deng YM; Zhao H; Xiong JP; Xu Q; Jiang WQ; Li YH |
[Ad] Endereço: | Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. |
[Ti] Título: | Efficacy and safety of recombinant human lymphotoxin-α derivative with cisplatin and fluorouracil in patients with metastatic esophageal squamous cell carcinoma: A randomized, multicenter, open-label, controlled, phase 2b trial. |
[So] Source: | Cancer;123(20):3986-3994, 2017 Oct 15. |
[Is] ISSN: | 1097-0142 |
[Cp] País de publicação: | United States |
[La] Idioma: | eng |
[Ab] Resumo: | BACKGROUND: Recombinant human lymphotoxin-α derivative (rhLTα-Da) is a lymphotoxin-α derivative that is missing 27 N-terminal amino acid residues. Previous studies indicated a benefit from the addition of rhLTα-Da to cisplatin-based treatment in patients with metastatic esophageal squamous cell carcinoma. The current study was conducted to evaluate the efficacy and safety of rhLTα-Da plus cisplatin and fluorouracil (PF) in patients with mESCC. METHODS: Patients from 15 centers in China were randomly assigned (1:1:1) to 3 arms (arm A, PF plus 10 µg/m daily rhLTα-Da; arm B, PF plus 20 µg/m daily rhLTα-Da; arm C, PF alone). The primary endpoints included progression-free survival (PFS) and the confirmed overall response rate (ORR). An exploratory analysis was performed to evaluate the role of serum tumor necrosis factor receptor II (TNFR II) in predicting the efficacy of rhLTα-Da. RESULTS: Between September 2010 and May 2013, 150 patients were enrolled. No significant differences in either PFS or ORR were observed between the 3 arms. However, in a small subset of patients who had low serum TNFR II levels, the median PFS was significantly longer for those in arm B than for these in other 2 arms (7.2 months [95% confidence interval, 5.1-8.6 months] for arm B vs 3.5 months [95% confidence interval, 1.7-5.5 months] for arm A [P = .022] and 4.0 months [95% confidence interval, 3.2-6.3 months] for arm C [P = .027]). The addition of rhLTα-Da significantly increased the incidence of chills (P < .001). CONCLUSIONS: rhLTα-Da combined with the PF regimen failed to improve PFS and ORR in patients with mESCC, except in a small subset that had low serum TNFR II concentrations. Cancer 2017;123:3986-94. © 2017 American Cancer Society. |
[Mh] Termos MeSH primário: |
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico Carcinoma de Células Escamosas/tratamento farmacológico Neoplasias Esofágicas/patologia Linfotoxina-alfa/uso terapêutico
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[Mh] Termos MeSH secundário: |
Adulto Idoso Carcinoma de Células Escamosas/metabolismo Carcinoma de Células Escamosas/secundário China Cisplatino/administração & dosagem Intervalo Livre de Doença Neoplasias Esofágicas/metabolismo Feminino Fluoruracila/administração & dosagem Seres Humanos Linfotoxina-alfa/efeitos adversos Masculino Meia-Idade Receptores Tipo II do Fator de Necrose Tumoral/sangue Proteínas Recombinantes/efeitos adversos Proteínas Recombinantes/uso terapêutico
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[Pt] Tipo de publicação: | CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL |
[Nm] Nome de substância:
| 0 (Lymphotoxin-alpha); 0 (Receptors, Tumor Necrosis Factor, Type II); 0 (Recombinant Proteins); Q20Q21Q62J (Cisplatin); U3P01618RT (Fluorouracil) |
[Em] Mês de entrada: | 1710 |
[Cu] Atualização por classe: | 171011 |
[Lr] Data última revisão:
| 171011 |
[Sb] Subgrupo de revista: | AIM; IM |
[Da] Data de entrada para processamento: | 170623 |
[St] Status: | MEDLINE |
[do] DOI: | 10.1002/cncr.30845 |
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