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[PMID]:25709090
[Au] Autor:Lamberti M; Porto S; Zappavigna S; Stiuso P; Tirino V; Desiderio V; Mele L; Caraglia M
[Ad] Endereço:Department of Experimental Medicine, Section of Occupational Medicine, Second University of Naples, Naples, Italy.
[Ti] Título:Levofolene modulates apoptosis induced by 5-fluorouracil through autophagy inhibition: clinical and occupational implications.
[So] Source:Int J Oncol;46(5):1893-900, 2015 May.
[Is] ISSN:1791-2423
[Cp] País de publicação:Greece
[La] Idioma:eng
[Ab] Resumo:5-Fluorouracil (5-FU), often used in combination with levofolene (LF), can induce, as an important side effect, the hand-foot syndrome (HFS) due to toxicity on keratinocytes. This can also damage workers involved in its handling. In the present study, we investigated the mechanisms of the toxicity induced by 5-FU alone or together with LF on human keratinocytes in culture. We found that the two drugs, as expected, had potentiating activity on keratinocyte growth inhibition and that this effect was mediated by induction of apoptosis. In our experimental model, an increased autophagic vacuole accumulation was observed in keratinocytes treated with 5-FU as a significant increase of the monodansylcadaverine (MDC) labeling (marker of late autophagy vacuoles) was recorded. However, the synergism of 5-FU with LF on apoptotic occurrence was not paralleled by a similar increase in autophagic vacuoles at 72 h suggesting an antagonistic effect of LF on autophagy elicited by 5-FU. Differential effects on reactive oxygen species (ROS) elevation in cells treated with 5-FU alone or the combination between 5-FU and LF were also observed. 5-FU induced a time-dependent increase of both O2- and lipid peroxidation while the combination of 5-FU and LF caused a stronger intracellular O2- increase only at 24 h while at 48 and 72 h its effect was lower when compared with that one of 5-FU alone. On the other hand, the addition of LF to 5-FU caused a stronger increase of lipid peroxidation at 48 and 72 h, but its effects were significantly lower at 24 h. These results suggest for the first time that LF potentiates the cytotoxicity of 5-FU on keratinocytes likely through the antagonism on autophagy escape pathway and consequent apoptosis potentiation.
[Mh] Termos MeSH primário: Antídotos/farmacologia
Antimetabólitos Antineoplásicos/toxicidade
Apoptose/efeitos dos fármacos
Autofagia/efeitos dos fármacos
Fluoruracila/toxicidade
Queratinócitos/efeitos dos fármacos
Levoleucovorina/farmacologia
[Mh] Termos MeSH secundário: Linhagem Celular
Combinação de Medicamentos
Sinergismo Farmacológico
Citometria de Fluxo
Seres Humanos
Queratinócitos/patologia
Peroxidação de Lipídeos/efeitos dos fármacos
Estresse Oxidativo
Espécies Reativas de Oxigênio/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antidotes); 0 (Antimetabolites, Antineoplastic); 0 (Drug Combinations); 0 (Reactive Oxygen Species); 990S25980Y (Levoleucovorin); U3P01618RT (Fluorouracil)
[Em] Mês de entrada:1602
[Cu] Atualização por classe:150408
[Lr] Data última revisão:
150408
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150225
[St] Status:MEDLINE
[do] DOI:10.3892/ijo.2015.2904


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[PMID]:25342290
[Au] Autor:Wettergren Y; Taflin H; Odin E; Kodeda K; Derwinger K
[Ad] Endereço:Department of Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden, yvonne.wettergren@dep-surg.gu.se.
[Ti] Título:A pharmacokinetic and pharmacodynamic investigation of Modufolin® compared to Isovorin® after single dose intravenous administration to patients with colon cancer: a randomized study.
[So] Source:Cancer Chemother Pharmacol;75(1):37-47, 2015 Jan.
[Is] ISSN:1432-0843
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Leucovorin is commonly used as folate supplement in 5-fluorouracil-based chemotherapy, but needs to be converted to active 5,10-methylenetetrahydrofolate (methyleneTHF) intracellularly. This provides for interindividual differences. MethyleneTHF has recently been developed into the stable, distributable drug, Modufolin®. The aim was to compare the concentration of folate metabolites in tumor, mucosa, and plasma of patients with colon cancer after administration of Modufolin® or Isovorin® (levo-leucovorin). METHODS: Thirty-two patients scheduled for colon resection were randomized to receive Modufolin® or Isovorin® at dosage of 60 or 200 mg/m². The study drug was given as one i.v. bolus injection after anesthesia. Plasma was collected for pharmacokinetic (PK) analysis before, during, and after surgery. Tissue biopsies were collected at surgery. Folate metabolites were analyzed by LC-MS/MS. RESULTS: MethyleneTHF and THF concentrations were significantly higher in mucosa (p < 0.01, both dosages) and tumors (p < 0.01, 200 mg/m²) after Modufolin® as compared to Isovorin® administration. The results correlated with PK observations. The Modufolin® to Isovorin® C(max) ratio for methyleneTHF was 113 at 200 mg/m² and 52 at 60 mg/m²; the AUC(last) ratios were 17 and 9, respectively. The THF plasma concentrations were also higher after Modufolin® administration (C(max) ratio 23, AUC(last) ratio 13 at 200 mg/m²; C(max) ratio 15, AUC(last) ratio 11 at 60 mg/m²). CONCLUSION: Modufolin® administration resulted in significantly higher methyleneTHF levels than Isovorin® and may potentially increase the efficacy of 5-fluorouracil-based chemotherapy. The results encourage further evaluation of Modufolin® as a substitute to Isovorin® including the potential clinical benefits.
[Mh] Termos MeSH primário: Antídotos/farmacocinética
Antimetabólitos Antineoplásicos/química
Neoplasias do Colo/metabolismo
Fluoruracila/antagonistas & inibidores
Levoleucovorina/farmacocinética
Pró-Fármacos/farmacocinética
Tetra-Hidrofolatos/farmacocinética
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Antídotos/administração & dosagem
Antídotos/efeitos adversos
Antídotos/uso terapêutico
Antimetabólitos Antineoplásicos/efeitos adversos
Antimetabólitos Antineoplásicos/uso terapêutico
Biotransformação
Neoplasias do Colo/sangue
Neoplasias do Colo/tratamento farmacológico
Neoplasias do Colo/cirurgia
Terapia Combinada/efeitos adversos
Relação Dose-Resposta a Droga
Feminino
Fluoruracila/efeitos adversos
Fluoruracila/uso terapêutico
Seres Humanos
Injeções Intravenosas
Mucosa Intestinal/efeitos dos fármacos
Mucosa Intestinal/metabolismo
Mucosa Intestinal/cirurgia
Levoleucovorina/administração & dosagem
Levoleucovorina/efeitos adversos
Levoleucovorina/uso terapêutico
Masculino
Meia-Idade
Período Perioperatório
Pró-Fármacos/administração & dosagem
Pró-Fármacos/efeitos adversos
Pró-Fármacos/uso terapêutico
Método Simples-Cego
Tetra-Hidrofolatos/administração & dosagem
Tetra-Hidrofolatos/efeitos adversos
Tetra-Hidrofolatos/sangue
Tetra-Hidrofolatos/metabolismo
Tetra-Hidrofolatos/uso terapêutico
Distribuição Tecidual
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; CLINICAL TRIAL, PHASE II; COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antidotes); 0 (Antimetabolites, Antineoplastic); 0 (Prodrugs); 0 (Tetrahydrofolates); 0SXY5ET48B (5,10-methylenetetrahydrofolic acid); 43ZWB253H4 (5,6,7,8-tetrahydrofolic acid); 990S25980Y (Levoleucovorin); U3P01618RT (Fluorouracil)
[Em] Mês de entrada:1503
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141025
[St] Status:MEDLINE
[do] DOI:10.1007/s00280-014-2611-9


  3 / 29 MEDLINE  
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[PMID]:24773330
[Au] Autor:Gellad WF; Choi P; Mizah M; Good CB; Kesselheim AS
[Ad] Endereço:Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, 7180 Highland Dr, Pittsburgh, PA 15206. E-mail: walid.gellad@va.gov.>
[Ti] Título:Assessing the chiral switch: approval and use of single-enantiomer drugs, 2001 to 2011.
[So] Source:Am J Manag Care;20(3):e90-7, 2014 Mar 01.
[Is] ISSN:1936-2692
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: A "chiral switch" occurs in the pharmaceutical market when a drug made up of 2 enantiomer forms is replaced with a purified single-enantiomer version, often in the context of a patent expiration. We studied the prevalence of chiral switching in the United States over the past decade, including trends in use of, and expenditures on, these products in Medicaid. STUDY DESIGN: Retrospective analysis. METHODS: We used US Adopted Names prefixes (lev/levo/ar/es/dex/dextro) to identify all single-enantiomer drugs approved from 2001 to 2011. From publicly available US Food and Drug Administration (FDA) approval documents, we extracted the characteristics of the pivotal premarket trials for the single enantiomers. Specifically, we evaluated whether the single enantiomer was directly compared with the precursor racemic drug and whether there was evidence of superior efficacy. We used quarterly drug expenditure data from each state Medicaid program to chart trends in use of, and spending on, the single-enantiomer products and their racemic precursors during the study period. RESULTS: From 2001 to 2011, the FDA approved 9 single-enantiomer products: dexlansoprazole, levoleucovorin, levocetirizine, armodafinil, arformoterol, eszopiclone, escitalopram, dexmethylphenidate, and esomeprazole. Of those 9 drugs, 3 had at least 1 pre-approval randomized trial that included the racemic precursor as a direct comparator, but there was no evidence of superiority of the single enantiomer over the racemic at comparable doses. Between 2001 and 2011, US Medicaid programs spent approximately $6.3 billion on these 9 single-enantiomer drugs. CONCLUSIONS: Recently approved single-enantiomer drugs showed no evidence of superior efficacy over the older racemic precursors in the pivotal trials leading to their approval, and in a majority of cases, they were not directly compared.
[Mh] Termos MeSH primário: Aprovação de Drogas
Prescrições de Medicamentos/estatística & dados numéricos
Medicaid/economia
[Mh] Termos MeSH secundário: Antídotos/química
Antídotos/economia
Compostos Azabicíclicos/química
Compostos Azabicíclicos/economia
Compostos Benzidrílicos/química
Compostos Benzidrílicos/economia
Broncodilatadores/química
Broncodilatadores/economia
Estimulantes do Sistema Nervoso Central/química
Estimulantes do Sistema Nervoso Central/economia
Cetirizina/química
Cetirizina/economia
Dexlansoprazol/química
Dexlansoprazol/economia
Cloridrato de Dexmetilfenidato/química
Cloridrato de Dexmetilfenidato/economia
Medicamentos Genéricos/economia
Esomeprazol/química
Esomeprazol/economia
Zopiclona
Etanolaminas/química
Etanolaminas/economia
Fumarato de Formoterol
Antagonistas dos Receptores Histamínicos H1 não Sedativos/química
Antagonistas dos Receptores Histamínicos H1 não Sedativos/economia
Seres Humanos
Hipnóticos e Sedativos/química
Hipnóticos e Sedativos/economia
Levoleucovorina/química
Levoleucovorina/economia
Patentes como Assunto
Piperazinas/química
Piperazinas/economia
Inibidores da Bomba de Prótons/química
Inibidores da Bomba de Prótons/economia
Estudos Retrospectivos
Estereoisomerismo
Estados Unidos
United States Food and Drug Administration
Promotores da Vigília/química
Promotores da Vigília/economia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.; RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
[Nm] Nome de substância:
0 (Antidotes); 0 (Azabicyclo Compounds); 0 (Benzhydryl Compounds); 0 (Bronchodilator Agents); 0 (Central Nervous System Stimulants); 0 (Drugs, Generic); 0 (Ethanolamines); 0 (Histamine H1 Antagonists, Non-Sedating); 0 (Hypnotics and Sedatives); 0 (Piperazines); 0 (Proton Pump Inhibitors); 0 (Wakefulness-Promoting Agents); 1678OK0E08 (Dexmethylphenidate Hydrochloride); 6U5EA9RT2O (levocetirizine); 990S25980Y (Levoleucovorin); N3PA6559FT (Esomeprazole); UYE4T5I70X (Dexlansoprazole); UZX80K71OE (Eszopiclone); V63XWA605I (armodafinil); W34SHF8J2K (Formoterol Fumarate); YO7261ME24 (Cetirizine)
[Em] Mês de entrada:1508
[Cu] Atualização por classe:151119
[Lr] Data última revisão:
151119
[Sb] Subgrupo de revista:H
[Da] Data de entrada para processamento:140430
[St] Status:MEDLINE


  4 / 29 MEDLINE  
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[PMID]:23173846
[Au] Autor:Martella B; Cardin F; Lorenzetti R; Terranova C; Amato B; Militello C
[Ad] Endereço:Department of Molecular Medicine, University of Padua, Italy. bruno.martella@sanita.padova.it
[Ti] Título:Local recurrence of gastric cancer after total gastrectomy: an unusual presentation.
[So] Source:BMC Surg;12 Suppl 1:S28, 2012.
[Is] ISSN:1471-2482
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:A 71 years old Italian man had type 3 gastric cancer of the greater curvature. Total gastrectomy with splenectomy and D2 lymph node dissection were performed. After discharge chemotherapy ELF regimen was administered for 6 months. After 16 months from the operation a local recurrence was discovered by CT scan. Surgical en-bloc resection was performed removing pancreatic tail, splenic colic flexure and a portion of left diaphragm. Histological examination confirmed local recurrence of gastric adenocarcinoma infiltrating pancreas, colon and diaphragm with lymph node metastasis.
[Mh] Termos MeSH primário: Adenocarcinoma/cirurgia
Gastrectomia
Recidiva Local de Neoplasia/diagnóstico por imagem
Neoplasias Gástricas/cirurgia
Tomografia Computadorizada por Raios X
[Mh] Termos MeSH secundário: Adenocarcinoma/diagnóstico por imagem
Adenocarcinoma/tratamento farmacológico
Adenocarcinoma/patologia
Idoso
Antineoplásicos/administração & dosagem
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Quimioterapia Adjuvante
Etoposídeo/uso terapêutico
Fluoruracila/uso terapêutico
Seres Humanos
Levoleucovorina/uso terapêutico
Masculino
Recidiva Local de Neoplasia/patologia
Neoplasias Gástricas/diagnóstico por imagem
Neoplasias Gástricas/tratamento farmacológico
Neoplasias Gástricas/patologia
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 6PLQ3CP4P3 (Etoposide); 990S25980Y (Levoleucovorin); U3P01618RT (Fluorouracil)
[Em] Mês de entrada:1305
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:121124
[St] Status:MEDLINE
[do] DOI:10.1186/1471-2482-12-S1-S28


  5 / 29 MEDLINE  
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[PMID]:23032661
[Au] Autor:Chuang VT; Suno M
[Ad] Endereço:School of Pharmacy, Faculty of Health Sciences, Curtin Health Innovation & Research Institute, Curtin University, Perth, Western Australia, Australia.
[Ti] Título:Levoleucovorin as replacement for leucovorin in cancer treatment.
[So] Source:Ann Pharmacother;46(10):1349-57, 2012 Oct.
[Is] ISSN:1542-6270
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To comprehensively review the literature regarding the efficacy, safety, and costs associated with the use of levoleucovorin in cancer treatment and to assess whether levoleucovorin would be a reasonable alternative to the use of racemic leucovorin. DATA SOURCES: A MEDLINE search was conducted for English-language human studies published between January 1980 and April 2012 using the terms l-LV, levoleucovorin, d,l-LV, leucovorin, folinic acid, folinate, 5-formyltetrahydrofolate, folic acid, folates, methotrexate, 5-fluorouracil, and clinical trials. STUDY SELECTION AND DATA EXTRACTION: Articles pertinent to clinical trials (Phase 1, 2, 3) related to evaluating the efficacy, interchangeability, and safety of levoleucovorin were collected and their contents reviewed. DATA SYNTHESIS: From these pharmacokinetics and clinical studies, information on the use of levoleucovorin as a modulator of fluorouracil as well as when combined with other antitumor agents were scrutinized and extracted for comparison with leucovorin whenever possible. Two randomized Phase 3 clinical studies comparing the efficacy and adverse effect profiles of leucovorin and levoleucovorin demonstrated that levoleucovorin is as effective as leucovorin in terms of response, toxicity, and survival. Six randomized Phase 3 clinical studies demonstrated the safety and efficacy of levoleucovorin as a modulator of fluorouracil in combination with/without other antitumor agents in colorectal cancer patients. Levoleucovorin has been studied in other cancers. These clinical Phase 1/2/3 studies demonstrated efficacy and safety of levoleucovorin in combination chemotherapeutic regimens comprising fluorouracil and other antitumor agents. CONCLUSIONS: The results of the clinical studies suggest that levoleucovorin is efficacious and can be used safely in combination with fluorouracil and other antitumor agents. Levoleucovorin can be used interchangeably with leucovorin for modulating fluorouracil. The current shortage of the supply of leucovorin centered in North America renders levoleucovorin a reasonable alternative in terms of efficacy and toxicity profile, but from the perspective of cost, leucovorin remains the drug of choice.
[Mh] Termos MeSH primário: Antineoplásicos/uso terapêutico
Levoleucovorina/uso terapêutico
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Antineoplásicos/farmacologia
Interações Medicamentosas
Seres Humanos
Levoleucovorina/farmacologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antineoplastic Agents); 990S25980Y (Levoleucovorin)
[Em] Mês de entrada:1302
[Cu] Atualização por classe:131121
[Lr] Data última revisão:
131121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:121004
[St] Status:MEDLINE
[do] DOI:10.1345/aph.1Q677


  6 / 29 MEDLINE  
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[PMID]:22790056
[Au] Autor:Yabuki H; Suto T; Inoue K; Fujimoto H; Sato T; Ikeda E; Iizawa H
[Ad] Endereço:Dept. of Surgery, Yamagata Prefectural Central Hospital, Japan.
[Ti] Título:[A case of colorectal neuroendocrine carcinoma effectively treated with bevacizumab+levofolinate+5-FU chemotherapy].
[So] Source:Gan To Kagaku Ryoho;39(7):1139-42, 2012 Jul.
[Is] ISSN:0385-0684
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:A 76-year-old woman was admitted to our hospital with diarrhea and weight loss in February 2007. A CT scan revealed a tumor in the abdominal cavity, and although a thorough investigation was conducted, no diagnosis was made. Therefore, she underwent diagnostic surgery in April 2007. Intraoperatively, the tumor was determined to have originated in the transverse colon, with invasion to other organs. The patient underwent a transverse colectomy, partial ileal resection, and partial resection of the bladder and peritoneum were performed. The pathological diagnosis was colorectal neuroendocrine carcinoma. FOLFOX4 chemotherapy was initiated in May 2007. However, a CT scan in June 2007 revealed a recurrent tumor in the right pelvis. Although right hemicolectomy and right oophorectomy were performed in August, a CT scan in September 2007 revealed a recurrent tumor in the right pelvis. Following treatment with bevacizumab+levofolinate+5-FU, the tumor disappeared. The patient continued to receive this chemotherapy regimen until August 2010, and CT scans showed a complete response. Even though colorectal neuroendocrine carcinoma is known to have a poor prognosis, the present case was effectively treated with bevacizumab+levofolinate+5-FU chemotherapy. Herein we provide discussion and suggestions about treatment for colorectal neuroendocrine carcinoma.
[Mh] Termos MeSH primário: Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Carcinoma Neuroendócrino/tratamento farmacológico
Neoplasias Colorretais/tratamento farmacológico
[Mh] Termos MeSH secundário: Idoso
Anticorpos Monoclonais Humanizados/administração & dosagem
Bevacizumab
Carcinoma Neuroendócrino/patologia
Carcinoma Neuroendócrino/cirurgia
Neoplasias Colorretais/patologia
Neoplasias Colorretais/cirurgia
Terapia Combinada
Feminino
Fluoruracila/administração & dosagem
Seres Humanos
Levoleucovorina/administração & dosagem
Tomografia Computadorizada por Raios X
[Pt] Tipo de publicação:CASE REPORTS; ENGLISH ABSTRACT; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 2S9ZZM9Q9V (Bevacizumab); 990S25980Y (Levoleucovorin); U3P01618RT (Fluorouracil)
[Em] Mês de entrada:1208
[Cu] Atualização por classe:151119
[Lr] Data última revisão:
151119
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:120714
[St] Status:MEDLINE


  7 / 29 MEDLINE  
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[PMID]:21078826
[Au] Autor:Labianca R; Sobrero A; Isa L; Cortesi E; Barni S; Nicolella D; Aglietta M; Lonardi S; Corsi D; Turci D; Beretta GD; Fornarini G; Dapretto E; Floriani I; Zaniboni A; Italian Group for the Study of Gastrointestinal Cancer-GISCAD
[Ad] Endereço:Oncologia Medica, Ospedali Riuniti, Bergamo. rlabian@tin.it
[Ti] Título:Intermittent versus continuous chemotherapy in advanced colorectal cancer: a randomised 'GISCAD' trial.
[So] Source:Ann Oncol;22(5):1236-42, 2011 May.
[Is] ISSN:1569-8041
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: In advanced colorectal cancer, chemotherapy is usually administered without pauses and until progression but patients can experience cumulative toxicity and cannot tolerate a heavy therapeutic charge. AIM: The aim of the present trial was to evaluate whether an intermittent chemotherapy with levo-leucovorin + 5-fluorouracil (5-FU) + irinotecan (CPT-11) was at least as effective as the same regimen given continuously, both administered until progression, in patients affected with advanced colorectal cancer and not previously exposed to chemotherapy for metastatic disease. PATIENTS, MATERIALS AND METHODS: A total of 337 patients from 27 institutions were randomised between levo-leucovorin, 100/mg/m(2) i.v. + 5-FU; 400 mg/m(2) i.v. bolus + 5-FU; 600 mg/m(2) 22-h continuous infusion, days 1 and 2 + CPT-11; 180 mg/m(2) day 1, administered every 2 weeks 2 months on and 2 months off (arm A) and the same regimen administered continuously (arm B), until progression in both arms. The main end point was overall survival (OS), the secondary progression-free survival (PFS) and toxicity. RESULTS: At a median follow-up of 41 months, OS was 18 months in arm A and 17 months in arm B [hazard ratio (HR), 0.88]. Also PFS was comparable in the two groups (6 months in both, with HR, 1.03), and even grades 3-4 toxicity (mainly myelosuppression, fever and diarrhoea) was similar. Second-line oxaliplatin-based treatment was administered in a similar percentage (66%) in the two arms. The median chemotherapy-free period (drug holiday) in arm A was 3.5 months. CONCLUSION: Reducing the charge of therapy in this population did not diminish the efficacy of treatment. Further studies with this strategy, including biologicals, are warranted.
[Mh] Termos MeSH primário: Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem
Neoplasias Colorretais/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Idoso
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Camptotecina/administração & dosagem
Camptotecina/análogos & derivados
Neoplasias Colorretais/mortalidade
Intervalo Livre de Doença
Feminino
Fluoruracila/administração & dosagem
Seres Humanos
Estimativa de Kaplan-Meier
Levoleucovorina/administração & dosagem
Masculino
Meia-Idade
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
7673326042 (irinotecan); 990S25980Y (Levoleucovorin); U3P01618RT (Fluorouracil); XT3Z54Z28A (Camptothecin)
[Em] Mês de entrada:1108
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:101117
[St] Status:MEDLINE
[do] DOI:10.1093/annonc/mdq580


  8 / 29 MEDLINE  
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[PMID]:20354823
[Au] Autor:Fujii H; Iihara H; Yasuda K; Matsuura K; Takahashi T; Yoshida K; Itoh Y
[Ad] Endereço:Department of Pharmacy, Gifu University Hospital, Gifu, Japan.
[Ti] Título:Evaluation of efficacy and safety of generic levofolinate in patients who received colorectal cancer chemotherapy.
[So] Source:Med Oncol;28(2):488-93, 2011 Jun.
[Is] ISSN:1559-131X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The efficacy and safety of generic and brand name levofolinate injectable drugs were evaluated in 42 chemotherapy-naïve patients with colorectal cancer who received the combination chemotherapy of levofolinate, 5-fluorouracil, and oxaliplatin with or without bevacizumab. The tumor response rate was similar between generic drug group and brand drug group, in which the efficacy rate (complete response plus partial response) was 50% for generic drug group and 42% for brand name drug (odds ratio: 1.400, 95% confidence intervals: 0.409-4.788, P = 0.756). The rates of the decrease in plasma tumor markers such as carcinoembryonic antigen and carbohydrate antigen 19-9 were not different between the two groups. The incidence of adverse drug reactions was not significantly different between the two groups, although the incidence rates of adverse events associated predominantly with 5-fluorouracil such as hand-and-foot syndrome, diarrhea, and oral mucositis were rather higher, though not significantly, in generic drug group than in brand drug group (16 vs. 4% for hand-and-foot syndrome; 33 vs. 25% for diarrhea; 33 vs. 25% for oral mucositis). These findings suggest that both the effectiveness and safety profiles of the generic name levofolinate are comparable to those of the brand name drug, when used in combination with 5-fluorouracil and oxaliplatin in patients with colorectal cancer.
[Mh] Termos MeSH primário: Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Neoplasias Colorretais/tratamento farmacológico
Medicamentos Genéricos/uso terapêutico
Levoleucovorina/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Idoso
Anticorpos Monoclonais/administração & dosagem
Anticorpos Monoclonais/uso terapêutico
Anticorpos Monoclonais Humanizados
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Bevacizumab
Feminino
Fluoruracila/administração & dosagem
Fluoruracila/uso terapêutico
Seres Humanos
Levoleucovorina/efeitos adversos
Masculino
Meia-Idade
Compostos Organoplatínicos/administração & dosagem
Compostos Organoplatínicos/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Antibodies, Monoclonal, Humanized); 0 (Drugs, Generic); 0 (Organoplatinum Compounds); 04ZR38536J (oxaliplatin); 2S9ZZM9Q9V (Bevacizumab); 990S25980Y (Levoleucovorin); U3P01618RT (Fluorouracil)
[Em] Mês de entrada:1110
[Cu] Atualização por classe:171108
[Lr] Data última revisão:
171108
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:100401
[St] Status:MEDLINE
[do] DOI:10.1007/s12032-010-9487-2


  9 / 29 MEDLINE  
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[PMID]:19538878
[Au] Autor:Lou F; Zhu YH; Pan HM
[Ad] Endereço:Department of Oncology Center, Sir Run Run Shaw Hospital, Medical College of Zhejiang University, SIR Run Run ShawInstitute of Clinical Medicine of Zhejiang University, Hangzhou 310016, China.
[Ti] Título:[Oxaliplatin combined with ELF regimen in the treatment of patients with advanced gastric cancer].
[So] Source:Zhonghua Zhong Liu Za Zhi;31(1):75-8, 2009 Jan.
[Is] ISSN:0253-3766
[Cp] País de publicação:China
[La] Idioma:chi
[Ab] Resumo:OBJECTIVE: To evaluate the efficacy and safety of the combination of oxaliplatin and ELF (VP16/CF/5-Fu) regimen in the treatment of patients with advanced gastric cancer. METHODS: Oxaliplatin was given at a dose of 100 mg/m(2) i.v. 2 hours D1, calcium folinate (CF) 200 mg/m(2) i.v. 1/2 hour D1 approximately D3, 5-fluorouracil (5-Fu) 500 mg/m(2) i.v. 2 hours D1 approximately D3 and etoposide 100 mg/m(2) i.v. 3 hours D1 approximately D3. Cycles were repeated every 21 days. Efficacy and safety were evaluated every 2 cycles. RESULTS: Sixty-nine patients were enrolled into the study. All cases were pathologically confirmed as gastric cancer (adenocarcinoma in 57 cases and signet ring cell carcinoma in 12 cases). 42 patients had newly diagnosed disease, and 27 patients had received previous chemotherapy. 62 patients were analyzed for response (7 complete responses and 25 partial responses) with total response rate 51.61%. The median time to progression was 5.7 months and the median overall survival was 9.2 months. The most common hematologic toxicities were anemia (29.0%), leucopenia (51.2%) and thrombocytopenia (21.2%). No grade 4 and grade 5 hematologic toxicities were observed. The most common non-hematologic toxicities were nausea (46.5%), vomiting (41.1%), peripheral sensory neuropathy (47.1%), and grade 2 alopecia (27.3%). CONCLUSION: This oxaliplatin combined with ELF regimen shows good efficacy and acceptable safety in advanced gastric cancer patients. It is worthy to be proved as a suitable alternative regimen in this indication.
[Mh] Termos MeSH primário: Adenocarcinoma/tratamento farmacológico
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Carcinoma de Células em Anel de Sinete/tratamento farmacológico
Compostos Organoplatínicos/administração & dosagem
Neoplasias Gástricas/tratamento farmacológico
[Mh] Termos MeSH secundário: Adenocarcinoma/patologia
Adulto
Idoso
Anemia/induzido quimicamente
Antineoplásicos/administração & dosagem
Antineoplásicos/efeitos adversos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Carcinoma de Células em Anel de Sinete/patologia
Etoposídeo/efeitos adversos
Etoposídeo/uso terapêutico
Feminino
Fluoruracila/efeitos adversos
Fluoruracila/uso terapêutico
Seres Humanos
Leucovorina/efeitos adversos
Leucovorina/uso terapêutico
Leucopenia/induzido quimicamente
Levoleucovorina
Masculino
Meia-Idade
Náusea/induzido quimicamente
Estadiamento de Neoplasias
Compostos Organoplatínicos/efeitos adversos
Indução de Remissão
Neoplasias Gástricas/patologia
Taxa de Sobrevida
Trombocitopenia/induzido quimicamente
Vômito/induzido quimicamente
[Pt] Tipo de publicação:CLINICAL TRIAL; ENGLISH ABSTRACT; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Organoplatinum Compounds); 04ZR38536J (oxaliplatin); 6PLQ3CP4P3 (Etoposide); 990S25980Y (Levoleucovorin); Q573I9DVLP (Leucovorin); U3P01618RT (Fluorouracil)
[Em] Mês de entrada:1008
[Cu] Atualização por classe:141120
[Lr] Data última revisão:
141120
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:090623
[St] Status:MEDLINE


  10 / 29 MEDLINE  
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[PMID]:16201130
[Au] Autor:Petrioli R; Sabatino M; Roviello F; Marrelli D; Nastri G; Marsili S; Correale P; Pozzessere D; Messinese S; De Martino A; Tani F; Marzocca G; Lorenzi M; Civitelli S; Tanzini G; Pinto E; Francini G
[Ad] Endereço:Department of Medical Oncology, University of Siena, Italy.
[Ti] Título:Folinic acid, 5-fluorouracil and etoposide after curative resection for gastric cancer.
[So] Source:Hepatogastroenterology;52(65):1626-30, 2005 Sep-Oct.
[Is] ISSN:0172-6390
[Cp] País de publicação:Greece
[La] Idioma:eng
[Ab] Resumo:BACKGROUND/AIMS: The aim of this study was to evaluate the survival benefit of adjuvant chemotherapy with etoposide, leucovorin and 5-fluorouracil (ELF) in gastric cancer patients undergoing previous surgery with a curative intent. METHODOLOGY: The clinical outcome of 49 patients with resected gastric cancer treated with adjuvant chemotherapy was compared with that of 85 surgically treated historical controls who did not receive any adjuvant treatment. The chemotherapy regimen consisted of six cycles of daily 1-hour intravenous infusions of folinic acid 100 mg/m2 and 5-FU 400 mg/ m2, and a 2-hour infusion of etoposide 100 mg/m2, for three days every 28 days. RESULTS: The 5-year relapse-free survival was 32% in the adjuvant arm and 27% in the control arm (p = 0.6). At the last follow-up, there were 32 deaths in the adjuvant arm and 60 in the control arm. The median duration of survival was respectively 23 and 19 months, and the 5-year survival rates were 34% and 29% (p = 0.4). The chemotherapy was well tolerated. CONCLUSIONS: Our data suggest that ELF adjuvant treatment is a safe and well tolerable combination chemotherapy in patients with resected gastric cancer, but it does not seem to improve prognosis in comparison with historical controls.
[Mh] Termos MeSH primário: Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Neoplasias Gástricas/tratamento farmacológico
Neoplasias Gástricas/cirurgia
[Mh] Termos MeSH secundário: Quimioterapia Adjuvante
Etoposídeo/uso terapêutico
Feminino
Fluoruracila/uso terapêutico
Gastrectomia
Seres Humanos
Leucovorina/uso terapêutico
Levoleucovorina
Masculino
Meia-Idade
Neoplasias Gástricas/mortalidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
6PLQ3CP4P3 (Etoposide); 990S25980Y (Levoleucovorin); Q573I9DVLP (Leucovorin); U3P01618RT (Fluorouracil)
[Em] Mês de entrada:0511
[Cu] Atualização por classe:131121
[Lr] Data última revisão:
131121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:051006
[St] Status:MEDLINE



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