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[PMID]:29175677
[Au] Autor:Røed Skårderud M; Polk A; Kjeldgaard Vistisen K; Larsen FO; Nielsen DL
[Ad] Endereço:Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej 75, DK- 2730 Herlev, Denmark. Electronic address: mariaskarderud@gmail.com.
[Ti] Título:Efficacy and safety of regorafenib in the treatment of metastatic colorectal cancer: A systematic review.
[So] Source:Cancer Treat Rev;62:61-73, 2018 Jan.
[Is] ISSN:1532-1967
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Despite advances in the treatment of colorectal cancer, third-line treatment options are still limited. Regorafenib was approved in 2012 for the treatment of patients with metastatic colorectal cancer previously treated with approved standard therapy. The purpose of this review is to present existing clinical data on regorafenib. METHOD: We systematically searched the PubMed and Embase databases, as well as ASCO and ESMO conference abstracts, for studies in English including ≥30 patients, evaluating the efficacy and safety of regorafenib in patients with metastatic colorectal cancer. A meta-analysis was conducted on the published, randomized phase III trials. RESULTS: 24 eligible studies were included. In two phase III trials, regorafenib significantly increased overall survival (OS), progression free survival (PFS), and disease control rate when compared to placebo. Survival benefits of 1.4 and 2.5 months were presented. The meta-analysis indicated a significant greater treatment effect on OS (hazard ratio 0.67) and PFS (hazard ratio 0.40), compared to placebo. The non-randomized studies mostly supported these results. The most frequently reported adverse events were hand-foot-skin reaction (25%-86%), hypertension (11%-47%) and fatigue (2%-73%). CONCLUSION: Large phase III randomized trials indicate that regorafenib provides a benefit in OS and PFS when compared to placebo. Adverse events were common, but manageable and typical of multi-target tyrosine kinase inhibitors. Further research is needed to investigate alternative approaches to the dosing of regorafenib and to explore clinical and molecular biomarkers that can guide patient selection.
[Mh] Termos MeSH primário: Antineoplásicos/uso terapêutico
Neoplasias Colorretais/tratamento farmacológico
Compostos de Fenilureia/uso terapêutico
Piridinas/uso terapêutico
[Mh] Termos MeSH secundário: Ensaios Clínicos Fase III como Assunto
Neoplasias Colorretais/patologia
Intervalo Livre de Doença
Fadiga/induzido quimicamente
Síndrome Mão-Pé/etiologia
Seres Humanos
Hipertensão/induzido quimicamente
Metástase Neoplásica
Modelos de Riscos Proporcionais
Taxa de Sobrevida
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Phenylurea Compounds); 0 (Pyridines); 24T2A1DOYB (regorafenib)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180102
[Lr] Data última revisão:
180102
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE


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[PMID]:29258090
[Au] Autor:Ogawa C; Morita M; Omura A; Noda T; Kubo A; Matsunaka T; Tamaki H; Shibatoge M; Tsutsui A; Senoh T; Nagano T; Takaguchi K; Tani J; Morishita A; Yoneyama H; Masaki T; Moriya A; Ando M; Deguchi A; Kokudo Y; Minami Y; Ueshima K; Sakurai T; Nishida N; Kudo M
[Ad] Endereço:Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
[Ti] Título:Hand-Foot Syndrome and Post-Progression Treatment Are the Good Predictors of Better Survival in Advanced Hepatocellular Carcinoma Treated with Sorafenib: A Multicenter Study.
[So] Source:Oncology;93 Suppl 1:113-119, 2017.
[Is] ISSN:1423-0232
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To determine the relationship between treatment outcomes and hand-foot syndrome (HFS), and the relationship between survival rate and post-progression treatment after sorafenib therapy. METHODS: The study assessed 314 patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib at 5 general hospitals in Kagawa Prefecture, Japan. RESULTS: At the start of sorafenib therapy, 23.6% of the patients had HCC of a Child-Pugh class other than A. The initial sorafenib dose was 800 mg in 9.2% of the patients and 400 mg in 64.3%. Time to progression was 129 days (95% CI: 87.3-170.7) and the median overall survival (OS) was 392 days (95% CI: 316.0-468.0). The OS of the patients with Child-Pugh class A HCC was significantly better than that of the patients with Child-Pugh class B HCC (p < 0.0001). The survival curves for Child-Pugh class A-5 points and class A-6 points were significantly different, with that for class A-5 points being better (p < 0.0001). A significant difference was observed between the patients who exhibited HFS and those who did not, with the former exhibiting a better survival rate (p < 0.001). In addition, the survival rate of the patients who received post-progression treatment after sorafenib therapy was significantly better than that of the patients who did not (p < 0.001). CONCLUSION: In sorafenib therapy, patients with HFS and those who received post-progression treatment exhibited good OS.
[Mh] Termos MeSH primário: Síndrome Mão-Pé/etiologia
Niacinamida/análogos & derivados
Compostos de Fenilureia/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Antineoplásicos/efeitos adversos
Antineoplásicos/uso terapêutico
Carcinoma Hepatocelular/tratamento farmacológico
Feminino
Seres Humanos
Neoplasias Hepáticas/tratamento farmacológico
Masculino
Meia-Idade
Niacinamida/uso terapêutico
Prognóstico
Inibidores de Proteínas Quinases/efeitos adversos
Inibidores de Proteínas Quinases/uso terapêutico
Taxa de Sobrevida
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Phenylurea Compounds); 0 (Protein Kinase Inhibitors); 25X51I8RD4 (Niacinamide); 9ZOQ3TZI87 (sorafenib)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171221
[Lr] Data última revisão:
171221
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171220
[St] Status:MEDLINE
[do] DOI:10.1159/000481241


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[PMID]:28635153
[Au] Autor:Elyasi S; Shojaee FSR; Allahyari A; Karimi G
[Ad] Endereço:Department of Clinical Pharmacy, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
[Ti] Título:Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.
[So] Source:Phytother Res;31(9):1323-1329, 2017 Sep.
[Is] ISSN:1099-1573
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of capecitabine in patient with gastrointestinal cancers. Silymarin is a polyphenolic flavonoid extracted from the Silybum marianum that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluated silymarin efficacy in prevention of capecitabine-induced HFS in patients with gastrointestinal cancers, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of silymarin gel 1%, which is applied on the palms and soles twice daily starting at the first day of chemotherapy for 9 weeks, on HFS occurrence was assessed. Forty patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization HFS grading scale scores were recorded at baseline and every 3 weeks during these 9 weeks. The median WHO HFS scores were significantly lower in silymarin group at the end of the 9 week (p < 0.05). The scores increased significantly in both placebo and silymarin groups during chemotherapy, but there was a delay for HFS development and progression in silymarin group. Prophylactic administration of silymarin topical formulation could significantly reduce the severity of capecitabine-induced HFS and delays its occurrence in patients with gastrointestinal cancer after 9 weeks of application. Copyright © 2017 John Wiley & Sons, Ltd.
[Mh] Termos MeSH primário: Antimetabólitos Antineoplásicos/efeitos adversos
Capecitabina/efeitos adversos
Síndrome Mão-Pé/tratamento farmacológico
Fitoterapia
Silimarina/uso terapêutico
[Mh] Termos MeSH secundário: Administração Cutânea
Idoso
Feminino
Seres Humanos
Masculino
Meia-Idade
Cardo Mariano/química
Silimarina/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antimetabolites, Antineoplastic); 0 (Silymarin); 6804DJ8Z9U (Capecitabine)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170925
[Lr] Data última revisão:
170925
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170622
[St] Status:MEDLINE
[do] DOI:10.1002/ptr.5857


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[PMID]:28600210
[Au] Autor:Cameron D; Morden JP; Canney P; Velikova G; Coleman R; Bartlett J; Agrawal R; Banerji J; Bertelli G; Bloomfield D; Brunt AM; Earl H; Ellis P; Gaunt C; Gillman A; Hearfield N; Laing R; Murray N; Couper N; Stein RC; Verrill M; Wardley A; Barrett-Lee P; Bliss JM; TACT2 Investigators
[Ad] Endereço:Cancer Research UK Edinburgh Centre, MRC Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK. Electronic address: D.Cameron@ed.ac.uk.
[Ti] Título:Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial.
[So] Source:Lancet Oncol;18(7):929-945, 2017 Jul.
[Is] ISSN:1474-5488
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Adjuvant chemotherapy for early breast cancer has improved outcomes but causes toxicity. The UK TACT2 trial used a 2×2 factorial design to test two hypotheses: whether use of accelerated epirubicin would improve time to tumour recurrence (TTR); and whether use of oral capecitabine instead of cyclophosphamide would be non-inferior in terms of patients' outcomes and would improve toxicity, quality of life, or both. METHODS: In this multicentre, phase 3, randomised, controlled trial, we enrolled patients aged 18 years or older from 129 UK centres who had histologically confirmed node-positive or high-risk node-negative operable breast cancer, had undergone complete excision, and were due to receive adjuvant chemotherapy. Patients were randomly assigned to receive four cycles of 100 mg/m epirubicin either every 3 weeks (standard epirubicin) or every 2 weeks with 6 mg pegfilgrastim on day 2 of each cycle (accelerated epirubicin), followed by four 4-week cycles of either classic cyclophosphamide, methotrexate, and fluorouracil (CMF; 600 mg/m cyclophosphamide intravenously on days 1 and 8 or 100 mg/m orally on days 1-14; 40 mg/m methotrexate intravenously on days 1 and 8; and 600 mg/m fluorouracil intravenously on days 1 and 8 of each cycle) or four 3-week cycles of 2500 mg/m capecitabine (1250 mg/m given twice daily on days 1-14 of each cycle). The randomisation schedule was computer generated in random permuted blocks, stratified by centre, number of nodes involved (none vs one to three vs four or more), age (≤50 years vs >50 years), and planned endocrine treatment (yes vs no). The primary endpoint was TTR, defined as time from randomisation to first invasive relapse or breast cancer death, with intention-to-treat analysis of standard versus accelerated epirubicin and per-protocol analysis of CMF versus capecitabine. This trial is registered with ISRCTN, number 68068041, and with ClinicalTrials.gov, number NCT00301925. FINDINGS: From Dec 16, 2005, to Dec 5, 2008, 4391 patients (4371 women and 20 men) were recruited. At a median follow-up of 85·6 months (IQR 80·6-95·9) no significant difference was seen in the proportions of patients free from TTR events between the accelerated and standard epirubicin groups (overall hazard ratio [HR] 0·94, 95% CI 0·81-1·09; stratified p=0·42). At 5 years, 85·9% (95% CI 84·3-87·3) of patients receiving standard epirubicin and 87·1% (85·6-88·4) of those receiving accelerated epirubicin were free from TTR events. 4358 patients were included in the per-protocol analysis, and no difference was seen in the proportions of patients free from TTR events between the CMF and capecitabine groups (HR 0·98, 95% CI 0·85-1.14; stratified p=0·00092 for non-inferiority). Compared with baseline, significantly more patients taking CMF than those taking capecitabine had clinically relevant worsening of quality of life at end of treatment (255 [58%] of 441 vs 235 [50%] of 475; p=0·011) and at 12 months (114 [34%] of 334 vs 89 [22%] of 401; p<0·001 at 12 months) and had worse quality of life over time (p<0·0001). Detailed toxicity and quality-of-life data were collected from 2115 (48%) of treated patients. The most common grade 3 or higher adverse events in cycles 1-4 were neutropenia (175 [16%]) and fatigue (56 [5%]) of the 1070 patients treated with standard epirubicin, and fatigue (63 [6%]) and infection (34 [3%]) of the 1045 patients treated with accelerated epirubicin. In cycles 5-8, the most common grade 3 or higher adverse events were neutropenia (321 [31%]) and fatigue (109 [11%]) in the patients treated with CMF, and hand-foot syndrome (129 [12%]) and diarrhoea (67 [6%]) in the 1044 patients treated with capcitabine. INTERPRETATION: We found no benefit from increasing the dose density of the anthracycline component of chemotherapy. However, capecitabine could be used in place of CMF without significant loss of efficacy and with improved quality of life. FUNDING: Cancer Research UK, Amgen, Pfizer, and Roche.
[Mh] Termos MeSH primário: Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem
Neoplasias da Mama/tratamento farmacológico
Carcinoma/tratamento farmacológico
Epirubicina/administração & dosagem
Recidiva Local de Neoplasia
[Mh] Termos MeSH secundário: Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Neoplasias da Mama/patologia
Neoplasias da Mama/cirurgia
Neoplasias da Mama Masculina/tratamento farmacológico
Neoplasias da Mama Masculina/cirurgia
Capecitabina/administração & dosagem
Capecitabina/efeitos adversos
Carcinoma/secundário
Carcinoma/cirurgia
Quimioterapia Adjuvante/métodos
Ciclofosfamida/administração & dosagem
Ciclofosfamida/efeitos adversos
Diarreia/induzido quimicamente
Intervalo Livre de Doença
Epirubicina/efeitos adversos
Fadiga/induzido quimicamente
Feminino
Filgrastim
Fluoruracila/administração & dosagem
Fluoruracila/efeitos adversos
Seguimentos
Fator Estimulador de Colônias de Granulócitos/administração & dosagem
Síndrome Mão-Pé/etiologia
Seres Humanos
Infecção/induzido quimicamente
Masculino
Metotrexato/administração & dosagem
Metotrexato/efeitos adversos
Meia-Idade
Recidiva Local de Neoplasia/diagnóstico
Neutropenia/induzido quimicamente
Polietilenoglicóis
Qualidade de Vida
Proteínas Recombinantes/administração & dosagem
Taxa de Sobrevida
Fatores de Tempo
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Recombinant Proteins); 143011-72-7 (Granulocyte Colony-Stimulating Factor); 30IQX730WE (Polyethylene Glycols); 3A58010674 (pegfilgrastim); 3Z8479ZZ5X (Epirubicin); 6804DJ8Z9U (Capecitabine); 8N3DW7272P (Cyclophosphamide); PVI5M0M1GW (Filgrastim); U3P01618RT (Fluorouracil); YL5FZ2Y5U1 (Methotrexate)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170611
[St] Status:MEDLINE


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[PMID]:28564564
[Au] Autor:Masuda N; Lee SJ; Ohtani S; Im YH; Lee ES; Yokota I; Kuroi K; Im SA; Park BW; Kim SB; Yanagita Y; Ohno S; Takao S; Aogi K; Iwata H; Jeong J; Kim A; Park KH; Sasano H; Ohashi Y; Toi M
[Ad] Endereço:From the National Hospital Organization Osaka National Hospital, Osaka (N.M.), Hiroshima City Hiroshima Citizens Hospital, Hiroshima (S. Ohtani), Kyoto Prefectural University of Medicine (I.Y.), and Graduate School of Medicine, Kyoto University (M.T.), Kyoto, Tokyo Metropolitan Cancer and Infectious
[Ti] Título:Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy.
[So] Source:N Engl J Med;376(22):2147-2159, 2017 06 01.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Patients who have residual invasive carcinoma after the receipt of neoadjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative breast cancer have poor prognoses. The benefit of adjuvant chemotherapy in these patients remains unclear. METHODS: We randomly assigned 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (containing anthracycline, taxane, or both) to receive standard postsurgical treatment either with capecitabine or without (control). The primary end point was disease-free survival. Secondary end points included overall survival. RESULTS: The result of the prespecified interim analysis met the primary end point, so this trial was terminated early. The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95% confidence interval [CI], 0.53 to 0.92; P=0.01). Overall survival was longer in the capecitabine group than in the control group (89.2% vs. 83.6% of the patients were alive at 5 years; hazard ratio for death, 0.59; 95% CI, 0.39 to 0.90; P=0.01). Among patients with triple-negative disease, the rate of disease-free survival was 69.8% in the capecitabine group versus 56.1% in the control group (hazard ratio for recurrence, second cancer, or death, 0.58; 95% CI, 0.39 to 0.87), and the overall survival rate was 78.8% versus 70.3% (hazard ratio for death, 0.52; 95% CI, 0.30 to 0.90). The hand-foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4% of the patients in the capecitabine group. CONCLUSIONS: After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing. (Funded by the Advanced Clinical Research Organization and the Japan Breast Cancer Research Group; CREATE-X UMIN Clinical Trials Registry number, UMIN000000843 .).
[Mh] Termos MeSH primário: Antimetabólitos Antineoplásicos/uso terapêutico
Neoplasias da Mama/tratamento farmacológico
Capecitabina/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Antimetabólitos Antineoplásicos/efeitos adversos
Neoplasias da Mama/mortalidade
Neoplasias da Mama/cirurgia
Capecitabina/efeitos adversos
Quimioterapia Adjuvante/efeitos adversos
Feminino
Síndrome Mão-Pé/etiologia
Seres Humanos
Meia-Idade
Terapia Neoadjuvante
Estadiamento de Neoplasias
Cuidados Pré-Operatórios
Receptor ErbB-2
Análise de Sobrevida
Neoplasias de Mama Triplo Negativas/tratamento farmacológico
Neoplasias de Mama Triplo Negativas/mortalidade
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antimetabolites, Antineoplastic); 6804DJ8Z9U (Capecitabine); EC 2.7.10.1 (ERBB2 protein, human); EC 2.7.10.1 (Receptor, ErbB-2)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170828
[Lr] Data última revisão:
170828
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170601
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1612645


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[PMID]:28526536
[Au] Autor:Diéras V; Miles D; Verma S; Pegram M; Welslau M; Baselga J; Krop IE; Blackwell K; Hoersch S; Xu J; Green M; Gianni L
[Ad] Endereço:Department of Medical Oncology, Institut Curie, Paris, France. Electronic address: veronique.dieras@curie.fr.
[Ti] Título:Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial.
[So] Source:Lancet Oncol;18(6):732-742, 2017 Jun.
[Is] ISSN:1474-5488
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The antibody-drug conjugate trastuzumab emtansine is indicated for the treatment of patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Approval of this drug was based on progression-free survival and interim overall survival data from the phase 3 EMILIA study. In this report, we present a descriptive analysis of the final overall survival data from that trial. METHODS: EMILIA was a randomised, international, open-label, phase 3 study of men and women aged 18 years or older with HER2-positive unresectable, locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane. Enrolled patients were randomly assigned (1:1) via a hierarchical, dynamic randomisation scheme and an interactive voice response system to trastuzumab emtansine (3·6 mg/kg intravenously every 3 weeks) or control (capecitabine 1000 mg/m self-administered orally twice daily on days 1-14 on each 21-day cycle, plus lapatinib 1250 mg orally once daily on days 1-21). Randomisation was stratified by world region (USA vs western Europe vs or other), number of previous chemotherapy regimens for unresectable, locally advanced, or metastatic disease (0 or 1 vs >1), and disease involvement (visceral vs non-visceral). The coprimary efficacy endpoints were progression-free survival (per independent review committee assessment) and overall survival. Efficacy was analysed in the intention-to-treat population; safety was analysed in all patients who received at least one dose of study treatment, with patients analysed according to the treatment actually received. On May 30, 2012, the study protocol was amended to allow crossover from control to trastuzumab emtansine after the second interim overall survival analysis crossed the prespecified overall survival efficacy boundary. This study is registered with ClinicalTrials.gov, number NCT00829166. FINDINGS: Between Feb 23, 2009, and Oct 13, 2011, 991 eligible patients were enrolled and randomly assigned to either trastuzumab emtansine (n=495) or capecitabine and lapatinib (control; n=496). In this final descriptive analysis, median overall survival was longer with trastuzumab emtansine than with control (29·9 months [95% CI 26·3-34·1] vs 25·9 months [95% CI 22·7-28·3]; hazard ratio 0·75 [95% CI 0·64-0·88]). 136 (27%) of 496 patients crossed over from control to trastuzumab emtansine after the second interim overall survival analysis (median follow-up duration 24·1 months [IQR 19·5-26·1]). Of those patients originally randomly assigned to trastuzumab emtansine, 254 (51%) of 495 received capecitabine and 241 [49%] of 495 received lapatinib (separately or in combination) after study drug discontinuation. In the safety population (488 patients treated with capecitabine plus lapatinib, 490 patients treated with trastuzumab emtansine), fewer grade 3 or worse adverse events occurred with trastuzumab emtansine (233 [48%] of 490) than with capecitabine plus lapatinib control treatment (291 [60%] of 488). In the control group, the most frequently reported grade 3 or worse adverse events were diarrhoea (103 [21%] of 488 patients) followed by palmar-plantar erythrodysaesthesia syndrome (87 [18%]), and vomiting (24 [5%]). The safety profile of trastuzumab emtansine was similar to that reported previously; the most frequently reported grade 3 or worse adverse events in the trastuzumab emtansine group were thrombocytopenia (70 [14%] of 490), increased aspartate aminotransferase levels (22 [5%]), and anaemia (19 [4%]). Nine patients died from adverse events; five of these deaths were judged to be related to treatment (two in the control group [coronary artery disease and multiorgan failure] and three in the trastuzumab emtansine group [metabolic encephalopathy, neutropenic sepsis, and acute myeloid leukaemia]). INTERPRETATION: This descriptive analysis of final overall survival in the EMILIA trial shows that trastuzumab emtansine improved overall survival in patients with previously treated HER2-positive metastatic breast cancer even in the presence of crossover treatment. The safety profile was similar to that reported in previous analyses, reaffirming trastuzumab emtansine as an efficacious and tolerable treatment in this patient population. FUNDING: F Hoffmann-La Roche/Genentech.
[Mh] Termos MeSH primário: Anticorpos Monoclonais Humanizados/uso terapêutico
Antineoplásicos/uso terapêutico
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Neoplasias da Mama/tratamento farmacológico
Maitansina/análogos & derivados
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Anemia/induzido quimicamente
Anticorpos Monoclonais Humanizados/efeitos adversos
Antineoplásicos/efeitos adversos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Aspartato Aminotransferases/sangue
Neoplasias da Mama/química
Neoplasias da Mama/patologia
Neoplasias da Mama Masculina/química
Neoplasias da Mama Masculina/tratamento farmacológico
Neoplasias da Mama Masculina/patologia
Hidrocarbonetos Aromáticos com Pontes/administração & dosagem
Capecitabina/administração & dosagem
Capecitabina/efeitos adversos
Diarreia/induzido quimicamente
Intervalo Livre de Doença
Feminino
Síndrome Mão-Pé/etiologia
Seres Humanos
Masculino
Maitansina/efeitos adversos
Maitansina/uso terapêutico
Meia-Idade
Quinazolinas/administração & dosagem
Quinazolinas/efeitos adversos
Receptor ErbB-2/análise
Critérios de Avaliação de Resposta em Tumores Sólidos
Retratamento
Taxa de Sobrevida
Taxoides/administração & dosagem
Trombocitopenia/induzido quimicamente
Trastuzumab/administração & dosagem
Vômito/induzido quimicamente
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Monoclonal, Humanized); 0 (Antineoplastic Agents); 0 (Bridged-Ring Compounds); 0 (Quinazolines); 0 (Taxoids); 0VUA21238F (lapatinib); 14083FR882 (Maytansine); 1605-68-1 (taxane); 6804DJ8Z9U (Capecitabine); EC 2.6.1.1 (Aspartate Aminotransferases); EC 2.7.10.1 (ERBB2 protein, human); EC 2.7.10.1 (Receptor, ErbB-2); P188ANX8CK (Trastuzumab); SE2KH7T06F (ado-trastuzumab emtansine)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171025
[Lr] Data última revisão:
171025
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170521
[St] Status:MEDLINE


  7 / 262 MEDLINE  
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[PMID]:28493546
[Au] Autor:Karol SE; Yang W; Smith C; Cheng C; Stewart CF; Baker SD; Sandlund JT; Rubnitz JE; Bishop MW; Pappo AS; Jeha S; Pui CH; Relling MV
[Ad] Endereço:Comprehensive Cancer Center, St. Jude Children's Research Hospital, Memphis, Tennessee.
[Ti] Título:Palmar-plantar erythrodysesthesia syndrome following treatment with high-dose methotrexate or high-dose cytarabine.
[So] Source:Cancer;123(18):3602-3608, 2017 Sep 15.
[Is] ISSN:1097-0142
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Palmar-plantar erythrodysesthesia syndrome (PPES) is an uncommon side effect of high-dose cytarabine or methotrexate. Prior case reports of PPES have been limited, and the predisposing factors for the development of PPES remain unknown. METHODS: A review of databases identified 22 patients (1.3%) who developed 39 episodes of PPES among 1720 patients after treatment with high-dose cytarabine or methotrexate. RESULTS: Symptoms lasted a mean of 6.4 days. Hands and feet were both involved in 68% of the initial episodes. Parenteral opioids were required for pain control by 27% of the patients. In comparison with the 1698 children treated with similar therapy, the children who developed PPES were older (mean age at diagnosis, 14.3 vs 7.7 years; P = 7.5 × 10 ). The frequency of PPES was less common in patients receiving methotrexate alone (7 of 946 or 0.7%) versus cytarabine (7 of 205 or 3.4%; P = .005) but was not different for those receiving both high-dose methotrexate and cytarabine (8 of 569 or 1.4%; P = .32). Prolonged infusions of methotrexate were associated with less frequent PPES in comparison with rapid infusions (P = 1.5 × 10 ), as was the co-administration of dexamethasone with cytarabine (P = 2.5 × 10 ). Self-described race and sex were not associated with PPES. In a multivariate analysis, older age and high-dose cytarabine administration without dexamethasone remained associated with PPES (P = 1.1 × 10 and P = .038, respectively). A genome-wide association study did not identify any associations with PPES meeting the genome-wide significance threshold, but top variants were enriched for skin expression quantitative trait loci, including rs11764092 in AUTS2 (P = 6.45 × 10 ). CONCLUSIONS: These data provide new insight into the incidence of PPES as well as its risk factors. Cancer 2017;123:3602-8. © 2017 American Cancer Society.
[Mh] Termos MeSH primário: Citarabina/efeitos adversos
Síndrome Mão-Pé/epidemiologia
Síndrome Mão-Pé/etiologia
Neoplasias Hematológicas/tratamento farmacológico
Metotrexato/efeitos adversos
[Mh] Termos MeSH secundário: Adolescente
Distribuição por Idade
Análise de Variância
Criança
Pré-Escolar
Citarabina/administração & dosagem
Bases de Dados Factuais
Relação Dose-Resposta a Droga
Esquema de Medicação
Feminino
Seguimentos
Síndrome Mão-Pé/fisiopatologia
Neoplasias Hematológicas/patologia
Seres Humanos
Incidência
Infusões Intravenosas
Masculino
Metotrexato/administração & dosagem
Análise Multivariada
Razão de Chances
Estudos Retrospectivos
Medição de Risco
Índice de Gravidade de Doença
Distribuição por Sexo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
04079A1RDZ (Cytarabine); YL5FZ2Y5U1 (Methotrexate)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171004
[Lr] Data última revisão:
171004
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170512
[St] Status:MEDLINE
[do] DOI:10.1002/cncr.30762


  8 / 262 MEDLINE  
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[PMID]:28295221
[Au] Autor:Berry V; Basson L; Bogart E; Mir O; Blay JY; Italiano A; Bertucci F; Chevreau C; Clisant-Delaine S; Liegl-Antzager B; Tresch-Bruneel E; Wallet J; Taieb S; Decoupigny E; Le Cesne A; Brodowicz T; Penel N
[Ad] Endereço:Medical Oncology Department, Oscar Lambret Center, Lille, France.
[Ti] Título:REGOSARC: Regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma-A quality-adjusted time without symptoms of progression or toxicity analysis.
[So] Source:Cancer;123(12):2294-2302, 2017 Jun 15.
[Is] ISSN:1097-0142
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: In a placebo-controlled, randomized phase 2 trial (ClinicalTrials.gov identifier NCT01900743), regorafenib improved progression-free survival (PFS) for patients with doxorubicin-pretreated advanced nonadipocytic sarcoma. A quality-adjusted time without symptoms of progression or toxicity (Q-TWiST) post hoc exploratory analysis was applied to provide an integrated measure of its clinical benefit. METHODS: In the base-case analysis, each patient's overall survival (OS) was partitioned into 3 mutually exclusive health states: the time with a grade 3 or 4 adverse event (TOX), the time without symptoms of disease or grade 3 or 4 toxicity from treatment, and the time after tumor progression or relapse. The time spent in each state was weighted with a health-state utility associated with that state and was summed to calculate the Q-TWiST. The stability of the base-case analysis was explored with several sensitivity analyses. RESULTS: In nonadipocytic sarcoma, the PFS was (4.0 months [2.6-5.5 months] with regorafenib vs 1.0 month [0.9-1.8 months] with a placebo; hazard ratio, 0.36 [0.25-0.53]; P < .0001); the OS was 13.4 months (8.6-17.3 months) with regorafenib and 9.0 months (6.8-12.5 months) with a placebo (hazard ratio, 0.67 [0.44-1.02]). With the classic definition of TOX (including all grade 3 and 4 clinical adverse events), the Q-TWiSTs were 8.0 months (7.0-9.0 months) with regorafenib and 5.7 months (4.9-6.4 months) with a placebo (P < .001). CONCLUSIONS: For patients with doxorubicin-pretreated soft-tissue sarcoma, regorafenib significantly improved quality-adjusted survival in comparison with a placebo. Cancer 2017;123:2294-2302. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
[Mh] Termos MeSH primário: Antineoplásicos/uso terapêutico
Compostos de Fenilureia/uso terapêutico
Piridinas/uso terapêutico
Sarcoma/tratamento farmacológico
[Mh] Termos MeSH secundário: Idoso
Alopecia/induzido quimicamente
Anorexia/induzido quimicamente
Astenia/induzido quimicamente
Diarreia/induzido quimicamente
Método Duplo-Cego
Incontinência Fecal/induzido quimicamente
Feminino
Síndrome Mão-Pé/etiologia
Hospitalização
Seres Humanos
Hipertensão/induzido quimicamente
Leiomiossarcoma/tratamento farmacológico
Lipossarcoma/tratamento farmacológico
Masculino
Meia-Idade
Mucosite/induzido quimicamente
Modelos de Riscos Proporcionais
Qualidade de Vida
Sarcoma Sinovial/tratamento farmacológico
Índice de Gravidade de Doença
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Phenylurea Compounds); 0 (Pyridines); 24T2A1DOYB (regorafenib)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170828
[Lr] Data última revisão:
170828
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170316
[St] Status:MEDLINE
[do] DOI:10.1002/cncr.30661


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[PMID]:28291905
[Au] Autor:Jagodzinska-Mucha P; Switaj T; Kozak K; Kosela-Paterczyk H; Klimczak A; Lugowska I; Rogala P; Wagrodzki M; Falkowski S; Rutkowski P
[Ad] Endereço:Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw - Poland.
[Ti] Título:Long-term results of therapy with sunitinib in metastatic alveolar soft part sarcoma.
[So] Source:Tumori;103(3):231-235, 2017 May 12.
[Is] ISSN:2038-2529
[Cp] País de publicação:Italy
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Alveolar soft part sarcoma (ASPS) is a rare, highly vascularized soft tissue sarcoma characterized by a high frequency of metastatic disease and resistance to classical chemotherapy. The purpose of our analysis was to assess long-term sunitinib activity in the treatment of metastatic ASPS. PATIENTS AND METHODS: Between 2009 and 2015, 15 patients were diagnosed with metastatic ASPS and received therapy with sunitinib at initial continuous daily dosing of 37.5 mg. Median age was 32 years. The primary tumor sites were lower extremities (8), trunk-retroperitoneum/pelvis (2), upper extremity (3) and other (2). All patients had unresectable disease (primary or relapse in the form of metastases to the lungs ± bones). Five patients received systemic therapy before initiating sunitinib. Median follow-up from start of sunitinib was 38 months (range 5-69 months). RESULTS: At the time of analysis 4 patients continue therapy and 9 are still alive. Six patients had RECIST partial remission as best response, 8 had stable disease, and 1 had disease progression. The median progression-free survival was 19 months, with 86% of patients being free of progression at 6 months. Median overall survival was 56 months; the 5-year overall survival rate was 49%. Five patients were treated with sunitinib longer than 2 years. All patients experienced some side effects: 8 patients (53%) had CTCAE grade 3/4 toxicity, 7 patients required dose reduction. The most common toxicities were neutropenia, thrombocytopenia, hypothyroidism, arterial hypertension, and hand-foot syndrome. CONCLUSIONS: Our analysis confirms the long-term efficacy of sunitinib in patients with advanced ASPS.
[Mh] Termos MeSH primário: Neoplasias Ósseas/tratamento farmacológico
Indóis/administração & dosagem
Neoplasias Pulmonares/tratamento farmacológico
Pirróis/administração & dosagem
Sarcoma Alveolar de Partes Moles/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Idoso
Neoplasias Ósseas/patologia
Neoplasias Ósseas/secundário
Intervalo Livre de Doença
Resistência a Medicamentos Antineoplásicos
Feminino
Síndrome Mão-Pé
Seres Humanos
Neoplasias Pulmonares/patologia
Neoplasias Pulmonares/secundário
Masculino
Meia-Idade
Recidiva Local de Neoplasia
Sarcoma Alveolar de Partes Moles/patologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Indoles); 0 (Pyrroles); V99T50803M (sunitinib)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170621
[Lr] Data última revisão:
170621
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170315
[St] Status:MEDLINE
[do] DOI:10.5301/tj.5000617


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[PMID]:28237700
[Au] Autor:Shichiri H; Yamamoto K; Tokura M; Ishida T; Uda A; Bito T; Nishigori C; Nakagawa T; Hirano T; Yano I; Hirai M
[Ad] Endereço:Division of Pharmaceutics, Department of Internal Related, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
[Ti] Título:Prostaglandin E reduces the keratinocyte toxicity of sorafenib by maintaining signal transducer and activator of transcription 3 (STAT3) activity and enhancing the cAMP response element binding protein (CREB) activity.
[So] Source:Biochem Biophys Res Commun;485(2):227-233, 2017 Apr 01.
[Is] ISSN:1090-2104
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Hand-foot skin reaction (HFSR) is a common side effect of multiple tyrosine kinase inhibitors (mTKIs). HFSR can necessitate dose reductions or interruption of therapy owing to its negative effect on the quality of life. Therefore, effective use of mTKIs requires measures to prevent HFSR. We evaluated the effect of prostaglandin E (PGE ) on HFSR, because PGE is already used to treat bed sores and skin ulcers and has established angiogenic and antiproliferative effects in keratinocytes. We found that the pathogenesis of sorafenib-induced HFSR is characterized by a decrease in levels of a phosphorylated signal transducer and activator of transcription 3 (STAT3). We investigated the effect of PGE on the sorafenib-mediated reduction in phosphorylated STAT3 levels in HaCaT human epidermal keratinocytes. In cells treated with sorafenib, phosphorylated STAT3 levels decreased in a concentration-dependent manner, and this effect was blocked in cells treated with sorafenib and PGE . Furthermore, the expression of phosphorylated STAT3, the antiapoptotic proteins myeloid cell leukemia-1 (Mcl-1) and survivin decreased in cells pretreated with an inhibitor of cAMP response element binding protein (CREB). Cell viability increased in cells treated with sorafenib and PGE compared with that in cells treated with sorafenib alone, and these effects were not observed in STAT3 knockdown HaCaT cells. Collectively, these findings indicate that PGE blocks the inhibitory effects of sorafenib on cell growth by maintaining the activity of STAT3 and enhancing the CREB activity. Therefore, PGE might represent an effective treatment for the prevention of sorafenib-induced HFSR.
[Mh] Termos MeSH primário: Alprostadil/farmacologia
Proteína de Ligação ao Elemento de Resposta ao AMP Cíclico/metabolismo
Síndrome Mão-Pé/tratamento farmacológico
Queratinócitos/efeitos dos fármacos
Niacinamida/análogos & derivados
Compostos de Fenilureia/efeitos adversos
Inibidores de Proteínas Quinases/efeitos adversos
Fator de Transcrição STAT3/metabolismo
Pele/efeitos dos fármacos
[Mh] Termos MeSH secundário: Antineoplásicos/efeitos adversos
Linhagem Celular
Proliferação Celular/efeitos dos fármacos
Síndrome Mão-Pé/metabolismo
Síndrome Mão-Pé/patologia
Seres Humanos
Queratinócitos/metabolismo
Queratinócitos/patologia
Niacinamida/efeitos adversos
Fosforilação/efeitos dos fármacos
Transdução de Sinais/efeitos dos fármacos
Pele/metabolismo
Pele/patologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Cyclic AMP Response Element-Binding Protein); 0 (Phenylurea Compounds); 0 (Protein Kinase Inhibitors); 0 (STAT3 Transcription Factor); 25X51I8RD4 (Niacinamide); 9ZOQ3TZI87 (sorafenib); F5TD010360 (Alprostadil)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170613
[Lr] Data última revisão:
170613
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170227
[St] Status:MEDLINE



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