Base de dados : MEDLINE
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[PMID]:29249005
[Au] Autor:Trevisani F; Brandi G; Garuti F; Barbera MA; Tortora R; Casadei Gardini A; Granito A; Tovoli F; De Lorenzo S; Inghilesi AL; Foschi FG; Bernardi M; Marra F; Sacco R; Di Costanzo GG
[Ad] Endereço:Department of Medical and Surgical Sciences, Medical Semeiotics, University of Bologna, via Albertoni 15, 40138, Bologna, Italy. franco.trevisani@unibo.it.
[Ti] Título:Metronomic capecitabine as second-line treatment for hepatocellular carcinoma after sorafenib discontinuation.
[So] Source:J Cancer Res Clin Oncol;144(2):403-414, 2018 Feb.
[Is] ISSN:1432-1335
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Metronomic capecitabine (MC) is a well-tolerated systemic treatment showing promising results in one retrospective study, as second-line therapy after sorafenib failure, in patients with hepatocellular carcinoma (HCC). METHODS: 117 patients undergoing MC were compared to 112 patients, eligible for this treatment, but undergoing best supportive care (BSC) after sorafenib discontinuation for toxicity or HCC progression. The two groups were compared for demographic and clinical features. A multivariate regression analysis was conducted to detect independent prognostic factors. To balance confounding factors between the two groups, a propensity score model based on independent prognosticators (performance status, neoplastic thrombosis, causes of sorafenib discontinuation and pre-sorafenib treatment) was performed. RESULTS: Patients undergoing MC showed better performance status, lower tumor burden, lower prevalence of portal vein thrombosis, and better cancer stage. Median (95% CI) post-sorafenib survival (PSS) was longer in MC than in BSC patients [9.5 (7.5-11.6) vs 5.0 (4.2-5.7) months (p < 0.001)]. Neoplastic thrombosis, cause of sorafenib discontinuation, pre-sorafenib treatment and MC were independent prognosticators. The benefit of capecitabine was confirmed in patients after matching with propensity score [PSS: 9.9 (6.8-12.9) vs. 5.8 (4.8-6.8) months, (p = 0.001)]. MC lowered the mortality risk by about 40%. MC achieved better results in patients who stopped sorafenib for adverse events than in those who progressed during it [PSS: 17.3 (10.5-24.1) vs. 7.8 (5.2-10.1) months, (p = 0.035)]. Treatment toxicity was low and easily manageable with dose modulation. CONCLUSIONS: MC may be an efficient and safe second-line systemic therapy for HCC patients who discontinued sorafenib for toxicity or tumor progression.
[Mh] Termos MeSH primário: Capecitabina/administração & dosagem
Carcinoma Hepatocelular/tratamento farmacológico
Neoplasias Hepáticas/tratamento farmacológico
Niacinamida/análogos & derivados
Compostos de Fenilureia/administração & dosagem
[Mh] Termos MeSH secundário: Administração Metronômica
Idoso
Antimetabólitos Antineoplásicos/administração & dosagem
Feminino
Seres Humanos
Masculino
Niacinamida/administração & dosagem
Niacinamida/efeitos adversos
Compostos de Fenilureia/efeitos adversos
Inibidores de Proteínas Quinases/administração & dosagem
Inibidores de Proteínas Quinases/efeitos adversos
Estudos Retrospectivos
Taxa de Sobrevida
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antimetabolites, Antineoplastic); 0 (Phenylurea Compounds); 0 (Protein Kinase Inhibitors); 25X51I8RD4 (Niacinamide); 6804DJ8Z9U (Capecitabine); 9ZOQ3TZI87 (sorafenib)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171218
[St] Status:MEDLINE
[do] DOI:10.1007/s00432-017-2556-6


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[PMID]:27777777
[Au] Autor:Weir GM; Hrytsenko O; Quinton T; Berinstein NL; Stanford MM; Mansour M
[Ad] Endereço:Immunovaccine Inc., 1344 Summer St., Halifax, NS B3H 0A8 Canada.
[Ti] Título:Anti-PD-1 increases the clonality and activity of tumor infiltrating antigen specific T cells induced by a potent immune therapy consisting of vaccine and metronomic cyclophosphamide.
[So] Source:J Immunother Cancer;4:68, 2016.
[Is] ISSN:2051-1426
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Future cancer immunotherapies will combine multiple treatments to generate functional immune responses to cancer antigens through synergistic, multi-modal mechanisms. In this study we explored the combination of three distinct immunotherapies: a class I restricted peptide-based cancer vaccine, metronomic cyclophosphamide (mCPA) and anti-PD-1 treatment in a murine tumor model expressing HPV16 E7 (C3). METHODS: Mice were implanted with C3 tumors subcutaneously. Tumor bearing mice were treated with mCPA (20 mg/kg/day PO) for seven continuous days on alternating weeks, vaccinated with HPV16 E7 peptide antigen formulated in the DepoVax (DPX) adjuvanting platform every second week, and administered anti-PD-1 (200 µg/dose IP) after each vaccination. Efficacy was measured by following tumor growth and survival. Immunogenicity was measured by IFN-γ ELISpot of spleen, vaccine draining lymph nodes and tumor draining lymph nodes. Tumor infiltration was measured by flow cytometry for CD8α peptide-specific T cells and RT-qPCR for cytotoxic proteins. The clonality of tumor infiltrating T cells was measured by TCRß sequencing using genomic DNA. RESULTS: Untreated C3 tumors had low expression of PD-L1 in vivo and anti-PD-1 therapy alone provided no protection from tumor growth. Treatment with DPX/mCPA could delay tumor growth, and tri-therapy with DPX/mCPA/anti-PD-1 provided long-term control of tumors. We found that treatment with DPX/mCPA/anti-PD-1 enhanced systemic antigen-specific immune responses detected in the spleen as determined by IFN-γ ELISpot compared to those in the DPX/mCPA group, but immune responses in tumor-draining lymph nodes were not increased. Although no increases in antigen-specific CD8α TILs could be detected, there was a trend for increased expression of cytotoxic genes within the tumor microenvironment as well as an increase in clonality in mice treated with DPX/mCPA/anti-PD-1 compared to those with anti-PD-1 alone or DPX/mCPA. Using a library of antigen-specific CD8α T cell clones, we found that antigen-specific clones were more frequently expanded in the DPX/mCPA/anti-PD-1 treated group. CONCLUSIONS: These results demonstrate how the efficacy of anti-PD-1 may be improved by combination with a potent and targeted T cell activating immune therapy.
[Mh] Termos MeSH primário: Antineoplásicos Imunológicos/farmacologia
Vacinas Anticâncer/imunologia
Ciclofosfamida/administração & dosagem
Linfócitos do Interstício Tumoral/efeitos dos fármacos
Linfócitos do Interstício Tumoral/imunologia
Neoplasias/imunologia
Receptor de Morte Celular Programada 1/antagonistas & inibidores
Subpopulações de Linfócitos T/efeitos dos fármacos
Subpopulações de Linfócitos T/imunologia
[Mh] Termos MeSH secundário: Administração Metronômica
Animais
Antineoplásicos Imunológicos/uso terapêutico
Antígeno B7-H1/genética
Antígeno B7-H1/metabolismo
Linfócitos T CD8-Positivos/efeitos dos fármacos
Linfócitos T CD8-Positivos/imunologia
Linfócitos T CD8-Positivos/metabolismo
Linhagem Celular Tumoral
Evolução Clonal/efeitos dos fármacos
Evolução Clonal/imunologia
Citotoxicidade Imunológica
Modelos Animais de Doenças
Epitopos de Linfócito T/química
Epitopos de Linfócito T/imunologia
Feminino
Expressão Gênica
Seres Humanos
Imunomodulação/efeitos dos fármacos
Linfócitos do Interstício Tumoral/metabolismo
Camundongos
Neoplasias/metabolismo
Neoplasias/patologia
Neoplasias/terapia
Receptor de Morte Celular Programada 1/genética
Receptor de Morte Celular Programada 1/metabolismo
Especificidade do Receptor de Antígeno de Linfócitos T/efeitos dos fármacos
Especificidade do Receptor de Antígeno de Linfócitos T/imunologia
Subpopulações de Linfócitos T/metabolismo
Microambiente Tumoral/efeitos dos fármacos
Microambiente Tumoral/imunologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents, Immunological); 0 (B7-H1 Antigen); 0 (Cancer Vaccines); 0 (Epitopes, T-Lymphocyte); 0 (Programmed Cell Death 1 Receptor); 8N3DW7272P (Cyclophosphamide)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161026
[St] Status:MEDLINE


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[PMID]:28655786
[Au] Autor:Ciccolini J; Barbolosi D; Meille C; Lombard A; Serdjebi C; Giacometti S; Padovani L; Pasquier E; André N
[Ad] Endereço:SMARTc Unit, Inserm S_911 CRO2, Aix Marseille Université, Marseille, France.
[Ti] Título:Pharmacokinetics and Pharmacodynamics-Based Mathematical Modeling Identifies an Optimal Protocol for Metronomic Chemotherapy.
[So] Source:Cancer Res;77(17):4723-4733, 2017 Sep 01.
[Is] ISSN:1538-7445
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Metronomic chemotherapy is usually associated with better tolerance than conventional chemotherapy, and encouraging response rates have been reported in various settings. However, clinical development of metronomic chemotherapy has been hampered by a number of limitations, including the vagueness of its definition and the resulting empiricism in protocol design. In this study, we developed a pharmacokinetic/pharmacodynamic mathematical model that identifies the most effective administration schedule for gemcitabine monotherapy. This model is based upon four biological assumptions regarding the mechanisms of action of metronomic chemotherapy, resulting in a set of 6 minimally parameterized differential equations. Simulations identified daily 0.5-1 mg/kg gemcitabine as an optimal protocol to maximize antitumor efficacy. Both metronomic protocols (0.5 and 1 mg/kg/day for 28 days) were evaluated in chemoresistant neuroblastoma-bearing mice and compared with the standard MTD protocol (100 mg/kg once a week for 4 weeks). Systemic exposure to gemcitabine was 14 times lower in the metronomic groups compared with the standard group. Despite this, metronomic gemcitabine significantly inhibited tumor angiogenesis and reduced tumor perfusion and inflammation , while standard gemcitabine did not. Furthermore, metronomic gemcitabine yielded a 40%-50% decrease in tumor mass at the end of treatment as compared with control mice ( = 0.002; ANOVA on ranks with Dunn test), while standard gemcitabine failed to significantly reduce tumor growth. Stable disease was maintained in the metronomic groups for up to 2 months after treatment completion (67%-72% reduction in tumor growth at study conclusion, < 0.001; ANOVA on ranks with Dunn test). Collectively, our results confirmed the superiority of metronomic protocols in chemoresistant tumors .
[Mh] Termos MeSH primário: Administração Metronômica
Inibidores da Angiogênese/administração & dosagem
Desoxicitidina/análogos & derivados
Modelos Teóricos
Neovascularização Patológica/tratamento farmacológico
Neuroblastoma/tratamento farmacológico
[Mh] Termos MeSH secundário: Inibidores da Angiogênese/farmacocinética
Inibidores da Angiogênese/farmacologia
Animais
Desoxicitidina/administração & dosagem
Desoxicitidina/farmacocinética
Desoxicitidina/farmacologia
Células Endoteliais/efeitos dos fármacos
Células Endoteliais/patologia
Seres Humanos
Camundongos
Neovascularização Patológica/patologia
Neuroblastoma/irrigação sanguínea
Neuroblastoma/patologia
Distribuição Tecidual
Ensaios Antitumorais Modelo de Xenoenxerto
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Angiogenesis Inhibitors); 0W860991D6 (Deoxycytidine); B76N6SBZ8R (gemcitabine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171031
[Lr] Data última revisão:
171031
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170629
[St] Status:MEDLINE
[do] DOI:10.1158/0008-5472.CAN-16-3130


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[PMID]:28551663
[Au] Autor:Mencoboni M; Filiberti RA; Taveggia P; Del Corso L; Del Conte A; Covesnon MG; Puccetti C; Donati S; Auriati L; Amoroso D; Camerini A
[Ad] Endereço:Oncology Unit, Villa Scassi Hospital, Genoa, Italy manlio.mencoboni@fastwebnet.it.
[Ti] Título:Safety of First-line Chemotherapy with Metronomic Single-agent Oral Vinorelbine in Elderly Patients with NSCLC.
[So] Source:Anticancer Res;37(6):3189-3194, 2017 06.
[Is] ISSN:1791-7530
[Cp] País de publicação:Greece
[La] Idioma:eng
[Ab] Resumo:BACKGROUND/AIM: The optimal therapeutic use of metronomic vinorelbine has not yet been defined. We aimed to assess the safety of metronomic oral vinorelbine in first-line treatment of elderly patients with advanced lung cancer who were unfit for polychemotherapy. Progression-free survival, response rate and overall survival were secondary end-points. PATIENTS AND METHODS: Seventy-six patients received 50 mg of oral vinorelbine three times per week, until disease progression, patient refusal or unacceptable toxicity. Patients were evaluated for response and toxicity after one cycle of chemotherapy. The treatment was considered feasible with a grade 3/4 toxicity rate lower than 20%. RESULTS: Clinical benefit was observed in 50% of patients. Median overall survival was 8.0 months. Grade 1/2 toxicity was observed in 53 patients (69.7%), grade 3 toxicity in eight patients (10.5%). One patient had grade 4 diarrhea. CONCLUSION: Metronomic oral vinorelbine is safe in elderly patients, allowing for long-term disease stabilization with optimal patient compliance.
[Mh] Termos MeSH primário: Antineoplásicos Fitogênicos/administração & dosagem
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico
Neoplasias Pulmonares/tratamento farmacológico
Vimblastina/análogos & derivados
[Mh] Termos MeSH secundário: Administração Metronômica
Administração Oral
Fatores Etários
Idoso
Idoso de 80 Anos ou mais
Antineoplásicos Fitogênicos/efeitos adversos
Carcinoma Pulmonar de Células não Pequenas/mortalidade
Carcinoma Pulmonar de Células não Pequenas/patologia
Intervalo Livre de Doença
Estudos de Viabilidade
Feminino
Seres Humanos
Itália
Estimativa de Kaplan-Meier
Neoplasias Pulmonares/mortalidade
Neoplasias Pulmonares/patologia
Masculino
Adesão à Medicação
Projetos Piloto
Fatores de Tempo
Resultado do Tratamento
Vimblastina/administração & dosagem
Vimblastina/efeitos adversos
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Antineoplastic Agents, Phytogenic); 5V9KLZ54CY (Vinblastine); Q6C979R91Y (vinorelbine)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170821
[Lr] Data última revisão:
170821
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170529
[St] Status:MEDLINE


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[PMID]:28406456
[Au] Autor:Su NW; Wu SH; Chi CW; Liu CJ; Tsai TH; Chen YJ
[Ad] Endereço:Division of Medical Oncology and Hematology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei 11094, Taiwan. medicine_su@hotmail.com.
[Ti] Título:Metronomic Cordycepin Therapy Prolongs Survival of Oral Cancer-Bearing Mice and Inhibits Epithelial-Mesenchymal Transition.
[So] Source:Molecules;22(4), 2017 Apr 13.
[Is] ISSN:1420-3049
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:Cordycepin (3'-deoxyadenosine) is a natural compound abundantly found in in natural and fermented sources. In this study, we examined the effects of cordycepin in a human oral squamous cell carcinoma (OSCC) xenograft model. Cordycepin was administered in a regular, low-dose and prolonged schedule metronomic therapy. Two doses of cordycepin (25 mg/kg, 50 mg/kg) were administrated five days a week for eight consecutive weeks. The tumor volumes were reduced and survival time was significantly prolonged from 30.3 ± 0.9 days (control group) to 56 days (50 mg/kg group, the day of tumor-bearing mice were sacrificed for welfare consideration). The weights of mice did not change and liver, renal, and hematologic functions were not compromised. Cordycepin inhibited the OSCC cell viability in vitro (IC 122.4-125.2 µM). Furthermore, morphological characteristics of apoptosis, increased caspase-3 activity and G2/M cell cycle arrest were observed. In wound healing assay, cordycepin restrained the OSCC cell migration. Cordycepin upregulated E-cadherin and downregulated N-cadherin protein expression, implying inhibition of epithelial-mesenchymal transition (EMT). The immunohistochemical staining of xenograft tumor with E-cadherin and vimentin validated in vitro results. In conclusion, metronomic cordycepin therapy showed effective tumor control, prolonged survival and low toxicities. Cytotoxicity against cancer cells with apoptotic features and EMT inhibition were observed.
[Mh] Termos MeSH primário: Antineoplásicos/administração & dosagem
Desoxiadenosinas/administração & dosagem
Transição Epitelial-Mesenquimal/efeitos dos fármacos
Neoplasias Bucais/patologia
[Mh] Termos MeSH secundário: Administração Metronômica
Animais
Antineoplásicos/química
Apoptose/efeitos dos fármacos
Carcinoma de Células Escamosas
Pontos de Checagem do Ciclo Celular/efeitos dos fármacos
Linhagem Celular Tumoral
Movimento Celular/efeitos dos fármacos
Proliferação Celular/efeitos dos fármacos
Desoxiadenosinas/química
Modelos Animais de Doenças
Relação Dose-Resposta a Droga
Seres Humanos
Camundongos
Estrutura Molecular
Neoplasias Bucais/tratamento farmacológico
Neoplasias Bucais/mortalidade
Carga Tumoral/efeitos dos fármacos
Cicatrização/efeitos dos fármacos
Ensaios Antitumorais Modelo de Xenoenxerto
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Deoxyadenosines); GZ8VF4M2J8 (cordycepin)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170531
[Lr] Data última revisão:
170531
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170414
[St] Status:MEDLINE


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[PMID]:28403082
[Au] Autor:Lee VH; Kwong DL; Lam KO; Lai YC; Li Y; Tong CC; Ho PP; Chan WL; Wong LS; Leung DK; Chan SY; Chan FT; Leung TW; Lee AW
[Ad] Endereço:Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
[Ti] Título:Metronomic oral cyclosphosphamide as third-line systemic treatment or beyond in patients with inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma.
[So] Source:Medicine (Baltimore);96(15):e6518, 2017 Apr.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:There is no standard third-line or further systemic treatment for patients with inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). Metronomic oral cyclophosphamide provides an acceptable and cheap option for these heavily pretreated patients who had limited choices. We conducted a prospective phase II single-arm open-label study of metronomic oral cyclophosphamide. Patients with locoregionally advanced recurrent inoperable (rT3/T4, rN2-N3b) or metastatic (rM1) NPC who had Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0-2) and had progressed after at least 2 lines of palliative systemic chemotherapy were eligible. They received oral cyclophosphamide between 50 and 150 mg once daily until progressive disease or unacceptable toxicity. Objective response rate (ORR), disease control rate (DCR), biochemical response (two consecutive declines of plasma EBV DNA after treatment), progression-free survival (PFS), overall survival (OS), and safety profiles were evaluated. A total of 56 patients were recruited. Thirty-three, 13, 6, 3, and 1 patients received cyclophosphamide as 3rd, 4th, 5th, 6th, and 7th line of therapy respectively. After a median follow-up of 9.95 months (range 1.76-59.51 months), the ORR was 8.9% and the DCR was 57.1%. The median PFS and OS were 4.47 and 9.20 months, respectively. Those with PS 1 had longer median PFS (5.49 months) compared to those with PS 2 (3.75 months, P = .011). Besides, those who had locoregionally recurrent disease had better PFS (8.97 months, 95% CI, 0.53-17.41 months) compared to those who had distant metastases (4.14 months, 95% CI, 2.53-5.75 months, P = .020). Multivariable analysis revealed that PS 1 (vs 2) (P = .020) and locoregional recurrence (vs metastasis) (P = .029) were the only significant independent prognostic factors of PFS. Around 16 (28.6%) patients developed grade ≥3 adverse events, including malaise (5.4%), hematological (8.9%), gastrointestinal (3.6%), feverish (3.6%), and hemorrhagic (1.8%) events. The median cost of the whole drug treatment was 51.65 US dollars (USD) (range 4.15-142.75 USD) (1 USD = 7.8 HK dollars [HKD]). Metronomic oral cyclophosphamide is an acceptable third-line or beyond systemic therapy for locoregionally advanced recurrent or metastatic NPC with acceptable toxicity and limited financial burden.
[Mh] Termos MeSH primário: Antineoplásicos Alquilantes/administração & dosagem
Ciclofosfamida/administração & dosagem
Neoplasias Nasofaríngeas/tratamento farmacológico
Recidiva Local de Neoplasia/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração Metronômica
Administração Oral
Adulto
Idoso
Antineoplásicos Alquilantes/economia
Carcinoma
Ciclofosfamida/economia
Progressão da Doença
Intervalo Livre de Doença
Feminino
Seguimentos
Seres Humanos
Masculino
Meia-Idade
Neoplasias Nasofaríngeas/mortalidade
Neoplasias Nasofaríngeas/patologia
Metástase Neoplásica
Recidiva Local de Neoplasia/mortalidade
Recidiva Local de Neoplasia/patologia
Estudos Prospectivos
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents, Alkylating); 8N3DW7272P (Cyclophosphamide)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170414
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000006518


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[PMID]:28384657
[Au] Autor:Pramanik R; Agarwala S; Gupta YK; Thulkar S; Vishnubhatla S; Batra A; Dhawan D; Bakhshi S
[Ad] Endereço:Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.
[Ti] Título:Metronomic Chemotherapy vs Best Supportive Care in Progressive Pediatric Solid Malignant Tumors: A Randomized Clinical Trial.
[So] Source:JAMA Oncol;3(9):1222-1227, 2017 Sep 01.
[Is] ISSN:2374-2445
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Although oral metronomic chemotherapy is often used in progressive pediatric solid malignant tumors, a literature review reveals that only small single-arm retrospective or phase 1 and 2 studies have been performed. Skepticism abounds because of the lack of level 1 evidence. Objectives: To compare the effect of metronomic chemotherapy on progression-free survival (PFS) with that of placebo in pediatric patients with primary extracranial, nonhematopoietic solid malignant tumors that progress after at least 2 lines of chemotherapy. Design, Setting, and Participants: A double-blinded, placebo-controlled randomized clinical trial was conducted from October 1, 2013, through December 31, 2015, at the cancer center at All India Institute of Medical Sciences in children aged 5 to 18 years with primary extracranial, nonhematopoietic solid malignant tumors that progressed after at least 2 lines of chemotherapy and had no further curative options. Interventions: One arm received a 4-drug oral metronomic regimen of daily celecoxib and thalidomide with alternating periods of etoposide and cyclophosphamide, whereas the other arm received placebo. Disease status was assessed at baseline, 9 weeks, 18 weeks, and 27 weeks or at clinical progression. Main Outcomes and Measures: The primary end point was PFS as defined by the proportion of patients without disease progression at 6 months, and PFS duration and overall survival (OS) were secondary end points. Results: A total of 108 of the 123 patients screened were enrolled, with 52 randomized to the placebo group (median age, 15 years; 40 male [76.9%]) and 56 to the metronomic chemotherapy group (median age, 13 years; 42 male [75.0%]). At a median follow-up of 2.9 months, 100% of the patients had disease progression by 6 months in the placebo group vs 96.4% in the metronomic chemotherapy group (P = .24). Median PFS and OS in the 2 groups was similar (hazard ratio [HR], 0.69; 95% CI, 0.47-1.03 [P = .07] for PFS; and HR, 0.74; 95% CI, 0.50-1.09 [P = .13] for OS). In post hoc subgroup analysis, cohorts receiving more than 3 cycles (HR for PFS, 0.46; 95% CI, 0.23-0.93; P = .03) and those without a bone sarcoma (ie, neither primitive neuroectodermal tumor nor osteosarcoma) (HR for PFS, 0.39; 95% CI, 0.18-0.81; P = .01) appeared to benefit from metronomic chemotherapy. Conclusions and Relevance: Metronomic chemotherapy does not improve 6-month PFS, compared with placebo, among pediatric patients with extracranial progressive solid malignant tumors . However, patients without bone sarcoma and those able to tolerate therapy for more than 3 cycles (9 weeks) benefit. Trial Registration: clinicaltrials.gov Identifier: NCT01858571.
[Mh] Termos MeSH primário: Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração Metronômica
Administração Oral
Adolescente
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
Neoplasias Ósseas/tratamento farmacológico
Celecoxib/administração & dosagem
Criança
Pré-Escolar
Ciclofosfamida/administração & dosagem
Progressão da Doença
Intervalo Livre de Doença
Método Duplo-Cego
Etoposídeo/administração & dosagem
Feminino
Seguimentos
Seres Humanos
Masculino
Elementos de Resposta
Retratamento
Sarcoma de Ewing/tratamento farmacológico
Taxa de Sobrevida
Talidomida/administração & dosagem
Fatores de Tempo
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
4Z8R6ORS6L (Thalidomide); 6PLQ3CP4P3 (Etoposide); 8N3DW7272P (Cyclophosphamide); JCX84Q7J1L (Celecoxib)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170928
[Lr] Data última revisão:
170928
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170407
[St] Status:MEDLINE
[do] DOI:10.1001/jamaoncol.2017.0324


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[PMID]:28323033
[Au] Autor:Ledzewicz U; Schättler H
[Ad] Endereço:Dept. of Mathematics and Statistics, Southern Illinois University Edwardsville, Edwardsville, IL, 62026-1653, USA; Institute of Mathematics, Lodz University of Technology, 90-924, Lodz, Poland. Electronic address: uledzew@siue.edu.
[Ti] Título:Application of mathematical models to metronomic chemotherapy: What can be inferred from minimal parameterized models?
[So] Source:Cancer Lett;401:74-80, 2017 Aug 10.
[Is] ISSN:1872-7980
[Cp] País de publicação:Ireland
[La] Idioma:eng
[Ab] Resumo:Metronomic chemotherapy refers to the frequent administration of chemotherapy at relatively low, minimally toxic doses without prolonged treatment interruptions. Different from conventional or maximum-tolerated-dose chemotherapy which aims at an eradication of all malignant cells, in a metronomic dosing the goal often lies in the long-term management of the disease when eradication proves elusive. Mathematical modeling and subsequent analysis (theoretical as well as numerical) have become an increasingly more valuable tool (in silico) both for determining conditions under which specific treatment strategies should be preferred and for numerically optimizing treatment regimens. While elaborate, computationally-driven patient specific schemes that would optimize the timing and drug dose levels are still a part of the future, such procedures may become instrumental in making chemotherapy effective in situations where it currently fails. Ideally, mathematical modeling and analysis will develop into an additional decision making tool in the complicated process that is the determination of efficient chemotherapy regimens. In this article, we review some of the results that have been obtained about metronomic chemotherapy from mathematical models and what they infer about the structure of optimal treatment regimens.
[Mh] Termos MeSH primário: Administração Metronômica
Antineoplásicos/administração & dosagem
Técnicas de Apoio para a Decisão
Modelos Teóricos
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Antineoplásicos/efeitos adversos
Simulação por Computador
Relação Dose-Resposta a Droga
Resistência a Medicamentos Antineoplásicos
Seres Humanos
Modelos Estatísticos
Neoplasias/patologia
Análise Numérica Assistida por Computador
Seleção de Pacientes
Fatores de Tempo
Resultado do Tratamento
Microambiente Tumoral
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antineoplastic Agents)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170828
[Lr] Data última revisão:
170828
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170322
[St] Status:MEDLINE


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[PMID]:28315702
[Au] Autor:Kumar MNVR; Sood AK
[Ad] Endereço:Department of Pharmaceutical Sciences, Texas A&M University, College Station, TX, USA. Electronic address: mnvrkumar@tamhsc.edu.
[Ti] Título:Editorial - Metronomic chemotherapy.
[So] Source:Cancer Lett;400:203, 2017 08 01.
[Is] ISSN:1872-7980
[Cp] País de publicação:Ireland
[La] Idioma:eng
[Mh] Termos MeSH primário: Antineoplásicos/administração & dosagem
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração Metronômica
Animais
Seres Humanos
Neoplasias/genética
Neoplasias/metabolismo
Neoplasias/patologia
Resultado do Tratamento
[Pt] Tipo de publicação:EDITORIAL; INTRODUCTORY JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171016
[Lr] Data última revisão:
171016
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170320
[St] Status:MEDLINE


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[PMID]:28314176
[Au] Autor:Lambrescu I; Fica S; Martins D; Spada F; Cella C; Bertani E; Rubino M; Gibelli B; Grana C; Bonomo G; Funicelli L; Ravizza D; Pisa E; Zerini D; Ungaro A; Fazio N; IEO ENETS Center of Excellence for GEP NET
[Ad] Endereço:Unit of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, Milan, Italy; Carol Davila University of Medicine and Pharmacy, Endocrinology Department, Bucharest, Romania.
[Ti] Título:Metronomic and metronomic-like therapies in neuroendocrine tumors - Rationale and clinical perspectives.
[So] Source:Cancer Treat Rev;55:46-56, 2017 Apr.
[Is] ISSN:1532-1967
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Metronomic therapy is characterized by the administration of regular low doses of certain drugs with very low toxicity. There have been numerous debates over the empirical approach of this regimen, but fewest side effects are always something to consider in order to improve patients' quality of life. Neuroendocrine tumors (NETs) are rare malignancies relatively slow-growing; therefore their treatment is often chronic, involving several different therapies for tumor growth control. Knowing that these tumors are highly vascularized, the anti-angiogenic aspect is highly regarded as something to be targeted in all patients harboring NETs. Additionally the metronomic schedule has proved to be effective on an immunological level, rendering this approach as a multi-targeted therapy. Rationalizing that advanced NETs are in many cases a chronic disease, with which patients can live for as long as possible, a systemic therapy with regular low doses and a very low toxicity is in many cases a judicious manner of pursuing stabilization. Metronomic schedule is usually correlated with chemotherapy in oncology, but other therapies, such as radiotherapy and biotherapy can be delivered in a metronomic like manner. This review describes clinical trials and case series involving metronomic therapies alone or in combination in patients with advanced NETs. Nowadays level of evidence about metronomic therapy in NETs is quite low, therefore future prospective clinical studies are needed to validate the metronomic approach in specific clinical settings.
[Mh] Termos MeSH primário: Administração Metronômica
Antineoplásicos/administração & dosagem
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem
Tumores Neuroendócrinos/tratamento farmacológico
[Mh] Termos MeSH secundário: Antineoplásicos/farmacocinética
Protocolos de Quimioterapia Combinada Antineoplásica/farmacocinética
Seres Humanos
Interferons/administração & dosagem
Tumores Neuroendócrinos/radioterapia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antineoplastic Agents); 9008-11-1 (Interferons)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170809
[Lr] Data última revisão:
170809
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170318
[St] Status:MEDLINE



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