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1.
Anticancer Res ; 40(1): 305-313, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31892581

RESUMO

BACKGROUND: Cancer-associated thrombosis (CAT), the second leading cause of death in patients with cancer can be treated with low molecular weight heparin (LMWH) according to guidelines. PATIENTS AND METHODS: A multicenter prospective observational study was carried out to record anti-thrombotic treatment practice, assess thrombosis recurrence and bleeding, and identify potential risk factors. Adult patients from 18 Oncology Departments throughout Greece were followed-up for 12 months. RESULTS: A total of 120 patients with CAT receiving anticoagulant treatment were enrolled (35% incidental); 85% were treated for more than 6 months, 95.8% were treated with tinzaparin and smaller percentages with other agents. Thrombosis recurred in three patients and there was minor bleeding in four patients. Bleeding was associated with high body mass index (>35 kg/m2), trauma history, renal insufficiency and bevacizumab use. CONCLUSION: Incidental thrombosis contributes significantly to CAT burden. Long-term use of LMWH seems to be effective and safe. Several risk factors associated with bleeding should be considered during anti-coagulation therapy planning.


Assuntos
Neoplasias/complicações , Trombose/etiologia , Trombose/terapia , Feminino , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/patologia , Fatores de Risco
2.
Ann Gastroenterol ; 29(4): 390-416, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27708505

RESUMO

There is discrepancy and failure to adhere to current international guidelines for the management of metastatic colorectal cancer (CRC) in hospitals in Greece and Cyprus. The aim of the present document is to provide a consensus on the multidisciplinary management of metastastic CRC, considering both special characteristics of our Healthcare System and international guidelines. Following discussion and online communication among the members of an executive team chosen by the Hellenic Society of Medical Oncology (HeSMO), a consensus for metastastic CRC disease was developed. Statements were subjected to the Delphi methodology on two voting rounds by invited multidisciplinary international experts on CRC. Statements reaching level of agreement by ≥80% were considered as having achieved large consensus, whereas statements reaching 60-80% moderate consensus. One hundred and nine statements were developed. Ninety experts voted for those statements. The median rate of abstain per statement was 18.5% (range: 0-54%). In the end of the process, all statements achieved a large consensus. The importance of centralization, care by a multidisciplinary team, adherence to guidelines, and personalization is emphasized. R0 resection is the only intervention that may offer substantial improvement in the oncological outcomes.

3.
Phys Chem Chem Phys ; 18(44): 30385-30393, 2016 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-27781216

RESUMO

Organic aerosols (OAs) play important roles in multiple atmospheric processes, including climate change, and can impact human health. The physico-chemical properties of OAs are important for all these processes and can evolve through reactions with various atmospheric components, including oxidants. The dynamic nature of these reactions makes it challenging to obtain a true representation of their composition and surface chemistry. Here we investigate the microscopic viscosity of the model OA composed of squalene, undergoing chemical aging. We employ Fluorescent Lifetime Imaging Microscopy (FLIM) in conjunction with viscosity sensitive probes termed molecular rotors, in order to image the changes in microviscosity in real time during oxidation with ozone and hydroxyl radicals, which are two key oxidising species in the troposphere. We also recorded the Raman spectra of the levitated particles to follow the reactivity during particle ozonolysis. The levitation of droplets was achieved via optical trapping that enabled simultaneous levitation and measurement via FLIM or Raman spectroscopy and allowed the true aerosol phase to be probed. Our data revealed a very significant increase in viscosity of the levitated squalene droplets upon ozonolysis, following their transformation from the liquid to solid phase that was not observable when the oxidation was carried out on coverslip mounted droplets. FLIM imaging with sub-micron spatial resolution also revealed spatial heterogeneity in the viscosity distribution of oxidised droplets. Overall, a combination of molecular rotors, FLIM and optical trapping is able to provide powerful insights into OA chemistry and the microscopic structure that enables the dynamic monitoring of microscopic viscosity in aerosol particles in their true phase.

4.
Front Public Health ; 4: 185, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27630983

RESUMO

BACKGROUND: Affordable, accessible, and innovation-promoting pharmaceutical care is essential to the operation of a sustainable health system. External reference pricing (ERP), a common pharmaceutical policy in Europe, suffers today from indigenous weaknesses that may cause market distortions and barriers to care, burdening mostly the weak economies, and hence, raising ethical and political worrying. OBJECTIVES AND METHODS: A non-randomized experiment was conducted, in order to examine the influence of flexible and adaptable to health systems' affordability ERP structures. Outcomes were assessed by measuring deviations from Greek prices' level ex ante, as well as effects on pharmaceutical markets affiliated to the European ERP system. RESULTS AND CONCLUSION: Pharmaceutical pricing models that fit prices to income and affordability are better in all aspects, as they produce fairer results, while resulting in low external costs for the European ERP network as a whole. Small sets of reference countries are preferred to large baskets, as they produce similar results, while presenting better qualities by increasing the flexibility of the reimbursement system and the transparency of the market.

5.
Ann Gastroenterol ; 29(2): 103-26, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27064746

RESUMO

In rectal cancer management, accurate staging by magnetic resonance imaging, neo-adjuvant treatment with the use of radiotherapy, and total mesorectal excision have resulted in remarkable improvement in the oncological outcomes. However, there is substantial discrepancy in the therapeutic approach and failure to adhere to international guidelines among different Greek-Cypriot hospitals. The present guidelines aim to aid the multidisciplinary management of rectal cancer, considering both the local special characteristics of our healthcare system and the international relevant agreements (ESMO, EURECCA). Following background discussion and online communication sessions for feedback among the members of an executive team, a consensus rectal cancer management was obtained. Statements were subjected to the Delphi methodology voting system on two rounds to achieve further consensus by invited multidisciplinary international experts on colorectal cancer. Statements were considered of high, moderate or low consensus if they were voted by ≥80%, 60-80%, or <60%, respectively; those obtaining a low consensus level after both voting rounds were rejected. One hundred and two statements were developed and voted by 100 experts. The mean rate of abstention per statement was 12.5% (range: 2-45%). In the end of the process, all statements achieved a high consensus. Guidelines and algorithms of diagnosis and treatment were proposed. The importance of centralization, care by a multidisciplinary team, adherence to guidelines, and personalization is emphasized.

6.
Ann Gastroenterol ; 29(1): 3-17, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26752945

RESUMO

Despite considerable improvement in the management of colon cancer, there is a great deal of variation in the outcomes among European countries, and in particular among different hospital centers in Greece and Cyprus. Discrepancy in the approach strategies and lack of adherence to guidelines for the management of colon cancer may explain the situation. The aim was to elaborate a consensus on the multidisciplinary management of colon cancer, based on European guidelines (ESMO and EURECCA), and also taking into account local special characteristics of our healthcare system. Following discussion and online communication among members of an executive team, a consensus was developed. Statements entered the Delphi voting system on two rounds to achieve consensus by multidisciplinary international experts. Statements with an agreement rate of ≥80% achieved a large consensus, while those with an agreement rate of 60-80% a moderate consensus. Statements achieving an agreement of <60% after both rounds were rejected and not presented. Sixty statements on the management of colon cancer were subjected to the Delphi methodology. Voting experts were 109. The median rate of abstain per statement was 10% (range: 0-41%). In the end of the voting process, all statements achieved a consensus by more than 80% of the experts. A consensus on the management of colon cancer was developed by applying the Delphi methodology. Guidelines are proposed along with algorithms of diagnosis and treatment. The importance of centralization, care by a multidisciplinary team, and adherence to guidelines is emphasized.

7.
Ann Gastroenterol ; 29(1): 18-23, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26751386

RESUMO

Colorectal cancer remains a major cause of cancer mortality in the Western world both in men and women. In this manuscript a concise overview and recommendations on adjuvant chemotherapy in colon cancer are presented. An executive team from the Hellenic Society of Medical Oncology was assigned to develop a consensus statement and guidelines on the adjuvant treatment of colon cancer. Fourteen statements on adjuvant treatment were subjected to the Delphi methodology. Voting experts were 68. All statements achieved a rate of consensus above than 80% (>87%) and none revised and entered to a second round of voting. Three and 8 of them achieved a 100 and an over than 90% consensus, respectively. These statements describe evaluations of therapies in clinical practice. They could be considered as general guidelines based on best available evidence for assistance in treatment decision-making. Furthermore, they serve to identify questions and targets for further research and the settings in which investigational therapy could be considered.

8.
Glob J Health Sci ; 7(6): 55-67, 2015 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-26153163

RESUMO

Decentralisation is a complex, yet basic feature of health care systems in many countries entailing the transfer of authority or dispersal of power in public planning, management and decision making from higher to lower levels of government. This paper describes the attempts made in Greece from 1923 until today to decentralise its highly centralised health care system, drawing on a thorough documentary analysis of legislative acts and official reports regarding regional health policy. The analysis shows that, although decentralisation has been attempted on several occasions, in the end it was abandoned every time. The first ever implementation of a decentralised system of governance in 2001 was also curtailed, resulting in only minor decentralisation of authority and real powers. It is suggested that decentralisation has been impeded by many factors, especially obstruction by opposition from key interest groups, absence of policy continuity between governments, the inability to tackle the bureaucratic and highly centralised system and lack of political will.


Assuntos
Assistência à Saúde/história , Política , Grécia , Política de Saúde/história , História do Século XX , História do Século XXI , Humanos
9.
Int J Endocrinol ; 2015: 251485, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26089879

RESUMO

Objective. To evaluate the differences in treatment compliance with vildagliptin/metformin fixed-dose versus free-dose combination therapy in patients with type 2 diabetes mellitus (T2DM) in Greece. Design. Adult patients with T2DM, inadequately controlled with metformin monotherapy, (850 mg bid), participated in this 24-week, multicenter, observational study. Patients were enrolled in two cohorts: vildagliptin/metformin fixed-dose combination (group A) and vildagliptin metformin free-dose combination (group B). Results. 659 patients were enrolled, 360 were male, with mean BMI 30.1, mean T2DM duration 59.6 months, and mean HbA1c at baseline 8%; 366 patients were assigned to group A and 293 to group B; data for 3 patients was missing. In group A, 98.9% of patients were compliant with their treatment compared to 84.6% of group B. The odds ratio for compliance in group A versus B was (OR) 18.9 (95% CI: 6.2, 57.7; P < 0.001). In group A mean HbA1c decreased from 8.1% at baseline to 6.9% (P < 0.001) at the study end and from 7.9% to 6.8% (P < 0.001) in group B. Conclusions. Patients in group A were more compliant than patients in group B. These results are in accordance with international literature suggesting that fixed-dose combination therapies lead to increased compliance to treatment.

10.
Am J Clin Oncol ; 38(1): 17-22, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23563209

RESUMO

INTRODUCTION: We conducted a feasibility study on docetaxel/capecitabine/cisplatin (DCX) with chemoradiotherapy as adjuvant treatment for gastric cancer patients. METHODS: Patients were scheduled to receive 2 cycles of DCX, followed by 50.4 Gy plus capecitabine as radiotherapy, followed by an additional 2-DCX cycles. RESULTS: From the 40 enrolled patients, 26 (65%) completed treatment as per protocol and 14 (35%) discontinued with the treatment (patients' refusal: n=6; adverse events: n=8). There were 2 toxic deaths. Grade >3 toxicity was 12.1% before and 13.3% after chemoradiotherapy. Disease progression was documented in 11 (27.5%) patients. CONCLUSIONS: No further development of this regimen is justified on the basis of poor tolerability in patients.


Assuntos
Adenocarcinoma/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Gastrectomia , Neoplasias Gástricas/terapia , Adulto , Idoso , Anemia/induzido quimicamente , Capecitabina , Quimiorradioterapia Adjuvante/métodos , Cisplatino/administração & dosagem , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Docetaxel , Estudos de Viabilidade , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/análogos & derivados , Parada Cardíaca/induzido quimicamente , Humanos , Leucopenia/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Neutropenia/induzido quimicamente , Sepse/etiologia , Taxoides/administração & dosagem , Resultado do Tratamento
11.
Breast Cancer Res Treat ; 148(3): 591-7, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25399229

RESUMO

Adding a taxane to anthracycline-based adjuvant chemotherapy prolongs survival in node-positive early breast cancer. However, which is the preferable taxane in a dose-dense regimen remains unknown. We conducted a randomized study to compare the efficacy of dose-dense paclitaxel versus docetaxel following 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) as adjuvant chemotherapy in women with node-positive early breast cancer. Following surgery women with HER2-negative breast cancer and at least one infiltrated axillary lymph node were randomized to receive four cycles of FEC (700/75/700 mg/m(2)) followed by four cycles of either paclitaxel (175 mg/m(2)) or docetaxel (75 mg/m(2)). All cycles were administered every 14 days with G-CSF support. The primary endpoint was disease-free survival (DFS) at 3 years. Between 2004 and 2007, 481 women were randomized to paclitaxel (n = 241) and docetaxel (n = 240). After a median follow-up of 6 years, 51 (21%) and 48 (20%) women experienced disease relapse (p = 0.753) and there was no significant difference in DFS between the paclitaxel- and docetaxel-treated groups (3-year DFS 87.4 vs. 88.3%, respectively; median DFS not reached; p = 0.633). Toxicities were manageable, with grade 2-4 neutropenia in 21 versus 31% (p = 0.01), thrombocytopenia 0.8 versus 3.4% (p = 0.06), any grade neurotoxicity 17 versus 7.5% (p = 0.35) and onycholysis 4.9 versus 12.1% (p = 0.03) for patients receiving paclitaxel and docetaxel, respectively. There were no toxic deaths. Dose-dense paclitaxel versus docetaxel after FEC as adjuvant chemotherapy results in a similar 3-year DFS rate in women with axillary node-positive early breast cancer. Due to its more favorable toxicity profile, paclitaxel is the taxane of choice in this setting.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Paclitaxel/administração & dosagem , Taxoides/administração & dosagem , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Intervalo Livre de Doença , Docetaxel , Feminino , Humanos , Metástase Linfática/patologia , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Taxoides/efeitos adversos , Resultado do Tratamento
12.
Breast Cancer Res Treat ; 119(1): 95-104, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19636702

RESUMO

A randomized multicenter phase III study was conducted to compare the sequential docetaxel followed by epirubicin/cyclophosphamide combination with that of FEC regimen as adjuvant chemotherapy in women with axillary node-positive early breast cancer. Seven hundred and fifty-six women with axillary lymph node-positive breast cancer were randomized to receive either 4 cycles of docetaxel (100 mg/m(2)) followed by 4 cycles of epirubicin (75 mg/m(2)) plus cyclophosphamide (700 mg/m(2)) (experimental arm) or 6 cycles of FEC (epirubicin 75 mg/m(2), cyclophosphamide 700 mg/m(2), and 5-fluorouracil 700 mg/m(2); control arm). All regimes were administered every 3 weeks. The primary end point was five-year disease-free survival (DFS). After a median follow-up period of 5 years, 233 (30.8%) relapses had occurred (108 and 125 in the experimental and control arms, respectively; P = 0.181). The five-year DFS was 72.6% (95% CI 63.8-81.3%) and 67.2% (95% CI 58.0-76.4%) for women randomized in the experimental and control arms, respectively (P = 0.041; log rank test). There was no difference in the overall survival between the two arms (83.8 and 81.4% in the experimental and control arms, respectively; P = 0.533). The experimental arm was associated with increased neutropenia requiring administration of granulocyte colony-stimulating factor in 90.5% of the patients as compared with 74.1% in the control arm (P = 0.0001). The sequential docetaxel followed by epirubicin/cyclophosphamide adjuvant chemotherapy regimen resulted in improved five-year DFS in women with axillary node-positive early breast cancer at the expense of increased but manageable myelotoxicity.


Assuntos
Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante/métodos , Ciclofosfamida/administração & dosagem , Epirubicina/administração & dosagem , Metástase Linfática , Adulto , Idoso , Neoplasias da Mama/metabolismo , Ciclofosfamida/uso terapêutico , Intervalo Livre de Doença , Epirubicina/uso terapêutico , Feminino , Fluoruracila/uso terapêutico , Humanos , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento
13.
Anticancer Drugs ; 21(2): 202-5, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20010424

RESUMO

Oral topotecan has been recently brought into clinical practice at a dose of 2.3 mg/m(2) for 5 days, every 3 weeks. Published data show quite high myelotoxicity. The aim of this trial was to define the daily dose and treatment duration, which permits safe toxicity. The study was designed to begin at a low daily dosage of 1.5 mg/m(2) and was escalated by increasing the topotecan dose and the day-treatment duration. The plan was to end up with 2.3 mg/m(2) daily for 5 days. In cases of tolerability with the last dosage given, we would then continue testing a higher daily dosage. Treatment repetition was planned to be every 21 days. Dosage levels were 1.5, 2.0 and 2.3 mg/m(2) for 3 days, 2.0 and 2.3 mg/m(2) for 4 days, and 2.3 mg/m(2) for 5 days. Toxicity was scored according to the Common Toxicity Criteria. Thirty-two patients (27 male, five female, median age 60 years, range 46-77 years) with small-cell lung cancer were included. The patients on 1.5 and 2 mg/m(2) for 3 days showed no myelotoxicity. Four (25%) patients on 2.3 mg/m(2) 3-day treatment developed grade 3-4 neutropenia. Three of five patients (60%) treated for 4 days at a dose of 2.3 mg/m(2) developed grade 3-4 neutropenia and less than half (two of five, 40%) of these patients had thrombocytopenia. Eight patients (66.7%) on the 5-day treatment presented with serious grade 3-4 myelotoxicity. Two treatment-related deaths were observed in the 5-day group and one in the 4-day group. Granulocyte growth factor was applied in over 60% of the patients. In conclusion, a dose of 2.3 mg/m(2) for 5 days was intolerable. Dose-limiting toxicity was 2.3 mg/m(2) for 4 days without prophylactic granulocyte colony-stimulating factor administration. The safe duration of oral topotecan treatment and the maximum tolerated dose seem to be not longer than 3 days at a dose of 2.3 mg/m(2).


Assuntos
Antineoplásicos/efeitos adversos , Neoplasias Pulmonares/tratamento farmacológico , Neutropenia/induzido quimicamente , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Trombocitopenia/induzido quimicamente , Topotecan/efeitos adversos , Administração Oral , Idoso , Antineoplásicos/administração & dosagem , Estudos de Coortes , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Dose Máxima Tolerável , Pessoa de Meia-Idade , Prognóstico , Taxa de Sobrevida , Fatores de Tempo , Topotecan/administração & dosagem , Resultado do Tratamento
14.
Oncol Rep ; 22(2): 345-8, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19578775

RESUMO

In the past, it was believed that when advanced-stage prostate cancer became resistant to hormonal management, no chemotherapy should be administered, as survival was not prolonged. Mitoxanthrone and prednisone were mostly administered, while recently, other agents such as docetaxel or paclitaxel have been tested both with and without hormonal treatment. The objective of the present phase II study was to determine the survival and the response rate of patients after the chemotherapy was administered. Sixty-five patients with advanced prostate cancer were included. The inclusion criteria involved histological confirmation of adenocarcinoma and resistance to hormonal therapy. The majority of the patients had stage IVa or IVb disease and a performance status of 0-1 to 2. The treatment involved chemotherapy in combination with a luteinizing hormone-releasing hormone (LHRH) or dexamethasone or estramustine. The hormone treatment preceded the cytotoxic administration and no amelioration in the patients nor prostate serum antigen (PSA) reduction was observed. The initial cytotoxic agents administered were docetaxel 75 mg/m(2) in 25 patients, mitoxanthrone 10 mg/m(2) in 15 patients, epirubicin 75 mg/m(2) in 15 patients and paclitaxel 175 mg/m(2) in 10 patients, all repeated every 3 weeks. The response rate was documented by bone scan, CT scan of the abdomen (and occasionally of the chest) and by the PSA serum value. Clinical benefit was also estimated. Thirty-three (50.77%) patients achieved a partial response; stable disease was observed in 24 (36.92%) patients and disease progression in 8 (12.31%). Twenty-two (33.85%) experienced clinical benefit. A significant PSA reduction was seen in 35 (53.85%) patients. The median survival was 18 months and the range 3-84 months. One, 2, 3 and five-year survival was 75.38, 23.07, 12.30 and 4.66%, respectively. Toxicity was well-tolerated. Patients with hormone-resistant advanced prostate cancer do have good prospects for receiving substantial benefit with the addition of chemotherapy, as observed in the present trial.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Próstata/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Resistencia a Medicamentos Antineoplásicos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/mortalidade
15.
Oncol Rep ; 20(4): 879-84, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18813830

RESUMO

Cisplatin-paclitaxel and cisplatin-etoposide combination therapies were compared in limited and extensive disease in patients with small-cell lung cancer. The primary objectives were to determine median and overall survival, time to tumor progression and tolerance and the secondary objective, the response rate. From January 2003 till July 2007, 108 patients were enrolled in the study. All patients had histologically- or cytologically-confirmed small-cell lung cancer. All patients were chemotherapy and radiotherapy naive. The patients were designated to receive six cycles: in the investigational Arm A, cisplatin, 80 mg/m(2) and paclitaxel 175 mg/m(2) were infused on day 1 (1 cycle) and repeated every 3 weeks. In the control Arm B, cisplatin, 80 mg/m(2) was administered on day 1 and etoposide, 120 mg/m(2) per day was given on days 1-3 (1 cycle), every 3 weeks. In Arm A, 6 (11.3%) patients achieved a complete response and 32 (58.1%), a partial response; in Arm B, 7 (12.7%) patients achieved a complete response and 32 (58.2%) a partial response. The median survival time in Arm A patients was 12 months and in Arm B, 13 months, p=0.354. The time to tumor progression (TTP) was 8 and 6 months for Arms A and B, respectively (p=0.060). Toxicity, although common in both Arms, was acceptable. Neutropenia, anemia and diarrhea were higher in the control Arm. The cisplatin-paclitaxel combination is not superior to cisplatin-etoposide with respect to survival, TTP, toxicity and response rate. The former combination could be applied as an alternative chemotherapy regimen for patients with limited or advanced small-cell lung cancer.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma de Células Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma de Células Pequenas/mortalidade , Cisplatino/administração & dosagem , Etoposídeo/administração & dosagem , Feminino , Humanos , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Cooperação do Paciente
16.
Cancer Chemother Pharmacol ; 56(6): 653-8, 2005 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-15937714

RESUMO

PURPOSE: This phase I study was designed to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the paclitaxel-gemcitabine combination in a biweekly schedule in chemotherapy-naive patients with advanced non small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Treatment was administered on an outpatient basis every 2 weeks: paclitaxel over a 1-h IV infusion and gemcitabine as a 30-min IV infusion immediately following paclitaxel. RESULTS: Twenty-nine patients were treated at six different dose levels, ranging from paclitaxel 135-175 mg/m2 and gemcitabine 1,500-3,000 mg/m2. A total of 198 cycles were administered (median 7, range 1-13). DLTs in the first two cycles were grade 4 neutropenia and myocardial ischemia at the dose level paclitaxel/gemcitabine 150/2,000 mg/m2, febrile neutropenia and grade 4 neutropenia at the dose level paclitaxel/gemcitabine 175/2,500 mg/m2, fatal pneumonitis, sudden death and grade 3 neutropenia at the dose level paclitaxel/gemcitabine 175/3,000 mg/m2. The MTD was paclitaxel 175 mg/m2 and gemcitabine 2,500 mg/m2. The average dose intensity at this dose level was 98%. The overall intent-to-treat response rate was 35.7% (95% confidence interval [CI] 17.97%-53.47%). Overall median survival was 36 weeks (95% CI, 24-48). CONCLUSION: Paclitaxel and gemcitabine can be safely administered at a high dose intensity on an every-other-week schedule. The recommended phase II dose is paclitaxel 175 mg/m2 and gemcitabine 2,500 mg/m2.


Assuntos
Antimetabólitos Antineoplásicos/uso terapêutico , Antineoplásicos Fitogênicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Desoxicitidina/análogos & derivados , Neoplasias Pulmonares/tratamento farmacológico , Paclitaxel/uso terapêutico , Idoso , Antimetabólitos Antineoplásicos/administração & dosagem , Antineoplásicos Fitogênicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , Desoxicitidina/administração & dosagem , Desoxicitidina/uso terapêutico , Relação Dose-Resposta a Droga , Esquema de Medicação , Doenças Hematológicas/induzido quimicamente , Doenças Hematológicas/patologia , Humanos , Infusões Intravenosas , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Pacientes Ambulatoriais , Paclitaxel/administração & dosagem , Taxa de Sobrevida
17.
Oncology ; 66(3): 192-6, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-15218309

RESUMO

OBJECTIVE: To evaluate efficacy and toxicity of the combination of irinotecan and gemcitabine in pretreated patients having small-cell lung cancer. PATIENTS AND METHODS: Thirty-one patients (median age 60 years, performance status 0-1 in 87% and 2 in 13% of the patients) with limited or extensive-stage disease, refractory or relapsing after at least one prior chemotherapy regimen, received gemcitabine 1,000 mg/m(2) on days 1 and 8 and irinotecan 300 mg/m(2) on day 8, every 21 days. Sixteen (52%) patients had sensitive and 15 (48%) refractory disease. Fifteen patients (48%) had received > or =2 prior regimens. RESULTS: All patients were evaluable for toxicity and 26 for response analysis. A median of three (range 1-6) cycles per patient was administered. Three partial responses were documented for an overall response rate of 10% (95% CI 0.73-20.09), and disease stabilization was obtained in 7 patients (22%; intention-to-treat analysis). Two of the responders had refractory, and 1 had sensitive disease. The median time to progression was 4.5 months, the median duration of responses was 2.5 months, and the median survival time was 6 months. Grade 3-4 (WHO) neutropenia was observed in 9 patients (29%), grade 3-4 thrombocytopenia in 4 (13%), and grade 3-4 diahrrea in 3 patients (10%). Three patients experienced febrile neutropenia. No toxic deaths occurred. CONCLUSIONS: The combination showed modest activity in this patient group with a poor prognosis. Thus we believe it merits further investigation in the treatment of patients with small-cell lung cancer who have failed one prior chemotherapy regimen.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Camptotecina/análogos & derivados , Carcinoma de Células Pequenas/tratamento farmacológico , Desoxicitidina/análogos & derivados , Neoplasias Pulmonares/tratamento farmacológico , Adulto , Idoso , Antimetabólitos Antineoplásicos/administração & dosagem , Antineoplásicos Fitogênicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Camptotecina/administração & dosagem , Desoxicitidina/administração & dosagem , Esquema de Medicação , Feminino , Humanos , Irinotecano , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
18.
Oncol Rep ; 10(6): 1817-9, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-14534702

RESUMO

Due to the cumulative cardiotoxicity of doxorubicin in cancer treatment, the tendency of the physician to find a substitute has led to the use of liposomal encapsulated doxorubicin, as well as other similar compounds. Doxorubicin and paclitaxel, two of the most active agents for breast cancer, have often been used in combination for this condition. In the present study we combined liposomal doxorubicin with paclitaxel with the intention of diminishing the toxicity of the cardiac muscle. Twenty-three patients were evaluated for response rate, survival and toxicity. All patients had metastatic disease and were chemotherapy-naïve after generalization of the disease. Liposomal doxorubicin was infused at a dose of 30 mg/m(2) and paclitaxel at a dose of 175 mg/m(2) once every 3 weeks. The response rate was complete in 2 patients (8.70%) and partial in 14 patients (60.87%) totalling 69.57%. The median duration of response was 6 months (range 2-13+) and median survival was 10 months (range 4-20+). Cardiotoxicity, myelotoxicity and gastrointestinal toxicity were well-tolerated. The high hand-foot adverse reaction (47.83%) inhibited the continuation of treatment in half of the patients and due to this toxicity the trial was terminated after the 23rd patient.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Doxorrubicina/administração & dosagem , Paclitaxel/administração & dosagem , Adulto , Idoso , Doxorrubicina/efeitos adversos , Feminino , Humanos , Lipossomos/metabolismo , Pessoa de Meia-Idade , Metástase Neoplásica , Paclitaxel/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
19.
Anticancer Res ; 23(3C): 3085-8, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-12926166

RESUMO

BACKGROUND: The objective of the present study was to investigate the effectiveness of weekly paclitaxel administration in combination with oral estramustine in patients with prostate cancer refractory to hormonal manipulation. PATIENTS AND METHODS: Between 1999 and 2000, 41 patients were included in the study. All patients had disease progression while on treatment with LH-RH and antiandrogens. After being off hormonal therapy for at least 4 weeks, oral estramustine 520 mg twice daily and 60 minutes paclitaxel 60 mg/m2 once weekly, were administered. In total 152 courses were given (median 3.71). RESULTS: Toxicity was well-tolerated. The most common adverse effect was low-grade (I-II) neurotoxicity. Objective partial responses were observed in 9 (22%) patients; when PSA decrease was included the total number of responders was 25 (61%) patients. Median survival was 17 months (range 4-42+ months). CONCLUSION: Long-term median and overall survival was achieved in patients with prostate cancer refractory to hormonal treatment, with oral estramustine and weekly paclitaxel administration. Toxicity was acceptable.


Assuntos
Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Próstata/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Esquema de Medicação , Estramustina/administração & dosagem , Estramustina/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos
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