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1.
J Clin Oncol ; 31(28): 3531-9, 2013 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-23980081

RESUMO

PURPOSE: Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use. PATIENTS AND METHODS: The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-ß of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed. RESULTS: Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093). CONCLUSION: Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Carcinoma Ductal de Mama/tratamento farmacológico , Carcinoma Lobular/tratamento farmacológico , Adulto , Idoso , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Capecitabina , Carcinoma Ductal de Mama/mortalidade , Carcinoma Ductal de Mama/patologia , Carcinoma Lobular/mortalidade , Carcinoma Lobular/patologia , Quimioterapia Adjuvante , Ciclofosfamida/administração & dosagem , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Difosfonatos/administração & dosagem , Epirubicina/administração & dosagem , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/análogos & derivados , Seguimentos , Alemanha , Humanos , Ácido Ibandrônico , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Paclitaxel/administração & dosagem , Prognóstico , Taxa de Sobrevida , Adulto Jovem
2.
Breast Care (Basel) ; 8(1): 60-6, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24715845

RESUMO

BACKGROUND: Elderly breast cancer patients are underrepresented in clinical trials and this leads to a lack of knowledge regarding the tolerance and side effects of modern chemotherapy regimens, especially in dose-dense (dd) or dose-intensified combination. PATIENTS AND METHODS: In this analysis, data from 4 German, randomized (neo-)adjuvant trials, including anthracycline-based chemotherapy, were evaluated for toxicity, compliance and feasibility. Patients were grouped according to age. RESULTS: Of the 4,775 patients, 73.6% were < 60 years, 15.8% were 60-64 years and 10.6% were > 64 years. The patients' compliance decreased with increasing age, the rate of therapy discontinuations was 10.3%; 16.0% were > 64 years old (p < 0.001). The rate of dose reductions also increased with increasing age in the docetaxel/doxorubicin/cyclophosphamide (TAC) (p overall = 0.02) and 5-fluorouracil/epirubicin-cyclophosphamide (FE120C) (p overall < 0.001) treatment groups. Neutropenia grade 3 + 4 in patients of > 64 years was 77% in FE120C- compared to 55% in TAC-treated patients (with primary granulocyte colony-stimulating factors (G-CSFs)). The incidence of febrile neutropenia (FN) was lowest in the regimens without additional taxanes. FN in patients aged > 64 years was lower in the FE120C- than in TAC-and dd-doxorubicin/docetaxel-treated groups. CONCLUSION: The range and intensity of toxicity increased with age. Neutropenia did not increase significantly in the dd groups; the highest rate was seen in FE120C-treated patients. FE120C without G-CSFs is not an option in patients older than 64 years.

3.
Breast Care (Basel) ; 7(1): 19-24, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22553468

RESUMO

BACKGROUND: The aim of this article was to evaluate the prognostic value of the MammaPrint(TM) signature in women $$ 60 years with invasive breast cancer. PATIENTS AND METHODS: 60 female patients were included in this prospective study. Eligibility criteria included: pT1c-3, pN0-1a, grade 2/3, hormone receptor-positive and HER2-negative tumor. The clinical risk was determined by Adjuvant! Online (AOL). RESULTS: 38 patients (63%) where considered to be low-risk patients by the 70-gene signature, while 22 (37%) were considered to be high-risk patients. No statistically significant differences between low- and high-risk groups could be detected for conventional prognostic parameters, particularly not for Ki-67. By AOL, 33 patients (55%) were considered to be at high risk, of which 20 had a discordant MammaPrint(TM) result. The discordance rate between the profile and AOL was 48%, which is higher than in previous publications. When the 70-gene signature was used in combination with the clinical risk assessment, the recommendation for adjuvant systemic treatment differed in 11 patients (18%). CONCLUSIONS: In the intermediate-risk subgroup, the 70-gene signature could be useful to decide in elderly patients whether they may benefit from adjuvant chemotherapy or not. Conventional clinicopathological factors were not suitable for a prediction of the 70-gene signature results in these patients.

4.
J Clin Oncol ; 29(28): 3791-7, 2011 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-21860000

RESUMO

PURPOSE: This open-label, randomized phase III study was designed to investigate the effects of erythropoietin alfa (EPO) in addition to adjuvant chemotherapy and pelvic radiotherapy (CRT) in patients with stage IB to II cervical cancer who had undergone radical hysterectomy. PATIENTS AND METHODS: Two hundred fifty-seven patients were randomly assigned to four cycles of carboplatin/ifosfamide chemotherapy followed by external-beam pelvic radiotherapy (CRT group) or four cycles of carboplatin/ifosfamide chemotherapy and EPO followed by pelvic radiotherapy and EPO (CRT + EPO group). The primary end point was recurrence-free survival (RFS). Secondary end points included overall survival (OS), change in hemoglobin levels, and safety, including thromboembolic events. RESULTS: The estimated 5-year RFS rates were 78% for patients receiving CRT + EPO and 70% for patients receiving CRT. There was no statistically significant difference in RFS, although a trend favoring patients treated with CRT + EPO was observed (hazard ratio [HR], 0.66; 95% CI, 0.39 to 1.12; log-rank P = .06). Exploratory analyses suggest a benefit with CRT + EPO for patients with stage IB to IIA disease (HR, 0.39; 95% CI, 0.18 to 0.85; P = .014) or patients with complete resection (HR, 0.55; 95% CI, 0.31 to 0.98; P = .039). OS was similar in both groups (HR, 0.88; 95% CI, 0.51 to 1.50; log-rank P = .63). Patients treated with EPO maintained higher hemoglobin levels throughout CRT. No significant differences in safety profiles were observed between the two groups. Incidence of thrombovascular events was low (2%) and comparable between both groups. CONCLUSION: This study confirms that EPO can be added safely to CRT in patients with cervical cancer, but it failed to demonstrate a significant benefit in RFS and OS.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Eritropoetina/uso terapêutico , Neoplasias do Colo do Útero/tratamento farmacológico , Neoplasias do Colo do Útero/radioterapia , Adulto , Idoso , Carboplatina/administração & dosagem , Quimiorradioterapia Adjuvante , Intervalo Livre de Doença , Epoetina alfa , Feminino , Humanos , Ifosfamida/administração & dosagem , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Proteínas Recombinantes/uso terapêutico , Fatores de Risco , Análise de Sobrevida , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/cirurgia , Adulto Jovem
5.
Anticancer Res ; 31(8): 2617-22, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21778313

RESUMO

BACKGROUND/AIM: The aim of the present study was to investigate the effects of conventional and dose-dense chemotherapy on serum levels of soluble adhesion molecules sICAM-1 and sVCAM-1 in node-positive patients with breast cancer. PATIENTS AND METHODS: sICAM-1 and sVCAM-1 were measured in the blood serum of 147 patients with breast cancer and with 1 to 3 affected lymph nodes prior to and after conventional or dose-dense chemotherapy within a randomized phase III study (NOGGO trial). RESULTS: The increase in sICAM-1 (p<0.0001) and sVCAM-1 (p<0.001) levels after chemotherapy was statistically significant within the entire sample and the dose-dense study arm. sVCAM-1 levels were not altered by conventional chemotherapy, but were markedly and significantly increased after the dose-dense regimen. Higher sICAM-1 concentrations were found in postmenopausal patients, and the difference was significant before, but not after treatment. There was no significant correlation with other prognostic criteria. CONCLUSION: Both sVCAM-1 and sICAM-1 levels changed significantly after adjuvant chemotherapy, the effect being more marked under the dose-dense regimen. The possible prognostic relevance of adhesion molecule concentration and the effect of different modes of chemotherapy remains to be determined.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Molécula 1 de Adesão Intercelular/sangue , Metástase Linfática , Molécula 1 de Adesão de Célula Vascular/sangue , Adulto , Idoso , Antineoplásicos/administração & dosagem , Neoplasias da Mama/sangue , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Relação Dose-Resposta a Droga , Feminino , Humanos , Pessoa de Meia-Idade , Pós-Menopausa , Pré-Menopausa
6.
Breast Care (Basel) ; 5(s1): 13-15, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20847831

RESUMO

SUMMARY: In women with estrogen receptor(ER)- and ErbB2 (HER2)-positive breast cancer, a vicious cycle is established between ER mechanisms of action and the growth factor receptor network, leading to enhanced cell proliferation and endocrine resistance. As such, co-targeting ErbB1 and ErbB2 with lapatinib in combination with hormonal therapy is an attractive approach to enhance the efficacy of either tamoxifen or estrogen deprivation. As demonstrated in the EGF30008 trial, a combined targeted strategy with letrozole and lapatinib significantly increased progression-free survival and clinical benefit rates in patients with metastatic breast cancer that co-expresses ER and ErbB2. Therefore, women who are not in an acutely life-threatening situation should be considered for upfront treatment with hormonal therapy (e.g. aromatase inhibitors) in combination with an anti-ErbB2 therapy.

7.
Surg Endosc ; 24(10): 2444-52, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20333406

RESUMO

BACKGROUND: Transvaginal video-assisted cholecystectomy with rigid instruments is a new procedure that combines natural orifice surgery (NOS) with classic laparoscopy. This hybrid technique requires conventional laparoscopy via an umbilical incision. To date it is unclear if this procedure is safe and feasible in routine practice. METHODS: We report on a case series of 128 women who consented to transvaginal cholecystectomy. Data, including visual analog scores (VAS), were collected prospectively via a standard digital spreadsheet. Patients completed satisfaction questionnaires within 10 days after discharge from hospital. We report on outcomes, age, body mass index, operating time, complications, pain scores, and patient satisfaction. RESULTS: In 115 (89.8%) patients the procedure was performed as a transvaginal operation. In 11 women (8.6%), we converted to standard laparoscopy, and in 2 cases (1.6%), we converted to an open procedure. Mean age was 52.4 years (range = 23-78 years) and mean body mass index was 27.8 (range = 18.8-42). Mean operating time was 60.6 min (range = 22-110 min). Other procedures were combined with hybrid cholecystectomy in six cases. Complications following transvaginal access included one vaginal bleeding, one perforation of the urinary bladder, and one superficial lesion of the rectum. In one case the hepatic duct had to be stented due to leakage after the procedure via endoscopic retrograde cholangiography. Mean VAS on day 1 was 2.26 (± 0.31 SEM) and on day 2 it was 1.53 (± 0.35 SEM). In a postoperative questionnaire, 95% of patients indicated that they would recommend this procedure to other patients. CONCLUSIONS: Transvaginal cholecystectomy is a safe and easy-to-learn procedure. Possible complications are different than those of standard laparoscopic procedures. Trauma to the abdominal wall and scarring is minimal. Postoperative pain scores were not different than those of standard laparoscopy and a high percentage of patients are satisfied with the procedure.


Assuntos
Colecistectomia Laparoscópica/métodos , Cirurgia Endoscópica por Orifício Natural/métodos , Cirurgia Vídeoassistida/métodos , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Cirurgia Endoscópica por Orifício Natural/efeitos adversos , Dor Pós-Operatória , Satisfação do Paciente , Inquéritos e Questionários , Vagina , Adulto Jovem
8.
Breast Cancer Res ; 10(5): R77, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18796139

RESUMO

INTRODUCTION: Despite the fact that people older than 65 years of age have the highest incidence of developing breast cancer, these patients are excluded from clinical trials in most cases. Furthermore, most physicians tend towards therapy regimens without the use of dose-dense, highly active taxane-based treatments because of a lack of data regarding toxicities of these compounds in older patients. METHODS: Pooled side-effect data were analyzed from four prospective, randomized clinical trials in which patients of different age groups (< 60 years, between 60 and 64 years, and > 64 years) with primary breast cancer received taxane-based chemotherapy. RESULTS: Dose delays, dose reductions, hospitalization, and therapy discontinuation increased with age. Hematologic toxicities and some nonhematologic toxicities were generally more common in older patients. Leucopenia increased from 55.3% in patients aged < 60 years to 65.5% in patients aged > 64 years (P < 0.001), and neutropenia increased from 46.9% to 57.4% (P < 0.001). There was no difference, however, in clinically more relevant febrile neutropenia between the different age groups. Thrombopenia shows a similar age-dependent increase, whereas there is no difference between the age groups concerning anemia. Hot flushes and elevated liver enzymes decreased with increasing age. CONCLUSIONS: The present pooled analysis of a substantial cohort of older primary breast cancer patients demonstrates that taxane-containing (neo)adjuvant chemotherapy is feasible in older patients and that toxicity can be reduced by sequential therapy regimens.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimioterapia Adjuvante , Terapia Neoadjuvante , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Capecitabina , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Desoxicitidina/análogos & derivados , Docetaxel , Relação Dose-Resposta a Droga , Epirubicina/administração & dosagem , Epirubicina/efeitos adversos , Fadiga/induzido quimicamente , Estudos de Viabilidade , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Fluoruracila/análogos & derivados , Gastroenteropatias/induzido quimicamente , Alemanha , Doenças Hematológicas/induzido quimicamente , Humanos , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Taxoides/administração & dosagem , Taxoides/efeitos adversos , Vimblastina/administração & dosagem , Vimblastina/efeitos adversos , Vimblastina/análogos & derivados , Vinorelbina
9.
Cancer Chemother Pharmacol ; 61(2): 243-50, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-17393164

RESUMO

OBJECTIVES: To study the toxicity and efficacy of weekly paclitaxel and carboplatin (PC-W) in women with primary ovarian cancer METHODS: This investigation extended a phase-I dose finding study and was approved by the institutional review boards of all participating institutions. Between 1999 and 2003, women with radically resected ovarian cancer of FIGO stages II B to IV were enrolled at 17 German centres. Patients received weekly paclitaxel at a dose of 100 mg/m2, followed by carboplatin AUC 2. After a first treatment block consisting of six cycles of chemotherapy, patients had a treatment-free interval of 14 days, followed by a second block of six cycles. Treatment was completed by a 28-days break and a final block of six cycles. RESULTS: Altogether, 129 women with a mean age of 59 +/- standard deviation 11 years entered the study. Most patients (82.9%) had serous papillary carcinoma of FIGO stage III (72.9%) and IV (20.9%). Participants received 1,851 cycles of chemotherapy; averaging 14.3 +/- 4.3 cycles each patient. PC-W produced low rates of peripheral neuropathy (grade 3: 2.3%, 95% confidence interval [CI] 0.5-6.6%), with rapid recovery after 3 months. However, 72 patients had grade III/IV anaemia (55.8%, 95% CI 46.8-64.5%). There were 36 events of grade III/IV leukopenia (27.9%, 95% CI 20.4-36.5%). One patient sustained neutropenic fever. CA-125- and objective response was noted in 73.9% (95% CI 64.7-81.8%) and 55.6% (95% CI 41.4-69.1%) of patients. Median progression free and overall survival was 21 and 43 months, respectively. CONCLUSIONS: PC-W is feasible; a randomized study is warranted to compare this new regimen with conventional 3-weekly treatment.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Ovarianas/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Alopecia/induzido quimicamente , Antineoplásicos/administração & dosagem , Antineoplásicos Fitogênicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Área Sob a Curva , Contagem de Células Sanguíneas , Superfície Corporal , Carboplatina/administração & dosagem , Feminino , Humanos , Pessoa de Meia-Idade , Síndromes Neurotóxicas/fisiopatologia , Neoplasias Ovarianas/patologia , Paclitaxel/administração & dosagem , Análise de Regressão , Análise de Sobrevida
10.
Anticancer Res ; 26(2C): 1673-6, 2006.
Artigo em Inglês | MEDLINE | ID: mdl-16617560

RESUMO

Due to improved life expectancy and the increase in incidence of breast cancer in old age, ever more older women are developing this disease. Although there is only limited evidence-based data from randomized trials on the treatment, older patients are still under-represented in clinical studies, and currently there is no clear consensus on chemotherapy treatment for older women with breast cancer. Adjuvant therapy strategies, in particular, suffer from a lack of uniform standards and reflect a generally less aggressive treatment. Recently published studies have shown that older women suffering from breast cancer can also profit from a treatment based on therapeutic standards and consensus guidelines. In spite of developments in adjuvant chemotherapy using increased amounts of therapeutic agent to improve survival, many older patients receive instead reduced quantities of chemotherapeutic agent. Thus, the questions arise, whether undertreatment of older patients with breast cancer can lead to a poorer outcome or whether new therapy strategies (e.g., dose-intensive chemotherapy) can be used with older patients. A common reason for dose reductions is neutropenia, but studies have shown that it is manageable by using granulocyte colony-stimulating factors (G-CSFs). In this review, the current status of clinical research in the area of adjuvant treatment and the necessity for clinical studies that take into account the special therapeutic requirements of older women are discussed.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Adjuvante , Tratamento Farmacológico/métodos , Feminino , Humanos , Pessoa de Meia-Idade
11.
Anticancer Res ; 26(2C): 1719-26, 2006.
Artigo em Inglês | MEDLINE | ID: mdl-16617567

RESUMO

BACKGROUND: The goal of the present study was to investigate the changes in concentration of the important lymph-angiogenesis factors vascular endothelium-derived growth factor (VEGF) and VEGF-D under adjuvant chemotherapy. MATERIALS AND METHODS: The blood plasma of a total of 142 patients with breast carcinoma and with 1 to 3 affected lymph nodes was investigated, using the quantitative sandwich enzyme immunoassay technique, prior to and following chemotherapy, within the framework of a randomized phase III study: the patients received either conventional or dose-intensified chemotherapy. RESULTS: In general, there was a significant reduction in VEGF levels after chemotherapy only in patients with large tumors (T3) (p = 0.043). There was also an almost significant reduction in patients with an overexpression of c-erbB-2 (Dako Score +3, p = 0.052). In contrast, the clearest reduction in VEGF-D occurred in patients with a positive hormone receptor status (p = 0.04) or in patients with a low expression of c-erbB-2 (Dako Score +1, p = 0.05). A significant effect of chemotherapy on VEGF-D was determined only in patients who had a baseline level that was above the normal (conventionel treatment p = 0.005; dose-intensified treatment p = 0.004). CONCLUSION: Both VEGF and VEGF-D levels changed after chemotherapy, depending on the patient and tumor characteristics. With respect to changes in the plasma levels of VEGF and VEGF-D, there were no significant differences between dose-intensified and conventional chemotherapy.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/sangue , Neoplasias da Mama/tratamento farmacológico , Fator A de Crescimento do Endotélio Vascular/sangue , Fator D de Crescimento do Endotélio Vascular/sangue , Adulto , Idoso , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Ciclofosfamida/administração & dosagem , Epirubicina/administração & dosagem , Feminino , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Humanos , Metástase Linfática , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Estudos Prospectivos
12.
Crit Rev Oncol Hematol ; 58(2): 166-75, 2006 May.
Artigo em Inglês | MEDLINE | ID: mdl-16387512

RESUMO

To evaluate the feasibility and tolerability of dose-dense adjuvant chemotherapy for older patients with node-positive breast cancer, a retrospective subset analysis compared dose delays and dose reductions for women aged > or = 60 years with those of younger women. Patients were randomized to a dose-dense (DD, 14-day cycle) or conventional-schedule (CS, 21-day cycle) regimen. DD patients (n = 104; 25 aged > or = 60 years) received epirubicin 90 mg/m2 plus paclitaxel 175 mg/m2 (four cycles), then cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2 and fluorouracil 600 mg/m2 (CMF 600/40/600) (three cycles), plus filgrastim 5 microg/kg per day in every cycle. CS patients (n = 107; 27 aged > or = 60 years) received epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 (four cycles), then CMF 600/40/600 (three cycles), plus filgrastim if required. Delays were more common in older patients in both the DD and CS groups (DD, 17% versus 6%; CS, 11% versus 6%), as were Grades 3-4 leukopenia (26% versus 12%) and neutropenia (33% versus 25%). All older DD and 89% of older CS patients received all seven chemotherapy cycles, with 99% of cycles at full dose. This study demonstrates that a dose-dense regimen combining epirubicin and paclitaxel can be administered to patients > or = 60 years of age with a tolerable safety profile.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/cirurgia , Adulto , Fatores Etários , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Ciclofosfamida/administração & dosagem , Relação Dose-Resposta a Droga , Esquema de Medicação , Epirubicina/administração & dosagem , Estudos de Viabilidade , Feminino , Filgrastim , Fluoruracila/administração & dosagem , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Humanos , Metástase Linfática , Metotrexato/administração & dosagem , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes , Estudos Retrospectivos
13.
Acta Oncol ; 44(3): 248-54, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-16076697

RESUMO

Sequential, dose-dense epirubicin plus docetaxel was evaluated as primary systemic therapy for women with inoperable, locally advanced breast cancer (LABC) or inflammatory breast cancer (IBC). Patients (LABC n=27; IBC n=7) received 3 cycles of epirubicin 120 mg/m2 every 2 weeks followed by 3 cycles of docetaxel 100 mg/m2 every 2 weeks, with granulocyte colony-stimulating factor. Grade 3-4 toxicities were observed in 21 of 195 cycles (10.8%). Grade 3 anemia and leukopenia each occurred in 1% of cycles. Following chemotherapy, all patients underwent surgery. Eight patients (23.5%) had a clinical complete response and 15 (44.1%) had a partial response. In patients with IBC, median skin thickness decreased from 5.85 mm (range: 3.1-6.2 mm) to 4 mm (range: 2.7-5.1 mm) (p<0.005). Sequential, dose-dense epirubicin plus docetaxel achieved a high response rate among patients with LABC or IBC with only moderate toxicity.


Assuntos
Antibióticos Antineoplásicos/administração & dosagem , Antineoplásicos Fitogênicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Epirubicina/administração & dosagem , Taxoides/administração & dosagem , Adulto , Idoso , Anemia/induzido quimicamente , Antibióticos Antineoplásicos/efeitos adversos , Antineoplásicos Fitogênicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/cirurgia , Docetaxel , Epirubicina/efeitos adversos , Feminino , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Leucopenia/induzido quimicamente , Excisão de Linfonodo , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão , Pele/efeitos dos fármacos , Taxoides/efeitos adversos
14.
Anticancer Drugs ; 16(1): 21-9, 2005 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-15613900

RESUMO

The primary objective was to determine the optimal doses for gemcitabine (prolonged infusion), liposomal doxorubicin (Myocet) and docetaxel as primary (neoadjuvant) chemotherapy for locally advanced breast cancer. Secondary objectives included evaluation of the safety and efficacy of the regimen. Patients (n=19) with histologically confirmed stage II or III breast cancer were treated with liposomal doxorubicin (50-60 mg/m2) and docetaxel (60-75 mg/m2) on day 1, and gemcitabine as 4-h infusion (350-400 mg/m2) on day 4. Treatment was repeated every 3 weeks for a maximum of 6 cycles. The maximum tolerated doses were gemcitabine 350 mg/m2, liposomal doxorubicin 60 mg/m2 and docetaxel 75 mg/m2. Dose-limiting toxicities were stomatitis, diarrhea and infection. The predominant hematologic toxicity was mild-to-moderate myelosuppression with grade 3/4 neutropenia in 20% of cycles. Non-hematologic toxicity was generally mild, with no grade 4 toxicities being observed. Predominant non-hematologic toxicity was stomatitis, which occurred in 95% of patients. Grade 3 toxicities were reported for stomatitis, nausea, diarrhea, infection and constipation. No cases of cardiac, renal, pulmonary or neurotoxicity were observed. The clinical response rate was 83% and histologically confirmed, clinically complete remissions occurred in two patients (11%). We conclude that the combination of gemcitabine (prolonged infusion), liposomal doxorubicin and docetaxel is safe and highly effective in patients with locally advanced breast cancer as defined by maximum tolerated doses. The evaluated schedule is suitable for phase II studies.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Desoxicitidina/análogos & derivados , Adulto , Idoso , Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/tratamento farmacológico , Carcinoma Ductal de Mama/patologia , Carcinoma Lobular/tratamento farmacológico , Carcinoma Lobular/patologia , Desoxicitidina/administração & dosagem , Docetaxel , Relação Dose-Resposta a Droga , Doxorrubicina/administração & dosagem , Feminino , Humanos , Dose Máxima Tolerável , Pessoa de Meia-Idade , Terapia Neoadjuvante , Estadiamento de Neoplasias , Taxoides/administração & dosagem , Resultado do Tratamento , Gencitabina
16.
Anticancer Res ; 24(2C): 1223-9, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-15154651

RESUMO

BACKGROUND: Granulosa cell tumor of the ovary is an uncommon neoplasm. The majority of patients are diagnosed in early stages of disease and overall prognosis is favorable. The stage at time of diagnosis is the only prognostic factor that is unequivocally related to survival. Other prognostic factors have not been well defined and are discussed in the literature controversially. MATERIALS AND METHODS: In a multi-institutional retrospective study we analyzed all relevant clinical data of patients with histologically proven granulosa cell tumor of the ovary. We applied the Kaplan-Meier method in order to estimate overall survival rates and evaluate prognostic factors. RESULTS: The median follow-up was 75 months (range, 6-315 months). Overall survival was 87% and 76% after 5 and 10 years, respectively. Eighty percent of granulosa cell tumors were diagnosed stage I (FIGO). The survival rate after recurrence was 56.8% after 10 years. Mitotic rate (p=0.003), tumor stage (p<0.001) and residual tumor disease (p<0.001) were associated with a poor prognosis (p<0.001). Age and rupture of the tumor could not be confirmed to be of prognostic value. CONCLUSION: The results of our study showed that the mitotic index may be a valuable prognostic factor. Complete tumor resection should always be attempted, since residual tumor disease is associated with a poor prognosis. Prospective studies are needed in order to confirm our findings.


Assuntos
Tumor de Células da Granulosa/patologia , Neoplasias Ovarianas/patologia , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Seguimentos , Tumor de Células da Granulosa/cirurgia , Humanos , Pessoa de Meia-Idade , Mitose/fisiologia , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Neoplasias Ovarianas/cirurgia , Estudos Retrospectivos , Taxa de Sobrevida
17.
Gynecol Oncol ; 85(2): 321-6, 2002 May.
Artigo em Inglês | MEDLINE | ID: mdl-11972395

RESUMO

OBJECTIVES: Carboplatin and paclitaxel can be applied safely and effectively as single agents for the treatment of ovarian cancer on a weekly basis. A multicenter, phase-I study was conducted to investigate the maximum tolerated dose of a weekly combination regimen. METHODS: We enrolled 21 patients with primary, surgically resected, advanced ovarian cancer (FIGO III/ IV) and a median age of 59 (range, 35 to 79) years. For a fixed dose of paclitaxel at 100 mg/m(2), carboplatin was administered at levels equating an area under the curve of 2.0 (6 patients), 2.5 (7 patients), and 3.0 (8 patients), respectively. Treatment schedule consisted of six cycles with drug delivery once a week, followed by a 2-week break, and another six cycles. After a treatment-free interval of 28 days, three more cycles were administered. RESULTS: No dose-limiting toxicity was observed at the first level. Three patients developed dose-limiting toxicity (thrombocytopenia, neutropenic fever, and grade 3 neuropathy) receiving carboplatin at area under the curve 2.5. Another three patients developed dose-limiting toxicity at the highest carboplatin dose, of whom two encountered refractory thrombocytopenia, whereas another experienced neutropenic fever despite prophylactic granulocyte-colony-stimulating factor use. Alopecia was documented in 17 patients. Neurotoxicity was usually mild to moderate. CA-125 concentrations normalized (<35 U/ml) in 13 of 19 patients (68%) by the end of therapy. A 50% response was observed in 16 of 19 subjects. CONCLUSIONS: Weekly carboplatin and paclitaxel is a well-tolerated combination regimen in patients with primary, advanced ovarian cancer. The recommended dose for a phase II study is carboplatin at 100 mg/m(2) and carboplatin at area under the curve 2.0.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias Ovarianas/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carboplatina/administração & dosagem , Carboplatina/efeitos adversos , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Ovarianas/patologia , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos
18.
Rev. cuba. obstet. ginecol ; 6(4): 306-18, oct.- dic. 1980. tab, Ilus
Artigo em Espanhol | CUMED | ID: cum-6108

RESUMO

Se describe una técnica quirúrgica para realizar histerectomía vaginal sin prolapso, así como un análisis retrospectivo de los resultados obtenidos en 50 pacientes intervenidas. Se señalan las ventajas de la técnicacomo son: corto tiempo operatorio; menor traumatismo quirúrgico; escaso sangramiento; confortable período posoperatorio; y la ventaja que significa aprovechar una vía natural (la vagina), para extraer el útero sin dejar cicatriz quirúrgica abdominal y sin riesgo de posibles complicaciones de las laparotomías. Las pacientes son seguidas en la consulta de posoperatorio de nuestro hospital, sin que hasta el momento se hayan detectado complicaciones tardías, como prolapso de cúpula o rompimiento de ésta; de trompas de ovarios; deshiscencia de peritoneo, enterocele, cistocele y rectocele. También se hace una breve revisión bibliográfica de materiales publicados.(AU)


Assuntos
Humanos , Feminino , Histerectomia
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