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2.
Clin. transl. oncol. (Print) ; 20(7): 862-869, jul. 2018. tab, graf
Article in English | IBECS | ID: ibc-173637

ABSTRACT

Introduction: This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data. Materials and methods: Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile. Results: A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2− patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%). Conclusions: Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials


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Subject(s)
Humans , Female , Breast Neoplasms/drug therapy , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Lobular/drug therapy , Breast Neoplasms/secondary , Drug Resistance, Neoplasm , Antineoplastic Agents, Hormonal/therapeutic use , Carcinoma, Ductal, Breast/pathology , Carcinoma, Lobular/pathology , Lymphatic Metastasis/pathology , Postmenopause , Retrospective Studies , Receptor, ErbB-2/genetics
3.
Clin Transl Oncol ; 20(7): 862-869, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29178019

ABSTRACT

INTRODUCTION: This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data. MATERIALS AND METHODS: Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile. RESULTS: A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2- patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%). CONCLUSIONS: Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials.


Subject(s)
Breast Neoplasms/drug therapy , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Lobular/drug therapy , Drug Resistance, Neoplasm , Estradiol/analogs & derivatives , Postmenopause , Aged , Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/metabolism , Carcinoma, Ductal, Breast/secondary , Carcinoma, Lobular/metabolism , Carcinoma, Lobular/secondary , Estradiol/therapeutic use , Female , Follow-Up Studies , Fulvestrant , Humans , Lymphatic Metastasis , Middle Aged , Prognosis , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Retrospective Studies
4.
Clin Transl Oncol ; 14(8): 564-74, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22855137

ABSTRACT

Angiogenesis is a cornerstone in the process of hepatocarcinogenesis. In the sorafenib era, other antiangiogenic targeted drugs, such as monoclonal antibodies and a new generation of tyrosine kinase inhibitors, have been shown in phase II trials to be safe and effective in the treatment of advanced hepatocellular carcinoma. Several currently active phase III trials are testing these drugs, both in first- and second-line settings. Strategies to overcome primary and acquired resistance to antiangiogenic therapy are urgently needed. Novel biomarkers may help in improving the efficacy of drugs targeting angiogenesis.


Subject(s)
Angiogenesis Inhibitors/therapeutic use , Carcinoma, Hepatocellular/drug therapy , Liver Neoplasms/drug therapy , Antibodies, Monoclonal/therapeutic use , Carcinoma, Hepatocellular/blood supply , Clinical Trials, Phase III as Topic , Humans , Liver Neoplasms/blood supply , Neovascularization, Pathologic/drug therapy , Niacinamide/analogs & derivatives , Niacinamide/therapeutic use , Phenylurea Compounds/therapeutic use , Sorafenib
5.
Clin. transl. oncol. (Print) ; 14(8): 564-574, ago. 2012.
Article in English | IBECS | ID: ibc-126952

ABSTRACT

Angiogenesis is a cornerstone in the process of hepatocarcinogenesis. In the sorafenib era, other antiangiogenic targeted drugs, such as monoclonal antibodies and a new generation of tyrosine kinase inhibitors, have been shown in phase II trials to be safe and effective in the treatment of advanced hepatocellular carcinoma. Several currently active phase III trials are testing these drugs, both in first- and second-line settings. Strategies to overcome primary and acquired resistance to antiangiogenic therapy are urgently needed. Novel biomarkers may help in improving the efficacy of drugs targeting angiogenesis (AU)


Subject(s)
Humans , Angiogenesis Inhibitors/therapeutic use , Carcinoma, Hepatocellular/drug therapy , Liver Neoplasms/drug therapy , Antibodies, Monoclonal/therapeutic use , Carcinoma, Hepatocellular/blood supply , Practice Guidelines as Topic , Liver Neoplasms/blood supply , Neovascularization, Pathologic/drug therapy , Niacinamide/analogs & derivatives , Niacinamide/therapeutic use
6.
Clin. transl. oncol. (Print) ; 13(5): 341-347, mayo 2011. tab, ilus
Article in English | IBECS | ID: ibc-124446

ABSTRACT

BACKGROUND: Cancer patients with chemotherapy-induced anaemia (CIA) often experience cancer-related fatigue (CRF). Darbepoetin alfa (DA) once every 3 weeks (q3w) is an effective and well tolerated erythropoiesis-stimulating agent. This study evaluated DA effectiveness and psychometric properties of the Functional Assessment of Cancer Therapy Fatigue-Subscale (FACT-F) and the Fatigue Symptom Inventory (FSI) in CIA patients. METHODS: This was a single-centre, prospective study in 100 patients with solid tumour and moderate to severe CRF (visual analogue scale [VAS-F] ≥ 30 mm) who received DA 500 μg q3w during chemotherapy (CT). Clinical data, VAS-F, FACT-F and FSI scores were collected at the beginning and at the end of CT (EOCT). RESULTS: Mean age was 62.7 years (SD: 12.1), 53.0% were women, 92.0% had ECOG 0-1 and 64% had stage IV tumours. Mean haemoglobin (Hb) significantly increased from baseline 10.2 g/dl to 11.3 g/dl at EOCT. Sixty-five percent of patients showed haematopoietic response at any study point (Hb ≥ 12 g/dl or an increase of ≥ 2 g/dl from baseline), 77% achieved Hb ≥ 11 g/dl and 7% required blood transfusions from week 5 to EOCT. CRF improvement was demonstrated by significant changes in VAS-F, FACT-F and FSI scores (decreases of 21.54, 3.56 and 12.97 points, respectively). FACT-F and FSI questionnaires showed high internal consistency (Cronbach's alpha of 0.98 and 0.98 for FACT-F and FSI, respectively, at the end of study) and satisfactory intra-class coefficients (FACT-F, r=0.73; FSI, r=0.83). There were significant correlations between scores and Hb changes (FACT-F, r=-0.44; FSI, r=-0.54). CONCLUSIONS: DA 500 μg q3w showed effectiveness in improving Hb and inducing a clinically significant decrease in CRF of patients with solid tumours undergoing CT. The three instruments, VAS-F, FACT-F and FSI, could be suitable for assessing CRF (AU)


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Anemia/drug therapy , Anemia/etiology , Antineoplastic Agents/therapeutic use , Erythropoietin/analogs & derivatives , Medical Oncology/methods , Antineoplastic Agents/adverse effects , Cohort Studies , Erythropoietin/therapeutic use , Fatigue/drug therapy , Fatigue/etiology , Hematinics/therapeutic use , Hemoglobins/metabolism , Longitudinal Studies , Prospective Studies , Quality of Life
7.
Clin Transl Oncol ; 9(2): 99-105, 2007 Feb.
Article in English | MEDLINE | ID: mdl-17329221

ABSTRACT

BACKGROUND: The incidence and prevalence of comorbid conditions in lung cancer patients increase with age. The aim of the study was to determine response and tolerability with the biweekly combination gemcitabine-vinorelbine in elderly non-small-cell lung cancer (NSCLC) patients. In order to characterise the population included in the study well and assess the results achieved properly, an evaluation of the functional status, comorbidity and survival was performed. PATIENTS AND METHOD: Between June 2001, and December 2003, 59 untreated advanced NSCLC patients over the age of 70 years entered the study. Treatment consisted of gemcitabine 1750 mg/m(2) and vinorelbine 30 mg/m(2) on day 1 every two weeks. The response was evaluated every f ive cycles (RECIST guidelines). Comorbidity was evaluated according to the Charlson and Kaplan Feinstein scales. To measure functional status, activities of daily living (ADL) and instrumental ADL (IADL) were considered. RESULTS: Median age was 74; ECOG performance status was >2 in 59.3%; no dependence in ADL or IADL was found in 24.8% and 42.4% of patients, respectively. A total of 381 courses were administered. Grade 3-4 neutropenia was present in 6.8% of these courses and correlated with IADL. Objective response was 22% (95% CI 12-32). Mean global survival and cause-specific survival were 29 weeks (95% CI 19.9-38.1) and 32 weeks (95% CI 23.4-40.8) respectively. Comorbidity displayed no close correlation with functional status, but comorbidity according to the Kaplan Feinstein index correlated with IADL. Performance status, ADL, IADL and weight loss were significantly related to survival in multivariate analysis. CONCLUSIONS: This biweekly combination is feasible in elderly lung cancer patients with a high burden of comorbidity and dependence. Toxicity is acceptable, whereas response rate and survival fall in the range of active regimens. ADL and IADL indices allow the identification of elderly patients with a worse prognosis.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Activities of Daily Living , Aged , Aged, 80 and over , Carcinoma, Non-Small-Cell Lung/complications , Carcinoma, Non-Small-Cell Lung/physiopathology , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Drug Administration Schedule , Female , Humans , Lung Neoplasms/complications , Lung Neoplasms/physiopathology , Male , Vinblastine/administration & dosage , Vinblastine/analogs & derivatives , Vinorelbine , Gemcitabine
8.
Clin. transl. oncol. (Print) ; 9(2): 99-105, feb. 2007. tab, ilus
Article in English | IBECS | ID: ibc-123274

ABSTRACT

BACKGROUND: The incidence and prevalence of comorbid conditions in lung cancer patients increase with age. The aim of the study was to determine response and tolerability with the biweekly combination gemcitabine-vinorelbine in elderly non-small-cell lung cancer (NSCLC) patients. In order to characterise the population included in the study well and assess the results achieved properly, an evaluation of the functional status, comorbidity and survival was performed. PATIENTS AND METHOD: Between June 2001, and December 2003, 59 untreated advanced NSCLC patients over the age of 70 years entered the study. Treatment consisted of gemcitabine 1750 mg/m(2) and vinorelbine 30 mg/m(2) on day 1 every two weeks. The response was evaluated every f ive cycles (RECIST guidelines). Comorbidity was evaluated according to the Charlson and Kaplan Feinstein scales. To measure functional status, activities of daily living (ADL) and instrumental ADL (IADL) were considered. RESULTS: Median age was 74; ECOG performance status was >2 in 59.3%; no dependence in ADL or IADL was found in 24.8% and 42.4% of patients, respectively. A total of 381 courses were administered. Grade 3-4 neutropenia was present in 6.8% of these courses and correlated with IADL. Objective response was 22% (95% CI 12-32). Mean global survival and cause-specific survival were 29 weeks (95% CI 19.9-38.1) and 32 weeks (95% CI 23.4-40.8) respectively. Comorbidity displayed no close correlation with functional status, but comorbidity according to the Kaplan Feinstein index correlated with IADL. Performance status, ADL, IADL and weight loss were significantly related to survival in multivariate analysis. CONCLUSIONS: This biweekly combination is feasible in elderly lung cancer patients with a high burden of comorbidity and dependence. Toxicity is acceptable, whereas response rate and survival fall in the range of active regimens. ADL and IADL indices allow the identification of elderly patients with a worse prognosis (AU)


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Small Cell Lung Carcinoma/drug therapy , Small Cell Lung Carcinoma/physiopathology , Lung Neoplasms/drug therapy , Lung Neoplasms/physiopathology , Activities of Daily Living , Small Cell Lung Carcinoma/complications , Small Cell Lung Carcinoma/diagnosis , Lung Neoplasms/complications , Lung Neoplasms/diagnosis , Vinblastine/analogs & derivatives , Vinblastine/administration & dosage , Deoxycytidine/analogs & derivatives , Deoxycytidine/administration & dosage , Drug Therapy/methods
9.
Clin Transl Oncol ; 8(7): 540-1, 2006 Jul.
Article in English | MEDLINE | ID: mdl-16870545

ABSTRACT

A 75-year-old woman was diagnosed of MCD plasma cell (PC) variant with B symptoms. Diffuse lymph-node enlargement, splenomegaly and pancytopenia were detected. Induction with Rituximab was made because pancytopenia was present. Actually patient is free of disease. This is the first complete response of MCD published, VIH negative, induced with anti CD20.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Castleman Disease/drug therapy , Aged , Antibodies, Monoclonal, Murine-Derived , Antigens, CD20 , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Castleman Disease/complications , Castleman Disease/immunology , Female , HIV Seronegativity , Herpesviridae Infections/complications , Herpesvirus 8, Human , Humans , Pancytopenia/complications , Remission Induction , Rituximab
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