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Esquerdo G.,Clinica Benidorm | Domenech M.,Fundacio Althaia | Lopez P.,Hospital General Virgen de Las Nieves | Pedro C.,Hospital Del Mar | And 27 more authors.
Tumori | Year: 2014

Aims and background. The present study aims to describe the hematological response to darbepoetin alfa (DA) under daily clinical practice conditions in anemic elderly patients with non-myeloid tumors receiving chemotherapy. Methods and study design. This was a prospective, observational, multicenter study in elderly (≥65 years) patients with non-myeloid cancer receiving DA (500 g every 3 weeks) for chemotherapy-induced anemia (hemoglobin [Hb] level ≤11.0 g/dL). Results. A total of 102 anemic patients with solid tumors and 51 with hematological malignancies were included in 28 centers in Spain. Mean age (±SD) was 73.4 (±5.8) years, and mean baseline Hb level was 10.0 (±0.8) g/dL. DA was administered for a median of 8 weeks. Of the 115 subjects with a post-baseline Hb value, the percentage of patients who achieved a hematopoietic response (Hb increase ≥2 g/dL or reaching ≥12 g/dL without transfusions in the previous 28 days) was 69.7% (95% CI 56.1% to 83.3%). Functional Assessment of Cancer Therapy-Fatigue subscale scores increased during the study (median change 1.0 [Q1 -5.0, Q3 9.0], P = 0.04). One patient (0.7%) experienced a non-serious adverse reaction (cutaneous rash). Conclusion. The study results suggest that DA is an effective and well-tolerated therapy for the treatment of chemotherapy-induced anemia in elderly patients. Copyright - Il Pensiero Scientifico Editore.


Alba E.,Hospital Clinico Universitario Virgen Of La Victoria | Ruiz-Borrego M.,Hospital Universitario Virgen Del Rocio | Margeli M.,Hospital Universitario Germans Trias i Pujol | Rodriguez-Lescure A.,Hospital General de Elche | And 11 more authors.
Breast Cancer Research and Treatment | Year: 2010

This randomized multicenter phase III trial evaluated the role of maintenance therapy with pegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to PLD (40 mg/m2) every 28 days for six cycles or to observation. Time to progression (TTP) was the primary endpoint. 288 patients were enrolled and received induction first-line chemotherapy. One hundred and fifty-five achieved response or stable disease and were randomized to maintenance PLD (n = 78) or observation (n = 77). With a median follow-up of 20 months from randomization (range 1-56), disease progression occurred in 94% of patients. PLD significantly improved TTP by 3.3 months (8.4 vs. 5.1 months; hazard ratio [HR] = 0.54, 95% CI: 0.39 to 0.76, P = 0.0002) compared with observation. Overall survival was not significantly prolonged with PLD (24.8 vs. 22.0 months, respectively; HR = 0.86, 95% CI: 0.58-1.27, P = 0.44). PLD-induced toxicity was mild and manageable with up to 5% of patients experiencing grade 3/4 non-hematologic events (fatigue, mucositis, palmar-plantar erythrodysesthesia). Grade 3/4 neutropenia occurred in 12% of patients; two patients developed febrile neutropenia. This phase III trial demonstrated that maintenance chemotherapy with PLD is well tolerated and offers improved TTP in patients with MBC following first-line chemotherapy. © 2010 Springer Science+Business Media, LLC.


Lopez R.,Complejo Hospitalario Universitario Of Santiago | Salgado M.,Complejo Hospitalario de Ourense | Reboredo M.,Complejo Hospitalario Universitario runa | Grande C.,Hospital Meixoeiro | And 6 more authors.
British Journal of Cancer | Year: 2010

Background:Combination of bevacizumab and FOLFIRI has currently become one of the standard therapeutic regimens. However, published information is still limited. The objective of the present retrospective observational study is to analyse the response and toxicity of first-line treatment with FOLFIRIbevacizumab in patients with metastatic colorectal cancer (mCRC).Methods:Data were collected from patients from nine Spanish sites diagnosed with mCRC, ECOG2, whose first treatment for advanced disease was at least three cycles of FOLFIRIbevacizumab.Results:A total of 95 patients were enrolled into the study: 64.2% males, median age of 59 years (53.2-67.1 years), ECOG0-1 in 96.9% of patients. The main site of primary tumour was the colon (69.7%), and most metastases occurred in the liver (71.6%). Clinical benefit was detected in 67.4% (57.0-76.6; 95% confidence interval (CI)), with 8.4% of CR and 42.1% of PR. Median TTP was 10.6 months (10.0-11.3; 95% CI), PFS was 10.6 months (9.8-11.3; 95% CI), and OS was 20.7 months (17.1-24.2; 95% CI). Main grade I-II toxicities included haematological toxicity (35.8%), diarrhea (27.3%), mucositis (25.3%), asthenia (19.0%), haemorrhages (11.6%), and emesis (10.6%). Toxicities reaching grades III-IV were haematological toxicity (9.5%), diarrhea (8.5%), mucositis (5.3%), hepatic toxicity (2.1%), asthenia (2.1%), proteinuria (1.1%), emesis (1.1%), pain (1.1%), and colics (1.1%).Conclusion: Results of this study support the beneficial effect of adding bevacizumab to FOLFIRI regimen in terms of efficacy and show a favourable tolerability profile. © 2010 Cancer Research UK All rights reserved.


Servitja S.,Hospital Del Mar | Ramos M.,Institute Catala dOncologia | Gil M.,Centro Oncologico Of Galicia | Sanchez-Rovira P.,Hospital General de Jaen | And 5 more authors.
Anti-Cancer Drugs | Year: 2012

Different anthracycline-free regimens have demonstrated activity, without serious cardiac events. This study was conducted to evaluate the activity and toxicity of docetaxel and trastuzumab given every 21 days in patients with metastatic breast cancer (MBC). The primary endpoint was time to progression and the secondary aims included response rate, safety, duration of response, and overall survival. Eligible patients were those with MBC human epidermal growth factor receptor-2+ (HER2+) with no previous chemotherapy for advanced disease. Patients received six cycles of docetaxel (100 mg/m 2) plus trastuzumab (8 mg/kg loading dose and 6 mg/kg every 21 days thereafter), followed by maintenance treatment with trastuzumab monotherapy every 21 days until disease progression. Forty-nine patients with HER2+ MBC were included. The overall response rate was 44.9% (22/49). With a median follow-up of 16.6 months, the median time to progression was 8.3 months and the median overall survival was 25.7 months. Nineteen patients did not receive treatment continuation with trastuzumab monotherapy. The most common toxicity was febrile neutropenia. A total of 10 patients were taken off the study due to treatment-related toxicity, mainly cardiac events. First-line trastuzumab combined with docetaxel is an effective and well tolerated regimen for HER2+ MBC. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Pinana J.L.,Polytechnic University of Valencia | Pinana J.L.,Hospital Clinico Universitario | Montesinos P.,Polytechnic University of Valencia | Martino R.,Hospital de la Santa Creu i Sant Pau | And 16 more authors.
Annals of Hematology | Year: 2014

Bacteremia is the most frequent infectious complication during neutropenia in patients receiving autologous hematopoietic stem cell transplantation (ASCT). The objective of this study was to analyze the incidence, characteristics, risk factors, and outcome of bacteremia during the early period after ASCT. A total of 720 patients undergoing ASCT in two observational prospective consecutive multicenter studies of the Programa Español para el Tratamiento de las Hemopatías group were analyzed. Bacteremia occurred in 20 % of patients. Coagulase-negative Staphylococcus was the most frequent (66 %) among the gram-positive agents and Escherichia coli (49 %) among the gram-negative agents. Multivariate analysis showed that the length of neutropenia <1 × 109/L (more than 9 days) [relative risk (RR) of 2.6, p < 0.001] was the sole risk factor for overall bacteremia. We identified the length of neutropenia <1 × 109/L (more than 9 days) (RR 4.98, p < 0.001) and the use of prophylactic fluoroquinolones (RR 0.46, p < 0.01) as specific risk factors for gram-negative bacteremia. Risk factors for gram-positive bacteremia were the use of total parenteral nutrition (RR 1.92, p < 0.01) and deep neutropenia (<0.1 × 109/L), with duration over 5 days (RR 1.67, p < 0.027). Bacteremia showed an increased morbidity with no impact on neither overall nor infectious related mortality. The identification of such risk factors may be helpful to implement prophylactic and therapeutic risk-adapted strategies to reduce the incidence of bacteremia in ASCT. © 2013 Springer-Verlag Berlin Heidelberg.

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