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Motllo C.,Autonomous University of Barcelona | Sancho J.-M.,Autonomous University of Barcelona | Grifols J.-R.,Hospital Germans Trias i Pujol | Junca J.,Autonomous University of Barcelona | And 11 more authors.
Cytotherapy | Year: 2014

Background aims: The increasing scarcity of young related donors has led to the use of older donors for related allogeneic hematopoietic stem cell transplantation (HSCT). This study analyzed the influence of age on the results of mobilization of peripheral blood stem cells (PBSCs) in healthy donors as well as on the engraftment and outcome of HSCT. Methods: A retrospective analysis from a single center was performed comparing the results of PBSC mobilization from related healthy donors according to their age. Results: The study included 133 consecutive related donors. The median age was 50 years (range, 4-77 years); 70 (53%) donors were males, and 44 (33%) were >55 years old. All donors were mobilized with granulocyte colony-stimulating factor for 5 days. The peak CD34+ cell count in peripheral blood was higher in younger than in older donors (median, 90.5 CD34+ cells/μL [range, 18-240 CD34+ cells/μL] versus 72 CD34+ cells/μL [range, 20-172.5 CD34+ cells/μL], P= 0.008). The volume processed was lower in younger than in older donors (16,131 mL [range, 4424-36,906 mL] versus 18,653 mL [range, 10,003-26,261 mL], P= 0.002) with similar CD34+ cells collected (579.3× 106 cells [range, 135.14× 106-1557.24× 106 cells] versus 513.69× 106 cells [range, 149.81× 106-1290× 106 cells], P= 0.844). There were no differences in time to recovery of neutrophils and platelets or in the incidences of acute and chronic graft-versus-host disease, overall survival, non-relapse mortality and relapse incidence. Conclusions: Donors >55 years old mobilized fewer CD34+ cells and required a greater volume to collect a similar number of CD34+ cells. The outcome of HSCT was not influenced by donor age. Donor age should not be a limitation for related allogeneic HSCT. © 2014 International Society for Cellular Therapy.


Gil-Gil M.J.,LHospitalet | Martinez-Garcia M.,Parc Of Salut Mar Hospital Del Mar | Conesa G.,Parc Of Salut Hospital Del Mar | Del Barco S.,ICO Hospital Josep Trueta | And 2 more authors.
Clinical and Translational Oncology | Year: 2014

Breast cancer represents the second most frequent etiology of brain metastasis (BM). It is estimated that 10-30 % of patients with breast cancer are diagnosed with BM. Breast cancer BM are increasing due to the aging population, detection of subclinical disease, and better control of systemic disease. BM is a major cause of morbidity and mortality affecting neurocognition, speech, coordination, behavior, and quality of life. The therapy of BM remains controversial regarding use and timing of surgical resection, application of whole-brain radiotherapy, stereotactic radiosurgery and systemic drugs in patients with particular tumor subtypes. Despite numerous trials, the range of interpretation of these has resulted in differing treatment perspectives. This paper is a review of the state of the art and a multidisciplinary guideline on strategies to improve the therapeutic index in this situation. © 2013 Federación de Sociedades Españolas de Oncología (FESEO).


PubMed | ICO Hospital Josep Trueta, Hospital Germans Trias i Pujol and Autonomous University of Barcelona
Type: Journal Article | Journal: Cytotherapy | Year: 2014

The increasing scarcity of young related donors has led to the use of older donors for related allogeneic hematopoietic stem cell transplantation (HSCT). This study analyzed the influence of age on the results of mobilization of peripheral blood stem cells (PBSCs) in healthy donors as well as on the engraftment and outcome of HSCT.A retrospective analysis from a single center was performed comparing the results of PBSC mobilization from related healthy donors according to their age.The study included 133 consecutive related donors. The median age was 50 years (range, 4-77 years); 70 (53%) donors were males, and 44 (33%) were >55 years old. All donors were mobilized with granulocyte colony-stimulating factor for 5 days. The peak CD34(+) cell count in peripheral blood was higher in younger than in older donors (median, 90.5 CD34(+) cells/L [range, 18-240 CD34(+) cells/L] versus 72 CD34(+) cells/L [range, 20-172.5 CD34(+) cells/L], P = 0.008). The volume processed was lower in younger than in older donors (16,131 mL [range, 4424-36,906 mL] versus 18,653 mL [range, 10,003-26,261 mL], P = 0.002) with similar CD34(+) cells collected (579.3 10(6) cells [range, 135.14 10(6)-1557.24 10(6) cells] versus 513.69 10(6) cells [range, 149.81 10(6)-1290 10(6) cells], P = 0.844). There were no differences in time to recovery of neutrophils and platelets or in the incidences of acute and chronic graft-versus-host disease, overall survival, non-relapse mortality and relapse incidence.Donors >55 years old mobilized fewer CD34(+) cells and required a greater volume to collect a similar number of CD34(+) cells. The outcome of HSCT was not influenced by donor age. Donor age should not be a limitation for related allogeneic HSCT.


Guerrero A.,Instituto Valenciano Of Oncologia | Servitja S.,Hospital Del Mar | Rodriguez-Lescure A.,Hospital General Universitario Of Elche | Calvo L.,Complejo Hospitalario Universitario Juan Canalejo | And 6 more authors.
Anti-Cancer Drugs | Year: 2011

The objective of this phase I/II study was to establish the recommended dose of biweekly vinorelbine and oxaliplatin in patients with metastatic breast cancer and to evaluate the efficacy and safety profile of this schedule as first-line treatment. Four different dose levels of vinorelbine and oxaliplatin were selected for the phase I study: (i) 25 and 80 mg/m2; (ii) 25 and 90 mg/m2; (iii) 25 and 100 mg/m2; and (iv) 30 and 90 mg/m2; respectively. At least three patients were treated at each dose level. Overall, 12 patients were included in the phase I trial. No dose-limiting toxicities occurred at any dose level. Therefore, the fourth dose level (30 mg/m of vinorelbine and 90 mg/m2 of oxaliplatin) every 2 weeks was selected for the phase II trial. In this part, 44 patients were included and 61% completed the eight 2-week cycles of study treatment. On an intention-to-treat basis, overall response rate was 59%, and median progression-free survival and overall survival were 9.2 months (95% confidence interval: 7.6-10.9) and 18.6 months (95% confidence interval: 14.4-22.9), respectively. The main severe toxicities were neutropenia (46%) and fatigue (14%). We conclude that the biweekly combination of vinorelbine and oxaliplatin at doses of 30 mg/m and 90 mg/m2, respectively, is highly active and well tolerated as first-line treatment for patients with metastatic breast cancer. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


PubMed | ICO Hospital Josep Trueta, Hospital Of Mataro, Autonomous University of Barcelona, Hospital Sant Jaume Of Calella and 2 more.
Type: Journal Article | Journal: European journal of haematology | Year: 2016

Somatic mutations in ASXL1 seem to have a negative prognostic impact in patients with several myeloid neoplasms, including myelofibrosis (MF). The aim of this work was to determine the prevalence and profile of ASXL1 mutations in MF.We analyzed mutations in ASXL1 in 70 consecutive MF patients from 8 Spanish hospitals by means of Sanger sequencing, as well as JAK2, CALR, and MPL mutations.ASXL1 mutations were found in 16/70 (23%) of cases, most commonly p.Gly646TrpfsX12 (5/16). Most mutations (13/16) were frameshift mutations. Of 54 ASXL1- wild-type patients, 32 (59%) had at least one single nucleotide polymorphism (SNP), 27 of them had g.78128C>T, g.79017A>C, and g.79085T>C [triple SNP (TSNP) patients]. The 5-yr overall survival probability of TSNP patients was 67% (95% CI, 43-91%) vs. 90% (95% CI, 77-100%) in ASXL1-WT patients (P = 0.152).ASXL1 mutations were found in 23% of cases, p.Gly646TrpfsX12 being the most frequent. About 85% of mutations were found only in individual cases and 46% had not previously been reported, a pattern also seen in other series. Fifty percent of ASXL1-WT patients had a combination of three specific SNPs that might have a prognostic correlation that needs to be determined in larger series.


Garcia-Alfonso P.,Hospital Universitario Gregorio Maranon | Chaves M.,Hospital Virgen del Rocio | Munoz A.,Hospital Universitario Gregorio Maranon | Salud A.,Hospital Lleida Arnau Of Vilanova | And 10 more authors.
BMC Cancer | Year: 2015

Background: The optimal sequence of chemotherapeutic agents is not firmly established for the treatment of metastatic colorectal cancer (mCRC). This phase II multi-centre study investigated the efficacy and tolerability of a standard capecitabine plus irinotecan (XELIRI) regimen with bevacizumab in previously untreated patients with mCRC. Methods: Patients received intravenous irinotecan 175 mg/m2 on day 1 and oral capecitabine 1000 mg/m2 (800 mg/m2 for patients >65 years of age) twice daily on days 2-8, followed by a 1-week rest, and bevacizumab 5 mg/kg as an intravenous infusion on day 1 every 2 weeks. Results: Seventy-seven patients were included in the intention-to-treat and safety populations. Progression-free survival at 9 months was 61%. The overall response and disease control rates were 51% and 84%, respectively. Median progression-free and overall survival times were 11.9 and 24.8 months, respectively. 48 patients (62%) had at least one grade 3/4 adverse event, the most common being asthenia, diarrhoea and neutropenia. Quality of life varied little over the study period with mean visual analogue scale general health scores ranging from 71 to 76 over cycles 1-11. Conclusion: Our study found irinotecan and capecitabine administered fortnightly with bevacizumab in patients with mCRC to be an effective and tolerable regimen. Trial registration: clinicaltrials.gov identifier NCT00875771. Trial registration date: 04/02/2009. © 2015 Garcia-Alfonso et al.; licensee BioMed Central.


PubMed | Ico Hospital Josep Trueta, Hospital Puerta del Mar, Hospital Universitario Gregorio Maranon, Hospital Lleida Arnau Of Vilanova and 9 more.
Type: | Journal: BMC cancer | Year: 2015

The optimal sequence of chemotherapeutic agents is not firmly established for the treatment of metastatic colorectal cancer (mCRC). This phase II multi-centre study investigated the efficacy and tolerability of a standard capecitabine plus irinotecan (XELIRI) regimen with bevacizumab in previously untreated patients with mCRC.Patients received intravenous irinotecan 175 mg/m(2) on day 1 and oral capecitabine 1000 mg/m(2) (800 mg/m(2) for patients >65 years of age) twice daily on days 2-8, followed by a 1-week rest, and bevacizumab 5 mg/kg as an intravenous infusion on day 1 every 2 weeks.Seventy-seven patients were included in the intention-to-treat and safety populations. Progression-free survival at 9 months was 61%. The overall response and disease control rates were 51% and 84%, respectively. Median progression-free and overall survival times were 11.9 and 24.8 months, respectively. 48 patients (62%) had at least one grade 3/4 adverse event, the most common being asthenia, diarrhoea and neutropenia. Quality of life varied little over the study period with mean visual analogue scale general health scores ranging from 71 to 76 over cycles 1-11.Our study found irinotecan and capecitabine administered fortnightly with bevacizumab in patients with mCRC to be an effective and tolerable regimen.clinicaltrials.gov identifier NCT00875771. Trial registration date: 04/02/2009.


Sancho J.-M.,Autonomous University of Barcelona | Morgades M.,Autonomous University of Barcelona | Grifols J.-R.,Banc de Sang i Teixits | Junca J.,Autonomous University of Barcelona | And 9 more authors.
Cytotherapy | Year: 2012

Background aims. Failure in mobilization of peripheral blood (PB) stem cells is a frequent reason for not performing hematopoietic stem cell transplantation (HSCT). Early identification of poor mobilizers could avoid repeated attempts at mobilization, with the administration of pre-emptive rescue mobilization. Methods. Data from the first mobilization schedule of 397 patients referred consecutively for autologous HSCT between 2000 and 2010 were collected. Poor mobilization was defined as the collection of < 2 × 106 CD34+cells/kg body weight (BW). Results. The median age was 53 years (range 4-70) and 228 (57%) were males. Diagnoses were multiple myeloma in 133 cases, non-Hodgkin's lymphoma in 114, acute myeloid leukemia or myelodysplastic syndrome in 81, Hodgkin's lymphoma in 42, solid tumors in 17 and acute lymphoblastic leukemia in 10. The mobilization regimen consisted of recombinant human granulocytecolony-stimulating factor (G-CSF) in 346 patients (87%) and chemotherapy followed by G-CSF (C G-CSF) in 51 (13%). Poor mobilization occurred in 105 patients (29%), without differences according to mobilization schedule. Diagnosis, previous therapy with purine analogs and three or more previous chemotherapy lines were predictive factors for poor mobilization. A CD34+cell count in PB > 13.8/μL was enough to ensure ≥ 2 × 106 CD34+cells/kg, with high sensitivity (90%) and specificity (91%). Conclusions. The prevalence of poor mobilization was high, being associated with disease type, therapy with purine analogs and multiple chemotherapy regimens. The threshold of CD34+ cell count in PB identified poor mobilizers, in whom the administration of immediate or pre-emptive plerixafor could be useful to avoid a second mobilization. © 2012 Informa Healthcare.


PubMed | ICO Hospital Josep Trueta, ICO Hospital Duran i Reynals and Autonomous University of Barcelona
Type: Journal Article | Journal: Oncotarget | Year: 2016

Clonal cytogenetic abnormalities are found in 20-30% of patients with chronic myelomonocytic leukemia (CMML), while gene mutations are present in >90% of cases. Patients with low risk cytogenetic features account for 80% of CMML cases and often fall into the low risk categories of CMML prognostic scoring systems, but the outcome differs considerably among them. We performed targeted deep sequencing of 83 myeloid-related genes in 56 CMML patients with low risk cytogenetic features or uninformative conventional cytogenetics (CC) at diagnosis, with the aim to identify the genetic characteristics of patients with a more aggressive disease. Targeted sequencing was also performed in a subset of these patients at time of acute myeloid leukemia (AML) transformation. Overall, 98% of patients harbored at least one mutation. Mutations in cell signaling genes were acquired at time of AML progression. Mutations in ASXL1, EZH2 and NRAS correlated with higher risk features and shorter overall survival (OS) and progression free survival (PFS). Patients with SRSF2 mutations associated with poorer OS, while absence of TET2 mutations (TET2wt) was predictive of shorter PFS. A decrease in OS and PFS was observed as the number of adverse risk gene mutations (ASXL1, EZH2, NRAS and SRSF2) increased. On multivariate analyses, CMML-specific scoring system (CPSS) and presence of adverse risk gene mutations remained significant for OS, while CPSS and TET2wt were predictive of PFS. These results confirm that mutation analysis can add prognostic value to patients with CMML and low risk cytogenetic features or uninformative CC.


PubMed | ICO Hospital Josep Trueta, University of Barcelona, Hospital Althaia, ICO Hospital Germans Trias i Pujol and 2 more.
Type: Journal Article | Journal: European journal of haematology | Year: 2016

A multicentre prospective non-randomised study of de novo acute myeloid leukaemia (AML) in patients aged 70yr was designed to reduce toxicity and achieve acceptable complete remission (CR) rates.The outpatient treatment included induction with oral fludarabine, subcutaneous cytarabine and subcutaneous filgrastim (FAG). The patients received more induction cycles according to the response achieved. If there was no response to induction with FAG, the following induction cycle included oral idarubicin, subcutaneous cytarabine and subcutaneous filgrastim (IAG). Patients achieving CR received one intensification (FAG on response to previous FAG or alternatively IAG) and one consolidation cycle (IAG).Thirty patients were enrolled from April 2004 to June 2007. The median age was 73yr (range 70-77). Fifteen patients (50%) achieved CR. The 2-yr DFS was 29% (95% CI, 5-47%), and the 2-yr OS was 23% (95% CI, 12-35%). Twenty-five of 69 cycles (36%) were managed on a completely outpatient basis. The median hospital stay per cycle was 10d (95% CI, 3-25).This study demonstrates the tolerability and efficacy of a semi-intensive treatment in elderly de novo patients with AML managed on an outpatient basis, without substantial toxicity.

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