ALBERT

All Library Books, journals and Electronic Records Telegrafenberg

feed icon rss

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
Filter
Collection
Years
  • 1
    Publication Date: 2015-12-03
    Description: INTRODUCTION Anemia is the most frequent cytopenia in lower-risk MDS. Erythropoietic-stimulating agents (ESAs) are commonly used in these patients. The use of ÒclassicalÓ parameters (EPO and ferritin levels) and the revised IPSS (IPSS-R) has been proposed1 (SantiniÕs score) to predict response to ESAs and overall survival (OS) among patients with lower risk MDS by IPSS and a favorable Nordic group score2. OBJECTIVES The main objective of the study was to evaluate overall response rate (ORR) to ESAs and OS according to the proposed SantiniÕs score in an independent and large cohort of anemic lower risk MDS patients receiving treatment with ESAs. METHODS Data from 530 anemic patients with low/int1 risk IPSS de novo MDS (according to FAB and WHO criteria) and sufficient follow-up data available were recorded in Spresas3 (SPanish Registry of Erythropoietic Stimulating Agents Study from GESMD). Two hundred and twenty six patients (42.6% of the patients) were selected according to specific criteria regarding the published SantiniÕs score1: Hb level 350 ng/mL(=1) and IPSS-R very low=0, low=1, intermediate=2 and high=3) yielded a score ranging from 0 to 5. ESAs response rate and overall survival were analysed according to these score. Response to treatment was evaluated according to IWG 2006 response criteria and a multivariate logistic regression analysis was used to identify independent predictors of erythroid response (ER). OS were defined as the time between diagnosis and the corresponding event or last follow up (Feb 2015) and were analyzed using univariable and multivariable Cox proportional hazards regression methods. RESULTS Median age was 77 years (interquartile range [IQR] 25%-75%: 71-83 y), median Hb level at start of treatment was 10 g/dL (IQR25-75: 9-10), median EPO level was 90 (IQR25-75: 27,25-108) and median ferritin level was 338,5 (IQR25-75: 146,5-568,75). Among 139 patients with this data available, 85 patients (61,1%) were RBC transfusion dependent before ESAs treatment. Median time from diagnosis to ESAs treatment was 82 (IQR25-75: 27-353) days. According to the IPSS, 68.6% (N=155) and 31.4% (N=71) were in low and Int-1 risk groups, respectively. Regarding IPSS-R, 23% (N=52), 66.8% (N=151), 9.7% (N=22) and 0.4% (N=1) were in very low, low, intermediate and high risk, respectively. ORR to ESA treatment was 71.2% (N=161), with a median duration of response of 2.06 years. Prognosis factors of ER showed a trend toward to a higher ER among patients in the lower IPSS-R (P〉0.05), low IPSS (p=0.039) and lower EPO levels (p
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 2
    Publication Date: 2009-11-20
    Description: Abstract 1121 Poster Board I-143 The Spanish Registry on CML ( RELMC ) is a multicentric, hospital-based cancer registry whose aim is to describe what is the actual treatment received by patients with CML in Spain, its outcome, and the variables which influence it. Aim To study the variables which could influence the outcome in newly diagnosed CML patients treated with Imatinib, including classic and new variables, such as phosphate serum levels, which are diminished in a substantial number of patients ( Osorio et al,2007) Patients 207 CP-CML patients, newly diagnosed, were included in 17 Spanish hospitals. Sex: 131 M,76F( 63%,37%). Age: Median: 51,5 (18,7-87,5).The risk group distribution was as follows: Sokal L/I/H: ((47%;35%;18%). Hasford ( 44%,49%,7%). The variables studied at diagnosis were sex, Sokal and Hasford group. During the treatment: dose of Imatinib, anemia, neutropenia, thrombocytopenia and hypophosphatemia. Results Median follow up of the series have been 19,1 months. Among 207 patients, frequency values for anemia, neutropenia, and thrombocytopenia were 21%, 29% and 11%, respectively. Ninety-one patients had serum phosphate measured during the treatment. Among them, 49(54%) had hypophosphatemia. Complete hematologic response ( CHR) was obtained in 94,6%.No significant association was found between Sokal or Hasford group and the achievement of complete HR. Complete cytogenetic response (CCR ) was obtained in 73%. A significant association was found between obtaining CCR and Low or intermediate Hasford group (p=0,013) or having hypophosphatemia during the treatment ( p=0,04). The probability of obtaining CCR was higher in patients having hypophosphatemia in the 9th month of therapy (Log Rank (Mantel-Cox) Chi2: 6,21 (p=0,013).Patients who had hypophosphatemia during the treatment also showed a trend for higher probability of CCR (p=0,096). Major and complete molecular response (MMR, CMR) were obtained in 71% and 48%, respectively. MMR was significant worse in Hasford high-risk patients (Pearson Chi-Square:6,909 (p=0,009), and the probability of MMR was higher in patients developing hypophosphatemia ( p=0,175). Regarding CMR, Hasford high risk had a significant association with worse rate of CMR (Chi-Square: 4,419; p=0,036. Also, the probability of CMR was significantly higher in patients having hypophosphatemia ( p=0,045). Conclusion In our series, Hasford risk system has a stronger predictive value than the Sokal classification. It is interesting to note that half of our patients had hypophosphatemia during the treatment with Imatinib. Intriguingly, having low serum levels of phosphate during treatment is associated with better response, and it invites to further study of the biological basis of this finding and its relevance as prognostic variable. This study has received the grant PI07/91015 from the Instituto de Salud Carlos III. Disclosures No relevant conflicts of interest to declare.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 3
    Publication Date: 2010-11-19
    Description: Abstract 2867 Introduction. Survival of Follicular Lymphoma patients has significantly increased with the introduction of immunomodulatory agents, such as Interferon (IFN) and Rituximab (R). Until 2002 our Follicular Lymphoma patients were included in a trial and received induction therapy with CVP + Interferon (LNH-pro, JCO 16; 1538–1546). Since 2006, Rituximab is being added to the same induction regimen (LNH-pro-05, EHA 09). Herein we communicate the comparative results between these two trials in Intermediate-High risk Follicular Lymphoma patients. Aim. To compare toxicity and efficacy in terms of complete remission (CR) and Progression Free Survival (PFS) between both trials in Intermediate-High risk Follicular Lymphoma patients. Methods. Patients in the LNH-pro trial (1990-2006) received CVP (CY 400mg/m2 p.o D1-5, VCR 1.4mg/m2 iv D1, PRD 100mg/m2 po D1-5) + IFN (3MU/m2 sc, 3 times/wk, for 12 wks). When it became available, G-CSF support was permited. In the LNH-pro-05 trial (2006-ongoing), Rituximab (R: 375mg/m2 iv D1) was added to the same induction regimen. All patients received 8 cycles as per protocol, with G-CSF support and Pn. jiroveci prophilaxis. In both studies, complete re-assessment was performed after cycle 4, at the end of induction therapy, every 4 months for the first 2 years and every 6 months thereafter. Results. We analysed data from 74 and 36 FL patients with FLIPI≥2, included in the LNH-pro and LNH-pro-05 trials, respectively. Patients' characteristics are shown in table 1. No significant differences were found between groups, except for a higher incidence of elevated B2-microglobulin in patients treated with CVP+IFN and higher Bulky disease (〉7cm) among patients with R+CVP+IFN. Median number number of cycles were 6 and 8, respectively. Response: Seventy one patients (96%) in the LNH-pro Trial (CVP+IFN) were evaluable for response. Overall Response (OR) rate was 87%, with 68% Complete Remission (CR) and 19% Partial Remission (PR) (9% non-responders). In the LNH-pro-05 Trial (R+CVP+IFN), 36 patients (92%) and 33 patients (83%) were evaluable for response after 4th and 8th cycle. At cycle 4, all assesed patients achieved remission (15% PRs and 85% CR+uCR), while after the 8th cycle 100% of patients are in CR or uCR. Toxicity. Main hematologic grade 3–4 toxicity was neutropenia, 33% for CVP+IFN and 28% for R+CVP+IFN, with 12% and 6% of infections, respectively. Other non-hematologic toxicities were infrequent and mild (5% and 10% in each group). Eight percent of patients in the LNH-pro trial withdrew treatment due to toxicity. At the moment, none of the patients in the LNH-pro-05 trial have experienced an unacceptable toxicity. Survival . Median follow-up was 7.7 years for CVP+IFN and 2 years for R+CVP+IFN. A significant increase of PFS was seen among patients who received R (66% vs. 86%, at 3 years, P 0.05). There is also a trend to a longer overall survival in patients treated with R+CVP+IFN (P 0.07). Conclusion. The addition of Rituximab to CVP+IFN induction regimen in Intermediate-High risk Follicular Lympoma patients, significantly increases complete remission rates (88% to 100%) and progression free survival (86%, at 3 years), with a low toxicity profile. Disclosure: No relevant conflicts of interest to declare.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 4
    Publication Date: 2012-11-16
    Description: Abstract 3142 Background: Recent studies indicate that the use of highly effective rituximab (R)-containing primary therapy in Diffuse Large B-cell Lymphoma (DLBCL) makes it more difficult to salvage patients who are refractory or who relapse. To date, peripheral-blood autologous stem-cell transplantation (PBASCT) is the reference treatment for these patients, but the impact of previous exposure to R on the ulterior results of ASCT is still unknown. Patients and methods: We have retrospectively analysed 252 patients (pts) with DLBCL or grade 3B follicular lymphoma with relapsed or refractory disease after at least one rituximab-containing regimen (“R+” group) who received PBASCT in 17 GELTAMO centers, in comparison to a control group of 127 patients who received APBSCT as salvage therapy without previous exposure to rituximab (“R-” group). Patients with refractory disease at transplant were excluded from the analysis. Results: No significant differences between R+ and R- groups were found with respect to age-adjusted IPI at transplant, disease status at salvage therapy and at transplant, nor number or prior chemotherapy regimens. More patients in the R+ group were ≥60 years (30% vs 19%, p=.02). Complete response (CR) (69% v 70%) and overall response (84% v 83%) rates to PBASCT were similar in R+ and R- groups. In multivariate analysis, factors with significant influence on CR rates were: age-adjusted IPI at diagnosis (
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 5
    Publication Date: 2013-11-15
    Description: Myelodysplastic syndrome with 5q- (MDS 5q-) is the only cytogenetically defined MDS category recognized by the world Health Organization (WHO) in 2001 and 2008 and is defined as a MDS with isolated deletion on the long arm of chromosome 5 and less than 5% of blast cells in bone marrow (BM). It is well known that for patients with MDS 5q- and transfusion dependence (TD), Lenalidomide is the first choice treatment. However, as far as we know there are no data regarding factors that may impact on the development of TD in these patients or the disease evolution in patients diagnosed without TD. In the present study a retrospective multicenter analysis on patients with low-int 1 MDS 5q- without TD at diagnosis has been performed in order to answer these questions. Patients and methods Data from eighty-four low-Int 1 risk MDS 5q- patients diagnosed between 1980 and 2012 were retrospectively analyzed. Ninety percent of patients had a single 5q deletion and according to IPSS-R 99% were in low and very low risk. Statistical analysis The event of TD was defined as the development of TD according to the IWG criteria (2006) and/or the beginning of a treatment which could modify disease course (Lenalidomide or ESA). Patients follow up was updated on March 30, 2013, and all follow up data were censored at that point. Transfusion free survival (TFS), Overall survival (OS) and AML were analyzed using the Kaplan – Meier method. TFS, OS, and Leukemia free survival (LFS) were measured from diagnosis to TD or to last follow up if transfusion free (TFS), death from any cause or last follow up (OS) and evolution to AML or last follow up (LFS). Multivariate analysis was performed using Cox’s proportional hazards regression model. Incidence of progression to AML was analyzed with cumulative incidence competing risk method. For comparison of Kaplan Meier curves the long rank test was used, with statistical significance with p
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 6
    Publication Date: 2014-12-06
    Description: Introduction: Indolent B cell non-Hodgkin lymphomas are entities without curative treatment nowadays. However, survival has significantly improved since the incorporation of immunomodulatory agents and now immunochemotherapy has become the gold standard. Most treatment strategies use progression free survival (PFS) as a surrogate marker for overall survival (OS), although updated long term results are frequently lacking. Since 1990 our group introduced IFNα-2b to Bagley’s CVP induction regimen, for naïve indolent NHL (LNH-pro study). Herein we report our long term results. Aim: To evaluate long term outcome and late toxicities of patients who received immunochemotherapy with IFN α-2b plus CVP. Patients and Methods: From February 1990 to November 2001, patients from 7 Spanish institutions were included. Induction therapy consisted of Cyclophosphamide (400 mgs/m2 po) and Prednisone (100 mg/m2 po) daily for 5 days, Vincristine (1.4mg/m2 iv) on day 1, and subcutaneous IFN α-2b (3 MU/m2, three times a week, for a total of 36 doses). Patients received the number of cycles necessary to achieve maximum response. Updated clinical data were retrieved from participating centres up to March 2012. Results. A hundred and seventy patients with low-grade NHL were analyzed. Included entities were: 65% grade 1-2 follicular lymphoma (FL), 21% lymphocytic lymphoma and 14% marginal zone lymphoma. Median age was 56 yo (range 22-78 yo), elevated LDH and β2-microglobuline were 13.6% and 26% respectively, 57.6% had bone marrow involvement and 7.6% bulky disease (〉7cm). According to FLIPI, 33% were high risk, 40% intermediate and 27% low risk FL. Median number of cycles was 6, and overall response rate achieved was 90%, with 68% complete remissions. Median follow up of surviving patients was 12.5 years (range 3-21 ys), with only 14.7% of patients lost to follow-up. Median PFS for all patients was 12.5 years (95% CI 10.5 – 14.5 years) and not reached for FL patients (20-year PFS of 63%; 95%CI: 54-72%). Median OS has not been reached, with a 20-year OS of 59.7% (CI 95%, 50.5-69%) for all low-grade NHL patients and 62% (IC 95%, 50-74%) for FL patients. Long-term toxicity is detailed in table 1. Incidence of secondary malignancies is 13.5%. At time of analysis, 57 out of 170 patients have died (33.5%), mainly due to lymphoma (58% of patients) and other non-lymphoma events (42%). Table Secondary malignancies 23 cases (13.5%) - MDS / AML 3 cases - Solid tumors 18 cases - Dermatologic neoplasia 2 cases Causes of death Number of patients (%) Induction toxicity events 4 (7%) Lymphoma progression / relapse 29 (51%) Secondary malignancies 9 (16%) Other non-lymphoma events 15 (26%) - Miocardiopathy 4 - Chronic Pulmonary disease 3 - Hepatic failure 2 - Brain traumatic injury 1 - Unknown cause 5 Figure 1 Figure 1. Conclusions: Our results confirm that immunochemotherapy with IFN α-2b plus CVP regimen induces a median PFS of 12.5 years and a 20-year OS of 59.7% (median not reached). With a median follow-up of 12.5 years, 58 % died due to lymphoma, 16% from secondary malignancies and 26% for non-lymphoma events. These results highlight the importance of performing long term follow-up in order to assess the real survival benefit of any treatment. Disclosures No relevant conflicts of interest to declare.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 7
    Publication Date: 2010-11-19
    Description: Abstract 1237 Background: The RELMC is a multicentric, 17-hospitals-based cancer registry whose aim is to describe the treatments received by patients with CML, their outcomes, and the variables that influence treatment choices. Aim: To study the response and survival outcomes, in newly diagnosed CML patients treated with Imatinib (Im) as first line treatment. Patients and methods: 249 newly diagnosed CML patients have been included. They are distributed in the following subgroups according to treatments received Im400. 166 patients received only Im400. Result: A summary of response and outcome is included in Table 1. Complete cytogenetic response with regards to the best response, the CCyR rate was lower in patients with Im400-HDIm-2GTKI (60%) and Im400-2GTKI (62%). The rates were 84% in Im400, 83% in Im400-HDIm and 85% in HDIm; P Chi2 8,381(a) p=0,079. The CCyR cumulative incidence was also lower in patients with Im400-HDIm-2GTKI and Im400-2GTKI in comparison to the other groups, although second line response was faster in patients who changed to 2GTKI after Im400. The frequency of CCyR as best response in the Hasford high risk patients was low in all groups (66%,50%,50%,50&55%). Major molecular response MMR as best response was lower in patients with Im400-HDIm-2GTKI (50%) and Im400-2GTKI (47%). The rates were 83%, 81% and 77% in the Im400, Im400-HDIm and HDIm groups respectively; P Chi2 19,4(a)p=0,001. The MMR cumulative incidence was higher in the HDIm group, lower in those treated with Im400-HDIm-2GTKI, and intermediate and similar in the other three groups. MMR as best response in the Hasford high risk patients was also low in all groups (60%, 75%, 50%, 50% & 33%). Complete molecular response regarding best response, the CMR rate was lower in patients with Im400-HDIm-2GTKI (37,5%), Im400-2GTKI (31,6%) and Im400-HDIm (34%). In the other groups, the rate was 48% (Im400), and 72% (HDIm); P Chi2 17,4(a) p=0,002. The CMR cumulative incidence was higher in the HDIm group, and nil in those treated with Im400-HDIm-2GTKI. Salvage therapy after suboptimal response (SR) or Failure (F). Two-thirds of patients with SR or F were able to obtain an optimal response and avoid transformation with a timely therapy change. All but one of the options (Im400-HDIm-2GTKI group) were similarly effective. Survival: 6 patients progressed (2,4%) (4 AP, 2 BC), and died; 6 patients changed to allo BMT and were censored; 6 patients died of non-CML related causes. Conclusion: Disclosures: Palomera: Janssen Cilag: Honoraria. Steegmann:Bristol-Myers Squibb: Honoraria, Participated in advisory boards, Research Funding; Novartis: Participated in advisory boards, Research Funding.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 8
    Publication Date: 2011-11-18
    Description: Abstract 3654 Background: Diffuse large B-cell lymphoma (DLBCL) is a heterogeneous entity, showing affected patients a highly variable outcome. The improvement in survival gained with the addition of rituximab to CHOP chemotherapy (R-CHOP) led to re-define the international prognostic index (IPI). The new index, known as revised IPI (R-IPI), showed to be simpler as it groups the patients in only 3 risk groups. However, the effect of prior rituximab-therapy upon the usefulness and significance of previously recognized prognostic factors on patients relapsed or refractory and receiving subsequent treatment with rituximab plus chemotherapy in DLBCL remains unexplored. Biological parameters, including expression of Bcl-6, Bcl-2, p53 and MUM-1 have been described as IPI-independent prognostic factors. Objectives: The objective of this study was to evaluate the benefit of the R-IPI to predict the outcome of DLBCL patients at the relapse time following a front line treatment with chemotherapy and rituximab. We also aimed to establish in this population the relationship between immunohistochemical expression of biological parameters and outcome. Patients and methods: this was a multicentric, observational, post-authorization and cross-sectional study (ClinicalTrials.gov identifier: NCT01369784). Inclusion criteria were: patients with age ≥ 18 years with DLBCL refractory/relapsed after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab. Written informed consent was obtained from participants. When the data of the biopsies at diagnosis and relapse were available, immunohistochemical results of bcl-2, bcl-6, p53 and MUM-1 were obtained. Results: 152 patients were included (146 evaluables) with a median age of 58 years. At LDBCG diagnosis 48% had 〉 1 extranodal localization (29% had bone marrow disease), and 30% had ECOG 2 or greater. Eighty-one percent presented stages III or IV and 72% had elevated LDH. Three percent had very good prognosis R-IPI, 69% good prognosis R-IPI and 27% poor prognosis R-IPI. Most patients received R-CHOP as first line therapy. Overall response rate was 79% (40% complete remission). Relapse was confirmed with biopsy and histological study in 55 patients. At relapse 31% presented 〉 1 extranodal localization, 30% ECOG 2–4, 64% stages III-IV and 72% elevated LDH. R-IPI prognostic groups distribution at relapse were as follows: 8% very good, 75% good and 27% poor. R-ESHAP and R-GEMOX were the two more used rescue therapies resulting in 60% overall response rate (31% complete remission). R-IPI at relapse was significantly associated (p 〈 0,05) with overall response rate following R-chemotherapy rescue therapy. None of the immunohistochemical parameters analized correlated with rescue therapy results. Conclusions: This is the largest reported series analizing R-IPI in DLBCL at relapse/refractory in patients receiving R-chemotherapy. In this series of patients R-IPI calculated at the relapse time was the only prognostic factor capable of predicting the overall response to the second line of treatment. Thus R-IPI prognostic score is a simple and useful predictor for outcome in DLBCL at relapse/refractory Disclosures: No relevant conflicts of interest to declare.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 9
    Publication Date: 2012-11-16
    Description: Abstract 3768 Introduction: Tyrosine kinase inhibitors (TKIs) have dramatically changed chronic myeloid leukemia prognostic. The European Leukemia Net guidelines are widely used for patients treated with TKIs. While strategies for patients with optimal response and failure after imatinib are clear, there are doubts about the best treatment option for patients with suboptimal response (SubR), specially for late SubR (patients with complete cytogenetic response (CCyR) but not mayor molecular response (MMR) after 18 months of treatment). Patients with MMR seem to have better outcomes than patients with CCyR but not MMR, but at this time, there are few data showing the benefits of treatment change in this group of patients. Aims: To identify the benefits of treatment change in patients with late SubR, outside clinical trials, in the setting of a multicenter hospital-based registry. Patients and methods: We have studied retrospectively a group of 488 CML chronic phase patients treated with imatinib as first TKI, identifying 96 patients (19%) with SubR criteria (following the ELN recommendations) after 18 months of treatment. These patients have been classified according to the strategy followed by their physician after SubR identification. Group 1 includes 65 patients (67%) continuing with imatinib (either initial dose or higher dose) and group 2 includes 31patients (33%) that were changed to second generation TKI (2GTKI: dasatinib or nilotinib). Sokal risk index was high in 17% and 9%; intermediate 44 % and 41%; and low in 39% and 50 % for group 1 and 2, respectively. 31% and 30% of patients had received interferon prior to imatinib. Molecular response was analyzed after 12 months of identifying late SubR (for group 1) or after switching to 2GTKI, for group 2. Results: The use of 2G TKIs resulted in significant benefit to patients in terms of improving molecular responses. Complete molecular responses (CMR) and MMR rates were 3.8% vs 27% and 41.5% vs 69% for group 1 and 2 respectively (p=0.006). Time for the achievements the best molecular responses was significantly lower for patients receiving second generation TKI (4.1 vs 20.2 months, p=0.004). Probabilities of treatment failure, defined as loss of CCR, were also higher in patients remaining with imatinib (15.4% vs 5.7% (p=0.12). Progression free survival was 93.8% vs 97.2% (p=0.18) for group 1 and 2 respectively. Changing treatment for late SubR patients was also safe, and only 17% of patients needed to switch to another TKI due to intolerance. Conclusions: In CML patients treated with Imatinib with late SubR, and outside clinical trials, switching to second generation TKI increased probabilities of achievement a deeper molecular response, with a good safety profile. Disclosures: Casado: Novartis: Consultancy, Speakers Bureau; BMS: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau. Steegmann:Novartis: Consultancy, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Research Funding, Speakers Bureau; Pfizer: Consultancy, Research Funding, Speakers Bureau.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
  • 10
    Publication Date: 2016-12-02
    Description: Introduction: TKIs introduction in the treatment of chronic myeloid leukemia (CML) has offered an outstanding improvement in prognosis, especially in survival. Data about TKIs were obtained from clinical trials but little is known about their translation to real life. In addition, clinical trials are mainly based on efficacy analysis to just one line of therapy, rather than treatment sequences (due to failure or intolerance). Objectives: To analyze the long-term survival of patients outside clinical trials in response to TKI treatment, describing the pattern of sequential treatments the patients actually received. Patients and methods: CML patients in first chronic phase, treated with TKIs (imatinib, nilotinib, dasatinib) either as monotherapy or in sequence, outside clinical trials. The setting was a multicentric, hospital-based registry. Survival and their potentially associated variables were studied. Results: Demographics, risk and treatment distribution: 696 patients (423 men, 273 women) with a median age at diagnosis of 41y (14-94y) were included with a follow up of 85±7 months (m) from diagnosis, 78±6.6 m from first treatment, and 69±6 m from first TKIs; 106 patients (15%) were over 70y. The risk distributions were as follows: Sokal: low (L) 48%, intermediate (I) 38% and high (H) 13%; Euro score: L 51%, I 45% and H 4%; EUTOS L: 91% and H 9%; EUTOS LT: L 68%, I 25% and H 7%. Treatment groups were the following: Group 1: IFN alpha and then imatinib or 2¼ GTKIs (176 patients); Group 2: imatinib only (340 patients); Group 3: imatinib and then nilotinib, dasatinib or both due to failure or intolerance (131 patients) and Group 4: 2¼GTKIs in first line (49 patients). Survival: Estimated survival by 10 years was 80%. Ninety-one patients have died (27 due to unknown reasons, 33 due to progression or BMT, 7 due to second neoplasias and 21 due to cardiac or neurological disease). Variables associated with survival: In the univariate survival analyses (log rank test) either from diagnosis, first therapy or first TKIs, the Sokal, Eutos, Euro and EUTOS LT scores as well as age over 70y were the only statistically significant variables associated with survival.(figure 1). In the multivariate analysis (Cox model), only Sokal and Eutos LT scores, and age over 70y were independent variables. Patients older than 70 years at diagnosis had a 50% probability of survival by 8 years. It is worth mentioning that, although the probability of overall survival from diagnosis was higher in the group receiving imatinib after IFN alpha, this difference was not seen when measuring the probability of survival after the first treatment o first TKI. This is probably explained by the higher proportion of low-risk score in patients having had previous IFN. Whereas the cause of death was progression in half of the patients aged equal or less than 70 years, in patients older than 70 years, two third of the deaths were not related to progression of CML. Conclusions: 1.These results show that the probability of survival by 10 years is roughly 80%, and extend the findings of our previous work showing that this probability is not different across different sequential treatments (imatinib before IFN, alone or switched to 2»GTKis due to intolerance o failure)(1). This fact emphasizes the rescue potential of available TKI therapies. 2. We have validated for the first time the Eutos LT score in real life population. 3. Patients over 70 years have shorter survival due to reasons different than progression, opening an interesting field of research, and a non-negligible room of improvement. Figure 1 (1)Casado LF, et al Cancer Med. 2015 Mar 10. Figure 1. (1)Casado LF, et al Cancer Med. 2015 Mar 10. Disclosures Casado Montero: BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Ariad: Consultancy, Research Funding. Steegmann:Novartis: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Ariad: Consultancy, Research Funding.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
    Location Call Number Expected Availability
    BibTip Others were also interested in ...
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...