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  • Online Resource  (6)
  • American Society of Hematology  (6)
  • Giraldo, Pilar  (6)
  • 1
    Online Resource
    Online Resource
    Switching to a Second Generation TKI in Chronic Myeloid Leukemia Patients with Late Suboptimal Response with Imatinib Obtained Better Molecular Responses That the “Watch and Wait” Approach. an Experience of a Multicenter Registry in Patients Outside Clinical Trials
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 3768-3768
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 3768-3768
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.3768.3768
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
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  • 2
    Online Resource
    Online Resource
    Real Life Long-Term Survival Analysis in Patients with Chronic Myeloid Leukemia Treated with Tkis in Spain
    American Society of Hematology ; 2016
    In:  Blood Vol. 128, No. 22 ( 2016-12-02), p. 3074-3074
    Details
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 3074-3074
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V128.22.3074.3074
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
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  • 3
    Online Resource
    Online Resource
    Outcomes of Chronic Myeloid Leukemia (CML) Patients Who Stopped Second Generation Tyrosine Kinase Inhibitors (2GTKIs) As Second Line Treatment. Results of the CML Spanish National Registry (RELMC)
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 3764-3764
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 3764-3764
    Abstract: Abstract 3764 Introduction: In CML-CP patients showing resistance or intolerance to imatinib, rescue therapy with second generation 2GTKIs produced nearly 50% of complete cytogenetic responses (CCyR). However, in the long term, a high percentage (roughly 70%) of patients abandoned the targeted treatment. The information about the outcome of patients treated in third line with TKI's is scarce, and come mostly form clinical trials. In these experiences CCyR were obtained in approximately 20%, and the duration of MCyR was around 18 months. Aims: To describe the evolution of patients who interrupted 2GTKI, given as 2nd line treatment, outside clinical trials. Patients and methods: In our registry, we have identified 105 patients treated with second generation TKI in second line out of 487 patients treated with imatinib as first TKI. Reasons for treatment change were failure in 53%, intolerant in 33% and suboptimal in 14%. Sokal risk indexes were 40%, 47% and 13% for low, intermediate and high risk, respectively. 33% of patients had received interferon prior to imatinib. Cummulative incidence of CCyR and major molecular responses (MMR) with a median follow up of 85.59 (8.93–130) months, were 65% and 49%. Fifty two (49%) withdrew treatment because of failure (22%), intolerance (18%), suboptimal response (7%) and exitus (8%). Results: A total of 31 patients started third-line therapy with a third TKI, representing 29% of patients who started second-line treatment and 78% of patients who discontinued the treatment. The reasons for starting the 3rd line treatment was failure in 55% and intolerance, in 44%. With a median follow up of 9 months, probabilities of achievement a complete hematological response (CHR) and CCR was 93% and 30%. These responses were influenced depending on the indication of treatment, with cummulative indidence of CCyR of 18% and 50% for resistant and intolerant patients, respectively (p = 0.031). The corresponding figures for transformation-free survival and overall survival were 61% vs 76, and 72% vs 88% for failure and intolerance settings, respectively. Conclusions: In this registry-based experience, outside clinical trials, 2GTKI have offered a substantial benefit to patients resistant or intolerant to Imatinib. However, the experience in 3rd line in patients resistant to 2GTKI in 2nd line, has been dismal, with less than 20% of CCyR. In this particular subgroup, BMT must be considered, and new experimental therapeutic schemes are necessary for those patients who are not suitable candidates for BMT. Disclosures: Casado: Novartis: Consultancy, Speakers Bureau; BMS: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau. Steegmann:Pfizer: Consultancy, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Research Funding, Speakers Bureau; Novartis: Consultancy, Research Funding, Speakers Bureau.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.3764.3764
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
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  • 4
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    Online Resource
    Survival and Response Outcomes to Different Treatment Schedules in CML Patients Starting Therapy with Imatinib. Results from the CML Spanish Registry (RELMC)
    American Society of Hematology ; 2010
    In:  Blood Vol. 116, No. 21 ( 2010-11-19), p. 1237-1237
    Details
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 1237-1237
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V116.21.1237.1237
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
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  • 5
    Online Resource
    Online Resource
    Hypophosphatemia During Imatinib Treatment of Newly Diagnosed Chronic Myeloid Leukemia Patients Is Associated with Better Response.
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 1121-1121
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 1121-1121
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.1121.1121
    RVK:
    XA 33000
    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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  • 6
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    Online Resource
    A Good Adherence to ELN 09 Recommendations in Chronic Myeloid Leukemia (CML) Treatment with Imatinib, Is Associated with Better Outcomes in Patients Treated Outside Clinical Trials
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 3762-3762
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 3762-3762
    Abstract: Abstract 3762 Introduction: In late 2009 it was published the second version of the international recommendations for CML monitoring and treatment with Imatinib and other tyrosine kinase inhibitors(TKI) (Bacarrani M et al JCO 2009). Although widely distributed and discussed, there has not been any report describing the adherence of hematologists to those guidelines, or analyzing the differential outcomes in the setting outside clinical trials. Objectives: To study the association between the compliance to ELN 09 recommendations in every timepoint, and the response to TKI treatment. Methods and patients: CML patients in first chronic phase, treated upfront with imatinib, outside clinical trials. The adherence to ELN 09 in the given timepoint was classified, as orthodox if, monitoring and treatment were done accordingly, and heterodox, if monitoring or treatment were done disaccordingly. Study variables: Best complete cytogenetic response (CCyR) and major molecular response (MMR) with Imatinib and second line TKI, and progression rates. Besides, we analyzed the association between response grades considering the value obtained in the precedent timepoint. Results: 374 patients (229 men, 145 women) were included. The Sokal risk distribution was: low (L): 138(39%), intermediate (I): 172 (48%), and high (H): 44(12%). Correspondent values for Euro score were 170(48%), 165(47%) y 19(5%). EUTOS score: L: 294(91%), H: 30(9%). Median age: 52 years (15–88). Median follow-up 59.3 months (0,6–131,9). A summary of the results is shown in Table 1. Most of the patients were evaluated on time (73–90%), and 2/3 of the patients were monitored and managed in an orthodox way in the specific timepoints. The rate of CCyR and MMR were significantly higher in patients managed in an orthodox way. In contrast, progression rates were significantly higher only in those patients whose management was heterodox at 3 months. Besides, a better response at any given timepoint was associated with better ulterior responses. Conclusions: Our results reinforce the use of ELN 09 recommendations, showing that those patients whose monitoring and treatment is done according to these recommendations have a higher probability of response. An orthodox management in the first trimester of treatment is specially important, because it is associated with a lower progression rate. Disclosures: Casado: Novartis: Consultancy, Speakers Bureau; BMS: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau. Martínez-López:Celgene: Honoraria. Steegmann:Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.3762.3762
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
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