Long-Term Outcome Of 151 Patients With Relapsed APL Receiving Second-Line With Chemotherapy Or Arsenic Trioxide-Based Regimens

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3922-3922
Author(s):  
Pau Montesinos ◽  
David Martínez-Cuadrón ◽  
Concha Rivas ◽  
Salut Brunet ◽  
José David González-San Miguel ◽  
...  

Abstract Introduction Arsenic trioxide (ATO) is currently regarded as the best treatment option in relapsed acute promyelocytic leukemia (APL). The long-term outcome of salvage therapy using an ATO-based approach compared with chemotherapy based regimens is not well established. We analyze the clinical outcome of 151 APL patients relapsing after front-line therapy with ATRA and anthracycline, who received second-line therapy with chemotherapy or ATO-based regimens. Methods From June 1997 to May 2013, 151 patients (94 M/57 F; median age: 42 years, 2-81) relapsed after front-line therapy with PETHEMA trials. Patients presented with either molecular relapse (n=47) or hematological relapse (n=104). Sixty-seven patients (44%) followed salvage therapy with chemotherapy-based regimens (chemotherapy group) consisting of induction with mitoxantrone plus cytarabine plus ATRA (n=45), EMA (n=7), or other regimens (n=15). Patients not eligible for stem-cell transplantation (SCT) received consolidation with or without maintenance therapy. From October 2003, 84 patients (56%) received salvage therapy with ATO-based regimens (ATO group), comprising induction with ATO (0.15 mg/kg intravenously until CR, with ATRA [n=19] or chemotherapy [n=6]) followed by one consolidation cycle with ATO plus ATRA. If the post-consolidation bone marrow PCR was negative an autologous (auto)-SCT was recommended, when the PCR was still positive an allogeneic (allo)-SCT was planned. Patients not eligible for SCT received maintenance therapy with ATO plus ATRA with or without low-dose chemotherapy. Results Baseline characteristics, including sex, relapse-risk at primary diagnosis, morphologic and BCR subtype, as well as age at relapse and type of relapse, were similar in both cohorts of patients. Although not significant, patients rescued in the chemotherapy group presented earlier relapses (<18 months after initial APL diagnosis) (55% vs. 43%, P=0.13). CR rates were 85% in the chemotherapy group (8 deaths and 2 resistances) and 92% in the ATO group (4 deaths and 3 resistances) (P=0.11). In patients achieving second CR, a molecular CR was achieved after consolidation in 78% and 84%, respectively (P=0.38). Twenty-two patients in the chemotherapy group (39%) and 16 in the ATO group (21%) were not transplanted in second CR (P=0.04). The reasons for not SCT in the chemotherapy and in the ATO group were ineligibility for SCT (6 vs. 8 patients), early relapse before planned SCT (10 vs. 7 patients), and mobilization failure (6 vs. 1 patients). Overall, 34 patients underwent SCT in the chemotherapy group (auto-SCT, 20; allo-SCT, 14), and 57 underwent SCT in the ATO group (auto-SCT, 47; allo-SCT, 10). The median follow-up in the chemotherapy group was 95 months (range, 24-167), and 33 months (range, 3-100) in the ATO group. The 5-year overall survival (OS), disease-free (DFS), and relapse-free survival (RFS) in the chemotherapy group and in the ATO group were 40% vs. 56% (P=0.01), 31% vs. 39% (P=0.07), and 34% vs. 48% (P=0.09), respectively. For patients not receiving SCT because of mobilization failure or ineligibility, the 5-year OS, DFS, and RFS in the chemotherapy group and in the ATO group were 56% vs. 19% (P=0.11), 42% vs. 19% (P=0.49), and 42% vs. 29% (P=0.63), respectively. For patients receiving auto-SCT, the 5-year OS, DFS, and RFS in the chemotherapy group and in the ATO group were 55% vs. 80% (P=0.04), 40% vs. 54% (P=0.06), and 44% vs. 57% (P=0.13), respectively. For patients receiving allo-SCT, the 5-year OS, DFS, and RFS in the chemotherapy group (P=0.48), and 31% vs. 57% (P=0.34), respectively. All but one patient underwent auto-SCT with negative PCR (this patient relapsed rapidly after auto-SCT). Regarding allo-SCT, 7 patients were PCR+ and 17 were PCR negative before SCT (5-year DFS 0% vs. 41%, respectively, P=0.01). Conclusions This study performed in a large series with prolonged follow-up of APL patients relapsing after upfront therapy with ATRA and anthracycline shows high rates of CR either with ATO (92%) or chemotherapy regimens (85%). Salvage therapy with ATO-based regimen allowed performing more frequently auto-SCT with negative PCR, and this strategy resulted in an overall improvement of the 5-year OS, DFS, and RFS. Disclosures: No relevant conflicts of interest to declare.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1062-1062
Author(s):  
Pau Montesinos ◽  
Jordi Esteve ◽  
Edo Vellenga ◽  
Concha Rivas ◽  
Salut Brunet ◽  
...  

Abstract Abstract 1062 Poster Board I-84 Background: Arsenic trioxide (ATO) is currently regarded as the best treatment option in relapsed acute promyelocytic leukemia (APL). The efficacy and safety of salvage therapy using an ATO-based approach compared with chemotherapy-based regimens is not well established. We analyze the clinical outcome of 110 APL patients relapsing after front-line therapy with ATRA and anthracycline, who received second-line therapy with chemotherapy- or ATO-based regimens. Methods: From June 1997 to May 2009, 110 patients (69 M/41 F; median age: 40 years, 2-81) relapsed after front-line therapy with PETHEMA trials (LPA96, n=30, LPA99, n=60; and LPA2005, n=20). Patients presented with either molecular relapse (n=37) or hematological relapse (n=73, 14 of them involving central nervous system). Sixty-seven patients (61%) followed salvage therapy with chemotherapy-based regimens. Therapy consisted of induction with mitoxantrone plus cytarabine plus ATRA (n=46), EMA (n=7), or other chemotherapy regimens (n=14). Thirty-four patients (51%) received one consolidation cycle followed by stem-cell transplantation (SCT) (autologous, 20; allogeneic, 14). Patients not eligible for SCT received consolidation therapy with or without maintenance therapy. From October 2003, 43 patients (49%) received salvage therapy with ATO-based regimens, comprising induction with ATO (0.15 mg/kg intravenously until CR) followed by one consolidation cycle with ATO plus ATRA. Twenty-three patients (53%) received intensification therapy with SCT (autologous, 19; allogeneic, 4). Patients not eligible for SCT received maintenance therapy with ATO plus ATRA with or without Mylotarg or other chemotherapy. Results: Baseline characteristics, including age at relapse, were similar in both cohorts of patients, but patients treated with ATO-based regimens were more frequently late relapses (>18 months after initial APL diagnosis) (67% vs. 40%, P=0.005). The median follow-up in the chemotherapy-based group was 62 months (range, 6-134), and 18 months (range, 2-53) in the ATO-based group. CR rates were 84% in the chemotherapy-based group (8 deaths and 3 resistances) and 88% in the ATO-based group (3 deaths and 2 resistances) (P=0.48). Molecular remission was achieved after consolidation in 79% and 91%, respectively (P=0.13). Twenty-two patients of the chemotherapy-based group that achieved CR were not transplanted because of ineligibility for SCT (n=4), early relapse before planned SCT (n=7), mobilization failure (n=4), clinical decision/toxicity (n=6), and short follow-up (n=1). Reasons for not SCT in the ATO-based group were ineligibility for SCT (n=6), early relapse before planned SCT (n=5), and short follow-up (n=4). The 2-year overall survival (OS), disease-free (DFS), and relapse-free survival (RFS) in the chemotherapy-based group and in the ATO-based group were 44% vs. 63% (P=0.05), 34% vs. 33% (P=0.51), and 37% vs. 34% (P=0.61), respectively. For patients not receiving SCT, the 2-year OS, DFS, and RFS in the chemotherapy-based group and in the ATO-based group were 38% vs. 26% (P=0.98), 34% vs. 23% (P=0.57), and 37% vs. 23% (P=0.46), respectively. For patients receiving autologous SCT, the 2-year OS, DFS, and RFS in the chemotherapy-based group and in the ATO-based group were 60% vs. 87% (P=0.03), 40% vs. 38% (P=0.38), and 42% vs. 41% (P=0.37), respectively. For patients receiving allogeneic SCT, the 2-year OS, DFS, and RFS in the chemotherapy-based group and in the ATO-based group were 56% vs. 100% (P=0.15), 26% vs. 37% (P=0.46), and 28% vs. 37% (P=0.53), respectively. Conclusions: this study performed in a large series of APL patients relapsing after upfront therapy with ATRA and anthracycline shows high rates of CR either with ATO (88%) or chemotherapy regimens (84%). The 2-year DFS and RFS were similar in patients who received second-line therapy with chemotherapy- or ATO-based regimens. However, an apparent benefit in terms of OS was observed in the ATO-based group (P=0.05), suggesting a potential role in minimizing toxicity after administering ATO as salvage therapy. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1866-1866
Author(s):  
Min Kyoung Kim ◽  
Chang-Ki Min ◽  
Myung Soo Hyun ◽  
Kihyun Kim ◽  
Sung-Soo Yoon ◽  
...  

Abstract Abstract 1866 Background: In multiple myeloma (MM), the association between the response to induction before autologous stem cell transplantation (ASCT) and long-term outcome is less clear but the situation may change with the introduction of novel agents. We therefore assessed the clinical relevance of response of bortezomib induction treatment or post-ASCT response for patients who received bortezomib-combined induction chemotherapy followed by ASCT. Methods: We retrospectively assessed 183 MM patients who received bortezomib-containing induction therapy (BTZ-IT) followed by ASCT in 24 institutions throughout Korea between 2003 and 2010. Records of these patients were reviewed using the Korean Myeloma Registry database (www.myeloma.or.kr). Each institution was requested to reconfirm the data using additional case report forms. Patients who had overt MM based on International Myeloma Working Group diagnostic criteria were selected. Results: One-hundred seventy eight patients were eligible. Their median age was 56 years (range, 28–69 years) and 96 (53.9%) were male. Forty nine (27.5%) received bortezomib as front-line therapy and 129 (72.5%) as second-line treatment. All patients underwent ASCT and 22 (12.4%) were treated with tandem ASCT. Ninety-seven (54.5%) patients were treated with maintenance therapy after ASCT. After BTZ-IT, the response rates in this selected series of patients were 37.6% CR, 12.4% VGPR, 41.0% PR, 7.3% SD and 1.7% PD (Figure 1A, 1B, 1C); the corresponding post-ASCT rates were 69.2% CR, 14.0% VGPR, 11.0% PR, 2.9% SD and 2.9% PD. At a median follow-up of 46.6 months, the 3-year overall survival (OS) and event-free survival (EFS) rates were 70.0% and 31.9%, respectively. Multivariate analysis showed that factors independently predictive of OS and EFS included achievement of BTZ-IT response °Ã PR (P=0.025 and P=0.014, respectively) and the treatment with maintenance therapy (P=0.048 and P=0.001, respectively). Post-ASCT CR vs. °Â VGPR was also an independent prognostic factor for OS and EFS (P=0.0001 and P=0.002, respectively). Conclusion: At least PR to BTZ-IT and CR after ASCT were predictive of survival. These findings suggest that patients who responded to BTZ-IT may benefit from ASCT due to an enhanced quality of response. Maintenance therapy can also affect patient outcomes. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2831-2831
Author(s):  
Deborah A. Thomas ◽  
Stefan Faderl ◽  
Susan O'Brien ◽  
William G. Wierda ◽  
Guillermo Garcia-Manero ◽  
...  

Abstract Abstract 2831 The long-term outcome for newly diagnosed LL has improved with use of intensive chemotherapy regimens designed for acute lymphoblastic leukemia (ALL) when compared to the historical experience with modified NHL regimens. An early report established the hyper-CVAD regimen (fractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone alternating with high dose methotrexate (MTX) and cytarabine) as an effective first line therapy for LL [Thomas D, Blood 104:1624, 2004]. From April 1992 to March 2009, 49 patients (pts) with de novo LL were treated with hyper-CVAD (n=20) or modified hyper-CVAD regimens (n=11 anthracycline intensification with liposomal daunorubicin-ara-C for course 2 [regimen detailed in Thomas D, Cancer, e-pub], n=18 without anthracycline intensification). CNS prophylaxis alternated intrathecal MTX and ara-C on days 2 and 7 of the first 4 courses in the absence of CNS disease. Bulky (> 7 cm) mediastinal disease at presentation was an indication for consolidative XRT (after consolidation prior to maintenance therapy). POMP (6-mercaptopurine, vincristine, MTX, prednisone) maintenance therapy was administered for 24 months with standard hyper-CVAD (MTX-L-asparaginase intensifications mos 7 & 11); and extended to 30 mos with the modified hyper-CVAD regimens (hyper-CVAD followed by MTX-L-asparaginase mos 6 & 7 and 18 & 19). Allogeneic stem cell transplant (SCT) was performed in first complete remission (CR) only if inadequate response to therapy. Median age was 31 yrs (range, 17–59); 77% were males. Mediastinal disease was noted in 74%; 30% were associated with pericardial and/or pleural effusions. Two pts had superior vena cava syndrome and five had CNS disease. T-lineage disease was present in majority (79%). Eight (17%) pts had bone marrow involvement. Overall CR rate was 96% in 46 evaluable patients (3 in CR at start), with remainder achieving partial response (PET scan negative residual mediastinal disease not qualifying for CR). Of the 23 pts with bulky mediastinal disease at presentation, 74% underwent XRT as planned. With a median follow-up of 80 months (range 30–187+ months), 31 (66%) pts remained alive without disease. Overall 5-yr rates for CR duration and survival were 72% and 68%, respectively. Fourteen pts relapsed or progressed within a median of 13 months (6 with standard, 8 with modified hyper-CVAD); five pts were successfully salvaged with chemotherapy and allogeneic SCT. The hyper-CVAD is a highly active regimen for de novo LL with long-term follow-up confirming the earlier report. Early anthracycline intensification was clearly not beneficial. The treatment paradigm for LL has recently changed owing to availability of new agents and data supporting superior efficacy of pediatric regimens compared with conventional adult regimens. For older adults with de novo LL, the deoxyguanosine analog nelarabine has now been incorporated into the hyper-CVAD regimen as a single agent during consolidation (cycles 9 & 10) and maintenance (in lieu of the early intensifications) [Vigil CE, ASCO 2010, abstract 6524], whereas adolescents and younger adults are treated according to the pediatric-inspired augmented Berlin-Frankfurt-Muenster regimen. An augmented hyper-CVAD regimen (dose intensifying VCR/dexamethasone components and incorporating pegylated asparaginase) has been successfully piloted in the salvage setting. The optimal first line chemotherapy of LL continues to be refined; the role of autologous or allogeneic SCT for LL in first CR remains unclear since majority of patients can be cured without use of these modalities. Disclosures: Off Label Use: Nelarabine for de novo T-lymphoblastic leukemia/lymphoma Nelarabine for de novo T-lymphoblastic leukemia/lymphoma.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2262-2262
Author(s):  
Motohiro Kato ◽  
Atsushi Manabe ◽  
Sae Ishimaru ◽  
Daisuke Tomizawa ◽  
Daisuke Hasegawa ◽  
...  

Abstract Maintenance therapy is a key component of ALL treatment. Although maintenance with 6-mercaptopurine (6-MP) and methotrexate (MTX) is generally less hemato-toxic, it occasionally causes severe complications such as infections, and too long maintenance is possibly associated with lower adherence. Thus, the duration of maintenance should be as short as possible, but excess shortening of maintenance therapy leads to high relapse incidence, as shown in our previous clinical trial, the Tokyo Children's Cancer Study Group (TCCSG) L92-13 (1992 - 1995, n = 347). In this study, the shortened maintenance therapy to 6 months resulted in EFS of 59.5% at 5.5 years although OS was as good as 81.5%. Especially, higher relapse rate in standard-risk (SR) resulted in EFS of as low as 60.2% (Toyoda Y, et al. J Clin Oncol 2000). However, it should be noted that about 60% of ALL achieved continuous complete remission (CCR) with short maintenance therapy. Thus, to confirm long-term outcome of ALL with this short maintenance therapy, we conducted an extended follow up study of patients enrolled on the TCCSG L92-13. In the L92-13 trial, previously untreated children (15 years or younger) with ALL were enrolled, and were assigned to three risk groups, standard-risk (SR), high-risk (HR) and extremely high-risk (HEX), according to age at diagnosis, immunephenotype, sentinel cytogenetics and initial leukocyte count. All patients received four-drug induction, followed by consolidation therapy including re-induction. Maintenance therapy with daily 6-MP and weekly MTX was shortened to 6 months, and all treatment was discontinued at 12 months after diagnosis. The data was analyzed as of 2014 July. A median of follow up period of this extended study was 14.8 years, and the survival curve is shown in Figure 1A. Relapse was reported in 128 patients, with a median time of relapse was 1.8 years from diagnosis. EFS at 12 years for all patients was 58.7 +- 2.7% (59.2% for SR [n = 127], 57.8% for intermediate-risk [IR, n = 122], and 59.2% for high-risk [HR, n = 101]) and OS was 78.7 +- 2.2% (85.4% for SR, 80.0% for IR, and 69.0% for HR). Incidences of relapse and non-relapse mortality were 37.2 +- 2.6% and 3.2 +- 0.9%, respectively. Five patients (0 in SR group, 3 in HR group, and 2 in HEX group) developed secondary malignant neoplasms before relapse, which resulted in cumulative incidence of secondary malignancy of 0.9 +- 0.5% at 12 years. Patient gender was associated with the outcome, and female had better EFS (65.3 +- 3.7%) compared to male (52.2 +- 3.8%) (p = 0.04, Figure 1B). High-hyperdiploid (HHD) patients had relatively worse prognosis, with EFS of 50.0 +- 11.8%, although it is generally considered as good prognostic factor, and most of the relapsed HHD patients were salvaged and OS was 94.4 +- 5.4%. It is confirmed that 6 months maintenance therapy is insufficient for male, HHD, and standard risk patients. In contrast, most of patients who had been in first CR at previous analysis maintained CCR status. Our results demonstrate that short maintenance therapy can cure a substantial portion of ALL with extremely low non-relapse mortality, and that it may be possible to shorten the duration of maintenance therapy for female and non-HHD patients. This study provides precise information of leukemia biology and highlights the role of maintenance therapy. Ongoing molecular characterization of the cured patients will clarify the subset of patients who can be cured with short maintenance therapy. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Daniela Pugliese ◽  
Annalisa Aratari ◽  
Stefano Festa ◽  
Pietro Manuel Ferraro ◽  
Rita Monterubbianesi ◽  
...  

Background and Aims. Thiopurines are commonly used for treating ulcerative colitis (UC), despite the fact that controlled evidence supporting their efficacy is limited. The aim of this study was to evaluate the long-term outcome of thiopurines as maintenance therapy in a large cohort of UC patients. Methods. All UC patients receiving thiopurine monotherapy at three tertiary IBD centers from 1995 to 2015 were identified. The primary endpoint was steroid-free clinical remission. Secondary endpoints were mucosal healing (MH), defined as Mayo endoscopic subscore 0, long-term safety, and predictors of sustained clinical remission. Results. We identified 192 patients, contributing a total of 747 person-years of follow-up (median follow-up 36 months, range 1–210 months). Steroid dependency was the most common indication for thiopurine treatment (58%). Steroid-free remission occurred in 45.3% of patients; 36.3% stopped thiopurines because of treatment failure and 18.2% for adverse events or intolerance. The cumulative probability of maintaining steroid-free remission while on thiopurine treatment was 87%, 76%, 67.6%, and 53.4% at 12, 24, 36, and 60 months, respectively. MH occurred in 57.9% of patients after a median of 18 months (range 5–96). No independent predictors of sustained clinical remission could be identified. Conclusions. Thiopurines represent an effective and safe long-term maintenance therapy for UC patients.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4210-4210 ◽  
Author(s):  
Michele Cavo ◽  
Monica Galli ◽  
Lucia Pantani ◽  
Francesco Di Raimondo ◽  
Claudia Crippa ◽  
...  

Abstract Abstract 4210 In a previous analysis performed with a median follow-up of 36 months (mos), superior CR/nCR rates and extended PFS were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) vs thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autotransplantation (ASCT) for newly diagnosed myeloma (MM). Here we report an updated analysis of that study, including a detailed analysis of outcomes after relapse or progression (R/P), an important issue for patients (pts) who received up-front a triplet novel agent-based therapy incorporated into ASCT. After a median follow-up of 52 mos, continued TTP and PFS benefits with VTD vs TD were demonstrated, while no difference in OS was seen between the two arms. Median PFS for pts randomized to the VTD arm was 56 mos vs 42 mos for those assigned to TD (HR=0.64, p=0.001). Similarly to PFS, median TTP for pts in the VTD group was longer than in the TD group (57 vs 45 mos, HR=0.63, p=0.0006), reflecting a 37% reduction in the risk of R/P with VTD. The probabilities of R/P in the VTD and TD arms were 41% vs 55% (p=0.002). In comparison with the VTD-treated group, a higher percentage of pts in the TD arm required the immediate start of salvage therapy after symptomatic R/P was documented (67% vs 82.5%). By the opposite, the fraction of pts with asymptomatic R/P that did not require any antimyeloma therapy until the cut-off date for the analysis was higher in the VTD arm compared with the TD-treated group (33% vs 17.5%, p=0.016). In these pts, the median interval from the date of R/P to the cut-off date for the analysis was 7 mos for the TD-treated group vs 17 mos for the VTD-treated group. Median time to subsequent antimyelomatherapy (defined as the interval between start of induction therapy and administration of the first dose of second-line therapy) was significantly longer for pts who experienced R/P in the VTD arm in comparison with pts who progressed in the TD arm (35 vs 29 mos, p=0.018). The associated interval between last administration of front-line therapy (e.g. consolidation for pts who received the entire treatment program or every other treatment before consolidation for those who discontinued earlier) and first administration of second-line therapy (salvage therapy-free interval) was 22.5 mos for the VTD-treated group vs 15 mos for the TD-treated group (p=0.009). Both bortezomib and lenalidomide were the most frequently used agents at the time of R/P (82% of all cases), while only 18% of pts were treated with conventional cytotoxic drugs. As expected, the majority of pts in the TD arm received a second-line therapy that included bortezomib (70%), while lenalidomide-dexamethasone was received by 10% of pts. By the opposite, in the VTD arm both bortezomib- and lenalidomide-based salvage therapies were equally distributed (41% vs 39%). The probability to achieve at least a partial response after second-line therapy including bortezomib was 60% for pts with prior exposure to VTD vs 63% for those randomized to TD. No difference in post-R/P OS was demonstrated between VTD-treated and TD-treated subgroups of pts who received bortezomib-based salvage therapy after R/P (2-yr estimates: 48% vs 53%, p=0.59). In the overall population, post-R/P OS was significantly shorter for pts who received salvage therapy with conventional cytotoxic drugs (2-yr estimate: 41%) in comparison with pts treated with novel agents, including bortezomib or lenalidomide (2-yr estimates: 52% and 53%, respectively) (p=0.0001). In conclusion, front-line therapy with VTD incorporated into ASCT was superior in comparison with TD plus ASCT in terms of extended TTP, PFS, time to subsequent antimyeloma therapy and salvage therapy-free interval. VTD-treated pts had a higher probability than TD-treated pts to experience long-lasting asymptomatic R/P not requiring second-line therapy. VTD-treated and TD-treated pts who subsequently received bortezomib-based salvage therapies had similar rates of response and post-R/P OS. This finding suggests that short-term exposure to VTD, as planned in our study, did not favor the selection of bortezomib-resistant clones, thus allowing to rechallenge bortezomib as (part of) second-line therapy after symptomatic R/P. Disclosures: Cavo: Janssen, Celgene, Millennium: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria. Di Raimondo:Celgene, Janssen: Honoraria, Speakers Bureau. Offidani:Janssen, Celgene: Honoraria. Caravita:Celgene, Janssen, Novartis, Genzyme: Honoraria. Boccadoro:Celgene, Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees.


VASA ◽  
2002 ◽  
Vol 31 (1) ◽  
pp. 36-42 ◽  
Author(s):  
. Bucek ◽  
Hudak ◽  
Schnürer ◽  
Ahmadi ◽  
Wolfram ◽  
...  

Background: We investigated the long-term clinical results of percutaneous transluminal angioplasty (PTA) in patients with peripheral arterial occlusive disease (PAOD) and the influence of different parameters on the primary success rate, the rate of complications and the long-term outcome. Patients and methods: We reviewed clinical and hemodynamic follow-up data of 166 consecutive patients treated with PTA in 1987 in our department. Results: PTA improved the clinical situation in 79.4% of patients with iliac lesions and in 88.3% of patients with femoro-popliteal lesions. The clinical stage and ankle brachial index (ABI) post-interventional could be improved significantly (each P < 0,001), the same results were observed at the end of follow-up (each P < 0,001). Major complications occurred in 11 patients (6.6%). The rate of primary clinical long-term success for suprainguinal lesions was 55% and 38% after 5 and 10 years (femoro-popliteal 44% and 33%), respectively, the corresponding data for secondary clinical long-term success were 63% and 56% (60% and 55%). Older age (P = 0,017) and lower ABI pre-interventional (P = 0,019) significantly deteriorated primary clinical long-term success for suprainguinal lesions, while no factor could be identified influencing the outcome of femoro-popliteal lesions significantly. Conclusion: Besides an acceptable success rate with a low rate of severe complications, our results demonstrate favourable long-term clinical results of PTA in patients with PAOD.


Crisis ◽  
1999 ◽  
Vol 20 (3) ◽  
pp. 115-120 ◽  
Author(s):  
Stephen Curran ◽  
Michael Fitzgerald ◽  
Vincent T Greene

There are few long-term follow-up studies of parasuicides incorporating face-to-face interviews. To date no study has evaluated the prevalence of psychiatric morbidity at long-term follow-up of parasuicides using diagnostic rating scales, nor has any study examined parental bonding issues in this population. We attempted a prospective follow-up of 85 parasuicide cases an average of 8½ years later. Psychiatric morbidity, social functioning, and recollections of the parenting style of their parents were assessed using the Clinical Interview Schedule, the Social Maladjustment Scale, and the Parental Bonding Instrument, respectively. Thirty-nine persons in total were interviewed, 19 of whom were well and 20 of whom had psychiatric morbidity. Five had died during the follow-up period, 3 by suicide. Migration, refusals, and untraceability were common. Parasuicide was associated with parental overprotection during childhood. Long-term outcome is poor, especially among those who engaged in repeated parasuicides.


2019 ◽  
Vol 24 (4) ◽  
pp. 415-422 ◽  
Author(s):  
Bianca K. den Ottelander ◽  
Robbin de Goederen ◽  
Marie-Lise C. van Veelen ◽  
Stephanie D. C. van de Beeten ◽  
Maarten H. Lequin ◽  
...  

OBJECTIVEThe authors evaluated the long-term outcome of their treatment protocol for Muenke syndrome, which includes a single craniofacial procedure.METHODSThis was a prospective observational cohort study of Muenke syndrome patients who underwent surgery for craniosynostosis within the first year of life. Symptoms and determinants of intracranial hypertension were evaluated by longitudinal monitoring of the presence of papilledema (fundoscopy), obstructive sleep apnea (OSA; with polysomnography), cerebellar tonsillar herniation (MRI studies), ventricular size (MRI and CT studies), and skull growth (occipital frontal head circumference [OFC]). Other evaluated factors included hearing, speech, and ophthalmological outcomes.RESULTSThe study included 38 patients; 36 patients underwent fronto-supraorbital advancement. The median age at last follow-up was 13.2 years (range 1.3–24.4 years). Three patients had papilledema, which was related to ophthalmological disorders in 2 patients. Three patients had mild OSA. Three patients had a Chiari I malformation, and tonsillar descent < 5 mm was present in 6 patients. Tonsillar position was unrelated to papilledema, ventricular size, or restricted skull growth. Ten patients had ventriculomegaly, and the OFC growth curve deflected in 3 patients. Twenty-two patients had hearing loss. Refraction anomalies were diagnosed in 14/15 patients measured at ≥ 8 years of age.CONCLUSIONSPatients with Muenke syndrome treated with a single fronto-supraorbital advancement in their first year of life rarely develop signs of intracranial hypertension, in accordance with the very low prevalence of its causative factors (OSA, hydrocephalus, and restricted skull growth). This illustrates that there is no need for a routine second craniofacial procedure. Patient follow-up should focus on visual assessment and speech and hearing outcomes.


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