scholarly journals DOP34 Long-term outcome of Acute Severe Ulcerative Colitis responsive to intravenous steroid: A multicenter study of the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S072-S073
Author(s):  
S Festa ◽  
M L Scribano ◽  
A Aratari ◽  
C Bezzio ◽  
M Principi ◽  
...  

Abstract Background The appropriate maintenance treatment for patients with acute severe ulcerative colitis (ASUC) responsive to intravenous steroids (IVS) is still a matter of debate. Although major Guidelines consider thiopurine maintenance an option in this setting, the long-term benefit of early immunomodulator (IMMs) initiation is not well established. The aim of our study was to explore the long-term outcome of patients with ASUC responsive to IVS who received different maintenance strategies Methods In a multicenter retrospective study, all patients with ASUC hospitalized between January 2005 and December 2017 in 14 Italian IBD referral centres were reviewed. Thiopurine and biologic-naïve patients experiencing their first acute severe attack and who responded to IVS were included in the study. Maintenance treatment was prescribed by attending physicians according to their clinical judgment. The main outcomes were recurrent flares requiring escalation of therapy, new hospitalization, and long-term colectomy rate. The Kaplan-Meier survival method was used to estimate the cumulative probability of a course without the main outcomes. Differences between curves were tested using the log-rank test. A propensity score matching analysis was performed to establish comparable groups of patients who received different maintenance treatment Results Overall 372 patients were reviewed. Of these, 141 met the inclusion criteria (males 61.7%, median age 34.5 (IQR 23–50). After response to IVS, 82 patients (58.1%) received maintenance treatment with aminosalicylates, 42 (29.8%) received IMMs and 17 (12.1%) were maintained with scheduled infliximab (IFX) + thiopurines. After a median follow-up of 48 (IQR 25–90) months, 94 patients (68.8%) experienced a flare requiring escalation of therapy, 51 (36.1%) required new hospitalization and 18 (12.8%) underwent colectomy. After 12, 36 and 60 months after the acute attack, the cumulative probability of a course without escalation of therapy was 59.6%, 33.3% and 23.1%; the cumulative probability of a hospitalization-free course was 83.9%, 67.4% and 59.5%; the cumulative probability of a colectomy-free course was 96.3%, 90.2%, and 88.9%. No differences were observed between patients receiving aminosalicylates, IMMs or IFX as maintenance treatment (log-rank test: p= 0.39; p = 0.41; p = 0.11 respectively). After a propensity score matching analysis, no significant difference in main outcomes was observed between patients maintained with aminosalicylates or IMMs/IFX Conclusion IMM-naïve ASUC patients responsive IVS remain at risk of relapse requiring escalation of therapy. Early IMMs introduction after the acute attack did not reduce the risk of escalation of therapy, hospitalization or colectomy

2021 ◽  
Vol 3 (Supplement_6) ◽  
pp. vi12-vi12
Author(s):  
Seiichiro Hirono ◽  
Ko Ozaki ◽  
Masayoshi Kobayashi ◽  
Ayaka Hara ◽  
Tomohiro Yamaki ◽  
...  

Abstract Purpose Mid- to long-term outcome in glioblastoma (GBM) patients following supratotal resection (SupTR), involving complete resection both of contrast-enhancing enhanced (CE) tumors and areas of methionine (Met) uptake on 11C-Met positron emission tomography (Met-PET), are not clarified. Methods A retrospective, single-center review was performed in newly diagnosed, IDH1 wild-type GBM patients, comparing SupTR with gross total resection (GTR), in which only CE tumor tissue was completely resected. Only patients who were operated on until November 2019 were included for evaluation of mid- to long-term outcome. Following resection, all patients underwent standard radiotherapy and temozolomide treatment, and were followed for progression-free survival (PFS) and overall survival (OS). Results Among the 30 patients included in this study, 7 underwent SupTR and 23 underwent GTR. Awake craniotomy with cortical and subcortical mapping was more frequently performed in the SupTR group than in the GTR group. During the follow-up period, significantly different patterns of disease progression were observed between groups. Although more than 80% of recurrences were local in the GTR group, all recurrences in the SupTR group were distant. Median PFS in the GTR and SupTR groups was 8.8 months (95% confidence interval [CI], 5.2–14.9) and 27.8 months (95% CI, 6.0-not estimable) respectively (p=0.08 by log-rank test). Median OS was 17.7 months (95% CI, 14.2–35.1) in GTR and not reached (95% CI, 30.5-not estimable) in SupTR, respectively; this difference was statistically significant (p=0.03 by log-rank test). No postoperative neurocognitive impairment was observed in SupTR patients. Conclusion Compared to GTR alone, SupTR strategy with aggressive resection of both CE tumors and Met uptake area in GBM patients under awake craniotomy with functional preservation results in a survival benefit associated with better local control.


2021 ◽  
pp. bjophthalmol-2020-318547
Author(s):  
Seitaro Komai ◽  
Tsutomu Inatomi ◽  
Takahiro Nakamura ◽  
Mayumi Ueta ◽  
Go Horiguchi ◽  
...  

Background/aimsTo investigate the long-term outcomes of cultivated oral mucosal epithelial transplantation (COMET) for fornix reconstruction in eyes with chronic cicatrising disease.MethodsThis retrospective cohort study involved 16 eyes of 15 patients who underwent COMET for symblepharon release and fornix reconstruction between June 2002 and December 2008. The mean postoperative follow-up period was 102.1±46.0 months (range: 32–183 months). The treated cicatrising disorders included ocular cicatricial pemphigoid (OCP, five eyes), thermal/chemical injury (three eyes) and other chronic diseases (seven eyes; including recurrent pterygium (two eyes), Stevens-Johnson syndrome (one eye) and graft-versus-host disease (one eye)). Ocular-surface appearance was evaluated before surgery, at 1, 4, 12 and 24 weeks postoperative, and then annually based on the previously reported scoring system. Main outcome measures included overall and disease-specific fornix-reconstruction success probabilities analysed by the Kaplan-Meier survival curve. Symblepharon/fornix-shortening recurrence at 24 weeks postoperative, and its relationship to long-term surgical success was also examined.ResultsAt 5 years postoperative, the mean±SD overall fornix-reconstruction success probability was 79.6%±10.7%, and success probability for thermal/chemical injury and OCP was 100% and 53.3%±24.8%, respectively (p=0.53, log-rank test). The 3-year success probability was significantly higher in the no-disease-recurrence group at 24 weeks postoperative (13 eyes) than in the disease-recurrence group (three eyes) (100% and 33.3%±27.2%, respectively) (p=0.0073, log-rank test).ConclusionCOMET was found to be safe and effective for symblepharon release and long-term fornix reconstruction in eyes with chronic cicatrisation. Although the 5-year success probability differed depend on the underlying disease, ocular-surface appearance at 24 weeks postoperative is a factor for predicting long-term outcome.


2008 ◽  
Vol 123 (3) ◽  
pp. 298-302 ◽  
Author(s):  
R J Sim ◽  
A H Jardine ◽  
E J Beckenham

AbstractA number of authors have suggested that surgery for suspected perilymph fistula is effective in preventing deterioration of hearing and in improving hearing in some cases in the short term. We present long-term hearing outcome data from 35 children who underwent exploration for presumed perilymph fistula at The Children's Hospital, Sydney, Australia, between 1985 and 1992.Methods:The pre-operative audiological data (mean of 500, 1000, 2000 and 4000 Hz results) were compared with the most recently available data (range two to 15 years) and the six-month post-operative data.Results:The short-term results showed no significant change in hearing at six months, with a subsequent, statistically significant progression of hearing loss in both operated and non-operated ears (Wilcoxon signed rank test: operated ear, p < 0.017; non-operated ear, p < 0.009).Conclusion:In this case series, exploratory surgery for correction of suspected perilymph fistula did not prevent progression of long-term hearing loss.


2019 ◽  
Vol 43 (9) ◽  
pp. 2281-2289 ◽  
Author(s):  
Ricardo Robles-Campos ◽  
Roberto Brusadin ◽  
Asunción López-Conesa ◽  
Víctor López-López ◽  
Álvaro Navarro-Barrios ◽  
...  

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17004-17004
Author(s):  
D. Schallier ◽  
H. Everaert ◽  
B. Neyns ◽  
N. Baelde ◽  
M. Meysman ◽  
...  

17004 Background: PET and computerized axial tomography scan (CT) are complimentary tools in the diagnosis and treatment of pts with LA NSCLC. Recent data have shown that response to IC as determined with PET has a better prognostic relevance for long term outcome than CT (Hoekstra et al JCO 2005;23:33:8362–70). Methods: PET and chest CT were performed before and after 3 cycles of IC in pts with LA NSCLC (D. Schallier et al, Suppl JCO 2005;23:165:7285, 6915). Response was defined according to WHO and EORTC criteria for CT and PET respectively (complete response: CR; partial response: PR; stable disease: SD; progressive disease: PD). PET images corrected for attenuation were acquired in 3D on a Siemens Accel camera starting 60 minutes after administration of 307–606 MBq 18FDG. The maximal standardized uptake value (SUVmax) within the tumor was measured and a SUVmax value ≥2.5 was used as a cut off. PET responses were classified either as complete (resolution of the enhanced uptake within the tumor) or non-complete. For each subgroup, classified according to CT and PET response, time to progression (TTP) and survival (S) was calculated and analysed statistically according to Kaplan-Meier and log rank test. Results: 21 pts were eligible for the PET and CT confrontation. Characteristics: 14 male, 7 female; median age 70 y (39–78); median KS: 90 (80–100); stage III A: 9; stage III B: 12; T1,2,3,4: 4/3/7/7; N0,1,2,3: 4/1/11/5. Response: CT: 12 PR; 9 SD; PET: 6 CR, 9 PR, 5SD, 1PD. Nine/12 PR on CT were also CR (5) and PR (4) on PET. Median TTP was correlated significantly with PR and CR (versus SD and non-CR) on CT and PET respectively (288 versus 606 days, p = 0.045 for CT and 299 versus median not reached p = 0.024 for PET); with a median follow up of 19+ month, median S was not significantly correlated with PR on CT but was highly significantly correlated with CR on PET (439 days versus median not reached p = 0.005). Conclusions: Assessment of response to IC using CT or PET largely overlaps. PET appears to be a more ‘sensitive‘ tool to measure response. CR on PET provides a better accuracy for determination of long term outcome than CT. The present results corroborate previously published results. No significant financial relationships to disclose.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 836-836 ◽  
Author(s):  
Marinus H.J. Van Oers ◽  
Martine Van Glabbeke ◽  
Liliana Baila ◽  
Livia Giurgia ◽  
Richard Klasa ◽  
...  

Abstract Background. In 2005 we analyzed the results of a prospective randomized phase III intergroup trial evaluating the role of rituximab (R) both in remission induction and maintenance treatment of 465 relapsed/resistant follicular lymphoma (FL) patients. Major conclusions were that addition of R to CHOP induction yielded an increased ORR and CR rate, and that R maintenance strongly improved median progression free survival (PFS), both after induction with CHOP and R-CHOP, and overall survival (OS (van Oers et al Blood2006;108:3295). At that time the median follow for the maintenance phase was 33 months. Now we report the long-term outcome of maintenance treatment, with a median follow up of 6 years from start of maintenance. Study design. Patients with stages III or IV FL at initial diagnosis and relapsed after or resistant to a maximum of two non-anthracycline containing systemic chemotherapy regimens, were randomized to remission induction with either 6 cycles of standard CHOP (once every 3 weeks) or CHOP + R (375 mg/m2 at day 1 of each cycle of CHOP). Those with a complete or partial remission after 6 cycles of therapy underwent a second randomization to no further treatment (observation) or maintenance treatment with R (375 mg/m2 once every 3 months) until relapse or for a maximum period of two years. Results. 465 patients were randomized to induction with either CHOP (231) or R-CHOP (234). As reported, CHOP and R-CHOP induction yielded similar partial response rates (57% vs.56%), but significantly different CR rates (16% and 29%; p=0.0001). 334 patients were randomized to either R maintenance treatment (167) or observation (167). R maintenance resulted in a highly significant improvement of PFS: median 3.7 years versus 1.3 years in the observation arm (p<0.0001; hazard ratio 0.55). The advantage of R maintenance was observed both after CHOP induction (p< 0001: HR 0.37) and R-CHOP induction (p= 0.003; HR 0.69). The 5 years OS was 74% in the R maintenance arm and 64 % in the observation arm (p=0.07). That the highly improved PFS after R maintenance did not translate into a significant OS advantage might partially be explained by the fact that 41% of progressing patients received R as salvage therapy. This varied according to treatment arm: from 59% after CHOP followed by observation to 26% after R-CHOP followed by R maintenance. R maintenance was associated with a significant increase in grade 3/4 infections: 9.7% vs.2.4% (p= 0.01). 7 of the 167 patients had to discontinue R maintenance because of toxicity, mostly recurrent infection. Conclusion. With long term follow-up we confirm the superior PFS with R maintenance. The improvement of OS did not reach statistical significance, possibly due to the abundant use of R in post-protocol salvage treatment.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 508-508 ◽  
Author(s):  
Christian J. Taverna ◽  
Giovanni Martinelli ◽  
Felicitas Hitz ◽  
Walter Mingrone ◽  
Thomas Pabst ◽  
...  

Abstract Background Rituximab maintenance has been shown to be effective in patients with follicular lymphoma. The optimal duration of maintenance treatment remains unknown. Methods 270 patients (median age 57 years: range 25-82) with either untreated, relapsed, stable or chemotherapy resistant follicular lymphoma of all grades were treated with 4 weekly doses of rituximab monotherapy (375 mg/m²). Patients responding to the induction treatment (partial or complete response) received rituximab (375 mg/ m²) maintenance and were randomized either to a short maintenance consisting of four administrations every two months (arm A), or a prolonged maintenance for a maximum of five years or until disease progression or unacceptable toxicity (arm B). The primary endpoint was event-free survival (EFS) from randomization. Sample size calculation allowed detecting a median EFS increase with prolonged maintenance from 2.5 to 4.5 years with 80% power. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and objective response. Comparisons between the two treatment arms were performed using the log-rank test for survival endpoints. Results From October 2004 to November 2007 165 patients were randomized, 82 in arm A and 83 in arm B. 124 patients were chemotherapy-naïve. The median EFS is 3.4 years (95% CI 2.1-5.3) in arm A and 5.3 years (95% CI 3.5-NA) in arm B. Using the prespecified log-rank test this difference is statistically not significant (p=0.14). We observed an unexplained difference in disease progression and relapse during the first 8 months after randomization (3 in arm A vs. 10 in arm B) when treatment in both arms was the same which led to an early crossing of the EFS curves at 18 months. Considering only patients at risk after 8 months from randomization EFS in arm B is significantly prolonged compared to arm A (median EFS 7.1 (95% CI 4.4-NA) vs. 2.9 years (95% CI 1.8-4.8); log-rank test p=0.004). Median PFS is significantly longer in arm B (7.4 (95% CI 5.1-NA) vs. 3.5 years (95% CI 2.1-5.9); log-rank test p=0.04). There is no significant difference in OS and in the observed best response. Maintenance treatment was stopped due to unacceptable toxicity in no patient in arm A vs. 3 in arm B. Six subsequent cancers developed in arm A and 8 in arm B. One infection grade ≥3 was reported in arm A whereas seven infections grade ≥3 occurred in 5 patients in arm B. Conclusions EFS, the primary endpoint was not met which is mainly due to the early separation of the survival curves favouring arm A, at a time when the treatment in both arms was the same. However, a retrospectively defined analysis considering only EFS events from the time when treatment was different in the two arms, shows a statistically significant increase in EFS with long-term maintenance compared to the 8 months maintenance regimen. Long-term rituximab maintenance also doubles the median PFS without leading to increased undue toxicity. Disclosures: Off Label Use: Rituximab for 5 years. Ghielmini:Roche: Consultancy, Honoraria, Research Funding, Speakers Bureau.


2009 ◽  
Vol 15 (6) ◽  
pp. 823-828 ◽  
Author(s):  
D. Bojic ◽  
Z. Radojicic ◽  
M. Nedeljkovic-Protic ◽  
M. Al-Ali ◽  
D. P. Jewell ◽  
...  

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