scholarly journals P.023 Clinical and patient satisfaction outcomes after partial sensory rhizotomy for refractory trigeminal neuralgia among MS patients

Author(s):  
M Bigder ◽  
S Krishnan ◽  
EF Cook ◽  
AM Kaufmann

Background: MS related trigeminal neuralgia (MS-TN) is associated with high recurrence and retreatment rates. Optimal treatment and role for partial sensory rhizotomy (PSR) for MS-TN remains to be determined. Methods: We analyzed time to treatment failure (TTF) after PSR (n=14) versus other prior procedures (n=53) among 12 consecutively treated MS-TN patients. Kaplan-Meier curves and Log-Rank tests were utilized to compare BNI pain scores and TTF after PSR vs prior procedures using the same patient cohort as their own control group. Subsequent analysis compared TTF after PSR to other procedures (n=93) among a second cohort of 18 MS-TN patients not undergoing PSR. Results: TTF was significantly longer after PSR compared to prior procedures among the PSR cohort (p<0.0001) with median TTF of 79 vs 10 months respectively. Similarly, there was a longer TTF after PSR compared to prior procedures among the MS-TN cohort with median TTF 79 vs 16 months respectively (p<0.001). PSR resulted in a higher proportion of excellent pain scores when compared to prior procedures in the MS-TN cohort (77% vs 29%, p<0.001). Conclusions: TTF was significantly longer following partial sensory rhizotomy compared to other prior procedures in MS-TN patients. A higher proportion of patients achieved excellent BNI pain scores after PSR.

2019 ◽  
Vol 130 (6) ◽  
pp. 1877-1888
Author(s):  
Mark G. Bigder ◽  
Sandeep Krishnan ◽  
E. Francis Cook ◽  
Anthony M. Kaufmann

OBJECTIVEPatients with multiple sclerosis (MS)–associated trigeminal neuralgia (TN) have higher recurrence and retreatment rates than non-MS patients. The optimal management strategy and role for microsurgical rhizotomy (MSR) for MS-TN remains to be determined. The aim of this study was to report time to treatment failure (TTF) and pain scores following MSR compared to percutaneous and Gamma Knife procedures.METHODSTime to treatment failure was analyzed after MSR (n = 14) versus prior procedures (n = 53) among MS-TN patients. Kaplan-Meier curves and log-rank test were utilized to compare TTF after MSR versus prior procedures using the same cohort of patients as their own control group. Subsequent analysis compared TTF after MSR to TTF after 93 other procedures among a second cohort of 18 MS-TN patients not undergoing MSR. BNI pain scores were compared between MSR and other procedures among the MS-TN cohort using a chi-square test.RESULTSTTF was significantly longer after MSR than after other procedures in the MSR cohort (median TTF 79 vs 10 months, respectively, p < 0.0001). Similarly, TTF was longer after MSR than after prior procedures in the non-MSR cohort (median TTF 79 vs 13 months, respectively, p < 0.001). MSR resulted in a higher proportion of excellent pain scores when compared to other procedures in the non-MSR cohort (77% vs 29%, p < 0.001). Probability of treatment survival was higher after MSR than after other procedures at all time points (3, 6, 12, 24, 36, and 48 months). There were no deaths or major complications after MSR.CONCLUSIONSTTF was significantly longer following MSR compared to prior procedures in MS-TN patients. Additionally, a higher proportion of patients achieved excellent BNI pain scores after MSR.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S120-S121
Author(s):  
M C Dubinsky ◽  
J W Chou ◽  
C Su ◽  
W Wang ◽  
I Modesto ◽  
...  

Abstract Background Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Safety and efficacy of tofacitinib were evaluated in two Phase 3 induction studies (OCTAVE Induction 1 and 2; NCT01465763, NCT01458951), a 52-week, Phase 3 maintenance study (OCTAVE Sustain, NCT01458574) and an ongoing, open-label, long-term extension study (NCT01470612).1,2 Here, we assess time to treatment failure among patients in remission at the end of OCTAVE Induction 1 and 2 who enrolled in OCTAVE Sustain. Methods In OCTAVE Induction 1 and 2, patients received placebo or tofacitinib 10 mg twice daily (BID) for 8 weeks; clinical responders were re-randomised to placebo, tofacitinib 5 or 10 mg BID in OCTAVE Sustain for 52 weeks. Kaplan–Meier method was used to estimate median time to treatment failure (withdrawal due to insufficient clinical response) in patients who received 10 mg BID in induction studies and entered OCTAVE Sustain in remission (total Mayo score ≤2 with no subscore &gt;1, and rectal bleeding subscore [RB] 0). Treatment failure: ≥3-point increase from baseline total Mayo score, plus ≥1-point increase in RB and endoscopic subscore (ES; centrally read) and absolute ES ≥2 after ≥8 weeks of maintenance therapy. Results Following induction, 156 patients in remission entered OCTAVE Sustain and received tofacitinib 5 mg BID (N = 57) or 10 mg BID (N = 50), or placebo (N = 49). Estimated treatment failure rates are reported in the table. At Week 52, Kaplan–Meier rates of treatment failure were higher in patients who switched to placebo (81.8% [95% confidence interval 67.0, 90.4]) vs. those who continued to receive tofacitinib 10 mg BID (25.6% [14.2, 38.6]) or reduced their dose to 5 mg BID (34.4% [21.8, 47.3]). Median time to treatment failure was 169 days for placebo and &gt;52 weeks for tofacitinib 5 and 10 mg BID (due to the low number of treatment failure events, exact median time to treatment failure was not available for tofacitinib 5 or 10 mg BID). Conclusion For patients in remission following 8 weeks of induction treatment with tofacitinib 10 mg BID, median time to treatment failure for those who continued tofacitinib treatment (5 or 10 mg BID) was &gt;52 weeks. After treatment interruption (remission patients who were re-randomised to placebo), median time to treatment failure was 169 days; this was similar to previously published time-to-treatment-failure data for patients with clinical response (including remission) following 8 weeks of induction treatment with tofacitinib who were re-randomised to placebo.3. References


Neurosurgery ◽  
2011 ◽  
Vol 70 (5) ◽  
pp. 1125-1134 ◽  
Author(s):  
Matthew Bender ◽  
Gustavo Pradilla ◽  
Sachin Batra ◽  
Alfred See ◽  
Neal Bhutiani ◽  
...  

Abstract BACKGROUND: Percutaneous glycerol rhizotomy (GR) is used to treat trigeminal neuralgia (TN), with satisfactory pain relief lasting 2 to 3 years in most patients after the first intervention. The efficacy of subsequent GRs, however, has not been studied. OBJECTIVE: To compare the pain relief and durability achieved by the first GR with those obtained after subsequent GRs in a retrospective cohort of TN patients. METHODS: Between 1998 and 2010, 548 patients with TN underwent 708 GRs. After exclusions, 430 initial GRs (GR1) and 114 subsequent GRs (GR2+) were compared in terms of initial pain relief, durability, sensory change, and complications. Durability was assessed by determining median time to treatment failure for all GRs achieving complete pain relief without medications (n = 375: 264 failures, 111 censored). Predictors of initial pain relief were assessed by logistic regression, and predictors of failure were assessed by Cox regression analysis. RESULTS: After GR1, pain relief results were as follows: 285 patients (66%) were pain free without medications, 26 (6%) were pain free with medications, 66 (15%) improved, and 53 (12%) were unchanged. After GR2+, results were as follows: 90 patients (79%) were pain free without medications, 6 (5%) were pain free with medications, 7 (6%) improved, and 11 (10%) were unchanged (P = .03). Median time to treatment failure was 26 months after GR1 and 25 months after GR2+ (P = .34). On multivariate analysis, prior GR was a positive predictor of initial pain relief (odds ratio, 2.067; 95% confidence interval, 1.243-3.437; P = .005) and had no effect on durability. CONCLUSION: TN patients experienced greater pain relief and equivalent durability after GR2+ beyond the initial treatment.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S227-S228
Author(s):  
Diana Fernández-Rodríguez ◽  
María de Lourdes García-Hernández ◽  
Guillermo Cerón-González ◽  
Claudia Adriana Colín-Castro ◽  
Melissa Hernández-Durán ◽  
...  

Abstract Background Approximately one-third of the prosthetic joint infections (PJIs) are polymicrobial. They are difficult to treat and there is an urgent need of clinical evidence that help to guide current protocols. We aimed to define the clinical characteristics and outcomes of patients with polymicrobial PJI. Methods We conducted a retrospective cohort study of patients with polymicrobial PJI treated at a referral hospital in Mexico City. Clinical data was retrieved and analyzed. Time to treatment failure, was evaluated for all cases. Results We identified 166 patients with a polymicrobial PJI from July 2011 to October 2020. The median follow-up period was 3.24 years (IQR, 1.45-6.42). Fistulae (77.7%) and pain (76.5%) were frequent. Patients required a median of 2 (IQR, 1-3) hospitalizations and 3 (IQR, 1-5) surgeries. Relapse, reinfection, and amputation ocurred in 21.1% (35), 10.2% (17), and 7.2% (12) of the cases, respectively. At 1-year follow-up 38.47% (63) patients failed to control the infection. At 2 and 5-year follow-up this rate increased to 50% (83) and 68% (112), respectively. The main infecting microorganisms were Staphylococcus epidermidis (51.8%), Enterococcus faecalis (47.6%), and Staphyloccocus aureus (34.9%). Anaerobes were identified in 38 (22.9%) cases. At 1 and 5-year follow-up, 39.31% (34) and 71.1% (61) of patients with S. epidermidis experienced treatment failure. On the other hand, those with S. aureus showed lower rates (log-rank p-value=0.03): 24.85% (14) and 50% (29), accordingly. Patients affected by anaerobes and E. faecalis exhibited similar trends, between them (log-rank p-value=0.73). Table1. Clinical findings of patients with polymicrobial PJI. Frequency distributions of sociodemographic factors, comorbidities, clinical presentation, outcomes, out-patient treatment, and etiology in patients with polymicrobial PJI. Data is presented as absolute frequency followed by relative frequency enclosed in parenthesis, otherwise specified. Abbreviations: SXT, Trimethoprim/Sulfamethoxazole. Figure 1. Kaplan‒Meier survivorship curve illustrating the time to treatment failure among patients with polymicrobial PJI. The shaded areas surrounding the gross line represent the 95% CI. Figure2. Kaplan‒Meier survivorship curves illustrating the time to treatment failure among patients with polymicrobial PJI, according to the infecting microorganisms.. Patients affected by S. epidermidis, E.faecalis, S. aureus, and anaerobes are represented with red, blue, green, and black lines, respectively. Conclusion Our study showed 61.53% of the patients with polymicrobial PJI controlled the infection at 1-year follow-up. This rate decreased over the years. These patients required a considerable number of hospitalizations and surgeries. Likewise, presenting with fistulae and pain ensured a high suspicion of PJI. S. epidermidis, E. faecalis, and S. aureus were the most frequent infecting microorganisms. The stratification of our cohort suggested the microbiology of polymicrobial PJI could have driven to differences in rates of treatment failure. Disclosures All Authors: No reported disclosures


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 163-163 ◽  
Author(s):  
M. Bilusic ◽  
J. L. Gulley ◽  
C. Heery ◽  
A. B. Apolo ◽  
P. M. Arlen ◽  
...  

163 Background: PSA-TRICOM is a vector-based, therapeutic cancer vaccine regimen consisting of recombinant poxviruses containing the transgenes for prostate-specific antigen (PSA) and 3 T-cell co-stimulatory molecules (TRICOM). A previous randomized, placebo-controlled phase II study demonstrated an 8.5-month improvement in median survival (25.1 months for PSA-TRICOM group vs. 16.6 months for control group) in men with metastatic CRPC. Methods: This study is currently enrolling patients with non-metastatic CRPC on testosterone suppression therapy who have a rising PSA. Patients are stratified by PSA doubling time and randomized to androgen receptor antagonist alone (flutamide) or flutamide plus PSA-TRICOM. Flutamide is given at the standard dose of 400 mg TID while PSA-TRICOM is given by monthly subcutaneous injections. The primary endpoint of the study is time to treatment failure (TTF) which is defined as biochemical recurrence (PSA rise) or development of metastatic lesions on scans. Results: The first 26 patients enrolled are evaluated in this analysis. For flutamide alone (n = 13), the median age at enrollment was 64.7 years and median Gleason Score was 8. For flutamide + PSA-TRICOM (n = 13), the median age at enrollment was 67.1 years and median Gleason score was 8. Median time to progression is 223 days for Fluatmide + PSA- TRICOM (range 70-638) vs. 85 days for Flutamide alone (56-372). Progression for 11/12 flutamide alone patients and 9/10 fluatmide + PSA-TRICOM patients has been by PSA rise only. Conclusions: Preliminary evidence suggests improvement in time to treatment failure using combination of hormonal therapy with flutamide + PSA-TRICOM vaccine compared to fluatmide alone in patients with non-metastatic CRPC. This trial will continue to accrue a total of 62 patients and also will evaluate immunological responses. No significant financial relationships to disclose.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 453-453
Author(s):  
Gurjyot K. Doshi ◽  
Mairead Kearney ◽  
Murtuza Bharmal ◽  
Hemant Phatak ◽  
Marley Boyd ◽  
...  

453 Background: With the introduction of immunotherapy (IO) for locally advanced or metastatic urothelial carcinoma (mUC), optimal treatment sequence should be considered. This study aimed to compare time to treatment failure (TTF) and overall survival (OS) among these patients (pts) treated with first-line (1L) systemic chemotherapy followed by second-line (2L) IO ( C-IO) vs 1L and 2L chemotherapy ( C-C) sequence within the US community oncology Network (USON). Methods: This was a retrospective study of adult locally advanced or mUC pts who initiated systemic therapy between 1/1/15 – 4/30/17 within USON and had a minimum of two-month follow-up. Descriptive analyses were performed, with Kaplan-Meier used for comparisons between pts who received C-IO vs C-C sequence. Pts considered for this analysis did not receive a third-line treatment. Regression analyses were performed to assess variables associated with TTF and OS. Results: 117 pts were included in the analysis ( C-IO n = 79, C-C n = 38). Median age (range) was 69 years (38, 90+), with 74.4% male. Baseline demographic and clinical characteristics were similar between the groups. The median (range) duration between start of 1L and start of 2L therapy was significantly longer among C-IO vs C-C pts (29.0 [4.1, 102.1] vs 20.0 [0.1, 63.1] weeks; P = 0.0047). Median TTF and OS were longer among C-IO vs C-C pts but the trends were not significant (Table). The duration between initial diagnosis and advanced disease status was associated with TTF (P = 0.0124) in univariate analysis. Conclusions: These results suggest that patients receiving C-IO demonstrated greater (>30 weeks) but statistically non-significant improvement in OS versus those receiving C-C. Considering these OS trends, future research should explore prognostic characteristics of IL chemotherapy treated pts who may benefit from an earlier switch to IO therapy. [Table: see text]


2018 ◽  
Vol 25 (6) ◽  
pp. 1374-1380 ◽  
Author(s):  
M Alexandra Schickli ◽  
Michael J Berger ◽  
Maryam Lustberg ◽  
Marilly Palettas ◽  
Craig A Vargo

Purpose The management of endocrine therapy resistance is one of the most challenging facets of advanced breast cancer treatment. Palbociclib is an inhibitor of cyclin-dependent kinases 4 and 6 approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with fulvestrant in postmenopausal women with disease progression following endocrine therapy. However, treatment responsiveness of tumors to palbociclib after multiple lines of endocrine therapy is not clearly established. The purpose of this study was to determine the efficacy of palbociclib and letrozole in patients pretreated with one or more lines of endocrine therapy. Methods This was a single-center, retrospective cohort study of all postmenopausal hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer patients who received palbociclib and letrozole as a second-line endocrine therapy or beyond (and no prior cyclin-dependent kinases 4 and 6 inhibitor therapy) between February 1, 2015, and July 31, 2016. The primary objective was to evaluate time to treatment failure of palbociclib in combination with letrozole as a second-line of therapy or beyond. Results Fifty-three patients meeting eligibility criteria were included in the analysis. For the primary outcome, the median time to treatment failure of palbociclib and letrozole was 6.3 months (95% CI 3.1–7.4 months). Progression-free survival of palbociclib and letrozole therapy was 6.4 months (95% CI 4.9–8.3 months). Conclusions Palbociclib and letrozole therapy is a viable, effective treatment option for metastatic breast cancer patients who were not exposed to cyclin-dependent kinases 4 and 6 inhibitors as a first-line endocrine therapy. The benefits of palbociclib and letrozole therapy were seen without excessive toxicity, and although neutropenia was common, it may be managed with dose reduction.


2003 ◽  
Vol 21 (18) ◽  
pp. 3402-3408 ◽  
Author(s):  
Margaret Tempero ◽  
William Plunkett ◽  
Veronique Ruiz van Haperen ◽  
John Hainsworth ◽  
Howard Hochster ◽  
...  

Purpose: To conduct a randomized phase II trial of dose-intense gemcitabine using a standard 30-minute infusion or the fixed dose rate (FDR) infusion (10 mg/m2/min) in patients with pancreatic adenocarcinoma. Patients and Methods: In this prospective trial, patients with locally advanced and metastatic pancreatic adenocarcinoma were treated with 2,200 mg/m2 gemcitabine over 30 minutes (standard arm) or 1,500 mg/m2 gemcitabine over 150 minutes (FDR arm) on days 1, 8, and 15 of every 4-week cycle. The primary end point of this trial was time to treatment failure. Secondary end points included time to progression, median survival, safety, and pharmacokinetic studies of gemcitabine. Results: Ninety-two patients were enrolled onto this study; 91% of the patients had metastatic disease. Time to treatment failure was comparable in both treatment groups; however, the median survival for all patients was 5.0 months in the standard arm and 8.0 months in the FDR arm (P = .013). For patients with metastases, the median survival was 4.9 months in the standard arm and 7.3 months in FDR arm (P = .094). The 1- and 2-year survival rates for all patients were 9% (standard arm) versus 28.8% (FDR; P = .014) and 2.2% (standard arm) versus 18.3% (FDR; P = .007), respectively. Patients in the FDR infusion arm experienced consistently more hematologic toxicity. Pharmacokinetic analyses demonstrated a two-fold increase in intracellular gemcitabine triphosphate concentration in the FDR arm (P = .046). Conclusion: Pharmacokinetic and clinical data in this trial supports the continued evaluation of the FDR infusion strategy with gemcitabine.


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