Contextualizing a single-arm trial of ceralasertib (cer) plus paclitaxel with real-world data (RWD) in patients (pts) with advanced melanoma previously treated with anti-PD-(L)1(PDx) therapies.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21542-e21542
Author(s):  
Miao Jiang ◽  
Jeeyun Lee ◽  
Daniel Jackson ◽  
Simon Smith ◽  
Sajan Khosla ◽  
...  
Keyword(s):  
Cox Regression ◽  
Unmet Need ◽  
Clinical Trial Data ◽  
Advanced Melanoma ◽  
Real World Data ◽  
Kaplan Meier ◽  
Improved Outcomes ◽  
Recent Phase ◽  
Previously Treated ◽  
Poor Outcomes

e21542 Background: Metastatic melanoma, especially in pts who do not respond to PDx therapy, is an area of high unmet need. Chemotherapy may be used but clinical efficacy is limited. A recent Phase I study (NCT02630199) showed that cer + paclitaxel had promising anti-tumor activity with durable responses in 34 melanoma pts after failing PDx therapy. Given the lack of published prospective clinical trial data in the post-PDx setting, RWD was used to contextualize the results of the trial. Methods: Adult pts (≥18 years) diagnosed with advanced melanoma between Jan2011-Jun2020, who received PDx therapy alone or in combination with anti-CTLA4, and also received chemotherapy immediately after the PDx line (chemo cohort) were selected from the nationwide US-based Flatiron Health EHR-derived de-identified database. A subgroup of pts who received taxane was also selected. Overall survival (OS) was assessed using Kaplan-Meier methods. Key covariates such as age, gender, LDH level, number of prior lines of therapy, presence of brain and liver metastases, and prior BRAF/MEK treatment, were adjusted using propensity score-based weighting approach. Cox regression models were used to obtain the effect estimates for OS comparing the trial arm against the RWD cohorts. Results: A cohort of 114 pts met the inclusion criteria, of which 69 received taxane. Compared with the trial arm, the RWD cohorts were older, contained more males, with higher proportions receiving prior BRAF/MEK inhibitors, with brain metastasis, and LDH≤ULN. Median OS was 7.4 months (mo) in the trial arm, compared to 5.6 (unadjusted) and 3.5 mo (adjusted) in the chemo cohort. Hazard ratio of 0.49 (95% CI: 0.29-0.83, trial vs. chemo) indicated significant benefits of the trial arm over the chemo cohort. Analyses using taxane subgroup showed similar findings. Conclusions: The RWD cohorts demonstrated poor outcomes for the pts receiving chemotherapy, in particular taxanes, confirming this is a population of unmet need. The results show the potential for improved outcomes using cer + paclitaxel in pts previously treated with PDx.[Table: see text]

The impact of multimodality therapies in marginally inoperable soft tissue sarcomas (STS): The Toronto Sarcoma Program (TSP) experience.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11548-11548
Author(s):  
Olga Vornicova ◽  
Jay Wunder ◽  
Peter W. M. Chung ◽  
Abha A. Gupta ◽  
Rebecca Anne Gladdy ◽  
...  
Keyword(s):  
Cox Regression ◽  
Soft Tissue Sarcomas ◽  
Tumor Board ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Progression Of Disease ◽  
Modality Approach ◽  
Poor Outcomes ◽  
The Impact

11548 Background: The mainstay therapy of operable STS remains surgery, which may include (neo)adjuvant therapies. Within the TSP, marginally inoperable STS are often treated with sequential chemo (CTX) and radiation (RT) therapy, followed by surgery (SX). Herein we present our experience of multi-modality therapies for marginally inoperable STS patients (pts). Methods: This was a dual-center, single program, retrospective review. Pts were included if deemed to have marginally inoperable primary or recurrent STS, as determined at the TSP tumor board. Pts included must have had CTX with the intent of having RT and SX after. Pts demographics, treatment details and clinical outcomes data were collected. Relapse free survival (RFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Multivariate analysis of the influence of disease characteristics and treatment on outcomes was assessed using Cox regression. Results: From June 2005 to May 2019, 75 pts were identified. Median age was 52 years (range 16-72). Pts were predominantly male (55%). Histological subtypes included dedifferentiated liposarcoma (29%), leiomyosarcoma (27%), synovial sarcoma (19%) and others (25%). Primary tumor was located in the retroperitoneum (48%), extremity (23%), pelvis (12%), thorax (9%), and other sites (8%). All pts had doxorubicin and ifosfamide CTX (median 4 cycles; range 1-6), while RT dose delivered was 50.4Gy/28 fractions in 58 (77%) of cases. Twenty three pts (31%) achieved partial response, 40 pts (53%) had stable disease and 12 pts (16%) had progression of disease (PD) on CTX, of which half (8%) did not undergo further treatment. Nine pts (12%) underwent CTX followed by SX due to significant response, 9 pts (12%) underwent CTX and RT without SX due to persistent tumor unresectability or PD. The final 50 pts (67%) completed multi-modality treatment (CTX, RT & SX). Overall, 59 pts (79%) had SX; negative margins were achieved in 53 (71%). 19 pts (25%) had postoperative complications, causing death in 2 pts (2.7%). With a median follow-up of 72 months, median RFS and OS were 26.9 months (95% CI: 0-86.0), and 65 months (95% CI: 13.5-116.4). Extremity location was associated with superior RFS (median not reached [NR], HR 0.28 95% CI 0.09-0.83, p = 0.022), and OS (median NR, HR 0.29 95% CI 0.09-0.90, p = 0.032). Receipt of RT was associated with superior RFS (median NR, HR 0.23 95% CI 0.10-0.52, p < 0.001); and OS (median NR, HR 0.21 95% CI 0.09-0.50, p < 0.001). Pts who had PD after CTX were associated with poor outcomes - RFS (median 4.7 months, HR 2.03 95% CI 0.61-6.76, p = 0.24); and OS (median 21.9 months, HR 2.48 95% CI 0.73-8.47, P = 0.144). Conclusions: Multi-modality approach resulted in successful resection for most pts with marginally inoperable STS. Extremity location and RT administration were associated with better RFS and OS, while progression on CTX confers worse survival outcomes.

Is conversion to resection possible with hepatic arterial infusion (HAI) and systemic (SYS) even in previously treated patients (pts) with unresectable colorectal liver metastases (UnCLM)?

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3577-3577 ◽  
Author(s):  
Nancy E. Kemeny ◽  
Yuman Fong ◽  
Philip Paty ◽  
Joanne F. Chou ◽  
Marinela Capanu ◽  
...  
Keyword(s):  
Regression Model ◽  
Cox Regression ◽  
Hepatic Arterial Infusion ◽  
Progression Free Survival ◽  
Multivariate Logistic Regression Model ◽  
Kaplan Meier ◽  
Pump Placement ◽  
Previously Treated ◽  
Portal Veins ◽  
Hepatic Portal

3577 Background: Previously, we showed thatHAI with FUDR + dexamethasone (Dex) plus SYS produced a 47 % resectability rate in a retrospective study of 49 pts with UnCLM. Methods: Prospectively evaluated UnCLM pts in a new protocol were combined with the above protocol (n=105 pts) and all were treated with HAI FUDR/Dex + Sys. Unresectability was defined as diffuse bilateral metastases, involvement of all hepatic/portal veins, and/or inability to preserve remaining liver with adequate perfusion. Factors associated with conversion were identified using a multivariate logistic regression model. Overall survival (OS) and progression free survival (PFS) were calculated from pump placement by the Kaplan-Meier method. Resectability was a time-dependent covariate in a Cox regression model. Results: 61 of the 105 pts had prior SYS (56 %with prior Oxali) and 45 (74%) were progressing at the time of pump placement. In previously treated pts, 44% underwent resection, with a median OS of 45 mos. Of 44 chemo-naïve pts, 57% underwent hepatectomy, with a median OS of 68 mos. The following were significantly associated with resection conversion: lesion number [p=0.02], baseline CEA [p=0.04], females [p=0.03] and clinical risk score (CRS) [p=0.05]. In multivariate analysis, gender and CRS remained predictive of resectability. Surgery greatly reduced the hazard of death by 67% [HR: 0.33, 95%CI: 0.17-0.61, p=0.0004], after adjusting for several risk factors (Table). Median PFS was 12 mos for all pts. Conclusions: Even in previously treated pts,HAI + SYS is an approach to convert UnCLM to resection. Gender and CRS are associated with conversion to resectability. [Table: see text]

Associations between K-ras mutation, smoking, and prognosis of pancreatic cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 298-298
Author(s):  
Kei Saito ◽  
Yousuke Nakai ◽  
Hiroyuki Isayama ◽  
Takashi Sasaki ◽  
Naminatsu Takahara ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Colon Cancer ◽  
Cox Regression ◽  
Performance Status ◽  
Rank Test ◽  
Ras Mutation ◽  
Kaplan Meier ◽  
Never Smokers ◽  
Poor Outcomes ◽  
The University

298 Background: Smoking is recognized as a risk factor for pancreatic cancer, but its associations with prognosis are not fully elucidated. Smoking was associated with poor outcomes in colon cancer, especially in patients with K-ras mutation (J Clin Oncol. 2013;31:2016-23). Therefore, we conducted this retrospective analysis of the associations of K-ras mutation, smoking and prognosis in patients with pancreatic cancer. Methods: Patients with pancreatic cancer who received surgery or chemotherapy at the University of Tokyo Hospital were retrospectively studied. The prognosis of patients with mutant and wild K-ras were compared. Overall survival was evaluated using Kaplan-Meier methods and compared by long-rank test. Cox regression models were used to calculate hazard ratios (HRs) to evaluate the prognostic factors in patients with pancreatic cancer with mutant K-ras or wild K-ras. Results: Between January 2009 and August 2013, K-ras mutation analysis was evaluated in 187 patients (47 surgical resection and 140 chemotherapy). K-ras mutation was detected in 74.3%. The rates of current-, ex- and never-smokers were 18.2%, 31.6% and 50.3%, respectively. In patients with mutant K-ras, the rate of male gender (46.0% vs. 29.0%), presence of distant metastasis (50.4% vs. 31.3%) and median CA19-9 (374 U/mL vs. 136 U/mL) were significantly higher than that in patients with wild K-ras. The rate of ever smokers (current- and ex-smokers) did not differ significantly (48.2% in mutant K-ras vs. 56.3% in wild K-ras, p=0.403). Median survival time (MST) was 16.7 (95%CI, 11.9-21.8) months in patients with mutant K-ras, compared with 20.3 (95%CI, 15.8-34.6) in patients with wild K-ras (p=0.193). Meanwhile, MST was 22.2 (95%CI, 16.9-27.9) vs. 14.8 (95%CI, 9.1-19.4) months in patients with and without smoking (p=0.024). After adjustment by age, gender, performance status, CA19-9 and treatment, HRs of smoking were 1.96 (95%CI, 1.06-3.68, p=0.032) in patients with mutant K-ras, but the association was not significant in patients with wild-K-ras (HR 1.35 [95%CI, 0.37-5.28], p=0.653). Conclusions: As previously reported in colon cancer, smoking was associated with poor prognosis in pancreatic cancer with K-ras mutation.

Activity of a novel immunotherapy combination of intralesional Coxsackievirus A21 and systemic ipilimumab in advanced melanoma patients previously treated with anti-PD1 blockade therapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3014-3014 ◽  
Author(s):  
Brendan D. Curti ◽  
Jon M. Richards ◽  
Sigrun Hallmeyer ◽  
Mark B. Faries ◽  
Robert Hans Ingemar Andtbacka ◽  
...  
Keyword(s):  
Immune Checkpoint ◽  
Immune Cell ◽  
Phase 1 ◽  
Unmet Need ◽  
Advanced Melanoma ◽  
Clinical Activity ◽  
Potential Marker ◽  
Previously Treated ◽  
Coxsackievirus A21 ◽  
Melanoma Patients

3014 Background: CAVATAK is a novel bio-selected oncolytic and immunotherapeutic strain of Coxsackievirus A21 (CVA21) that when injected into melanoma lesions can increase immune-cell infiltration, up-regulation of γ-INF response and immune-checkpoint genes, including CD122, which may be a potential marker for enhanced anti-tumor activity by anti-CTLA-4 blockade. Intratumoral replication of CVA21 may act as a strong “immune-sequestration signal” to circulating activated T-cells following CTLA-4 blockade. A large unmet need exists for active therapies in melanoma patients (pts) following treatment (tx) with anti-PD1 therapies. We present in a Phase 1 study, the clinical activity of a CVA21/ ipilimumab (ipi) combination following anti–PD1 therapy in advanced melanoma pts. Methods: The Phase Ib MITCI study (NCT02307149) investigated the efficacy and safety of i.t. CVA21 and i.v. ipi in 26 pts with unresectable Stage IIIB/C-IVM1c melanoma with 13 pts previously treated with anti-PD1 therapies. Pts received up to 3 x 108 TCID50CVA21 i.t. on study days 1, 3, 5, 8 and 22, and then q3w for a further 6 series of injections. Ipi (3 mg/kg) q3w was given as 4 i.v. infusions starting at Day 22. Results: Analysis of the prior anti–PD1 treated pts (n=13) revealed that the combination tx was generally well-tolerated with one case of Gr 3 ipi-related liver toxicity observed. Of the tx population, 54% (7/13) had received prior ipi tx in addition to anti-PD1, 85% (11/13) of pts were stage IV M1b/c, with the median time between the last anti-PD1 and first CVA21 and ipi doses being 5.7 and 8.7 weeks, respectively. The mean number of prior systemic therapies including anti-PD1 tx was 2.6. For all pts completing at least the first investigator response assessment (irWHO criteria at Day 106) we observed a confirmed BORR of 38.0% (3/8) and a DCR (CR+PR+SD) of 88% (7/8). Conclusions: Intratumoral CVA21 + ipilimumab treatment in anti–PD1 treated pts has displayed promising clinical activity together with low adverse toxicity and as such this regimen may represent a valuable tx option for pts that have been administered previous lines of immune checkpoint therapy. Clinical trial information: NCT02307149.

scholarly journals Real-world effectiveness outcomes in patients diagnosed with metastatic triple-negative breast cancer

2020 ◽  
Author(s):  
Karen E Skinner ◽  
Amin Haiderali ◽  
Min Huang ◽  
Lee S Schwartzberg
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Cox Regression ◽  
Unmet Need ◽  
Progression Free Survival ◽  
Free Survival ◽  
Regression Methods ◽  
Kaplan Meier ◽  
Community Oncology

Aim: This study examined treatment patterns and effectiveness outcomes of patients with metastatic triple-negative breast cancer (mTNBC) from US community oncology centers. Materials & methods: Eligible patients were females, aged ≥18 years, diagnosed with mTNBC between 1 January 2010 and 31 January 2016. Kaplan–Meier and Cox regression methods were used. Results: Sample comprised 608 patients with average age of 57.5 years and 505/608 patients (83.1%) received systemic treatment. Overall survival (OS) from first-line treatment found that African–American patients had shorter OS than White (9.3 vs 13.7 months; hazard ratio: 1.35; p = 0.006). Conclusion: More than 15% of women with mTNBC were not treated, indicating a high unmet need. Overall prognosis remains poor, which highlights the opportunity for newer therapies to improve progression-free survival and OS.

FRI0462 PREDICTIVE FACTORS OF RELAPSE AFTER METHOTREXATE DISCONTINUATION IN JIA PATIENTS WITH INACTIVE DISEASE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 828-829
Author(s):  
S. Azevedo ◽  
J. Tavares-Costa ◽  
A. T. Melo ◽  
R. Freitas ◽  
M. Cabral ◽  
...  
Keyword(s):  
Predictive Factors ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Inactive Disease ◽  
Real World Data ◽  
Inflammatory Parameters ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Multicentre Cohort Study ◽  
Univariate Analyses

Background:Methotrexate (MTX) is the most widely used conventional synthetic disease-modifying antirheumatic drug (csDMARD) in the treatment of juvenile idiopathic arthritis (JIA).1,2When remission is achieved, questions remain about discontinuing MTX. There is some evidence that a longer period of inactive disease before MTX withdrawal is associated with lower likelihood of relapse, while both rheumatoid factor (RF) positive polyarthritis and extended oligoarthritis categories are associated with higher probability of disease relapse.2,3Objectives:To identify predictive factors of relapse after discontinuation of MTX in JIA patients with inactive disease.Methods:Prospective multicentre cohort study in patients diagnosed with JIA, according to the ILAR classification, using real world data from the Portuguese national register database, Reuma.pt (Fig 1).4We evaluated patients who have reached JADAS27 inactive disease (≤1 and no active extra-articular manifestations) and discontinued MTX before the age of 18 years-old.5Relapse was defined as recurrence (>1 or extra-articular manifestations) or restarting a DMARD.5To identify differences of relapse risk, univariate analyses were performed. Persistence in remission was estimated using the Kaplan-Meier method. Subsequently, Cox regression analyses were performed to identify predictors of relapse.Results:119 JIA patients discontinued MTX due to inactive disease (Fig 1). 69.7% were females and 60.6% had oligoarticular JIA. Sociodemographic and clinical characteristics are shown in Table 1. Relapse has occurred in 32.8%. Table 2 shows the disease characteristics at MTX initiation and discontinuation and at relapse or last visit.In univariate analysis, relapse was associated with the use of NSAIDs at the time of MTX discontinuation (p=.027) and with a period of less than two years in inactive disease before MTX suspension (p=.040). We found no association with gender, race, immunology (RF, antinuclear and cyclic citrullinated peptide antibodies), MTX dose, discontinuation modality (tapering and spacing the doses or just tapering the dose), extra-articular manifestations, previous corticotherapy, family history, body mass index, JADAS, CHAQ index, inflammatory parameters, tender and swollen joint counts at MTX initiation or discontinuation nor with age at remission or at MTX suspension. Median persistence in inactive disease was significantly higher in patients with more than two years in remission before MTX discontinuation (p=.034) and in those who did not use NSAIDs at time of MTX discontinuation (p=.026) (Fig 2).After adjustment for age at diagnosis, MTX tapering and JIA category, use of NSAIDs at the time of discontinuation (HR, 1.98 95%CI 1.03-3.82) and less than two years in remission (HR, 3.12 95%CI 1.35-7.13) remained associated with relapse.Conclusion:In this large cohort we found that the use of NSAIDs at the time of MTX discontinuation was associated with two times the likelihood of relapse. Like in other studies we also showed that the time in remission before MTX discontinuation is the main predictor of relapse. We found no association between the JIA category and the risk of relapse.References:[1]Hügle B 2016[2]Klotsche J 2018[3]Guzman J 2014[4]Canhão H 2011[6]Consolaro A 2014Disclosure of Interests:Soraia Azevedo: None declared, José Tavares-Costa: None declared, Ana Teresa Melo: None declared, Raquel Freitas: None declared, Marta Cabral: None declared, Marta Conde: None declared, Francisca Aguiar: None declared, Agna Neto: None declared, Ana Filipa Mourão: None declared, Filipa Oliveira-Ramos: None declared, Maria Jose Santos Speakers bureau: Novartis and Pfizer, Daniela Peixoto: None declared

XEN45 real-life evaluation: Survival analysis with bleb needling and major revision outcomes

2021 ◽  
pp. 112067212110128
Author(s):  
Néstor Ventura-Abreu ◽  
Marina Dotti-Boada ◽  
María Jesús Muniesa-Royo ◽  
Jordi Izquierdo-Serra ◽  
Andrea González-Ventosa ◽  
...  
Keyword(s):  
Cox Regression ◽  
Real Life ◽  
Glaucoma Surgery ◽  
Success Rates ◽  
Life Outcomes ◽  
Kaplan Meier ◽  
Real Life Setting ◽  
Complete Failure ◽  
Poor Outcomes

Purpose: To evaluate real-life outcomes of XEN45 stent surgery including bleb needling (BN) and surgical bleb revision (SBR). Methods: Retrospective analysis of all XEN45 gel stents implanted in a tertiary glaucoma center with a minimum follow-up of 6 months. The main outcomes were intraocular pressure (IOP), the number of glaucoma medications, postoperative maneuvers like BN, and subsequent SBR. Success was defined as IOP ⩽ 18 and 20% reduction (criterion A), ⩽15 and 25% reduction (criterion B), and ⩽12 mmHg and 30% reduction (criterion C) reached with (qualified) or without (complete) medications at the last visit. Complete failure was defined as additional glaucoma surgery, loss of light perception, or sight-threatening complications. Multivariable Cox regression and Kaplan-Meier survival estimates tests were performed. Results: Fifty-eight eyes with either stand-alone or combined Phaco-XEN surgery were included. Complete success by the different definitions was 50.0% (95% confidence interval, 5.8%–84.5%) (A), 50.0% (5.8%–84.5%) (B), and 25% (0.9%–66.5%) (C) whereas qualified success was 38.3% (1.6%–80.1%), 31.7% (2.0%–71.4%), and 0%, respectively, at the 24-months visit. 30% of cases underwent BN with 5-Fluorouracil, and SBR was performed in 17.5% of eyes. Low IOP levels at 1-month and early BN were significantly associated with success. The highest chance of failure was achieved in the combined Phaco-XEN group undergoing SBR. Conclusions: In our real-life setting, the first month IOP was associated with greater success rates. Although BN obtained improved IOP values, SBR was associated with a greater bleb survival in the stand-alone XEN group. Both BN and SBR had poor outcomes in the combined Phaco-XEN group.

High-dose melphalan (MEL) based autotransplants (AT) for multiple myeloma (MM): The Arkansas experience since 1989 in more than 2,800 patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8043-8043 ◽  
Author(s):  
M. Pineda-Roman ◽  
J. Haessler ◽  
K. Hollmig ◽  
E. Anaissie ◽  
F. van Rhee ◽  
...  
Keyword(s):  
Platelet Count ◽  
Cox Regression ◽  
High Dose ◽  
Kaplan Meier ◽  
Long Term Follow Up ◽  
Previously Treated Patients ◽  
High Platelet Count ◽  
Previously Treated ◽  
Dose Response Effect ◽  
High Dose Melphalan

8043 Background: The dose-response effect for MEL has been safely exploited through the use of AT. Long-term follow-up studies from large centers are critical to understand who benefits most and who should be considered for alternative treatment approaches. Methods: 2,836 patients receiving at least one MEL AT were considered. Kaplan-Meier analysis was used to estimate median event-free survival (EFS) and overall survival (OS). Cox regression was used to evaluate independent prognostic factors of EFS and OS from AT. Results: Of the 2,836 patients, 979 were enrolled into front-line Total Therapy protocols 1/2/3 (TT); 1,064 were entered on protocols for previously treated patients (non-TT); and 793 were treated off protocol (non-P). Overall median EFS and OS from 1st AT are 31mo and 53 mo; 10-yr EFS and OS were 19% and 24%; 15% survived >15 yr. The 5 strongest favorable OS features included TT (HR 0.46, p<0.001), absence of cytogenetic abnormalities (no CA) (HR 0.48, p<0.001), B2M <3 mg/L (HR 0.46, p<0.001), albumin >=3g/dL (HR 0.45, p<0.001) and platelet count >=100.000/microL (HR 0.41, p<.001), so that 10-yr OS rates were 58% with 5, 24% with 4, 16% with 3, 4% with 2 and 0% with =<1 favorable parameter (p<0.0001). The corresponding median durations of EFS were 80 mo, 37 mo, 27 mo, 18 mo and 7 mo (p<0.0001). Conclusion: This large single institution experience demonstrates that > 10 yr OS can be accomplished in over one-half of the 16% of all patients presenting without CA, with low levels of B2M and albumin, high platelet count and receiving TT. The worst constellation affected 3% of all patients presenting with at most 1 good-risk feature whose 5-yr survival was only 7%. These data should serve as guidepost for MM investigators and patients alike, against which newer treatments should be measured. No significant financial relationships to disclose.

Emerging clinical phenotype of bone metastatic urothelial cancer (mUC): Association of early osseous metastases (EOM) and outcomes.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17007-e17007
Author(s):  
Ariel Ann Nelson ◽  
Robert Cronk ◽  
Aniko Szabo ◽  
Emily Lemke ◽  
Thomas A. Giever ◽  
...  
Keyword(s):  
Cox Regression ◽  
De Novo ◽  
Opioid Analgesic ◽  
Unmet Need ◽  
Chi Square ◽  
Cox Regression Analysis ◽  
Osseous Metastases ◽  
Kaplan Meier ◽  
Metastatic Urothelial Cancer ◽  
Platinum Based Chemotherapy

e17007 Background: Outcomes of patients (pts) with mUC with EOM have not thoroughly been described in the age of immuno-oncology. We hypothesized that EOM is associated with worse outcomes when compared to pts with non-osseous metastases (NOM). Methods: We used a multi-institutional database of pts with mUC who received systemic treatment (trt) between March 2005 and August 2019, to assess survival and palliative outcomes of pts with EOM vs NOM at the time of metastatic diagnosis (met dx). Wilcoxon rank-sum and chi-square tests were performed. Survival was estimated by Kaplan-Meier method, Cox regression analysis was performed. Results: We identified 270 pts, 72% men, mean age 67 ± 11 years, 28% never smokers. At met dx, 27% (n = 72) had ≥ 1 EOM; these pts were more likely to have de novo metastases vs. those with recurrent metastases (42% vs 19%, p < 0.001). Pts with EOM were more likely to have a change or stop in 1st line trt due to clinical progression (30.6% vs 15.7%, p = 0.006), and received fewer total lines of systemic trt, median of 1.0 (1.0-5.0) vs. 2.0 (1.0-8.0), p = 0.05. Pts with EOM had shorter median overall survival (OS) vs. those with NOM, (6.1 vs 13.7 months, p < .0001), HR = 2.79 (95% CI:1.95-3.97, p < .0001). Median OS was shorter for pts with EOM who received 1st line immune checkpoint inhibitor (n = 14) vs platinum-based chemotherapy (n = 43), (1.6 vs 9.1 months, p = 0.003). Pts with EOM received higher opioid analgesic doses at the first and last oncology outpatient visits compared to pts with NOM with mean morphine milligram equivalent (MME) dose of 60 ± 91 vs 28 ± 65 at first visit, p = 0.004, and 171 ± 214 vs. 94 ± 229 at last visit, p < 0.001. Conclusions: The presence of EOM in mUC is associated with worse outcomes vs. pts with NOM. Pts with EOM may benefit from 1st line platinum-based chemotherapy vs. checkpoint immunotherapy. Furthermore, pts with EOM experience more pain than pts with NOM and may benefit from early engagement with palliative care. Pts with EOM represent a population with a highly unmet need for systemic, targeted and/or radiation interventions. Molecular subtypes may further define these pts and analysis is planned. We encourage ongoing clinical trials to report outcomes in pts with EOM. A consensus on reporting of non-measurable disease is also needed. [Table: see text]

scholarly journals Systemic Immune-Inflammation Index Predicted Short-Term Outcomes in Patients Undergoing Isolated Tricuspid Valve Surgery

2021 ◽  
Vol 10 (18) ◽  
pp. 4147
Author(s):  
Jungpil Yoon ◽  
Jaewan Jung ◽  
Youngick Ahn ◽  
Jimi Oh
Keyword(s):  
Postoperative Complications ◽  
Tricuspid Valve ◽  
Cox Regression ◽  
Inflammatory Marker ◽  
Gastrointestinal Complications ◽  
Neutrophil Lymphocyte Ratio ◽  
Kaplan Meier ◽  
Cerebrovascular Events ◽  
Immune Inflammation ◽  
Poor Outcomes

Systemic immune-inflammation index (SII, platelet × neutrophil/lymphocyte ratio) has recently been identified as an inflammatory marker. We aimed to evaluate the prognostic implications of preoperative SII in patients undergoing isolated tricuspid valve (TV) surgery. In total, 213 patients who underwent isolated TV surgery between January 2000 and December 2018 were enrolled. They were divided into two groups, as follows: low SII (<455.6 × 109/L), and high SII (≥455.6 × 109/L). The correlation between SII and clinical outcomes was analyzed via the Cox regression and the Kaplan–Meier analyses. The primary outcomes considered were all-cause mortality and major postoperative complications within a 30-day period after isolated TV surgery, including major adverse cardiovascular or cerebrovascular events, pulmonary and renal complications, stroke, sepsis, multi-organ failure, wound, and gastrointestinal complications. In total, 82 (38.5%) patients experienced postoperative complications. Multivariable analyses revealed that high preoperative SII values were independently associated with the major 30-day postoperative complications (hazard ratio 3.58, 95% confidence interval 1.62–7.95, p = 0.001). Additionally, Kaplan–Meier analysis revealed that the probability of undergoing major 30-day postoperative complications was significantly elevated in patients with high versus low SII values (p < 0.001). These results indicate that SII, a readily available parameter, is significantly associated with poor outcomes in patients undergoing isolated TV surgery.

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