Post-hoc analysis of long-term outcomes in patients with CR, PR, or SD to pembrolizumab (pembro) or platinum-based chemotherapy (chemo) as 1L therapy for advanced urothelial carcinoma (UC) in KEYNOTE-361.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 435-435
Author(s):  
Yohann Loriot ◽  
Ajjai Shivaram Alva ◽  
Tibor Csőszi ◽  
Mustafa Ozguroglu ◽  
Nobuaki Matsubara ◽  
...  
Keyword(s):  
Phase Iii ◽  
Term Survival ◽  
Landmark Analysis ◽  
Kaplan Meier ◽  
Best Response ◽  
Platinum Based Chemotherapy ◽  
Duration Of Response ◽  
Post Hoc ◽  
To Receive

435 Background: The phase III KEYNOTE-361 study compared efficacy and safety of 1L pembro + chemo or pembro vs chemo in pts with advanced UC. The trial did not meet its primary endpoints of PFS or OS superiority for pembro + chemo vs chemo; formal testing for OS for pembro vs chemo was not performed. We present a post hoc landmark analysis to examine the durability of CR/PR/SD and long-term survival in pts with CR, PR, or SD to pembro vs chemo at week 9 in KEYNOTE-361 (NCT02853305). Methods: Landmark analyses of OS by CR/PR/SD at 9 weeks after randomization in the ITT population were performed. Pts were included if they had a best response of CR/PR/SD per RECIST v1.1 by blinded independent central review at the landmark date of week 9 (first imaging assessment per study protocol). Duration of CR/PR/SD and OS were estimated by the Kaplan-Meier method. No formal comparisons were performed. Results: 307 pts were randomized to receive pembro and 352 pts to receive chemo in the KEYNOTE-361 study. As of Apr 29, 2020, the median (range) time from randomization to data cutoff was 32.5 (22.0-42.4) mo for the pembo arm and 31.4 (22.1-41.6) mo for the chemo arm. In the landmark analysis, fewer pts had CR/PR/SD at week 9 with pembro (n=137 [45%]) than with chemo (n=253 [72%]). Median (range) duration of response for pembro vs chemo was 18.7 (4.4+-35.4+) vs 12.3 (0.0+-29.7+) mo for pts with CR, and 35.0 (1.1-36.1+) vs 6.1 (0.0+-36.3+) mo for pts with PR. Median (range) duration of SD was 4.8 mo (0.0-38.2+) with pembro and 4.6 mo (0.0-16.1+) with chemo. Median OS (95% CI) for pembro vs chemo was not reached (NR) (25.5-NR) vs NR (19.1-NR) for pts with CR; NR (NR-NR) vs 14.8 mo (12.1-21.0) for pts with PR; and 18.5 mo (13.8-28.8) vs 11.1 mo (8.1-14.6) for pts with SD, respectively. Long-term OS rates were higher with pembro vs chemo across all groups (CR/PR/SD) at week 9 (Table). Conclusions: In this post hoc landmark analysis, chemo was associated with more initial responses than pembro, whereas pembro was associated with longer median duration of CR and PR, and generally longer median OS than chemo. Among pts who achieved CR/PR/SD at week 9, the relative OS benefit for pembro vs chemo increased over time. Clinical trial information: NCT02853305. [Table: see text]

scholarly journals LTBK-12. EORTC 26951, RANDOMIZED STUDY OF ADJUVANT PCV AFTER 59.4 GY RADIOTHERAPY: VERY LONG TERM FOLLOW-UP

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi285-vi285
Author(s):  
Martin van den Bent ◽  
Khe Hoang-Xuan ◽  
Alba Brandes ◽  
Johan Kros ◽  
M C M Kouwenhoven ◽  
...  
Keyword(s):  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Term Survival ◽  
Long Term Survival ◽  
Kaplan Meier ◽  
Tumor Group ◽  
Long Term Follow Up

Abstract BACKGROUND Between 1995 and 2002 the EORTC Brain Tumor Group conducted a prospective phase III study on adjuvant procarbazine, CCNU and vincristine (PCV) chemotherapy in anaplastic oligodendroglioma (AOD). A mature follow-up presented in 2012 showed survival benefit of the addition of PCV, in particular in 1p/19q co-deleted tumors and tumors with MGMT promoter methylation. We now present very long term follow-up. MATERIALS AND METHODS Patients were eligible if locally diagnosed with a newly diagnosed AOD. They were randomized between radiotherapy (RT, 33 x 1.8 Gy) and the same RT followed by 6 cycles PCV (RT/PCV). Primary endpoints were overall survival (OS) and progression free survival (PFS). 1p/19q status (FISH) was determined in 300 patient. Kaplan- Meier technique and Cox modeling were used for long term survival analysis. Primary analyses were adjusted for known prognostic factors. For other analyses no adjustment was performed. RESULTS With 368 patients included, a median follow-up of 18.4 years and 307 (83%) survival events, median and 20-year survival after RT/PCV versus RT alone were 42.3 mo and 16.8% vs 30.6 months and 10.1% (HR 0.78; 95% CI (0.63, 0.98), adjusted p=0.06). Eighty patients were 1p/19q codel of which 26 (33%) were still alive, in this subgroup median and 20-year survival after RT/PCV versus RT alone were 14 years and 37.1% versus 9.3 years and 13.6% (HR 0.60, 95% CI (0.35, 1.03), unadjusted p=0.06). Twenty year PFS in 1p/19q codel was 31.3% in RT/PCV treated patients and 10.8% in RT only treated patients (HR 0.49, 95% CI (0.29, 0.83), unadjusted p=0.007). In the 1p/19q codel subgroup age, WHO PS and necrosis at pathology were identified to be of independent prognostic value for OS. CONCLUSION This long term analysis confirms the earlier conclusions and provides data on long term survival in this patient group. In 1p/19q codel patients treated with RT/PCV, the 20-year PFS and OS rates are 31% and 37% respectively.

scholarly journals Five-Year Survival Rates for Treatment-Naive Patients With Advanced Melanoma Who Received Ipilimumab Plus Dacarbazine in a Phase III Trial

2015 ◽  
Vol 33 (10) ◽  
pp. 1191-1196 ◽  
Author(s):  
Michele Maio ◽  
Jean-Jacques Grob ◽  
Steinar Aamdal ◽  
Igor Bondarenko ◽  
Caroline Robert ◽  
...  
Keyword(s):  
Survival Rate ◽  
Survival Benefit ◽  
Survival Rates ◽  
Advanced Melanoma ◽  
Phase Iii ◽  
Term Survival ◽  
Phase Iii Trial ◽  
Treatment Naïve ◽  
To Receive

Purpose There is evidence from nonrandomized studies that a proportion of ipilimumab-treated patients with advanced melanoma experience long-term survival. To demonstrate a long-term survival benefit with ipilimumab, we evaluated the 5-year survival rates of patients treated in a randomized, controlled phase III trial. Patients and Methods A milestone survival analysis was conducted to capture the 5-year survival rate of treatment-naive patients with advanced melanoma who received ipilimumab in a phase III trial. Patients were randomly assigned 1:1 to receive ipilimumab at 10 mg/kg plus dacarbazine (n = 250) or placebo plus dacarbazine (n = 252) at weeks 1, 4, 7, and 10 followed by dacarbazine alone every 3 weeks through week 22. Eligible patients could receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24. A safety analysis was conducted on patients who survived at least 5 years and continued to receive ipilimumab as maintenance therapy. Results The 5-year survival rate was 18.2% (95% CI, 13.6% to 23.4%) for patients treated with ipilimumab plus dacarbazine versus 8.8% (95% CI, 5.7% to 12.8%) for patients treated with placebo plus dacarbazine (P = .002). A plateau in the survival curve began at approximately 3 years. In patients who survived at least 5 years and continued to receive ipilimumab, grade 3 or 4 immune-related adverse events were observed exclusively in the skin. Conclusion The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at 5 years compared with those who initially received placebo plus dacarbazine. These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma.

A Post Hoc Landmark Analysis of Survival Probabilities in a Multinational Phase III Trial of Decitabine in Older Patients with Newly Diagnosed Acute Myeloid Leukemia

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3623-3623
Author(s):  
Xavier Thomas ◽  
Christopher Arthur ◽  
Jacques Delaunay ◽  
Mark M Jones ◽  
Erhan Barrak ◽  
...  
Keyword(s):  
De Novo ◽  
Fixed Time ◽  
Phase Iii ◽  
Refractory Anemia ◽  
Data Set ◽  
Once Daily ◽  
Phase Iii Trial ◽  
Landmark Analysis ◽  
Kaplan Meier ◽  
Post Hoc

Abstract Abstract 3623 Introduction: In a recent large, international, multicenter, randomized phase III trial (NCT00260832), the hypomethylating agent decitabine elicited a significantly greater response rate (complete remission [CR] rate plus CR without platelet recovery [CRp]) of 17.8%, with an odds ratio of 2.5 (95% CI: 1.4, 4.8; P=.001), at the time of the primary analysis (clinical cut-off [CCO] date October 28, 2009, at which time 396 deaths had occurred) compared with a response rate of 7.8% for patient's treatment choice (TC), with physician's advice, of low-dose cytarabine or supportive care (SC) in older patients with newly diagnosed acute myeloid leukemia (AML). A nonsignificant trend toward an overall survival (OS) benefit was observed with decitabine (median 7.7 months) versus TC (5.0 months). A subsequent analysis on a more mature data set (CCO date October 29, 2010; 446 deaths) confirmed this trend, finding that the median OS data were the same (Kantarjian et al. J Clin Oncol 2012;30:2760). This post hoc analysis aimed to further delineate the OS trend seen with decitabine by conducting a landmark analysis to determine OS for each treatment group in the trial at fixed time points based on the mature data set. Methods: In this multicenter, randomized, open-label phase III study, patients aged ≥65 years with de novo or secondary AML received decitabine 20 mg/m2 intravenously once daily for 5 days every 4 weeks or TC (SC or cytarabine 20 mg/m2 subcutaneously once daily for 10 days every 4 weeks). The primary efficacy population comprised all randomized patients. In the landmark analysis, OS at 3, 6, 12, 18, and 24 months postrandomization was estimated for each treatment group using the Kaplan-Meier method. Hazard ratios (HRs) were calculated using a Cox regression model; P values for the difference between the decitabine and TC arms were calculated using a 2-sided log-rank test. Results: In total, 485 patients were randomized to receive decitabine (n=242) or TC (n=243: 215 cytarabine; 28 SC). This was a high-risk AML population: at baseline, median patient age was 73.0 years (range, 64.0–91.0; 70.9% were ≥70 years), 59.4% were men, 35.3% had secondary AML, 36.0% had poor-risk AML, 25.8% had ECOG PS of 2 or higher, and median baseline blasts in bone marrow were 46.0%. In the post hoc landmark analysis using the mature data set (2010 CCO), a survival advantage was seen with decitabine at each time point (Table), with significant differences in OS at 6, 18, and 24 months (P=.009, .027, and .019, respectively). Conclusions: At fixed time points over 2 years, treatment with decitabine showed a trend toward improved OS compared with TC. CI, confidence interval. <>*Survival rates based on Kaplan-Meier product limit estimates. Three patients with no prerandomization choice available and later randomized to the decitabine group were excluded from the analysis. Note: Analysis based on the mature data set (2010 CCO). Disclosures: Off Label Use: Decitabine is a nucleoside metabolic inhibitor indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Delaunay:Novartis, Genzyme: Consultancy. Jones:Eisai Inc: Employment. Barrak:Eisai Inc.: Employment. Kantarjian:Eisai: Research Funding.

Long-term follow-up of the first randomized study of cisplatin versus carboplatin for advanced epithelial ovarian cancer.

1994 ◽  
Vol 12 (10) ◽  
pp. 2066-2070 ◽  
Author(s):  
A E Taylor ◽  
E Wiltshaw ◽  
M E Gore ◽  
I Fryatt ◽  
C Fisher
Keyword(s):  
Ovarian Cancer ◽  
Single Agent ◽  
Survival Rates ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Term Survival ◽  
Gynecology And Obstetrics ◽  
To Receive

PURPOSE A phase III trial was performed between October 1981 and June 1984 to compare the efficacy of single-agent cisplatin and single-agent carboplatin in previously untreated patients with International Federation of Gynecology and Obstetrics stage III or IV carcinoma of the ovary following surgery. This report describes the survival rates of patients in this study after a minimum follow-up duration of 8 years. PATIENTS AND METHODS Sixty-four patients were randomized to receive cisplatin and 67 patients to receive carboplatin. Cisplatin was administered every 4 weeks for a total of 10 courses, courses 1 to 5 at a dosage of 100 mg/m2 and courses 6 to 10 at 30 mg/m2. Carboplatin was administered at a dosage of 400 mg/m2 every 4 weeks for 10 courses. Patients who had clinical or radiologic evidence of response after five courses of chemotherapy underwent second-look surgery. The study was designed to allow crossover between the two arms. Thirteen patients were excluded from response analyses because they were incorrectly randomized. Patients were crossed over to the other arm of the study because of progressive disease (PD), nonresponse, or toxicity. RESULTS The overall response rate for patients randomized to the cisplatin arm was 53.8% (28 of 52; 95% confidence interval [CI], 39% to 68%) and for those randomized to the carboplatin arm, 38.4% (20 of 52; 95% CI, 25% to 53%). There were 16 (30.8%) and 14 (26.9%) complete remissions (CRs) in the cisplatin and carboplatin arms, respectively. None of these differences were statistically significant. The median duration of response for the cisplatin and carboplatin arms was 21 months and 17 months, and the 5-year relapse-free survival rates were 22% and 25%, respectively. The median survival durations for the cisplatin and carboplatin arms were 19.5 and 13 months, and the 5-year survival rates were 15% (95% CI, 8% to 26%) and 19% (95% CI, 11% to 30%), respectively. None of these differences was statistically significant. The median follow-up duration of patients is 9 years. Crossover due to toxicity was more frequent in the cisplatin than the carboplatin arm, occurring in 50% and 3.3% of patients, respectively. CONCLUSION The mature data from this study of patients with advanced ovarian cancer show that cisplatin and carboplatin have similar long-term survival results.

Surgery, Radio- and Chemo- therapy for Multimodal Treatment of Rectal Cancer

Swiss Surgery ◽  
2001 ◽  
Vol 7 (6) ◽  
pp. 256-274 ◽  
Author(s):  
Link ◽  
Staib ◽  
Kornmann ◽  
Formentini ◽  
Schatz ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Multimodal Treatment ◽  
Local Relapse ◽  
Phase Iii ◽  
Neoadjuvant Radiotherapy ◽  
Term Survival ◽  
Primary Tumors ◽  
Impact On Survival ◽  
Relapse Rates

The possibilities and results of multimodal treatment in rectal cancer were reviewed with respect to the results of surgical treatment only. Based on the results of 4 studies, reducing local relapse rates and increasing long term survival rates significantly, postoperative radiochemotherapy (RCT) + chemotherapy (CT) should remain the recommended standard for R0 resected UICC II and III rectal cancers. The addition of RT to adjuvant CT reduces local relapses without significant impact on survival (NSABP R-02). Vice versa, the addition of CT to RT or an improved CT in the RCT-concept prolongs survival. Preoperative neoadjuvant radiotherapy (RT) reduced local relapse rates in 9 studies, and extended survival in one study that evaluated all eligible patients. Preoperative RT reduced local relapse rates in addition to total mesorectal excision (TME) but did not extend survival. The preoperative RCT + CT downstages resectable and nonresectable tumors and induces a higher sphincter preservation rate. Phase III data justifying its routine use in all UICC II + III stages are not yet available. This treatment may be routinely applied in nonresectable primary tumors or local relapses. Preoperative RCT (or RT) may evolve as standard, if the patient selection is improved and postoperative morbidity and long term toxicity reduced. Intraoperative RT could be added to this concept or be used together with preoperative/postoperative RT at the same indications. Postoperative adjuvant RT reduced local relapses significantly in a single trial, and no impact on survival time is reported. Since postoperative RT is inferior to preoperative RT, this treatment cannot be recommended, if RT is chosen as a single treatment modality in adjunction to surgery. The results of local tumor excisions may be improved with pre- or postoperative RCT + CT. In the future, multimodal treatment of rectal cancer might be more effective, if individualized according to prognostic factors.

Transapical versus Conventional Aortic Valve Replacement�A Propensity-Matched Comparison

2012 ◽  
Vol 15 (1) ◽  
pp. 4 ◽  
Author(s):  
David M. Holzhey ◽  
William Shi ◽  
A. Rastan ◽  
Michael A. Borger ◽  
Martin H�nsig ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Survival Rates ◽  
Long Term Results ◽  
Term Survival ◽  
Kaplan Meier ◽  
Risk Patients ◽  
Short And Long Term ◽  
Good Treatment Option ◽  
Matched Comparison

<p><b>Introduction:</b> The goal of this study was to compare the short- and long-term outcomes after aortic valve (AV) surgery carried out via standard sternotomy/partial sternotomy versus transapical transcatheter AV implantation (taTAVI).</p><p><b>Patients and Methods:</b> All 336 patients who underwent taTAVI between 2006 and 2010 were compared with 4533 patients who underwent conventional AV replacement (AVR) operations between 2001 and 2010. Using propensity score matching, we identified and consecutively compared 2 very similar groups of 167 patients each. The focus was on periprocedural complications and long-term survival.</p><p><b>Results:</b> The 30-day mortality rate was 10.8% and 8.4% (<i>P</i> = .56) for the conventional AVR patients and the TAVI patients, respectively. The percentages of postoperative pacemaker implantations (15.0% versus 6.0%, <i>P</i> = .017) and cases of renal failure requiring dialysis (25.7% versus 12.6%, <i>P</i> = .004) were higher in the TAVI group. Kaplan-Meier curves diverged after half a year in favor of conventional surgery. The estimated 3-year survival rates were 53.5% � 5.7% (TAVI) and 66.7% � 0.2% (conventional AVR).</p><p><b>Conclusion:</b> Our study shows that even with all the latest successes in catheter-based AV implantation, the conventional surgical approach is still a very good treatment option with excellent long-term results, even for older, high-risk patients.</p>

scholarly journals Improved Long-Term Survival with Edaravone Therapy in Patients with Amyotrophic Lateral Sclerosis: A Retrospective Single-Center Study in Japan

2021 ◽  
Vol 14 (8) ◽  
pp. 705
Author(s):  
Hideki Houzen ◽  
Takahiro Kano ◽  
Kazuhiro Horiuchi ◽  
Masahiro Wakita ◽  
Azusa Nagai ◽  
...  
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Rank Test ◽  
Positive Pressure ◽  
Control Group ◽  
Single Center ◽  
Term Survival ◽  
Long Term Survival ◽  
Kaplan Meier ◽  
Lateral Sclerosis

Reports on the long-term survival effect of edaravone, which was approved for the treatment of amyotrophic lateral sclerosis (ALS) in 2015 in Japan, are rare. Herein, we report our retrospective analysis of 45 consecutive patients with ALS who initially visited our hospital between 2013 and 2018. Of these, 22 patients were treated with edaravone for an average duration of 26.6 (range, 2–64) months, whereas the remaining patients were not treated with edaravone and comprised the control group. There were no differences in baseline demographics between the two groups. The primary endpoint was tracheostomy positive-pressure ventilation (TPPV) or death, and the follow-up period ended in December 2020. The survival rate was significantly better in the edaravone group than in the control group based on the Kaplan–Meier analysis, which revealed that the median survival durations were 49 (9–88) and 25 (8–41) months in the edaravone and control groups, respectively (p = 0.001, log-rank test). There were no serious edaravone-associated adverse effects during the study period. Overall, the findings of this single-center retrospective study suggest that edaravone might prolong survival in patients with ALS.

Overall survival benefit from tebentafusp in patients with best response of progressive disease.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9509-9509
Author(s):  
Anthony M. Joshua ◽  
Jean-Francois Baurain ◽  
Sophie Piperno-Neumann ◽  
Paul Nathan ◽  
Jessica Cecile Hassel ◽  
...  
Keyword(s):  
Overall Survival ◽  
Safety Profile ◽  
Progressive Disease ◽  
Analysis Data ◽  
Cell Receptor ◽  
Kaplan Meier ◽  
Immortal Time Bias ◽  
Best Response ◽  
Overall Survival Benefit

9509 Background: Tebentafusp (tebe) is the first T cell receptor (TCR) therapeutic to demonstrate an overall survival (OS) benefit in a randomized Phase 3 (Ph3) study [ NCT03070392 ]. In Ph2, 42% of pts with best overall response (BOR) of progressive disease (PD) survived > 1 year (yr), suggesting RECIST-based radiographic assessments underestimate OS benefit of tebe. Here we analyzed OS in the Ph3 study in a cohort of pts with BOR of PD by comparing tebe to the control arm of investigator’s choice (IC). Methods: 378 pts were randomized in a 2:1 ratio to tebe vs. IC. BOR was assessed by investigators using RECIST v1.1. Treatment beyond first disease progression (TBP) was permitted for both arms. On the IC arm, only patients receiving pembrolizumab (pembro) continued with TBP and were included in the TBP-related analyses. No crossover to tebe was permitted; investigators were free to choose subsequent therapy. This analysis was conducted on the first interim analysis (data extracted Nov-2020). Kaplan-Meier estimates of OS were based on Day 100 landmark to eliminate immortal time bias and to capture majority of the PDs. Results: By Day 100, PD as BOR occurred in 52% (130/252) of tebe pts (PD-tebe) vs. 60% (76/126) of IC pts (PD-IC). Key baseline characteristics including lactate dehydrogenase, alkaline phosphatase, ECOG performance, age, and sex were similar between PD-tebe vs PD-IC. The proportion of pts with PD due to progression of target lesions (TL), non-TL, or new lesions were also similar between the two groups. More pts received TBP among PD-tebe 53% (69/130) vs PD-pembro 16% (10/61). Median duration of TBP was longer for PD-tebe (7 weeks) vs PD-Pembro (3 weeks). The safety profile of PD-tebe pts during TBP was similar to all tebe-treated pts. OS was superior for PD-tebe vs PD-IC, HR = 0.41 (95%CI 0.25-0.66), even when considering key baseline covariates. While some pts had regression of TL despite diagnosis of PD ( < 10% of pts), the OS benefit remained even when limited to pts with best change of tumor growth of TL, HR 0.46 (0.29, 0.73). 58% (75/130) PD-tebe and 52% (40/76) PD-IC pts received subsequent therapies. In a landmark OS analysis of these pts beginning on 1st day of subsequent therapy, prior tebe was associated with better OS vs. prior IC, HR 0.59 (95%CI 0.36-0.96). Conclusions: Tebe is the first TCR therapeutic to demonstrate an OS benefit in a solid tumor. Surprisingly, a strong OS benefit from tebe is observed even in pts with BOR of PD, suggesting that RECIST-based radiographic assessments do not capture the complete benefit from tebe. The safety profile of tebe during TBP was consistent with that for long-term tebe treatment. Clinical trial information: NCT03070392.

scholarly journals Colonization with Extensively Drug-Resistant Acinetobacter Baumannii and Prognosis in Critically Ill Patients: An Observational Cohort Study

2021 ◽  
Author(s):  
Yue Zheng ◽  
Nana Xu ◽  
Jiaojiao Pang ◽  
Hui Han ◽  
Hongna Yang ◽  
...  
Keyword(s):  
Regression Model ◽  
Acinetobacter Baumannii ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Drug Resistant ◽  
Short Term ◽  
Term Survival ◽  
Extensively Drug Resistant ◽  
Kaplan Meier

Abstract Background: Acinetobacter baumannii is one of the most often isolated opportunistic pathogens in intensive care units (ICUs). Extensively drug-resistant A. baumannii (XDR-AB) strains lack susceptibility to almost all antibiotics and pose a heavy burden on healthcare institutions. In this study, we evaluated the impact of XDR-AB colonization on both the short-term and long-term survival of critically ill patients.Methods: We prospectively enrolled patients from two adult ICUs in Qilu Hospital of Shandong University from April 2018 through December 2018. Using nasopharyngeal and perirectal swabs, we evaluated the presence of XDR-AB colonization. Participants were followed up for six months. Primary endpoints were 28-day and six-month mortality after ICU admission. For survival analysis, we used the Kaplan-Meier curve. We identified risk factors associated with 28-day and six-month mortality using the logistic regression model and Cox proportional-hazards survival regression model, respectively. Results: Out of 431 patients, 77 were colonized with XDR-AB. Based on the Kaplan-Meier curve results, the survival before 28 days did not differ by colonization status; however, a significant lower survival rate was obtained at six months in colonized patients. Univariate and multivariate results confirmed that XDR-AB colonization was not associated with 28-day mortality, but was an independent risk factor of lower survival days at six months, resulting in a 1.97 times higher risk of death at six months.Conclusions: XDR-AB colonization has no effect on short-term mortality but is associated with lower long-term survival in critically ill patients.

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