Tumor IGF-1 expression as a predictive biomarker for IGF1R-directed therapy in advanced pancreatic cancer (APC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4054-4054 ◽  
Author(s):  
Milind M. Javle ◽  
Rachna T. Shroff ◽  
Gauri R. Varadhachary ◽  
Robert A. Wolff ◽  
David R. Fogelman ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Predictive Biomarker ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Primary Study ◽  
Study Objective ◽  
Log Rank Test ◽  
Hazards Model

4054 Background: IGF-1 up-regulates PC proliferation and invasiveness through activation of PI3K/Akt signaling pathway and down-regulates PTEN. We investigated IGF-1 expression in tissue and blood as potential predictive markers in phase II study of IGF1R-directed monoclonal antibody, MK-0646 in APC. Prior phase I established the MTD of MK0646 at 5 mg/kg with gemcitabine (G) and erlotinib (E) and 10 mg/kg with G alone. Methods: Patients (pts) with stage IV, previously untreated APC, ECOG PS 0-1, adequate hematologic and organ function were enrolled. Arm A: G 1,000 mg/m2 over 100 min, weekly x 3, MK-0646 weekly x 4; Arm B: G 1000 mg/m2 and MK-0646 + E 100 mg daily. Arm C (control) was G 1,000 mg/m2 + E 100 mg. Cycles were repeated every 4 weeks. Pts were equally randomized in the 3 arms. Primary study objective was progression-free survival (PFS). Pre-treatment peripheral blood samples were measured for IGF-1 level by ELISA; archival core biopsies were analyzed for IGF-1 mRNA expression. RNA extraction from FFPE samples used Roche Transcriptor First Strand cDNA Synthesis Kit. TaqMan PreAmp technique was used to amplify target cDNA prior to TaqMan RT-PCR analysis. Cox proportional hazards model for PFS analyzed the interaction between tissue IGF-1 expression and treatment. Results: 50 pts were enrolled (A=15, B=16,C=16 pts, 3 ineligible). Median PFS of arms A, B and C were 5.5 months (95% CI: 3.9 – NA), 3.0 months (95% CI:1.8 – 5.6) and 2.0 months (95% CI: 1.8 – NA), respectively (log-rank test; p = 0.17). Median OS of A was 11.3 months (95% CI: 8.9 – NA), B 8.9 months (95% CI: 5.3 – NA) and C 5.7 months (95% CI: 2.0 – NA) (log-rank test; p = 0.44). 35 archival core biopsies were analyzed, 21 had adequate tissue for analysis. Using a Multivariable Cox proportional hazards model for PFS, where IGF-1 was dichotomized at the median, there was a 76% reduction in the risk of disease progression or death in arm A as compared with the control (arm C) at high IGF-1 level (p = 0.16). When IGF-1 was fitted as a continuous variable, this reduction was 96% (p = 0.08). There was no correlation between tissue and serum IGF-1. Conclusions: Tissue expression of IGF-1 level may represent a promising predictive biomarker for IGF1R-directed therapy in APC.

CEA response at four weeks as an early predictor for outcomes in patients (pts) with metastatic colorectal cancer (mCRC) treated with first-line cetuximab-based chemotherapy: A STEP-analysis in the JACCRO CC-05/06 trials.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 543-543 ◽  
Author(s):  
Yu Sunakawa ◽  
Xuemin Fang ◽  
Masahito Kotaka ◽  
Hiroaki Tanioka ◽  
Akinori Takagane ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Phase Ii Trials ◽  
Clinical Biomarkers ◽  
Log Rank Test ◽  
Hazards Model ◽  
Early Tumor

543 Background: We have reported that carcinoembryonic antigen (CEA) response correlated with clinical outcomes of 1st-line cet-based therapy (Target Oncol 2017). Early tumor shrinkage (ETS) is considered to be an on-treatment biomarker for outcomes of chemotherapy; however, clinical biomarkers to predict outcomes earlier are warranted. Methods: This study included 69 pts who were assessable for CEA at baseline and 4 wks, and with observed survival time from 2 phase II trials of 1st-line therapy for KRAS exon2 wild-type mCRC; JACCRO CC-05 of cet plus FOLFOX (UMIN000004197) and CC-06 of cet plus SOX (UMIN000007022). We investigated the influence of baseline age, gender, PS, primary tumor sidedness (PTS), number of tumor sites, as well as the CEA decrease at 4 wks to the patient’s OS and PFS. Results: PTS and the CEA decrease at 4 wks were found to be important predictors to OS and PFS. Baseline CEA and CEA decrease at 4 wks were median of 31.0 (range, 1.0-20920.0) and median of 35% (range, -259%-97%), respectively. The STEP-analysis indicated that CEA response was most significantly associated with OS when a cut-off value of 50% for CEA-responder (HR 0.49, log-rank test p = 0.03). Median OS in responders (n = 25) and non-responders (n = 44) were 36.2 m and 21.5 m, respectively. When the same cut-off value was used, median PFS in responders and non-responders were 11.6 m and 6.5 m, respectively (HR 0.64, log-rank test p = 0.08). In addition, a multivariate Cox Proportional-Hazards Model with both PTS and CEA response as risk factors showed that PTS correlated with both OS and PFS. In pts with left-sided tumors, non-responders (n = 33) had shorter OS and PFS compared to responders (n = 23). In the above 2-covariate Cox proportional hazard model, adjusted HR for CEA 50% decrease is 0.55, p = 0.1; adjusted HR for PTS is 2.66, p = 0.008. Conclusions: Our analysis suggests 50% CEA decrease at 4 wks as an early on-treatment biomarker for 1st-line cet-based therapy in mCRC. It may potentially predict outcomes earlier compared to ETS. Also, CEA response at 4 wks may differentiate pts who receive more benefit from cet treatment in left-sided tumors. Clinical trial information: UMIN000004197 and UMIN000007022.

Hypertension (HTN) as a potential biomarker of efficacy in patients (pts) with gastrointestinal stromal tumor (GIST) treated with sunitinib (SU).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 38-38 ◽  
Author(s):  
S. George ◽  
T. Lechner ◽  
S. Li ◽  
D. P. Cohen ◽  
G. D. Demetri
Keyword(s):  
Clinical Outcomes ◽  
Tyrosine Kinases ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Significant Independent Predictor ◽  
Hazards Model ◽  
Potential Biomarker

38 Background: HTN is a class effect of VEGF signaling pathway inhibitors. SU is a multitargeted inhibitor of VEGFRs and other receptor tyrosine kinases. Associations between SU-induced HTN and efficacy endpoints (OS, PFS, TTP, and ORR) in pts with imatinib-resistant/intolerant GIST from 2 prospective clinical trials were investigated retrospectively. Methods: This analysis included pooled data from 319 pts who received SU and had post-baseline blood pressure (BP) data available. Tumor response data were based on investigator assessments. Most pts (87%) received SU 50 mg/d on the standard 4-wk-on/2-wk-off schedule. BP was measured on the first and last day of dosing in each treatment cycle at a minimum. HTN was defined as max or mean SBP ≥ 140 or DBP ≥ 90 mmHg. OS, PFS, and TTP were estimated by Kaplan—Meier methods and compared between pts with vs. without HTN using the log-rank test. The influence of prognostic risk factors was analyzed using a Cox proportional hazards model. Results: 233 and 187 pts (73% and 59%) had ≥ 1 HTN episode as defined by max SBP and DBP, respectively. Efficacy results significantly favored pts who developed HTN on SU based on max SBP or DBP (eg, median OS for pts with HTN [max SBP] was 89.4 weeks vs. 53.1 weeks for pts without HTN [p = 0.0001]). Using HTN onset as a time-dependent covariate, HTN defined by max DBP was a significant predictor of prolonged TTP and PFS, and HTN defined by both max SBP and DBP was a significant predictor of prolonged OS (p < 0.05). In multivariate analysis, HTN defined by max SBP or DBP was a significant independent predictor of improved OS, PFS, and TTP (p < 0.0001). Analysis of any-grade and grade ≥3 cerebrovascular, ocular, cardiac, and renal AEs in pts with/without HTN is ongoing and will be presented. Clinical outcomes were not compromised in pts treated with anti-HTN medications. Conclusions: SU-associated HTN was significantly and independently associated with improved clinical outcomes, supporting the hypothesis that HTN is a biomarker for antitumor efficacy in pts with GIST treated with SU. Serial BP monitoring and standard use of anti-HTN medications, which were not shown to compromise efficacy, are recommended during SU therapy. [Table: see text]

CA19-9 decrease at 8 weeks as a predictor of overall survival (OS) in a randomized phase III trial (MPACT) of weekly nab-paclitaxel (nab-P) plus gemcitabine (G) versus G alone in patients with metastatic pancreatic cancer (MPC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4058-4058 ◽  
Author(s):  
E. Gabriela Chiorean ◽  
Daniel D. Von Hoff ◽  
Thomas J. Ervin ◽  
Francis P. Arena ◽  
Jeffrey R. Infante ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Phase Iii ◽  
Rank Test ◽  
Hazards Model ◽  
Relationship Of ◽  
To Receive ◽  
The Relationship

4058^ Background: nab-P + G showed promising efficacy in a phase I/II study in MPC, and decreases in CA19-9 correlated with OS. In MPACT, patients (pts) who received nab-P + G vs G had improved median OS (8.5 vs 6.7 mo; HR 0.72; p = 0.000015), PFS (5.5 vs 3.7 mo; HR 0.69; p = 0.000024) and ORR (23% vs 7%; p = 1.1 × 10−10). Here we present a prespecified exploratory analysis of CA19-9 from the MPACT trial. Methods: 861 previously untreated pts with MPC were randomized 1:1 to receive nab-P 125 mg/m2 + G 1000 mg/m2 days 1, 8, and 15 every 4 weeks or G alone 1000 mg/m2 weekly for 7 weeks followed by a week of rest (cycle 1) and then days 1, 8, and 15 every 4 weeks (cycle ≥ 2). CA19-9 was evaluated at baseline and then every 8 weeks. OS comparisons at different CA19-9 criteria were performed by stratified Cox proportional hazards model (P by stratified log-rank test using randomization criteria). Results: 750 pts had an evaluable CA19-9 at baseline. More pts in the nab-P + G arm vs the G arm demonstrated a best CA19-9 decrease from baseline of ≥ 20% and ≥ 90% (61% vs 44% and 31% vs 14%, respectively; Table). At the first postbaseline assessment (week 8), greater proportions of pts in the nab-P + G arm vs the G arm had CA19-9 decreases of ≥ 20% and ≥ 90% (Table). At that time point, for pts with a decrease of ≥ 20% in CA19-9, nab-P + G demonstrated a significantly longer OS vs G. The risk reduction for pts with a ≥ 90% decrease was greater than in pts with a ≥ 20% decrease. In pts with an 8-week CA19-9 decrease < 20%, median OS for nab-P + G vs G was 8.3 vs 8.0 mo (HR 0.92; p = 0.705). The relationship of CA19-9 kinetics with OS will also be examined. Conclusions: Higher proportions of pts in the nab-P + G arm had CA 19-9 responses of ≥ 20% and ≥ 90% vs the G arm. Pts who achieved a CA19-9 decrease at 8 weeks of ≥ 20% or ≥ 90% had significantly longer OS with nab-P + G than with G. Clinical trial information: NCT00844649. [Table: see text]

Results of the randomized phase II portion of NRG Oncology/RTOG 0848 evaluating the addition of erlotinib to adjuvant gemcitabine for patients with resected pancreatic head adenocarcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4007-4007 ◽  
Author(s):  
Howard Safran ◽  
Kathryn A Winter ◽  
Ross A. Abrams ◽  
William Regine ◽  
Karyn A. Goodman ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Pancreatic Head ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Adjuvant Radiation ◽  
Pancreatic Head Cancer ◽  
Hazards Model ◽  
Kaplan Meier

4007 Background: NRG/RTOG 0848 is a 2-step study designed to determine whether erlotinib (E) added to gemcitabine (G) (randomized Ph II) &/or adjuvant radiation with concurrent 5-FU or capecitabine following 6 months of systemic chemotherapy (Ph III), improve survival in patients (pts) with resected pancreatic head adenocarcinoma. The erlotinib results are reported here. Methods: Eligible pts include those with resected pancreatic head adenocarcinoma, pathologic stage T1-T3, N0-1, M0; PS 0-1, & CA19-9 ≤ 180 IU/L. Pts in Arms 1 & 2 received G 1 gm/m2 weekly for 3 weeks in a 28-day cycle for 6 cycles. Pts in Arm 2 also received E 100 mg/day. The primary hypothesis for the E portion was that G+E would increase overall survival (OS) compared to G alone. With a 1-sided alpha of 0.15, 200 OS events provide 80%/90% power to detect a signal for an increase in median OS from 22 to 28.8/30.6 months (mos). OS was estimated by the Kaplan-Meier method & arms compared using the log rank test. The Cox proportional hazards model was used to analyze treatment effect. Results: 336 pts were randomized from 11/17/2009 to 2/28/2014, with 163 pts evaluable for G and 159 for G+E. Median age was 63 years (39-86). Most pts had pathologic T3 disease (78%) & CA19-9 ≤ 90 (93%). There are 32 pts (20%) with grade 4 adverse events (AEs) & 2 pts (1%) with grade 5 AEs on G and 27 (17%) & 3 (2%) on G+E arm, respectively. There are fewer grade ≥ 3 GI AEs on the G arm (22%) as compared to the G+E arm (28%), and 110 (69.2%) & 93 (59.6%) pts received at least 85% of planned G dose for the G & G+E arms, respectively. 58% of E pts received at least 85% of planned E dose. The median follow-up for alive pts is 42.5 mos (min-max: < 1-75). With 203 deaths, median & 3-yr OS (95% CI) are 29.9 mos (21.7-33.4) & 39% (30, 45) for G and 28.1 mos (20.7-30.9) & 39% (31, 47) for G+E; log-rank p = 0.62. The hazard ratio (95% CI) comparing OS of G+E to G is 1.04 (0.79- 1.38). Conclusions: The addition of adjuvant E to G did not provide a signal for increased OS in pts with resected pancreatic head cancer compared to G alone. Accrual to the trial is continuing to answer the Ph III radiation question. Clinical trial information: NCT01013649.

Glucocorticoid receptor (GR) expression in circulating tumor cells (CTCs) to prognosticate overall survival (OS) for metastatic castration-resistant prostate cancer (mCRPC) patients (pts) treated with androgen receptor signaling inhibitors (ARSi).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 194-194 ◽  
Author(s):  
David Wise ◽  
James Kelvin ◽  
Ryon Graf ◽  
Nicole A. Schreiber ◽  
Brigit McLaughlin ◽  
...  
Keyword(s):  
Protein Expression ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Predictive Biomarker ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Castration Resistant Prostate Cancer ◽  
Hazards Model ◽  
Kaplan Meier ◽  
The Impact

194 Background: Upregulation of GR protein expression in metastatic biopsies from pts with CRPC has previously been shown to correlate with resistance to enzalutamide and has been validated as a therapeutic target in pre-clinical studies. We sought to determine whether upregulated GR protein expression in CTCs from pts with progressing mCRPC predicted clinical outcomes following treatment with enzalutamide (E) or abiraterone (A). Methods: Pre-therapy blood samples from 54 pts with progressing mCRPC were subjected to CTC analysis using the Epic Sciences platform. Samples were examined to identify CK+ (CK+, CD45- cells, with intact nuclei, morph distinct) CTCs for GR protein expression. GR+ CTCs were defined as having expression greater than the 95th percentile of GR expression in the GR negative LNCAP cell line. Kaplan-Meier analysis was used to test the impact of GR+ CTCs on OS following treatment with A or E. A Cox proportional hazards model with CTC number and GR positivity was used in a multivariate analysis. Results: 37 out of 54 pts (69%) had detectable and viable CK+ CTCs. 28 out of 37 pts (76%) had CTCs with upregulated GR staining with a median of 6 GR+/CK+ cells/ml per patient (range 0.7 – 244 cells/ml). The OS of patients with GR+ CTCs treated with ARSi was significantly worse than that of patients without detectable GR+ CTCs (11.4 mo. vs NA, p < 0.01), an effect independent and additive to the presence of viable CTCs, a previously described prognostic biomarker (see Table). Conclusions: GR protein upregulation in CTCs can be detected in a significant percentage of pts with progressing mCRPC and the presence of GR+ CTCs predicts worse OS in response to ARSi. The data supports previously reported pre-clinical data proposing a pathogenic role for GR in mediating resistance to ARSi therapy. Detection of GR in patient CTCs may be a useful predictive biomarker to guide GR-directed therapies. [Table: see text]

scholarly journals The Association between Serum Hemoglobin and Renal Prognosis of IgA Nephropathy

2021 ◽  
Vol 10 (2) ◽  
pp. 363
Author(s):  
Tae Ryom Oh ◽  
Su Hyun Song ◽  
Hong Sang Choi ◽  
Chang Seong Kim ◽  
Seung Hyeok Han ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iga Nephropathy ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Hazards Model ◽  
Renal Prognosis

Immunoglobin A (IgA) nephropathy causes chronic kidney disease worldwide. Therefore, identifying risk factors associated with the progression of IgA nephropathy is crucial. Anemia is a common complication of chronic kidney disease; however, few studies have investigated the effect of serum hemoglobin on the renal prognosis of IgA nephropathy. This study aimed to determine the effect of serum hemoglobin on the progression of IgA nephropathy. We retrospectively analyzed 4326 patients with biopsy-proven IgA nephropathy. We evaluated the effect of serum hemoglobin on IgA nephropathy progression using Kaplan–Meier survival analyses, the log-rank test, and the Cox proportional hazards model. The primary end-point was progression of IgA nephropathy, defined as dialysis initiation or kidney transplantation. Serum hemoglobin showed a nonlinear relationship with the progression of IgA nephropathy. The Cox proportional hazards model showed that the risk of progression of IgA nephropathy decreased 0.87 times for every 1.0 g/dL increase in serum hemoglobin. In subgroup analyses, reduced serum hemoglobin was an independent risk factor for IgA nephropathy progression only in women. There was no statistically significant interaction of serum hemoglobin between men and women (Pinteraction = 0.177). Results of Sensitivity analysis were robust and consistent. Serum hemoglobin at diagnosis was an independent predictor for IgA nephropathy progression.

scholarly journals Clinicopathological Characteristics and Prognostic Prediction in Pseudomyxoma Peritonei Originating From Mucinous Ovarian Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Fengxian Fu ◽  
Xulan Ma ◽  
Yiyan Lu ◽  
Hongbin Xu ◽  
Ruiqing Ma
Keyword(s):  
Ovarian Cancer ◽  
Pseudomyxoma Peritonei ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Survival Rates ◽  
Clinicopathological Characteristics ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Hazards Model

ObjectiveTo describe the clinicopathological characteristics of mucinous ovarian cancer (MOC)-derived pseudomyxoma peritonei (PMP) and identify prognostic factors for survival.MethodsMedical records from patients with MOC-derived PMP who attended the Aerospace Center Hospital, Beijing, China between January 2009, and December 2019 were retrospectively reviewed. Survival analysis was performed with the Kaplan-Meier method, the log-rank test, and a Cox proportional hazards model.ResultsCytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for PMP originating from MOC were performed on 22 patients, who had a median age of 52 years at the time of surgery. At the last follow-up in June 2020, 9 (41%) patients were still alive. Median OS was 12 months (range, 1 to 102 months), and the 2-, 3-, and 5-year survival rates were 23, 9, and 5%, respectively.ConclusionHistopathologic subtype and PCI may be applied as predictors of prognosis in patients with MOC-derived PMP. Patients with high-grade disease could benefit from completeness of cytoreduction (CCR) 0/1.

The outcome of patients with stage I endometrial cancer involving the lower uterine segment

2008 ◽  
Vol 18 (5) ◽  
pp. 1079-1083 ◽  
Author(s):  
O. Lavie ◽  
L. Uriev ◽  
M. Gdalevich ◽  
F. Barak ◽  
G. Peer ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Carcinoma ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Myometrial Invasion ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Stage I ◽  
Rank Test ◽  
Log Rank Test

The objective of this study was to evaluate whether lower uterine segment involvement (LUSI) correlates with recurrence and survival in women with stage I endometrial adenocarcinoma and whether it is associated with poor prognostic histopathologic features. Three hundred seventy-five consecutive patients with endometrial carcinoma stage I compromised the study population. The patients were divided into two groups according to the presence of LUSI with endometrial carcinoma. The two groups were compared with regard to prognostic factors and outcome measures by using the Pearson χ2 test, log-rank test, and Cox proportional hazards model. LUSI was present in 89 (24%) patients with stage I endometrial carcinoma. LUSI was significantly associated with grade 3 tumor (P= 0.022), deep myometrial invasion (P< 0.0001), and the presence of capillary space-like involvement (CSLI) (P= 0.003). Kaplan–Meier survival curves demonstrated that patients with LUSI had a lower recurrence-free survival (log-rank test; P= 0.009) and a worse overall survival (log-rank test; P= 0.0008). In the Cox proportional hazards model, only a trend toward higher recurrence rate (HR = 2.4, 95% CI 0.7, 8.2; P= 0.16) and a trend toward poorer overall survival (HR = 1.54, 95% CI 0.82, 2.91; P= 0.18) were noted when LUSI was present. In patients with stage I endometrial cancer, the presence of LUSI is associated with grade 3 tumor, deep myometrial invasion, and the presence of CSLI. A larger group of patients is necessary to conclude whether higher recurrence rate and poorer overall survival are associated with the presence of LUSI.

scholarly journals Association between coordination of long-term care insurance service and adverse outcome after discharge in older patients with heart failure

2021 ◽  
Vol 20 (Supplement_1) ◽  
Author(s):  
Y Tsunekawa ◽  
T Adachi ◽  
T Kameyama ◽  
K Kobayashi ◽  
A Matsuoka ◽  
...  
Keyword(s):  
Older Patients ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Adverse Outcome ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Term Care ◽  
Hazards Model ◽  
Group I

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Long-term care insurance (LTCI) has a key role in the disease management of older patients in Japan. However, clinical benefit of coordinating LTCI service during hospitalization has not been examined in patients with heart failure (HF). Purpose We aimed to examine the association between the coordination of LTCI service and adverse outcome after discharge in Japanese older patients with HF. Methods The inclusion criteria of this retrospective cohort study were patients aged ≥ 65 years hospitalised for HF who used any LTCI services after discharge. In Japan, people aged ≥ 65 who satisfy the eligibility criteria are eligible to receive LTCI services. Questionnaires regarding daily life and activities are used to assess eligibility and create the 7 certification levels: support required 1 or 2, and care levels 1 (least disabled) to 5 (most disabled). In this study, patients were divided into 1) patients without any change in LTCI service during hospitalisation (Group N), 2) patients with coordination of LTCI services during hospitalization (Group C), 3) patients who newly initiated LTCI service after discharge (Group I). The primary outcome was a composite of HF rehospitalisation and all-cause mortality. Survival rate was compared using Kaplan-Meier curve analysis and log-rank test. Multivariate analysis was conducted using Cox proportional-hazards model adjusted for propensity score calculated based on age, gender, brain natriuretic peptide, β-blocker, angiotensin converting enzyme inhibitor /angiotensin II receptor blocker, need of any walking device or assistance at discharge, living alone, LTCI level. Results A total of 135 older patients were included (mean age 84 years, men 46%). During the median follow-up of 580 days, 43 events occurred. The number of patients for each group was as following: Group N, n = 91; Group C, n = 20; Group I, n = 24. The survival rates were significantly different among the three groups (log-rank test p = 0.039 , Figure 1). In Cox proportional-hazards model with Group N as a reference, Group C was associated with reduced risk of the study outcome (hazard ratio 0.22, 95% confidence interval 0.05-0.91, p = 0.036). Group I also showed lower event rate but not statistically significant (hazard ratio 0.81, 95% confidence interval 0.20-0.30, p = 0.756). All the patients in Group C used visiting nurse service, whereas the implementation rates were 12.1% and 37.5% in Group N and Group I, respectively. Implementation rate of visiting rehabilitation was higher in Group C (20.0%) compared to Group N (1.1%) and Group I (4.2). Conclusions Patients with coordination of LTCI service during HF hospitalization showed reduced risk of adverse outcome after discharge, implying the clinical benefits of utilization of LTCI service. Further large-scale studies are needed to examine the optimal utilization of tailor-made LTCI service according to the patient’s condition.

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