Estimation of Cumulative Incidence in the Presence of Competing Risks

2005 ◽  
pp. 577-586
Keyword(s):  
Competing Risks ◽  
Cumulative Incidence

Estimation of Cumulative Incidence in the Presence of Competing Risks

2005 ◽  
pp. 557-565 ◽  
Author(s):  
Wendy Leisenring ◽  
Barry Storer ◽  
Ted Gooley ◽  
John Crowley
Keyword(s):  
Competing Risks ◽  
Cumulative Incidence

scholarly journals Rivaroxaban for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation and Active Cancer

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2621-2621 ◽  
Author(s):  
Eva Simona Laube ◽  
Anthony Yu ◽  
Dipti Gupta ◽  
Yimei Miao ◽  
Patrick Samedy ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
General Population ◽  
Competing Risks ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Research Funding ◽  
Chronic Phase ◽  
Systemic Embolism ◽  
Safety And Efficacy ◽  
Active Cancer

Abstract BACKGROUND: The link between aging, cancer and atrial fibrillation is well known and the appropriate anticoagulation management of non-valvular atrial fibrillation (NVAF) in patients with active cancer is of growing clinical concern. Rivaroxaban has been broadly used for the primary prevention of stroke and systemic embolism in the general population of patients with NVAF. However, individuals with a serious concomitant illness associated with a life expectancy of less than 2 years were excluded from pivotal trials including the ROCKET-AF study, limiting the generalizability of results to patients with active cancer. There is little published evidence on the safety and efficacy of rivaroxaban for NVAF in this specific subgroup. OBJECTIVES: The aim of this study was to assess the safety and efficacy of rivaroxaban in patients with active cancer and NVAF. METHODS: The use of rivaroxaban in cancer patients at Memorial Sloan Kettering Cancer Center (MSKCC) was monitored in the setting of a Quality Assessment Initiative. Patients with active cancer and NVAF treated with rivaroxaban from 1/1/2014 through 3/31/2016 are included in this analysis. Endpoints of interest were defined a priori and include stroke, systemic embolism, major bleeding and clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban for at least 7 days (CRNMB). Clinical events were assessed through text searches of medical records. The analysis was performed respecting different times on previous anticoagulation, considering the first 90 days as the acute phase of treatment and contrasting it with the subsequent chronic phase. RESULTS: A total of 163 evaluable patients were included in the analysis, with a median age of 72.0 years (interquartile range=67.0-77.5 years) and 56% of these individuals being men. The majority had a solid tumor (85%), with stage IV disease reported in 50% of cases. The mean CHA2DS2-Vasc score was 3.2 (standard deviation=1.5) and 64% of patients were already in the chronic phase of anticoagulation. Results for the acute, chronic and combined phases of anticoagulation are presented in the Table and plotted in the Figure. The estimated cumulative incidence of ischemic stroke, major bleeding, and CRNMB at 1 year were 1.4% (95% CI=0-3.4%), 1.2% (95% CI=0-2.9%) and 14.0% (95% CI=4.2-22.7%) respectively, after adjusting for competing risks. Interestingly, the cumulative incidence of major bleeding in our cohort is lower than the value reported for the ORBIT-AF registry of cancer patients on dabigatran or a vitamin K antagonist for NVAF, in which the estimated rate of this complication was 5.1/100 patient-years. Lastly, the 1-year cumulative incidence of mortality was 22.6% (95% CI=12.2-31.7%). This high risk of death was present throughout the observation period and reflects the cancer population. One patient died after developing an acute ischemic cerebrovascular insult and a myocardial infarction. There were no deaths related to bleeding and no recorded systemic embolism episodes. CONCLUSIONS: The safety and efficacy profile of rivaroxaban treatment for NVAF in patients with active cancer seems comparable to what was observed for the general population in the ROCKET-AF study, but ideally a prospective study would be required to confirm these findings. Table Cumulative Incidence of Competing risks for Patients in the Acute, Chronic and Combined Phases of Anticoagulation* *Cumulative incidence estimates for the chronic phase are conditional to reaching day 90 of anticoagulation without sustaining an event. The chronic phase was defined as lasting 275 days and the combined period encompasses 365 days. CRNMB: Clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban for at least 7 days. *Clinically-relevant non-major bleeding leading to discontinuation of rivaroxabanfor at least7 days. Table. Cumulative Incidence of Competing risks for Patients in the Acute, Chronic and Combined Phases of Anticoagulation*. / *Cumulative incidence estimates for the chronic phase are conditional to reaching day 90 of anticoagulation without sustaining an event. The chronic phase was defined as lasting 275 days and the combined period encompasses 365 days. / CRNMB: Clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban for at least 7 days. / *Clinically-relevant non-major bleeding leading to discontinuation of rivaroxabanfor at least7 days. Figure Figure. Disclosures Yu: Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees. Soff:Janssen Scientific Affairs, LLC: Consultancy, Research Funding. Mantha:Janssen Scientific Affairs, LLC: Research Funding.

scholarly journals Prognostic factors in Asian and white American patients with cervical cancer, considering competing risks

2019 ◽  
Vol 26 (3) ◽  
Author(s):  
Y. Hou ◽  
S. Guo ◽  
J. Lyu ◽  
Z. Lu ◽  
Z. Yang ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Prognostic Factors ◽  
Competing Risks ◽  
Asian American ◽  
Cumulative Incidence ◽  
Figo Stage ◽  
Cumulative Incidence Function ◽  
White American ◽  
Node Metastasis ◽  
Incidence Function

Background Cervical cancer is the 2nd most common malignant tumour in women worldwide. Previous research studies have given little attention to its prognostic factors in the rapidly growing Asian American population. In the present study, we explored prognostic factors in Asian and white American patients with cervical cancer, considering competing risks.Methods The study included 58,780 patients with cervical cancer, of whom 54,827 were white and 3953 were Asian American, and for all of whom complete clinical information was available in the U.S. Surveillance, Epidemiology, and End Results database. Death from cervical cancer was considered to be the event of interest, and deaths from other causes were defined as competing risks. The cumulative incidence function and the Fine–Gray method were applied for univariate and multivariate analysis respectively.Results We found that, for all patients (white and Asian American combined), the cumulative incidence function was associated with several factors, such as age at diagnosis, figo (Fédération internationale de Gynécologie et d’Obstétrique) stage, registry area, and lymph node metastasis. Similar results were found when considering white patients only. However, for Asian American patients, registry area was not associated with the cumulative incidence function, but the other factors (for example, figo stage) remained statistically significant. Similarly, in multivariate analyses, we found that age at diagnosis, figo stage, lymph node metastasis, tumour histology, treatment method, and race were all associated with prognosis.Conclusions Survival status differs for white and Asian American patients with cervical cancer. Our results could guide the treatment of, and facilitate prognostic judgments about, white and Asian American patients with cervical cancer.

Estimating sample size in the presence of competing risks – Cause-specific hazard or cumulative incidence approach?

2015 ◽  
Vol 27 (1) ◽  
pp. 114-125 ◽  
Author(s):  
BC Tai ◽  
ZJ Chen ◽  
D Machin
Keyword(s):  
Sample Size ◽  
Competing Risks ◽  
Cumulative Incidence ◽  
Exponential Model ◽  
Sample Sizes ◽  
Subdistribution Hazard ◽  
Competing Events ◽  
Event Times ◽  
The Impact

In designing randomised clinical trials involving competing risks endpoints, it is important to consider competing events to ensure appropriate determination of sample size. We conduct a simulation study to compare sample sizes obtained from the cause-specific hazard and cumulative incidence (CMI) approaches, by first assuming exponential event times. As the proportional subdistribution hazard assumption does not hold for the CMI exponential (CMIExponential) model, we further investigate the impact of violation of such an assumption by comparing the results obtained from the CMI exponential model with those of a CMI model assuming a Gompertz distribution (CMIGompertz) where the proportional assumption is tenable. The simulation suggests that the CMIExponential approach requires a considerably larger sample size when treatment reduces the hazards of both the main event, A, and the competing risk, B. When treatment has a beneficial effect on A but no effect on B, the sample sizes required by both methods are largely similar, especially for large reduction in the main risk. If treatment has a protective effect on A but adversely affects B, then the sample size required by CMIExponential is notably smaller than cause-specific hazard for small to moderate reduction in the main risk. Further, a smaller sample size is required for CMIGompertz as compared with CMIExponential. The choice between a cause-specific hazard or CMI model in competing risks outcomes has implications on the study design. This should be made on the basis of the clinical question of interest and the validity of the associated model assumption.

Syngeneic Donor Hematopoietic Stem Cell Transplantation Is Associated with High Rates of Engraftment Syndrome

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1323-1323
Author(s):  
John Koreth ◽  
Melinda Biernacki ◽  
Julie Aldridge ◽  
Haesook T Kim ◽  
Edwin P Alyea ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Competing Risks ◽  
Cumulative Incidence ◽  
Hla Class I ◽  
Hematopoietic Stem ◽  
Engraftment Syndrome

Abstract Abstract 1323 Engraftment syndrome (ES), typically characterized by non-infectious fever, rash and/or non-cardiogenic pulmonary edema, is a complication of autologous and allogeneic hematopoietic stem cell transplantation (HSCT). There is no data on ES after syngeneic HSCT. We retrospectively analyzed syngeneic HSCT outcomes and determined ES incidence, risk factors, and prognostic impact. 32 adult patients with a median age of 46 years (range, 22–60) underwent syngeneic HSCT at our institution between July 1986-April 2009, primarily for hematologic malignancies (31% myeloid, 66 % lymphoid-including 16% plasma cell). Syngeneic donor typing methods varied over the time-period of this report and included: serologic HLA Class I and II typing; confirmatory SSP molecular HLA Class I typing; molecular PCR-RFLP and SSP HLA Class II typing; and STR genotyping using ABI Profile Plus Kit Human Identity markers. Patient characteristics: 15 (47%) were male; 28 (88%) had high-risk disease; 18 (56%) received total-body irradiation (TBI) as a component of myeloablative conditioning; 16 (50%) received donor peripheral blood stem cell infusion; and 14 (41%), 10 (31%) and 9 (28%) had low-, intermediate- and high-risk HCT-comorbidity index score respectively. No graft-versus-host-disease prophylaxis, T-cell depletion, or pre-emptive or prophylactic donor lymphocyte infusion was utilized. The median duration of follow-up was 6.1 years (range, 3.7 months-18.1 years). 5-year progression-free and overall survival (PFS, OS) was 52% and 67% respectively. 5-year overall cumulative incidence of relapse and non-relapse mortality (NRM) was 37.6% and 10.2% respectively. 15 patients (47%) met diagnostic criteria for ES, 10 (67%) of whom received a brief course of systemic steroids with prompt clinical response in all except one patient (who died of respiratory failure). Patient age ≥50 years was a risk factor for developing ES (p=0.05). Median time to engraftment was 12 days in patients with ES vs. 11.5 days in those without ES. 5-year PFS was 47% in patients with ES vs. 56% in those without (p=0.37). 5-year OS was 63% with ES vs. 71% without (p=0.8). 5-year cumulative incidence of relapse was 32% with ES and 44% without (p=0.68). 5-year cumulative incidence of NRM was 21% with ES vs. 0% without (p=0.06). In multivariable Cox-models only myeloid diagnosis (vs. lymphoid) impaired PFS and OS (HR 4.83, 95% CI 1.33–17.53, p=0.02; HR 8.47, 95% CI 1.73–41.58, p<0.01 respectively). In summary, we document a high incidence of ES after syngeneic HSCT. While syngeneic ES did not impact HSCT survival outcomes, the trend of increased NRM with ES is concerning and needs re-evaluation in a larger cohort.Figure:Cumulative Incidence of Relapse and NRM as Competing Risks-by ES cohortFigure:. Cumulative Incidence of Relapse and NRM as Competing Risks-by ES cohort Disclosures: No relevant conflicts of interest to declare.

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