Outcome of Definitive Treatments in Primary Vaginal Cancer Patients: An Institutional Review

Abstract Background Immune checkpoint inhibition (ICI) improves survival outcomes for patients with several types of cancer including metastatic melanoma (MM), but serious immune-related adverse events requiring intervention with immunosuppressive medications occur in a subset of patients. Skin toxicity (ST) has been reported to be associated with better response to ICI. However, understudied factors, such as ST severity and potential survivor bias, may influence the strength of these observed associations. Methods To examine the potential confounding impact of such variables, we analyzed advanced cancer patients enrolled prospectively in a clinicopathological database with protocol-driven follow up and treated with ICI. We tested the associations between developing ST, stratified as no (n = 617), mild (n = 191), and severe (n = 63), and progression-free survival (PFS) and overall survival (OS) in univariable and multivariable analyses. We defined severe ST as a skin event that required treatment with systemic corticosteroids. To account for the possibility of longer survival associating with adverse events instead of the reverse, we treated ST as a time-dependent covariate in an adjusted model. Results Both mild and severe ST were significantly associated with improved PFS and OS (all P < 0.001). However, when adjusting for the time from treatment initiation to time of skin event, severe ST was not associated with PFS benefit both in univariable and multivariable analyses (P = 0.729 and P = 0.711, respectively). Receiving systemic steroids for ST did not lead to significant differences in PFS or OS compared to patients who did not receive systemic steroids. Conclusions Our data reveal the influence of time to event and its severity as covariates in analyzing the relationship between ST and ICI outcomes. These differences in outcomes cannot be solely explained by the use of immunosuppressive medications, and thus highlight the importance of host- and disease-intrinsic factors in determining ICI response and toxicity. Trial registration: The patient data used in this manuscript come from patients who were prospectively enrolled in two institutional review board-approved databases at NYU Langone Health (institutional review board #10362 and #S16-00122).

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Awareness and attitude of cancer patients about participation in clinical research (CR) in Saudi Arabia.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e17528 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e17528-e17528 ◽

Cited By ~ 1

Author(s):

Nagham Ramzi Sheblaq ◽

Sara Traifi ◽

Moahmmed Al Sakiani ◽

Ahmed Gasmelseed ◽

Mostafa A Abolfotouh ◽

...

Keyword(s):

Higher Education ◽

Cancer Patients ◽

Influencing Factors ◽

Standard Treatment ◽

Multivariate Analyses ◽

Public Awareness ◽

Cross Sectional Study ◽

Willingness To Participate ◽

Cross Sectional ◽

Institutional Review

e17528 Background: Enrollment of patients in CR may be impacted by their levels of awareness and attitude toward participation. Our study aims at assessing the awareness and willingness to participate in CR and identifying the barriers and influencing factors for participation. Methods: A cross-sectional study was performed using an interview-based questionnaire composed of close-ended questions conducted by trained research coordinators. Descriptive statistics, univariate and multivariate analyses were applied. Results: A total of 300 patients were enrolled in the study with a median age of 53.6 (42.2 - 64.0), and 188 patients (62.67%) were females. The majority of patients 289 (97.31%) were not aware of what is institutional review board. On the other hand, 226 (75.33%) showed interest in CR participation, if offered. The trust in treating physician (88.33 %) and the belief that participation in CR offers a better chance of cure (73.14%) were the two most important influencing factors to participate, while the preference of receiving standard treatment (43.13%) and the unknown efficacy of treatment (40.32%) were the top two barriers to participate. In univarate analyses, patients younger than 45 years (p<0.015) and those with higher education (more than middle school) (p<0.022) were significantly more interested in CR participation. However; in a multivariate analysis, higher education was the only significant predictor of interest to participate (p<0.023). Conclusions: There is an apparent gap in cancer patients’ awareness about CR. However, there is an obvious interest in participation in CR especially in patients with higher education level. Enhancing public awareness is crucial to improve CR participation.

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An open trial of aripiprazole for the treatment of delirium in hospitalized cancer patients

Palliative & Supportive Care ◽

10.1017/s1478951511000368 ◽

2011 ◽

Vol 9 (4) ◽

pp. 351-357 ◽

Cited By ~ 40

Author(s):

Soenke Boettger ◽

William Breitbart

Keyword(s):

Cancer Patients ◽

Clinical Care ◽

Performance Status ◽

Preliminary Finding ◽

Cancer Center ◽

Delirium Assessment ◽

Institutional Review ◽

The Mean ◽

Hypoactive Delirium ◽

Clinically Significant

AbstractObjective:The purpose of this study was to examine the efficacy and safety of aripiprazole in the treatment of delirium in hospitalized cancer patients, and to examine differential responses based on delirium subtypes.Method:We conducted an analysis of 21 hospitalized cancer patients at Memorial Sloan-Kettering Cancer Center (MSKCC) who had been evaluated and treated for delirium with aripiprazole, using an MSKCC Institutional Review Board (IRB) approved Clinical Delirium Database. Measures used were the Memorial Delirium Assessment Scale (MDAS), the Karnofsky Scale of Performance Status (KPS), and side effect rating at baseline (T1), 2–3 days (T2), and 4–7 days (T3). All measurements were integrated into the routine clinical care of patients. Doses of aripiprazole were adjusted based on clinical response.Results:Patients treated for delirium with aripiprazole experienced significant improvement and resolution of delirium, with MDAS scores declining from a mean of 18.0 at baseline (T1) to mean of 10.8 at T2 and a mean of 8.3 at T3. KPS scores improved from 28.1 at baseline (T1) to 35.2 at T2 and 41 at T3. Delirium resolved (based on MDAS < 10) in 52.4% of cases at T2 and in 76.2% at T3. The mean dosage of aripiprazole required was 18.3 mg (range of 5–30) daily at T3. In our cohort of patients with hypoactive delirium, we observed a delirium resolution rate of 100% compared to the cohort of patients with hyperactive delirium (58.3% rate of delirium resolution). MDAS scores improved from 15.6 at T1 to 5.7 at T3 in hypoactive delirium and from 19.9 at T1 to 10.2 at T3 in hyperactive delirium. In patients with pre-morbid cognitive deficits and the hyperactive subtype of delirium, we observed a more limited treatment response to aripiprazole treatment for delirium. There were no clinically significant side effects noted.Significance of results:Aripiprazole is effective and safe in the treatment of delirium in hospitalized cancer patients. These preliminary finding suggest that aripiprazole may be most effective in resolving delirium of the hypoactive subtype.

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Cervical cancer patients’ preferences and use of various cancer information sources in South Korea

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.16073 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 16073-16073

Author(s):

H. Noh ◽

M. Lee ◽

Y. Yun ◽

S. Park ◽

D. Bae ◽

...

Keyword(s):

Cervical Cancer ◽

South Korea ◽

Cancer Patients ◽

Information Sources ◽

Age Groups ◽

Cancer Center ◽

Cancer Information ◽

Age Group ◽

Institutional Review ◽

Personal Accounts

16073 Background: Accessing appropriate facts is important in enabling cancer patients cope with the disease. This study focused on the utilization and preferences of cancer information sources by cervical cancer patients in terms of ease in receiving and searching the available data. Methods: The study included 830 women over the age of 18 years treated for cervical cancer at six hospitals in South Korea between 1983 and 2004. All the participants provided written informed consent, and the Institutional Review Board of the National Cancer Center approved the protocol. A questionnaire addressed the patients’ use of and preferences for sources and forms of cancer information. Data were collected by mail. Results: Television and/or the radio were the the most frequently cited sources of cancer information by the middle and oldest age groups: 45–64 years (52.0%), =65 years (47.3%), while patients in the youngest age group (<45 years) used the Internet (38.8%). Booklets and/or pamphlets (24.0%) were the source of cancer information preferred by the youngest age group, while patients in the middle and oldest age groups preferred TV/radio: 45–64 years (35.7%) and =65 years (55.0%). Life notes and/or experiences (43.2%), that is, personal accounts, comprised the most easily understood form of information regardless of age group. Conclusions: Our findings indicate that cervical cancer patients’ utilization of and preferences for sources of cancer information vary according to patient age. Tailored educational materials that consider the users’ age and condition should be customized to best fit their specific preferences. No significant financial relationships to disclose.

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Once-Daily Versus Twice-Daily Enoxaparin for the Treatment of Acute Venous Thromboembolism in Cancer Patients

Annals of Pharmacotherapy ◽

10.1177/1060028017737094 ◽

2017 ◽

Vol 52 (3) ◽

pp. 257-262

Author(s):

Katherine Fuller ◽

Stephanie Malecki ◽

Lisa Anselmo ◽

Matthew E. Borrego ◽

Bernadette Jakeman ◽

...

Keyword(s):

Venous Thromboembolism ◽

Cancer Patients ◽

Statistical Power ◽

Once Daily ◽

Daily Group ◽

Institutional Review ◽

Enoxaparin Group ◽

Observational Cohort ◽

Acute Venous Thromboembolism ◽

Active Cancer

Background: No randomized controlled trials have investigated enoxaparin once versus twice daily for venous thromboembolism (VTE) treatment in cancer patients. Objective: To compare the safety and efficacy of enoxaparin 1 mg/kg twice daily versus enoxaparin 1.5 mg/kg/day for the treatment of acute VTE in cancer patients. Methods: This was a single-center, retrospective, observational cohort study. Adults with active cancer and an acute VTE were included. The primary outcome evaluated was the incidence of clinically relevant (major and nonmajor) bleeding (CRB) within 30 days of enoxaparin initiation. Secondary outcomes included the incidence of CRB, thrombosis, and death at 30, 90, and 180 days. The study protocol was approved by the institutional review board. Results: A total of 123 patients met inclusion criteria; 85 patients (69%) were treated with once-daily and 38 patients (31%) with twice-daily enoxaparin. CRB was numerically higher at 30 days in the twice-daily enoxaparin group compared with the once-daily group (5.3% vs 2.4%, P = 0.587). There was a nonsignificant higher incidence of CRB in the once-daily enoxaparin group compared with the twice-daily group at 90 days (8.3% vs 8%, P = 1.0) and 180 days (12.5% vs 7.1%, P = 1.0). The composite outcome of CRB, thrombosis, and death was higher at all time points with enoxaparin once daily. Conclusions: Lack of statistical power in this study precludes definitive conclusions. Clinicians may consider twice-daily enoxaparin because of potentially fewer adverse events but may be limited by patient preference and/or financial constraints.

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