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A gynecologic oncology group phase II trial of two p53 peptide vaccine approaches: subcutaneous injection and intravenous pulsed dendritic cells in high recurrence risk ovarian cancer patients.

ABSTRACT: Peptide antigens have been administered by different approaches as cancer vaccine therapy, including direct injection or pulsed onto dendritic cells; however, the optimal delivery method is still debatable. In this study, we describe the immune response elicited by two vaccine approaches using the wild-type (wt) p53 vaccine.Twenty-one HLA-A2.1 patients with stage III, IV, or recurrent ovarian cancer overexpressing the p53 protein with no evidence of disease were treated in two cohorts. Arm A received SC wt p53:264-272 peptide admixed with Montanide and GM-CSF. Arm B received wt p53:264-272 peptide-pulsed dendritic cells IV. Interleukin-2 (IL-2) was administered to both cohorts in alternative cycles.Nine of 13 patients (69%) in arm A and 5 of 6 patients (83%) in arm B developed an immunologic response as determined by ELISPOT and tetramer assays. The vaccine caused no serious systemic side effects. IL-2 administration resulted in grade 3 and 4 toxicities in both arms and directly induced the expansion of T regulatory cells. The median overall survival was 40.8 and 29.6 months for arm A and B, respectively; the median progression-free survival was 4.2 and. 8.7 months, respectively.We found that using either vaccination approach generates comparable specific immune responses against the p53 peptide with minimal toxicity. Accordingly, our findings suggest that the use of less demanding SC approach may be as effective. Furthermore, the use of low-dose SC IL-2 as an adjuvant might have interfered with the immune response. Therefore, it may not be needed in future trials.

SUBMITTER: Rahma OE

PROVIDER: S-EPMC3708463 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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A gynecologic oncology group phase II trial of two p53 peptide vaccine approaches: subcutaneous injection and intravenous pulsed dendritic cells in high recurrence risk ovarian cancer patients.

Rahma Osama E OE Ashtar Ed E Czystowska Malgorzata M Szajnik Marta E ME Wieckowski Eva E Bernstein Sarah S Herrin Vincent E VE Shams Mortada A MA Steinberg Seth M SM Merino Maria M Gooding William W Visus Carmen C Deleo Albert B AB Wolf Judith K JK Bell Jeffrey G JG Berzofsky Jay A JA Whiteside Theresa L TL Khleif Samir N SN

Cancer immunology, immunotherapy : CII 20110917 3

<h4>Purpose</h4>Peptide antigens have been administered by different approaches as cancer vaccine therapy, including direct injection or pulsed onto dendritic cells; however, the optimal delivery method is still debatable. In this study, we describe the immune response elicited by two vaccine approaches using the wild-type (wt) p53 vaccine.<h4>Experimental design</h4>Twenty-one HLA-A2.1 patients with stage III, IV, or recurrent ovarian cancer overexpressing the p53 protein with no evidence of di ...[more]

PMID: 21927947

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Project description:ObjectivesFinancial toxicity is increasingly recognized as an adverse outcome of cancer treatment. Our objective was to measure financial toxicity among gynecologic oncology patients and its association with demographic and disease-related characteristics; self-reported overall health; and cost-coping strategies.MethodsFollow-up patients at a gynecologic oncology practice completed a survey including the COmprehensive Score for Financial Toxicity (COST) tool and a self-reported overall health assessment, the EQ-VAS. We abstracted disease and treatment characteristics from medical records. We dichotomized COST scores into low and high financial toxicity and assessed the correlation (r) between COST scores and self-reported health. We calculated risk ratios (RR) and 95% confidence intervals (CI) for the associations of demographic and disease-related characteristics with high financial toxicity, as well as the associations between high financial toxicity and cost-coping strategies.ResultsAmong 240 respondents, median COST score was 29. Greater financial toxicity was correlated with worse self-reported health (r = 0.47; p < 0.001). In the crude analysis, Black or Hispanic race/ethnicity, government-sponsored health insurance, lower income, unemployment, cervical cancer and treatment with chemotherapy were associated with high financial toxicity. In the multivariable analysis, only government-sponsored health insurance, lower income, and treatment with chemotherapy were significantly associated with high financial toxicity. High financial toxicity was significantly associated with all cost-coping strategies, including delaying or avoiding care (RR: 7.3; 95% CI: 2.8-19.1).ConclusionsAmong highly-insured gynecologic oncology patients, many respondents reported high levels of financial toxicity. High financial toxicity was significantly associated with worse self-reported overall health and cost-coping strategies, including delaying or avoiding care.

Project description:Introduction/objectivesMultiple modes of administration are available for systemic lupus erythematosus (SLE) treatments. This study examined patient and physician characteristics associated with the choice of weekly subcutaneous (SC) injection or monthly intravenous (IV) infusion for an unspecified SLE treatment.MethodsThis was a cross-sectional, US web-based survey using a direct elicitation, stated-preference methodology (HO-16-16706). Two hundred patients and 200 physicians were asked to choose between IV or SC administration in a hypothetical scenario. Pairwise and multivariate analyses estimated the odds ratio (OR) for the likelihood of choosing SC over IV for respondent characteristics.ResultsAmong patients, taking non-steroidal anti-inflammatory drugs increased the likelihood of choosing SC injection (OR 3.884), whilst having SLE-related skin problems, a fear of needles or self-injection, and never needing help around the house decreased the likelihood (OR 0.28, 0.13, 0.12, respectively; all p ≤ 0.05). Among physicians, > 95% recommended SC injection for patients who live or work far from an infusion center, prefer SC administration, and never or rarely miss medication doses. Physician characteristics including age and treatment practice also influenced choice.ConclusionsPatient and physician characteristics influence choice of SC versus IV therapy for SLE. These findings might inform shared decision-making, which could lead to improved patient outcomes. Key Points • Data regarding patient and physician preference for different modes of administration of SLE therapy are sparse. • This cross-sectional, US web-based study showed that patient and physician characteristics influence choice of SC versus IV therapy for SLE. • A degree of disconnect exists between how factors influence patients' choice and how those characteristics influence physicians' choice of SLE treatment mode of administration. • The findings from this study might inform shared decision-making, which could improve alignment between treatment choice and patient preferences, treatment satisfaction, adherence, and improved patient outcomes.

Project description:BackgroundRituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings.MethodsThis non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient's first year of treatment (11 rituximab sessions).ResultsMean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27-58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1-5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53-91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1-5.5 eight-hour days.ConclusionsCompared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units.Trial registrationClinicalTrials.gov NCT01200758.

Dataset Information

A gynecologic oncology group phase II trial of two p53 peptide vaccine approaches: subcutaneous injection and intravenous pulsed dendritic cells in high recurrence risk ovarian cancer patients.

Publications

A gynecologic oncology group phase II trial of two p53 peptide vaccine approaches: subcutaneous injection and intravenous pulsed dendritic cells in high recurrence risk ovarian cancer patients.

Similar Datasets

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