Treatment patterns and costs in second-line (2L) metastatic colorectal cancer (mCRC).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 544-544 ◽  
Author(s):  
April H. Teitelbaum ◽  
Dana Evans ◽  
Elaine Yu ◽  
Robert Morlock ◽  
Stacey DaCosta Byfield
Keyword(s):  
Healthcare Costs ◽  
Linear Models ◽  
Small Sample Size ◽  
Medical Costs ◽  
Small Sample ◽  
Administrative Claims ◽  
Second Line ◽  
Claims Database ◽  
Match Rate ◽  
Before And After

544 Background: Administrative claims databases are an important data source to examine treatment (tx) patterns, costs and outcomes, but are subject to limitations. This study included a chart review to assess a claims-based algorithm for identifying 2L mCRC patients (pts). Tx patterns and costs were compared between mCRC pts treated with bevacizumab (BEV) or cetuximab (CET). Methods: 2LmCRC pts were identified from a US commercial insurance claims database (1/2008-6/2011). Initial identification required pts to have ≥2 claims ≥30 d apart for colon or rectal cancer and metastatic (met) disease. Continuous enrollment for ≥6 mo before and after the date of 1st met claim, ≥2 lines of therapy (LOT), and 2L tx with BEV or anti-EGFR was required. 2L was defined as addition of any new agent ≥28 d after start of 1st LOT. Charts from 92 pts were abstracted and used to refine and corroborate the algorithm. Generalized Linear Models (GLM) were used to assess differences in healthcare costs between patients on BEV or CET during 2L. Results: The match rate of claims identified mCRC pts treated with multiple lines of therapy confirmed by chart abstraction ranged from 85% to 97%. Applying the final algorithm to the overall claims data resulted in the identification of 569 pts: 450 pts receiving BEV and 119 pts receiving CET. A total of 38 panitumumab patients were excluded from analysis due to small sample size. Pt characteristics were similar; mean age was 61 years and 58% were males. In 2L, BEV was commonly used with 5FU or capecitabine-based regimens (81%) and CET with irinotecan-based regimens (73%). BEV pts had significantly lower all-cause healthcare costs (adjusted difference: –$12,239, p=0.02), and medical costs (–$13,672, p=0.01) during 2L. While on second-line therapy, BEV pts also had lower average monthly all-cause and medical costs than CET pts. Sensitivity analysis using variations of the case finding algorithm yield similar results. Conclusions: The use of BEV during second line treatment of mCRC was found to be associated with significantly lower healthcare costs relative to the use of CET from a large US healthcare claims database.

Participant Reactions to Suicide-Focused Research

Crisis ◽  
2020 ◽  
Vol 41 (5) ◽  
pp. 367-374
Author(s):  
Sarah P. Carter ◽  
Brooke A. Ammerman ◽  
Heather M. Gebhardt ◽  
Jonathan Buchholz ◽  
Mark A. Reger
Keyword(s):  
Medical Records ◽  
Research Study ◽  
Small Sample Size ◽  
Psychiatric Inpatient ◽  
Small Sample ◽  
Inpatient Unit ◽  
Online Laboratory ◽  
Psychiatric Inpatient Unit ◽  
Before And After ◽  
Participant Reactions

Abstract. Background: Concerns exist regarding the perceived risks of conducting suicide-focused research among an acutely distressed population. Aims: The current study assessed changes in participant distress before and after participation in a suicide-focused research study conducted on a psychiatric inpatient unit. Method: Participants included 37 veterans who were receiving treatment on a psychiatric inpatient unit and completed a survey-based research study focused on suicide-related behaviors and experiences. Results: Participants reported no significant changes in self-reported distress. The majority of participants reported unchanged or decreased distress. Reviews of electronic medical records revealed no behavioral dysregulation and minimal use of as-needed medications or changes in mood following participation. Limitations: The study's small sample size and veteran population may limit generalizability. Conclusion: Findings add to research conducted across a variety of settings (i.e., outpatient, online, laboratory), indicating that participating in suicide-focused research is not significantly associated with increased distress or suicide risk.

scholarly journals O-225 Effects of SARS-Corona virus 2 on IVF treatment parameters: A cohort study of post COVID-19 patients

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Y Kabalkin ◽  
M Gil ◽  
E Lifshitz ◽  
A Moav ◽  
M Kabessa ◽  
...  
Keyword(s):  
Cohort Study ◽  
Virus Disease ◽  
Small Sample Size ◽  
Sperm Concentration ◽  
Small Sample ◽  
Cycle Performance ◽  
Ang Ii ◽  
P Values ◽  
Corona Virus ◽  
Before And After

Abstract Study question Does recovery from SARS–Corona virus 2 (SARS–CoV-2) infection negatively effect IVF cycle parameters? Summary answer Female IVF treatment parameters were comparable to the pre-Covid-19 infection cycle performance. Sperm concentration and motility demonstrated lower mean counts following Covid-19 infection. What is known already Corona-virus disease-19 (Covid-19) is a global pandemic caused by SARS–Corona virus 2 (SARS–CoV-2). The virus primarily affects the respiratory system, but other systemic and immune mediated effects have been reported. The spikes of SARS-CoV-2 have strong affinity for the Angiotensin converting enzyme (ACE) 2 receptor, leading to an increased Angiotensin II (Ang II) mediated pro-inflammatory response. ACE2 receptors exist in the human reproductive tract (more in males) and pose a regulatory role together with Ang II. So far, reports have been inconsistent regarding testicular effects. Other implications involving fertility and fertility treatment post infection are scarce. Study design, size, duration In this retrospective cohort study, IVF cycle performance was compared before and after Corona-virus disease-19. Patients were included only in cases where an IVF cycle was initiated within 3 months of Covid-19 recovery, between March 2020-December 2020. Participants/materials, setting, methods The study was conducted in a University affiliated IVF unit. Post Covid- 19 cycle parameters were compared to previous cycles of the same individual prior to infection. If previous cycles were not available, parameters were compared to non-exposed patients of same age, same treatment and identical indication. Sperm concentration and motility were compared before and after infection. Non exposure was defined by a lack of past Covid-19 diagnosis and a negative PCR throughout the treatment. Main results and the role of chance All together, including the matched cycles, we compared 40 cycles which started within 3 months of recovery: 26 fresh stimulation cycles and 14 frozen thawed transfer cycles. In 28 of these cycles the patient could serve as its own control. Mean age for the female partner was 33.2 years ±6.5 years. Eight male partners presented post infection and provided fresh samples for a cycle involving fertilization. We compared stimulation parameters including maximal Estradiol level, stimulation length, FSH dosage, number of oocytes retrieved, fertilization rates, number of embryos created, high quality embryo number and endometrial thickness. All of these were comparable to non-exposed cycles (generalized estimating equations, p values >0.1). No complications were recorded, specifically no thromboembolic events or respiratory complications. A total of 8 patients conceived: 1 was a chemical pregnancy, 1 extra-uterine pregnancy, 3 miscarriages and 3 ongoing, of those 1 was complicated by early bleeding. Male sperm analyses showed a trend towards lower post disease parameters, not reaching a statistical significance: 23mil/ml compared to 13.6 and 20.7% progressive motility compared to 12.3% (p values 0.09 and 0.17, respectively). Limitations, reasons for caution Current results are based on a small sample size, still insufficient for deducing definite conclusions or guidelines. Pregnancy outcome following IVF treatment in Covid-19 recoverees should further be studied. By the time of the conference, the number of cases is expected to be significantly higher. Wider implications of the findings This study provides preliminary data regarding the effects of SARS-COV-2 infection on IVF treatment outcomes. Despite the small sample size, treatment parameters seem unaffected, however, sperm performance seems to be compromised. Health policy and patients’ decisions regarding whether or not to postpone IVF procedures necessitates additional data. Trial registration number Not applicable - retrospective

scholarly journals A Pilot Placebo Controlled Randomized Trial of Dexamethasone for Chronic Subdural Hematoma

2016 ◽  
Vol 43 (2) ◽  
pp. 284-290 ◽  
Author(s):  
Michel Prud’homme ◽  
François Mathieu ◽  
Nicolas Marcotte ◽  
Sylvine Cottin
Keyword(s):  
Conservative Treatment ◽  
Adverse Events ◽  
Small Sample Size ◽  
Chronic Subdural Hematoma ◽  
Symptomatic Patient ◽  
Placebo Treatment ◽  
Small Sample ◽  
Chi Square ◽  
Serious Adverse Events ◽  
Before And After

AbstractBackground: Current opinions regarding the use of dexamethasone in the treatment of chronic subdural hematomas (CSDH) are only based on observational studies. Moreover, the use of corticosteroids in asymptomatic or minimally symptomatic patient with this condition remains controversial. Here, we present data from a prospective randomized pilot study of CSDH patients treated with dexamethasone or placebo. Methods: Twenty patients with imaging-confirmed CSDH were recruited from a single center and randomized to receive dexamethasone (12 mg/day for 3 weeks followed by tapering) or placebo as a conservative treatment. Patients were followed for 6 months and the rate of success of conservative treatment with dexamethasone versus placebo was measured. Parameters such as hematoma thickness and clinical changes were also compared before and after treatment with chi-square tests. Adverse events and complications were documented. Results: During the 6-month follow-up, one of ten patients treated with corticosteroids had to undergo surgical drainage and three of ten patients were treated surgically after placebo treatment. At the end of the study, all remaining patients had complete radiological resolution. No significant differences were observed in terms of hematoma thickness profile and impression of change; however, patients experienced more severe side effects when treated with steroids as compared with placebo. Dexamethasone contributed to many serious adverse events. Conclusions: Given the small sample size, these preliminary results have not shown a clear beneficial effect of dexamethasone against placebo in our patients. However, the number of secondary effects reported was much greater for corticosteroids, and dexamethasone treatment was responsible for significant complications.

Abstract 13215: Gender-affirming Hormones Are Associated With Increased Risk of QT Prolongation in Transgender Females

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Daniel Antwi Amoabeng ◽  
Ahmed Hanfy ◽  
Munadel Awad ◽  
Bryce D Beutler ◽  
Amneet Rai ◽  
...  
Keyword(s):  
Qt Interval ◽  
Small Sample Size ◽  
Qt Prolongation ◽  
Small Sample ◽  
Rank Test ◽  
Qt Interval Prolongation ◽  
Northern Nevada ◽  
Increased Risk ◽  
Before And After ◽  
Signed Rank Test

Introduction: Women have a longer QT interval than men. This sex-specific difference is attributed to hormones associated with the biological female sex. Male-to-female transgender individuals often take antiandrogens such as spironolactone or goserelin in addition to estrogens to suppress testosterone effects while increasing feminine features. Effects of gender-affirming hormone therapy (GHT) on the QT interval in these individuals remains to be elucidated. Hypothesis: We assessed the hypothesis that the use of GHT is associated with an increased risk for QT interval prolongation in transgender females. Methods: We identified 46 transgender females through a search of the electronic medical records of a Veterans Administration hospital in Northern Nevada. Patients with a diagnosis of congenital long QT syndrome were excluded. Of these, 13 patients had ECGs before and after initiation of GHT and were included. We adapted the Tisdale score using the auto-calculated corrected QT interval (QTc) to estimate the risk of QT prolongation. Age, QTc, and Tisdale scores before and after GHT initiation were compared using the Wilcoxon signed-rank test. All tests were performed as two-tailed at a 5% level of significance. Results: All 13 study patients were taking estrogens. Of these, 3 (23.1%) were taking goserelin and 9 (69.2%) were taking spironolactone. Mean ± SEM age at ECG acquisition was 45.0 ± 4.4 and 47.7 ± 4.7 years before and after the initiation of GHT respectively. Mean ± SEM QTc after initiation of GHT was significantly higher compared to the baseline (467.5 ± 12.8 ms vs. 428.2 ± 7.1 ms) (Figure 1A). The average baseline Tisdale score was significantly smaller on follow-up (1-point vs. 3 points) (Figure 1B). Conclusions: GHT appears to be associated with increased QTc in transgender women. This needs to be interpreted with caution owing to the very small sample size in this study. Further studies to investigate the strength of this association, if it exists, are warranted.

Persistent Molecular Remission in Patients Treated with Imatinib-IFNa Combination or Imatinib Monotherapy.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4784-4784
Author(s):  
Monica Schippa ◽  
Enrico Gottardi ◽  
Debora Luzi ◽  
Lorenzo Falchi ◽  
Rita Emili ◽  
...  
Keyword(s):  
Real Time ◽  
Small Sample Size ◽  
Philadelphia Chromosome ◽  
Small Sample ◽  
Molecular Response ◽  
Second Line ◽  
Molecular Remission ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Line Of Therapy

Abstract INTRODUCTION. Continously improving results have been obtained during the last two decades in the control of Philadelphia chromosome (Ph’) positive chronic myeloid leukemia (CML). However, the final goal of molecular remission remains difficult to be obtained, even in the imatinib era. AIMS: Evaluation of the rate of long lasting molecular remission (undetectable p210 transcript at RQ-PCR confirmed by NESTED/RT-PCR in at least two subsequent tests performed over a period of 12 months or more) in response to imatinib or to imatinib-IFNa combination employed as first, second or subsequent line of therapy. PATIENTS. Imatinib alone or in combination with IFNa was given as first, second or subsequent line of therapy to a total of 47 patients. In particular, twenty-one patients were treated at the time of diagnosis with imatinib alone (18,G1) or imatinib-pegilated IFN combination (3,G2). Twenty-three additional patients (G3) received imatinib as second line therapy. Finally, 11 patients were treated with the imatinib-IFNa combination as second (5,G4) or third (6,G5) line therapy. In details, G4 consisted of three patients in cytogenetic relapse (3) or no response (2) after first line imatinib (1)or IFNa-ARA-C(1)therapy. All six patients included in G5 were complete kariotypic, but not molecular responder to imatinib given as second line treatment. METHODS. Molecular response was evaluated by NESTED/real-time-PCR (Guo JQ et al.; Leukemia : 2002; 15:2447–53) and real-time quantitative-PCR (Gabert J et al. Leukemia : 2003; 17: 2318–57) time intervals of 3–6 months from the beginning of therapy. RESULTS. A complete molecular remission lasting 12 months or more was obtained in 11 of 42 evaluable patients(therapy duration ≥ 18 mths).The response rate was higher in patients receiving the imatinib-IFNa combination(6/14) than in those given imatinib in monotherapy (5/36).In details, 4/14 and 1/3 patients respectively receiving early imatinib or imatinib-IFNa combination achieved a stable molecular remission. Two to four consecutive negative tests were documented in all five cases over a period ranging from 12 to 19 mths with 4 patients still in continous remission. Furthermore, 1/22 and 5/11 patients obtained a complete molecular response to imatinib given as second line therapy or imatinib-IFNa combination employed as second (4) or third (1) line therapy. Five negative tests were documented over a period of 12 mths in the patient responsive to imatinib monotherapy. Three to 7 negative consecutive tests were obtained during a period of 12 to 36 mths in the remaining five cases while receiving the imatinib-IFN-a combination. At the present time, 5 of these 6 patients are in continous molecular remission. In all molecularly responsive patients, stable molecular remission was usually preceded by a period of fluctuating negative-positive results of NESTED-PCR tests. CONCLUSIONS. It is not possible to achieve any firm conclusion regarding the effect of the imatinib-INFa combination on molecular response because of the small sample size of treated patients. However, our findings suggest an additive effect of imatinib and IFNa in Ph’ clone control as indicated by the improvement of the quality of remission in long lasting kariotypically, but not molecularly responsive patients when this combination therapy was utilized.

Bevacizumab (BEV) plus second-line taxane (TAX) or other chemotherapy (CT) for triple-negative breast cancer (TNBC): Subgroup analysis of RIBBON-2.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 290-290
Author(s):  
A. Brufsky ◽  
V. Valero ◽  
B. Tiangco ◽  
S. R. Dakhil ◽  
A. Brize ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Primary Endpoint ◽  
Small Sample Size ◽  
Objective Response ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Small Sample ◽  
Second Line ◽  
First Line ◽  
Free Survival

290 Background: In three randomized trials in the first-line metastatic breast cancer (MBC) setting, combining BEV with CT significantly improved progression-free survival (PFS; primary endpoint) and objective response rate (ORR) vs. CT alone. BEV also showed a significant PFS benefit in the second-line MBC setting (RIBBON-2) when combined with TAX or other CT. We analyzed data from the subgroup of patients (pts) with TNBC in RIBBON-2. Methods: Eligible pts had MBC that had progressed on first-line CT without BEV. Second-line CT (TAX, gemcitabine, capecitabine, or vinorelbine) was chosen before 2:1 randomization to CT with either BEV (10 mg/kg q2w or 15 mg/kg q3w) or placebo (PLA). All pts could receive BEV at progression. The primary endpoint was PFS. Results: RIBBON-2 included 684 pts; 159 (23%) had TNBC and of these, 67 (42%) received TAX with BEV/PLA. Baseline characteristics were broadly similar in the two treatment arms. In an exploratory analysis of pts with TNBC, BEV + CT led to significantly improved PFS and ORR vs. CT alone, and a trend toward improved overall survival (OS). The magnitude of the effect was particularly pronounced in pts receiving TAX CT. Conclusions: Pts with TNBC derive significant ORR and PFS benefit from BEV combined with second-line CT. Despite the small sample size, there was a trend (HR 0.624; p = 0.0534) toward OS benefit in pts treated with BEV, especially with TAX CT. [Table: see text]

Molecular profiling of TOPO1: A way to evaluate irinotecan treatment in colorectal cancer?

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 546-546
Author(s):  
Julia Marie Cunningham ◽  
Petra Prins ◽  
Brian Conkright ◽  
Simina Boca ◽  
Shruti Rao ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Small Sample Size ◽  
Predictive Marker ◽  
Molecular Profiling ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Similar Response ◽  
Second Line

546 Background: Front-line chemotherapy for metastatic colorectal cancer (mCRC) consists of a fluoropyrimidine backbone plus either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Large, prospective trials enrolling chemotherapy-naïve patients (pts) show FOLFOX and FOLFIRI treatment to be equivalent with similar response rates. Methods: Irinotecan inhibits TOPO1, which is now a candidate marker for irinotecan treatment benefit. Thus, we retrospectively analyzed TOPO1 expression level in 49 pts with mCRC who were treated with irinotecan-containing regimens at the Lombardi Comprehensive Cancer Center between 2009 and 2014. Patient characteristics and outcomes were compiled through chart review and the effect of TOPO1 expression on clinical outcomes was assessed. TOPO1 expression in tumor tissue from each pt was analyzed using a commercially available molecular profiling (MP) service (Caris Life Sciences). Results: The median overall survival (OS) for all pts was 33.9 months (mo), defined as the time from metastasis to death or censorship. When grouped by “high” or “low” TOPO1 expression, as defined by Caris at the time of the testing, 29 pts were high-expressers and 20 were low-expressers. High TOPO1 expressers receiving irinotecan (n = 22) had a median OS of 27.2 mo, compared with median 41.5 mo for low-expressers (n = 14) (p = 0.27). Irinotecan is conventionally given as second-line therapy. The median OS of pts receiving second-line irinotecan was 38.2 mo for high-expressers [n = 11] vs. 68.5 mo for low-expressers [n = 5]) (p = 0.32). Conclusions: Our limited data do not support the use of TOPO1 expression levels as a predictive marker for irinotecan therapy in mCRC. However, our conclusions are limited by small sample size, lack of a control group to distinguish prognostic from predictive markers, and timing of TOPO1 measurement, which in many cases was after irinotecan therapy. Physicians currently lack an evidence-based way to choose between potentially efficacious regimens for mCRC. More rigorous studies are needed to assess the benefit of MP in mCRC care. We are currently planning a prospective study with the hope of validating the use of TOPO1 expression as a predictive marker for treatment of this disease.

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