Quality of life (QoL) and symptoms evaluation in metastatic breast cancer (MBC) patients (pts) treated with eribulin: Preliminary results of a prospective observational study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12031-e12031
Author(s):  
Teresa Gamucci ◽  
Lucia Mentuccia ◽  
Silvia Quadrini ◽  
Luca I. Moscetti ◽  
Patrizia Vici ◽  
...  
Keyword(s):  
Observational Study ◽  
Prospective Observational Study ◽  
Metastatic Breast ◽  
Her2 Positive ◽  
Microtubule Inhibitor ◽  
Preliminary Results ◽  
Kaplan Meier ◽  
Trial Outcome Index ◽  
Third Line ◽  
Outcome Index

e12031 Background: Eribulin (E) is a nontaxane microtubule inhibitor currently indicated for third-line chemotherapy (CHT) of MBC. To evaluate its tolerability and impact on QoL and symptoms improvement in MBC pts, from April 2012, we conducted a prospective observational study. Methods: Pts pretreated with anthracycline (A) and taxane (T) who has received 2 CHT lines for MBC, scheduled to be treated with E were considered eligible. Pts complete the Edmonton Symptoms Assessment Scale (ESAS) at each cycle and the Functional Assessment of Cancer Therapy-Breast (FACT-B) every 2 cycles. Outcome of QoL included the FACT-B total score, FACT-General (FACT-G) score and the Trial Outcome Index (TOI) score. Groups of data were analyzed using ANOVA and the Friedman test. Kaplan-Meier method was used for survival calculation. Overall Survival was calculated by the Kaplan-Meier product-limit method. Results: 25 consecutive MBC pts entered the study. Median age 65 (range 31-77), PS (ECOG) 0-1 96%, 24% had triple-negative MBC, 70% ER/PgR positive and 5% HER2 positive. All pts were pretreated with A and T, 19 (76%) also with capecitabine. Median cycles 6 (range 3-13), 36% received more than 6 cycles. Five pts are to early for evaluation. Of the 20 evaluable pts main toxicity were: alopecia G1 58% and G2 42%, asthenia G2 40% peripheral neuropathy G2 25% neutropenia G2 0% and G3-G4 10%.At a median follow-up of 6 months 16% of pts achieved partial response (PR) 44% stable disease (SD) and 20% progressive disease; disease control rate (PR+SD ≥ 6 m) occurred in 40% of pts. Median PFS is 5 m (95% CI, 4-6) currently 70% of pts are alive. Data of ESAS and QoL are reported in table. Conclusions: Our preliminary results shows that treatment with E is associated with a significant improvement of ESAS scores (p=0.03) mainly in responders pts (p=0.02) and with a good maintenance of QoL with expected and manageable toxicities. Data collection is ongoing and update results will be presented. [Table: see text]

Patient-reported outcomes (PROs) from the systemic therapies for HER2-positive metastatic breast cancer (MBC) registry study (SystHERs): Eliciting the patient experience.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 286-286 ◽  
Author(s):  
Sara A. Hurvitz ◽  
Mohammad Jahanzeb ◽  
Peter Kaufman ◽  
Ginny Mason ◽  
Musa Mayer ◽  
...  
Keyword(s):  
Patient Experience ◽  
Economic Burden ◽  
Metastatic Breast ◽  
Reference Ranges ◽  
Her2 Positive ◽  
Job Effectiveness ◽  
Patient Reported ◽  
Trial Outcome Index ◽  
Observational Cohort ◽  
Outcome Index

286 Background: Patients with HER2-positive MBC are, on average, living longer. Data are limited on patient-reported quality of life (QoL) and economic burden during these extended survival periods. In accordance with guidelines for comparative effectiveness research in oncology (Basch et al, 2012), SystHERs, initiated in 2012, includes PROs to capture the patient experience. Here we report baseline (at enrollment) PRO results from SystHERs. Methods: SystHERs is a US-based prospective observational cohort study that aims to enroll 1000 patients with HER2-positive MBC within 6 months of metastatic diagnosis. Patients will be followed for 5–8 years.PROs, including QoL, economic burden, and symptoms related to neuropathy, alopecia, and cognition, are collected at baseline and ~90-day intervals during clinic visits, including after disease progression. Results: As of Feb 17, 2014, 319 patients were enrolled, and baseline data from 306 eligible patients are reported. Median time to enrollment since MBC diagnosis was 2.4 months. At least 1 PRO item was completed by 90% of eligible patients. Scale reference ranges (higher scores indicate better status) and median scores at baseline were: overall HRQoL (0–100)=80.0; FACT-B Trial Outcome Index (0–96)=58.0, and the Rotterdam Activities of Daily Living Scale (0–100)=85.7. One hundred patients (40.3%) were employed. These patients reported on average 36% work time missed (absenteeism) and 30% decreased on-the-job effectiveness (presenteeism) due to MBC. Patients reported a median out-of-pocket MBC-related expenditure of $735 in the past 3 months (range $0–11,700). Of this, the median deductible and copay-related cost was $350. Conclusions: To our knowledge, this is the only HER2-positive MBC patient registry that includes comprehensive PROs to supplement clinical data. To date, participation in PROs is high at baseline (90%).QoL and economic burden were consistent with other studies (Cortés et al, 2013; Zafar et al, 2013). Baseline results for ~500 patients are expected by the time of the congress presentation and will include data on symptoms related to neuropathy, alopecia, and cognition. Clinical trial information: NCT01615068.

scholarly journals Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917)

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Takahiro Nakayama ◽  
Tetsuhiro Yoshinami ◽  
Hiroyuki Yasojima ◽  
Nobuyoshi Kittaka ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Real World ◽  
Metastatic Breast ◽  
Trastuzumab Emtansine ◽  
Her2 Positive ◽  
The Real ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Abstract Background Trastuzumab emtansine (T-DM1) is a second-line standard therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Evidence regarding post–T-DM1 treatments is currently lacking. We evaluated the effectiveness of post–T-DM1 drug therapy in patients with HER2-positive, unresectable and/or metastatic breast cancer. Methods In this multicenter, retrospective, observational study, real-world clinical data of female patients with HER2-positive breast cancer who had a history of T-DM1 treatment were consecutively collected from five sites in Japan. We investigated the effectiveness of post–T-DM1 therapy by evaluating the real-world progression-free survival (rwPFS), time to treatment failure (TTF), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Tumor response was assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines. Subgroup and exploratory analyses according to background factors were also undertaken. Results Of the 205 patients who received T-DM1 treatment between 1 January 2014 and 31 December 2018, 128 were included in this study. Among the 128 patients analyzed, 105 (82%) patients received anti-HER2 therapy and 23 (18%) patients received regimens without anti-HER2 therapy. Median (95% confidence interval [CI]) rwPFS, TTF, and OS were 5.7 (4.8–6.9) months, 5.6 (4.6–6.4) months, and 22.8 (18.2–32.4) months, respectively. CBR and ORR (95% CI) were 48% (38.8–56.7) and 23% (15.1–31.4), respectively. Cox-regression analysis showed that an ECOG PS score of 0, a HER2 immunohistochemistry score of 3+, recurrent type, ≥12 month duration of T-DM1 therapy, and anti-HER2 therapy were independent variables for rwPFS. An exploratory subgroup analysis of regimens after T-DM1 showed that those with anti-HER2 therapy had a median rwPFS of 6.3 and those without anti-HER2 therapy had a median rwPFS of 4.8 months. Conclusions In the real-world setting in Japan, several post–T-DM1 regimens for patients with unresectable and/or metastatic HER2-positive breast cancer, including continuation of anti-HER2 therapy, showed some effectiveness; however, this effectiveness was insufficient. Novel therapeutic options are still needed for further improvement of PFS and OS in later treatment settings. Trial registration UMIN000038296; registered on 15 October 2019.

scholarly journals Diagnostic and Prognostic Value of Presepsin in Patients with Non-Infectious Organ Failure, Sepsis, and Septic Shock: A Prospective Observational Study According to the Sepsis-3 Definitions

2021 ◽  
Author(s):  
Sukyo Lee ◽  
Juhyun Song ◽  
Dae Won Park ◽  
Hyeri Seok ◽  
Jae-hyung Cha ◽  
...  
Keyword(s):  
Septic Shock ◽  
Observational Study ◽  
Organ Failure ◽  
Prospective Observational Study ◽  
Survival Curve ◽  
Curve Analysis ◽  
Roc Curve Analysis ◽  
Kaplan Meier ◽  
Sepsis And Septic Shock ◽  
Meier Survival Curve

Abstract Background: Sepsis is life-threatening organ dysfunction due to a dysregulated host response to infection. Early diagnosis of sepsis is challenging due to unknown sources of infection, and mortality prediction is usually complex. We aimed to investigate the clinical value of presepsin for discriminating sepsis from non-infectious organ failure and predicting mortality among sepsis patients in the emergency department (ED).Methods: This prospective observational study included 420 patients divided into three groups according to the Sepsis-3 definitions: non-infectious organ failure (n=142), sepsis (n=141), and septic shock (n=137). Blood samples for biomarker measurement of presepsin, procalcitonin, and C-reactive protein were drawn in the ED and biomarker levels were compared between the groups. Optimal cut-off values for presepsin to discriminate between the three clinical diagnoses were evaluated using receiver operating characteristic (ROC) curve analysis. We also performed ROC curve analysis for each biomarker as a predictor of mortality. After excluding non-infectious organ failure, we extracted the optimal cut-off value of presepsin to predict mortality associated with sepsis and septic shock and performed Kaplan–Meier survival curve analysis according to the cut-off value.Results: Presepsin levels (median [IQR]) were significantly higher in sepsis than in non-infectious organ failure (792 [450–1273] vs. 286 [170–417], p <0.001) and significantly higher in septic shock than in sepsis (1287 [589–2365] vs. 792 [450–1273], p=0.002). The optimal cut-off value for presepsin to discriminate between sepsis and non-infectious organ failure was 582 pg/mL (sensitivity, 70.1; specificity, 89.4; AUC, 0.877; p <0.001) and to discriminate between sepsis and septic shock was 1285 pg/mL (sensitivity, 50.4; specificity, 76.6; AUC, 0.618; p <0.001). The optimal cut-off value for presepsin for predicting 30-day mortality was 821 pg/mL (sensitivity, 68.9; specificity, 50.5; AUC, 0.605; p=0.005) in patients with sepsis and septic shock. Kaplan-Meier survival curve analysis showed that patients with higher presepsin levels (≥821 pg/mL) had significantly higher mortality than patients with lower presepsin levels (<821 pg/mL) (log-rank test; p=0.004). Conclusions: Presepsin levels could effectively differentiate sepsis from non-infectious organ failure and septic shock from sepsis. Presepsin levels could help clinicians predict mortality in patients with sepsis and septic shock.

AF.131 CHROMOENDOSCOPY FOR DETECTING DYSPLASIA IN IBD PATIENTS: PRELIMINARY RESULTS FROM A SINGLE-CENTRE, PROSPECTIVE OBSERVATIONAL STUDY

2021 ◽  
Vol 53 ◽  
pp. S197
Author(s):  
M.V. Lenti ◽  
F. De Grazia ◽  
M. Bardone ◽  
F. Borrelli De Andreis ◽  
S. Maimaris ◽  
...  
Keyword(s):  
Observational Study ◽  
Prospective Observational Study ◽  
Single Centre ◽  
Preliminary Results

scholarly journals Mortality dynamics of Pseudomonas aeruginosa bloodstream infections and the influence of defective OprD on mortality: prospective observational study

2019 ◽  
Vol 74 (9) ◽  
pp. 2774-2783 ◽  
Author(s):  
Eun-Jeong Yoon ◽  
Dokyun Kim ◽  
Hyukmin Lee ◽  
Hye Sun Lee ◽  
Jeong Hwan Shin ◽  
...  
Keyword(s):  
Risk Factors ◽  
Pseudomonas Aeruginosa ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Cox Regression ◽  
Bloodstream Infections ◽  
Clinical Settings ◽  
Kaplan Meier ◽  
Steep Decrease

Abstract Background To assess the mortality dynamics of patients with Pseudomonas aeruginosa bloodstream infections (BSIs) and the influence of OprD deficiencies of the microorganism on early mortality. Methods A prospective multicentre observational study was conducted with 120 patients with P. aeruginosa BSIs occurring between May 2016 and April 2017 in six general hospitals in South Korea. PCR and sequencing were carried out to identify the alterations in oprD and the presence of virulence factors. Cox regression was used to estimate the risk factors for mortality at each timepoint and Kaplan–Meier survival analyses were performed to determine the mortality dynamics. Results During the 6 week follow-up, 10.8% (13/120) of the patients with P. aeruginosa BSIs died in 2 weeks, 14.2% (17/120) in 4 weeks and 20.0% (24/120) in 6 weeks, revealing a steep decrease in cumulative survival between the fourth and sixth weeks. ICU admission and SOFA score were risk factors for mortality in any weeks after BSI onset and causative OprD-defective P. aeruginosa had a risk tendency for mortality within 6 weeks. Among the 120 P. aeruginosa blood isolates, 14 were XDR, nine produced either IMP-6 or VIM-2 MBL, and 21 had OprD deficiency. Conclusions BSIs caused by OprD-defective P. aeruginosa resulted in a 2-fold higher 6 week mortality rate (33.3%) than that of BSIs caused by OprD-intact P. aeruginosa (17.2%), likely due to the decreased susceptibility to carbapenems and bacterial persistence in clinical settings.

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