The study of tamoxifen and raloxifene (STAR): First report of patient-reported outcomes (PROs) from the NSABP P-2 Breast Cancer Prevention Study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. LBA561-LBA561 ◽  
Author(s):  
P. A. Ganz ◽  
S. R. Land ◽  
D. L. Wickerham ◽  
M. Lee ◽  
M. Ritter ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Statistical Power ◽  
Phase Iii ◽  
Double Blind ◽  
Mixed Effects Modeling ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Musculoskeletal Problems ◽  
Pre Treatment

LBA561 Background: STAR is a double-blind, randomized phase III prevention trial designed to evaluate the relative efficacy of raloxifene (R) compared to tamoxifen (T) in reducing the incidence of invasive breast cancer in high-risk postmenopausal women. In addition to standard safety monitoring, PROs were measured for quality of life (QOL) and symptoms (SXs). Methods: QOL was measured with the MOS SF-36, the CES-D, and the MOS Sexual Activity Questionnaire. SXs were measured using a modified checklist (SCL) from the NSABP P-1 BCPT. Primary endpoints were the SF-36 physical (PCS) and mental (MCS) component scales. A sample size of 1,670 provided statistical power of at least 0.8 (two-tailed test, alpha = .05). The QOL study was open to accrual at selected sites between 1/4/2000 and 5/31/2001, with questionnaires administered at baseline (pre-treatment), q 6 mos until 60 mos, and at 72 mos. SCL data were collected on all STAR participants. Longitudinal analyses used mixed effects modeling for the PCS, MCS, CES-D, and regression analyses were used to compare the average severity of SCL scores between T and R. Results: 19,747 participants enrolled in STAR and were eligible for the SCL assessment, with median follow-up time (mFU) 4.6 yrs. The QOL study enrolled 1,983 participants, 973 assigned to T and 1,010 assigned to R, mFU 5.4 yrs. QOL participants were comparable to women accrued concurrently at non-participating institutions. SCL and QOL forms compliance was high (with a low of 75% at 4.5 yrs for SCL and 74% for QOL). Mean PCS and MCS scores declined modestly over the 60 mos on study, with no significant difference between T and R. Mean CES-D scores worsened slightly on study, but with no significant difference between T and R. However, statistically significant differences (all p’s < .002) were noted between the T and R for severity of SXs, with R women reporting greater musculoskeletal problems, dyspareunia and weight gain and T women reporting greater vasomotor symptoms, leg cramps, bladder and gynecological problems. Conclusions: There were no significant differences between T and R in PROs for physical & mental health or depresson. While SX severity was generally low in this postmenopausal sample, the pattern of SXs differed between T and R. [Table: see text]

The Study of Tamoxifen and Raloxifene (STAR): Change in patient-reported outcomes (PROs) after the end of treatment

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1506-1506
Author(s):  
P. A. Ganz ◽  
S. R. Land ◽  
D. L. Wickerham ◽  
M. Lee ◽  
M. Ritter ◽  
...  
Keyword(s):  
Weight Gain ◽  
Post Treatment ◽  
Phase Iii ◽  
Double Blind ◽  
Main Trial ◽  
End Of Treatment ◽  
Sf 36 ◽  
Patient Reported ◽  
Stopping Treatment ◽  
Pre Treatment

1506 Background: STAR is a double-blind, placebo controlled, randomized phase III prevention trial to evaluate the efficacy of 5 years of raloxifene (R) compared to tamoxifen (T) in reducing the incidence of breast cancer in high-risk postmenopausal women. STAR was unblinded on 3/30/2006. Primary clinical outcomes, quality of life (QOL) and symptoms (SXs) were reported (JAMA, 6/2006). We now describe changes in QOL and SXs post-treatment. Methods: Endpoints for QOL were the MOS SF-36 physical (PCS) and mental (MCS) component scales and the CES-D. SXs were measured using a modified checklist from the NSABP BCPT. Questionnaires were administered before treatment, every 6 months until 60 months, and then at 66 or 72 months. Participants enrolled in QOL study at selected sites from 1/4/2000–5/31/2001. SX data were collected on all participants in the main trial. The change in PCS, MCS and SX scales after the end of treatment was analyzed with linear regression. Results: From 7/1/1999–11/4/2004, 19,747 participants enrolled in STAR and were eligible for the SX assessment; 4,338 completed both on- and post-treatment assessments. The QOL study enrolled 1983 participants; 400 completed both on- and post-treatment assessments. CES-D scores improved significantly from on- to off-treatment (p=.007), but less so for those stopping treatment early (p=.03). The MCS and CES-D returned to pre-treatment levels; the PCS remained below (p=0.02). These endpoints did not differ by treatment group. Forgetfulness (p=.01), musculoskeletal (p=.01), vasomotor (p<.0001), dyspareunia (p<.0001), bladder (p=.0002), weight gain (p<.0001), gynecological (p<.0001), and leg cramp (p<.0001) scales decreased in severity after treatment. Those who stopped treatment early had a greater decrease in vasomotor SXs (p=.01) but a lesser decrease in gynecological SXs (p=.02). Patients on T had a greater decrease in the vasomotor (p=.02) and bladder (p=.009) scales and a lesser decrease in weight gain (p=.04). Compared to pre-treatment levels, post-treatment vasomotor SXs decreased (p=0.009) and leg cramps increased (p<.0001). Conclusions: QOL and SXs changed significantly after treatment, largely returning to pre-treatment levels. No significant financial relationships to disclose.

Patient-reported outcomes from MA.17R: A randomized trial of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.

2016 ◽  
Vol 34 (18_suppl) ◽  
pp. LBA506-LBA506 ◽  
Author(s):  
Julie Lemieux ◽  
Paul E. Goss ◽  
Wendy R. Parulekar ◽  
James N. Ingle ◽  
Kathleen I. Pritchard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Aromatase Inhibitor ◽  
Sexual Functioning ◽  
Disease Free Survival ◽  
Wilcoxon Test ◽  
Phase Iii ◽  
Vasomotor Symptoms ◽  
Change Scores ◽  
Sf 36 ◽  
Patient Reported

LBA506 Background: MA.17R is a Canadian Cancer Trials Group (CCTG) led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor (AI) as adjuvant therapy for hormone-receptor positive breast cancer. The primary endpoint was disease-free survival. Quality of life (QOL) was a secondary endpoint. Methods: QOL was measured with the SF-36 (2 summary scores and 8 domains) and menopause-specific QOL (MENQOL) (4 symptom domains) at baseline and every 12 months (mo) up to 60 mo. QOL assessment was mandatory for CCTG centres but optional to centres in other groups. Mean change scores from baseline were calculated at 12 and 36 mo. Between-arm differences were assessed with the Wilcoxon test. Results: 1918 patients were randomized and 1428 patients completed the baseline QOL assessment. Compliance with QOL measures was over 85%. Baseline summary scores for SF-36 physical (PCS, 47.5 for letrozole and 47.9 for placebo) and mental (MCS, 55.5 for letrozole and 54.8 for placebo) were close to population norms (50). No differences were seen between groups in mean change scores for the SF-36 PCS and MCS and the other 8 QOL domains. Patients randomized to letrozole reported worse vasomotor symptoms (12 mo p = 0.02, 36 mo p = 0.03) and worse sexual functioning (12 mo p = 0.01, 36 mo p = 0.01). Further analyses with follow up to 60 months will be presented. Conclusions: No differences were seen in overall QOL measured by the SF 36 summary measures between letrozole and placebo groups. Differences existed for vasomotor symptoms and sexual functioning which were worse in the letrozole group and attributed to improvements in mean scores seen for women randomized to placebo. The data indicate that continuation of AI therapy after 5 years prior treatment is not associated with a deterioration of overall QOL. Treatment related vasomotor and sexual functioning alterations occur with ongoing treatment. Clinical trial information: NCT00754845.

Changes in patient-reported outcomes in women with breast cancer in a multicenter double-blind randomized controlled trial assessing the effect of acupuncture in reducing aromatase inhibitor-induced musculoskeletal symptoms (AIMSS).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9103-9103
Author(s):  
Ting Bao ◽  
Kelly Betts ◽  
Karineh Tarpinian ◽  
Ling Cai ◽  
Jeff Gould ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Depression Scale ◽  
Sham Acupuncture ◽  
Menopausal Symptoms ◽  
Musculoskeletal Symptoms ◽  
Double Blind ◽  
Hot Flash ◽  
Significant Difference ◽  
Patient Reported

9103 Background: Aromatase Inhibitors (AIs) have been associated with worsening of patient related outcomes (PROs) such as AIMSS, menopausal symptoms and depression. Acupuncture has been reported to alleviate such symptoms. We hypothesized that real acupuncture (RA) would improve PROs more than sham acupuncture (SA). Methods: We collected PROs at baseline, 4, 8, and 12 weeks (wks), from women enrolled in a multi-center double blind RCT designed to assess the effect of acupuncture in reducing PROs. Patients were randomized to 8 wkly RA or SA. PROs were measured by the revised National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological Studies Depression Scale (CESD), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQoL survey. We measured estrogen and cytokines concentrations at baseline and wk 8. We used Wilcoxon rank sum and signed-rank tests to make comparisons between and within group, respectively. Results: We included 23 patients from RA and 24 from SA arms in the intent-to-treat analysis. We have previously reported no significant difference in reduction of AIMSS between two arms. RA caused reduction of CESD scores compared to SA (median: -2 vs 0, p = 0.057). When compared to baseline, there were statistically significant improvements at wk 8 in hot flash severity score (p=0.006), hot flash frequency (p=0.011), HFRDI (p=0.014) and NSABP menopausal symptoms (p=0.022) scores in RA arm; for EuroQoL (p=0.022), HFRDI (p=0.043) and NSABP menopausal symptoms (p=0.005) scores in SA arm. The majority of patients’ estradiol concentrations were undetectable at baseline and wk 8. Changes in other time points, data and analysis of cytokines changes will be presented at the meeting. Conclusions: Real and sham acupuncture were both associated with improvement in PROs in breast cancer patients taking AIs. We detected no significant difference in the change of PROs between real and sham acupuncture, except for CESD.

Sucralfate in the Prevention of Treatment-Induced Diarrhea in Patients Receiving Pelvic Radiation Therapy: A North Central Cancer Treatment Group Phase III Double-Blind Placebo-Controlled Trial

2000 ◽  
Vol 18 (6) ◽  
pp. 1239-1245 ◽  
Author(s):  
James A. Martenson ◽  
John W. Bollinger ◽  
Jeff A. Sloan ◽  
Paul J. Novotny ◽  
Rodolfo E. Urias ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Gastrointestinal Symptoms ◽  
Phase Iii ◽  
Double Blind ◽  
North Central ◽  
Pelvic Radiation ◽  
Significant Difference ◽  
Patient Reported

PURPOSE: Randomized studies have suggested that sucralfate is effective in mitigating diarrhea during pelvic radiation therapy (RT). This North Central Cancer Treatment Group study was undertaken to confirm the antidiarrheal effect of sucralfate. Several other measures of bowel function were also assessed.PATIENTS AND METHODS: Patients receiving pelvic RT to a minimum of 45 Gy at 1.7 to 2.1 Gy/d were eligible for the study. Patients were assigned randomly, in double-blind fashion, to receive sucralfate (1.5 g orally every 6 hours) or an identical looking placebo during pelvic RT.RESULTS: One hundred twenty-three patients were randomly assigned and found assessable. Overall, there was no significant difference in patient characteristics between those receiving sucralfate and those receiving placebo. Moderate or worse diarrhea was observed in 53% of patients receiving sucralfate versus 41% of those receiving placebo. Compared with patients receiving placebo, more sucralfate-treated patients reported fecal incontinence (16% v 34%, respectively; P = .04) and need for protective clothing (8% v 23%, respectively; P = .04). The incidence and severity of nausea were worse among those taking sucralfate (P = .03). Analysis of patient-reported symptoms 10 to 12 months after RT showed a nonsignificant trend toward more problems in patients taking sucralfate than in those taking placebo (average, 2.3 v 1.9 problems, respectively; P = .34).CONCLUSION: Sucralfate did not decrease pelvic RT-related bowel toxicity by any of the end points measured and seems to have aggravated some gastrointestinal symptoms.

A randomized, multicenter, double-blind phase III study of palbociclib (PD-0332991), an oral CDK 4/6 inhibitor, plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with ER(+), HER2(–) breast cancer who have not received any prior systemic anticancer treatment for advanced disease.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS652-TPS652 ◽  
Author(s):  
Richard S. Finn ◽  
Veronique Dieras ◽  
Karen A. Gelmon ◽  
Nadia Harbeck ◽  
Stephen E. Jones ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Postmenopausal Women ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Advanced Disease ◽  
Phase Iii ◽  
Double Blind ◽  
Patient Reported ◽  
To Receive

TPS652 Background: Palbociclib (PD-0332991) is an orally bioavailable selective inhibitor of CDK4/6 that prevents DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase. In a randomized phase II trial comparing palbociclib (PD-0332991) plus letrozole (P + L) to letrozole (L) in postmenopausal women with ER(+), HER2(–) advanced breast cancer (ABC) who had not received any prior systemic anticancer therapy for their advanced disease, P + L demonstrated significantly longer progression-free survival (PFS) vs L (26.1 vs 7.5 mo; HR = 0.37, P < .001) and was generally well tolerated, with uncomplicated neutropenia as the most frequent adverse event (Finn et al SABCS 2012). Methods: Based on phase II data, a global, randomized, double-blind, phase III clinical trial was designed to demonstrate that P + L provides superior clinical benefit compared with L + placebo in postmenopausal women with ER(+), HER2(–) ABC who have not received any prior systemic therapy for their advanced disease. The study aims to assess whether P + L improves median PFS over L at HR of at least 0.7. Approximately 450 eligible patients with locoregionally recurrent or metastatic, pathologically confirmed ABC who are candidates to receive L as first-line treatment for their advanced disease will be randomized 2:1 to receive either P (125 mg QD 3 wk on, 1 wk off) + L (2.5 mg QD) or L (2.5 mg QD) + placebo. Patients who received anastrozole or letrozole as part of their (neo)adjuvant regimen are eligible if their disease progressed more than 12 months from completion of adjuvant therapy. Tumor tissue is required for participation. Secondary endpoints include overall survival, objective response, duration of response, clinical benefit, safety and tolerability, and patient-reported outcomes of health-related quality of life and disease- or treatment-related symptoms. Clinical trial information: NCT01740427.

Pertuzumab (P) with trastuzumab (T) and chemotherapy (CTX) in patients (pts) with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) cancer: An international phase III study (JACOB).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS4150-TPS4150 ◽  
Author(s):  
Josep Tabernero ◽  
Paulo Marcelo Hoff ◽  
Lin Shen ◽  
Atsushi Ohtsu ◽  
Ron Yu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Gastroesophageal Junction ◽  
Objective Response ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Her2 Positive ◽  
Double Blind ◽  
Patient Reported ◽  
Phase Iii Study ◽  
Unacceptable Toxicity

TPS4150 Background: Human epidermal growth factor receptor 2 (HER2) is overexpressed in ~20% of gastric cancers. Specific targeting of HER2 by T in combination with CTX has demonstrated significantly improved overall survival (OS) vs CTX in pts with advanced gastric or GEJ cancer (Bang Lancet 2010). In HER2-positive 1L metastatic breast cancer the combination of T plus docetaxel with a second HER2-targeted antibody, P, demonstrated significant improvement of progression-free survival (PFS) and OS vs placebo+T+docetaxel (Baselga NEJM 2012; Swain SABCS 2012). Based on these positive findings with HER2-targeted therapies in gastric and breast cancer, JACOB, a double-blind, placebo-controlled, randomized Phase III study, is designed to evaluate efficacy and safety of P+T+CTX in pts with HER2-positive 1L metastatic gastric or GEJ cancer. Methods: Pts will be randomized 1:1 to receive P+T+cisplatin+fluoropyrimidine or the same regimen replacing P with placebo, q3w (P: 840 mg; T: 8 mg/kg first dose, then 6 mg/kg; cisplatin: 80 mg/m2; 5-fluorouracil: 800 mg/m2/24 h given continuously for 120 h or capecitabine: 1000 mg/m2 bid for 14 days). P/placebo+T will be given until progressive disease (PD) or unacceptable toxicity. On or before Cycle 6, CTX should only be discontinued for PD or unacceptable toxicity. Continuation of CTX after Cycle 6 is at the discretion of pt and physician. Randomization will be stratified by region (Japan vs North America/Western Europe/Australia vs Asia [excluding Japan] vs South America/Eastern Europe), prior gastrectomy, and HER2-positivity (IHC 3+ vs IHC 2+ and ISH+). Primary endpoint: OS; secondary endpoints include PFS, objective response rate, duration of response, clinical benefit rate, safety, pharmacokinetics of P, and patient-reported outcomes. Tumor and blood samples for biomarker evaluation will be collected. The study is estimated to have 80% power to detect a significant improvement in OS at a two-sided α-level of 5% (HR=0.777), with ~502 deaths required for the primary analysis. Target enrollment is 780 pts from ~200 sites and 35 countries; FPI is planned for April 2013. NCT01774786 Clinical trial information: NCT01774786.

Denosumab versus placebo as adjuvant treatment for women with early-stage breast cancer at high risk of disease recurrence (D-CARE): An international, placebo-controlled, randomized, double-blind phase III clinical trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS662-TPS662
Author(s):  
Paul E. Goss ◽  
Carlos H. Barrios ◽  
Arlene Chan ◽  
Dianne M. Finkelstein ◽  
Hiroji Iwata ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
High Risk ◽  
Bone Metastasis ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Phase Iii ◽  
Double Blind ◽  
Free Survival ◽  
Patient Reported

TPS662 Background: In women with early-stage breast cancer, bone is a common site of distant recurrence and represents approximately 40% of all first recurrences. Preclinical studies demonstrated that inhibition of RANKL significantly delays skeletal tumor formation, reduces skeletal tumor burden, and prolongs survival of tumor-bearing mice. Denosumab is approved for the prevention of skeletal-related events (SREs) in patients with established bone metastases from solid tumors. The D-CARE trial is designed to assess if denosumab treatment prolongs bone metastasis-free survival (BMFS) and disease-free survival (DFS) in the adjuvant breast cancer setting. The primary endpoint of this event-driven trial is BMFS. Secondary endpoints include DFS and overall survival. Additional endpoints include safety, breast density, time to first on-study SRE (following the development of bone metastasis), patient reported outcomes, and biomarkers. Methods: In this international, randomized, double-blind, and placebo-controlled phase 3 trial, 4509 women with stage II or III breast cancer at high risk for recurrence and with known hormone and HERE2 receptor status were randomized. High risk was defined as biopsy evidence of breast cancer in regional lymph nodes, tumor size > 5 cm (T3), or locally advanced disease (T4). Standard-of-care adjuvant or neoadjuvant chemo-, endocrine, or HER-2 targeted therapy, alone or in combination, must be planned. Patients with a prior history of breast cancer (except DCIS or LCIS) or distant metastasis, oral bisphosphonate (BP) use within 1 year of randomization, or any intravenous BP use, were not eligible. Patients were randomized 1:1 to receive denosumab 120 mg or placebo subcutaneously monthly for 6 months, then every 3 months for a total of 5 years of treatment. Supplemental vitamin D (≥ 400 IU) and calcium (≥ 500 mg) were required. The trial, sponsored by Amgen Inc., began enrolling patients in June 2010 and completed enrollment in late 2012. Clinical trial information: NCT01077154.

Six-month and 12-month patient outcomes based on inflammatory subphenotypes in sepsis-associated ARDS: secondary analysis of SAILS-ALTOS trial

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-216613
Author(s):  
Mohamed D Hashem ◽  
Ramona O Hopkins ◽  
Elizabeth Colantuoni ◽  
Victor D Dinglas ◽  
Pratik Sinha ◽  
...  
Keyword(s):  
Mental Health ◽  
Patient Reported Outcomes ◽  
Secondary Analysis ◽  
Cognitive Outcomes ◽  
Short Term ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Sepsis Trial

BackgroundPrior acute respiratory distress syndrome (ARDS) trials have identified hypoinflammatory and hyperinflammatory subphenotypes, with distinct differences in short-term outcomes. It is unknown if such differences extend beyond 90 days or are associated with physical, mental health or cognitive outcomes.Methods568 patients in the multicentre Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo were included and assigned a subphenotype. Among 6-month and 12-month survivors (N=232 and 219, respectively, representing 243 unique survivors), subphenotype status was evaluated for association with a range of patient-reported outcomes (eg, mental health symptoms, quality of life). Patient subsets also were evaluated with performance-based tests of physical function (eg, 6 min walk test) and cognition.FindingsThe hyperinflammatory versus hypoinflammatory subphenotype had lower overall 12-month cumulative survival (58% vs 72%, p<0.01); however, there was no significant difference in survival beyond 90 days (86% vs 89%, p=0.70). Most survivors had impairment across the range of outcomes, with little difference between subphenotypes at 6-month and 12-month assessments. For instance, at 6 months, in comparing the hypoinflammatory versus hyperinflammatory subphenotypes, respectively, the median (IQR) patient-reported SF-36 mental health domain score was 47 (33–56) vs 44 (35–56) (p=0.99), and the per cent predicted 6 min walk distance was 66% (48%, 80%) vs 66% (49%, 79%) (p=0.76).InterpretationComparing the hyperinflammatory versus hypoinflammatory ARDS subphenotype, there was no significant difference in survival beyond 90 days and no consistent findings of important differences in 6-month or 12-month physical, cognitive and mental health outcomes. These findings, when considered with prior results, suggest that inflammatory subphenotypes largely reflect the acute phase of illness and its short-term impact.

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