Patient-reported outcomes (PROs) from the phase III IMpassion130 trial of atezolizumab (atezo) plus nabpaclitaxel (nP) in metastatic triple-negative breast cancer (mTNBC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1067-1067 ◽  
Author(s):  
Sylvia Adams ◽  
Veronique Dieras ◽  
Carlos H. Barrios ◽  
Eric P. Winer ◽  
Andreas Schneeweiss ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Physical Function ◽  
Clinical Benefit ◽  
Phase Iii ◽  
Role Function ◽  
End Of Treatment ◽  
Patient Reported ◽  
Clinical Trial Information ◽  
Better Than

1067 Background: In the IMpassion130 study in 1L mTNBC (N = 902), PFS with atezo + nP was significantly better than with placebo (P) + nP in ITT (HR, 0.80) and PD-L1 IC+ (HR, 0.62) patients (pts). Clinically meaningful OS improvement (HR, 0.62) was also seen in PD-L1+ pts. PROs were used to document pt perspectives on overall clinical benefit of atezo + nP. Methods: Pts received either atezo 840 mg or P q2w + nP 100 mg/m2 on days 1, 8 and 15 of each 28-day cycle until disease progression or intolerance. Pts completed the EORTC QLC-C30 and breast cancer module (QLQ-BR23) on day 1 of each cycle, at end of treatment (Tx) and q4w during follow-up for 1 y. Time to deterioration (TTD; first ≥ 10-point decrease from baseline [BL] held for 2 cycles) in HRQoL was a pre-defined secondary endpoint. Exploratory endpoints included TTD in function, and mean and mean change from BL scores (changes ≥ 10 considered clinically meaningful) in HRQoL, function and disease/Tx-related symptoms. Results: BL completion was 92% (QLQ-C30) and 89% (QLQ-BR23) and remained > 80% through Cycle 20 in both ITT and PD-L1 IC+ pts. No differences in median TTD in HRQoL (ITT: HR, 0.97 [95% CI: 0.80, 1.18]; PD-L1 IC+: HR, 0.94 [95% CI: 0.69, 1.28]), physical function (ITT: HR, 1.04 [95% CI: 0.86, 1.26]; PD-L1 IC+: HR, 1.02 [95% CI: 0.76, 1.37]) or role function (ITT: HR, 1.01 [95% CI: 0.83, 1.22]; PD-L1 IC+: HR, 0.77 [95% CI: 0.57, 1.04]) were observed between arms in either population. Mean scores at BL for HRQoL (ITT: 66.0 [atezo + nP] vs 64.3 [P + nP]; PD-L1 IC+: 67.5 vs 65.0), physical function (ITT: 80.4 vs 79.2; PD-L1 IC+: 82.8 vs 79.4) and role function (ITT: 72.7 vs 71.0; PD-L1 IC+: 73.7 vs 71.7) were similar between arms and throughout the course of Tx. In both arms, HRQoL, physical and role function, and Tx symptoms (fatigue, diarrhea, nausea, vomiting) were stable during Tx, with no clinically meaningful changes seen until pts discontinued Tx. Conclusions: PRO data suggest that atezo + nP was tolerable and similar to nP alone in maintaining HRQoL and day-to-day function relative to BL. This confirms atezo + nP had clinical benefit without compromising HRQoL, physical and role function, or worsening Tx symptoms vs P + nP in 1L mTNBC. Clinical trial information: NCT02425891.

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.

Evaluation of the patient-reported outcomes common terminology criteria for adverse events (PRO-CTCAE) with abiraterone acetate plus prednisone (AAP), degarelix (D), or the combination in men with biochemically recurrent prostate cancer (BCRPC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5080-5080
Author(s):  
Karen A. Autio ◽  
Emmanuel S. Antonarakis ◽  
Raymond Baser ◽  
Mark N. Stein ◽  
Daniel H. Shevrin ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Hot Flashes ◽  
Abiraterone Acetate ◽  
Phase 2 Trial ◽  
End Of Treatment ◽  
Patient Reported ◽  
Fatigue Severity ◽  
Anxiety Depression ◽  
Clinical Trial Information

5080 Background: Patient-reported symptoms using the PRO-CTCAE provide insights into the patient experience with care. Earlier use of AAP (an androgen biosynthesis inhibitor plus prednisone) with androgen deprivation therapy in castration sensitive disease may lead to increased symptoms. We previously reported a randomized phase 2 trial of intermittent AAP, D, or AAP+D in BCRPC (NCT01751451) and now share the PRO-CTCAE results. Methods: Men were randomized 1:1:1 to AAP, D, or AAP+D for 8 months, then entered follow up with PSA, testosterone, and safety monitoring. PRO-CTCAE was elicited from patients monthly for hot flashes (HF), fatigue, arthralgias, myalgias, anxiety, depression, sexual function, plus overall QOL. Changes from baseline to end of treatment were compared between groups. AUCs were calculated for each item as a measure of symptom severity over time. Results: 110 men were included. Compliance with PRO-CTCAE reporting from baseline to EOT was 93%. HF did not differ between AAP+D and D, but were increased relative to AAP (all p < 0.05). These differences were consistent when HF were measured as an AUC (all p < 0.01). Fatigue severity did not differ between groups however men receiving AAP reported a small worsening in activity interference from fatigue as compared to AAP+D (p < 0.05). Overall QOL scores were high and did not differ with AAP+D relative to AAP or D. Conclusions: Collection of PRO-CTCAE was feasible and did not demonstrate differences in fatigue, HF, or QOL between AAP+D and D. Comparisons of PRO-CTCAE to matched clinician-reported AEs, and changes in PRO-CTCAE with testosterone recovery during follow up are planned. Clinical trial information: NCT01751451.

scholarly journals Patient-proxy agreement on change in acute stroke patient-reported outcome measures: a prospective study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brittany R. Lapin ◽  
Nicolas R. Thompson ◽  
Andrew Schuster ◽  
Irene L. Katzan
Keyword(s):  
Physical Function ◽  
Inpatient Rehabilitation ◽  
Patient Reported Outcome Measures ◽  
Meaningful Change ◽  
Meaningful Improvement ◽  
T Score ◽  
Patient Reported ◽  
Exact Agreement ◽  
Over Time

Abstract Objectives Research has indicated proxies overestimate symptoms on patients’ behalves, however it is unclear whether patients and proxies agree on meaningful change across domains over time. The objective of this study is to assess patient-proxy agreement over time, as well as agreement on identification of meaningful change, across 10 health domains in patients who underwent acute rehabilitation following stroke. Methods Stroke patients were recruited from an ambulatory clinic or inpatient rehabilitation unit, and were included in the study if they were undergoing rehabilitation. At baseline and again after 30 days, patients and their proxies completed PROMIS Global Health and eight domain-specific PROMIS short forms. Reliability of patient-proxy assessments at baseline, follow-up, and the change in T-score was evaluated for each domain using intra-class correlation coefficients (ICC(2,1)). Agreement on meaningful improvement or worsening, defined as 5+ T-score points, was compared using percent exact agreement. Results Forty-one patient-proxy dyads were included in the study. Proxies generally reported worse symptoms and functioning compared to patients at both baseline and follow-up, and reported less change than patients. ICCs for baseline and change were primarily poor to moderate (range: 0.06 (for depression change) to 0.67 (for physical function baseline)), and were better at follow-up (range: 0.42 (for anxiety) to 0.84 (for physical function)). Percent exact agreement between indicating meaningful improvement versus no improvement ranged from 58.5–75.6%. Only a small proportion indicated meaningful worsening. Conclusions Patient-proxy agreement across 10 domains of health was better following completion of rehabilitation compared to baseline or change. Overall change was minimal but the majority of patient-proxy dyads agreed on meaningful change. Our study provides important insight for clinicians and researchers when interpreting change scores over time for questionnaires completed by both patients and proxies.

scholarly journals Sequential Versus Concurrent Trastuzumab in Adjuvant Chemotherapy for Breast Cancer

2011 ◽  
Vol 29 (34) ◽  
pp. 4491-4497 ◽  
Author(s):  
Edith A. Perez ◽  
Vera J. Suman ◽  
Nancy E. Davidson ◽  
Julie R. Gralow ◽  
Peter A. Kaufman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Growth Factor Receptor ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Phase Iii ◽  
P Value ◽  
Sequential Administration ◽  
Taxane Chemotherapy

Purpose NCCTG (North Central Cancer Treatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2–positive breast cancer. Patients and Methods Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles, followed by paclitaxel weekly for 12 weeks (arm A), paclitaxel plus sequential trastuzumab weekly for 52 weeks (arm B), or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks (arm C). The primary end point was disease-free survival (DFS). Results Comparison of arm A (n = 1,087) and arm B (n = 1,097), with 6-year median follow-up and 390 events, revealed 5-year DFS rates of 71.8% and 80.1%, respectively. DFS was significantly increased with trastuzumab added sequentially to paclitaxel (log-rank P < .001; arm B/arm A hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.85). Comparison of arm B (n = 954) and arm C (n = 949), with 6-year median follow-up and 313 events, revealed 5-year DFS rates of 80.1% and 84.4%, respectively. There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration (arm C/arm B HR, 0.77; 99.9% CI, 0.53 to 1.11), but the P value (.02) did not cross the prespecified O'Brien-Fleming boundary (.00116) for the interim analysis. Conclusion DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy. On the basis of a positive risk-benefit ratio, we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important standard-of-care treatment alternative to a sequential regimen.

scholarly journals Short-term serial assessment of electronic patient-reported outcome for depression and anxiety in breast Cancer

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jeeyeon Lee ◽  
Jin Hyang Jung ◽  
Wan Wook Kim ◽  
Byeongju Kang ◽  
Jungmin Woo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Period ◽  
Depression Scale ◽  
Patient Reported Outcome ◽  
Depression And Anxiety ◽  
Short Term ◽  
Web Based ◽  
Patient Reported ◽  
Patient Health

Abstract Purpose The incidence of depression and anxiety is higher in patients with breast cancer than in the general population. We evaluated the degree of depression and anxiety and investigated the changes in patients with breast cancer during the treatment period and short-term follow-up period. Methods Overall, 137 patients with breast cancer were evaluated using the Patient Health Questionnaire 9-item depression scale (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). The scales were developed as a web-based electronic patient-reported outcome measure, and serial results were assessed before the operation, after the operation, in the post-treatment period, and in the 6-month follow-up period after surgery. Results The degree of depression and anxiety increased during treatment and decreased at 6-month follow-up, even if there were no statistical differences among the four periods (PHQ-9: p = 0.128; GAD-7: p = 0.786). However, daily fatigue (PHQ-9 Q4) and insomnia (PHQ-9 Q3) were the most serious problems encountered during treatment and at 6-month follow-up, respectively. In the GAD-7, worrying too much (Q3) consistently showed the highest scores during the treatment and follow-up periods. Of the patients, 7 (5.11%) and 11 (8.03%) patients had a worsened state of depression and anxiety, respectively, after treatment compared with before treatment. Conclusion Most factors associated with depression and anxiety improved after treatment. However, factors such as insomnia and worrying too much still disturbed patients with breast cancer, even at 6-month follow-up. Therefore, serial assessment of depression and anxiety is necessary for such patients.

Final analysis of the PROMISE-GIM6 phase III trial assessing GnRH agonist use during chemotherapy as a strategy to preserve ovarian function in premenopausal patients with early breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 516-516
Author(s):  
Matteo Lambertini ◽  
Luca Boni ◽  
Andrea Michelotti ◽  
Emanuela Magnolfi ◽  
Alessio Aligi Cogoni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Ovarian Function ◽  
Final Analysis ◽  
Post Treatment ◽  
Phase Iii ◽  
Hormone Receptor Positive ◽  
Premenopausal Patients

516 Background: Current guidelines recommend GnRH agonist (GnRHa) use during chemotherapy (CT) as a strategy to reduce the risk of premature ovarian insufficiency (POI) in premenopausal patients with early breast cancer (EBC). However, no long-term safety data are available raising some concerns on concurrent use of GnRHa during CT in patients with hormone receptor-positive disease. In addition, there is no evidence on the protective role of this strategy in patients with germline BRCA mutations ( mBRCA). Here, we report the final analysis of the PROMISE-GIM6 phase III randomized study, the largest trial addressing the role of GnRHa use during CT in premenopausal EBC patients (Del Mastro et al, JAMA 2011 & Lambertini et al, JAMA 2015). Methods: From October 2003 to January 2008, 281 premenopausal patients aged 18 to 45 years with stage I-III EBC candidates for (neo)adjuvant CT were randomized to receive CT alone or combined with the GnRHa triptorelin. Primary endpoint was incidence of CT-induced POI (defined as amenorrhea and post-menopausal FSH/estradiol levels 1 year following CT). This final analysis reports on post-treatment pregnancies, disease-free survival (DFS) and overall survival (OS). An exploratory descriptive analysis in mBRCA patients is also reported. (ClinicalTrial.gov: NCT00311636) Results: Of the 281 randomized patients (CT+GnRHa arm = 148; CT alone arm = 133), 80% had hormone receptor-positive disease. At the time of this final analysis, 38 (13.5%) patients were lost to follow-up. Median follow-up was 12.4 years (IQR: 11.3-13.2 years). In the CT+GnRHa and CT alone arms, respectively, 9 (10-year cumulative incidence of pregnancy 6.5%, 95% CI 3.5%-12.3%) and 4 (10-year cumulative incidence of pregnancy 3.2%, 95% CI 1.2%-8.3%) patients had a post-treatment pregnancy (HR 2.14, 95% CI 0.66-6.92). No differences in 10-year DFS (72.4% in CT+GnRHa arm vs. 71.2% in CT alone arm: HR 1.16, 95% CI 0.76-1.77) nor in 10-year OS (82.0% in CT+GnRHa arm vs. 85.9% in CT alone arm: HR 1.17, 95% CI 0.67-2.03) were observed. There was no interaction between treatment effect and hormone receptor status. In patients with hormone receptor-positive disease, HR was 1.02 (95% CI 0.63-1.63) for DFS and 1.12 (95% CI 0.59-2.11) for OS. Out of 43 patients tested for BRCA, overall incidence of POI, irrespective of treatment arm, was 20% in mBRCA patients (n = 10) and 12% in patients without mBRCA (n = 33). In mBRCA patients, incidence of POI was 0% and 33% in the CT+GnRHa and CT alone arms, respectively. One post-treatment pregnancy was described in a patient with mBRCA1 in the CT alone arm. Conclusions: The final analysis of the PROMISE-GIM6 trial at a median follow-up of 12.4 years provides reassuring evidence on the safety of GnRHa use during CT as a strategy to preserve ovarian function in premenopausal patients with hormone receptor-positive EBC. Clinical trial information: NCT00311636.

Moving from a ‘One Size Fits All’ to Personalized Follow-Up in Breast Cancer Survivors—Connecting Patient-Reported Outcomes with Economic Considerations

2019 ◽  
pp. 307-316
Author(s):  
Carmen Dirksen ◽  
Merel Kimman ◽  
Manuela Joore ◽  
Liesbeth Boersma
Keyword(s):  
Breast Cancer ◽  
Economic Evaluation ◽  
Patient Reported Outcomes ◽  
Care Delivery ◽  
Process Of Care ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Economic Considerations

Abstract: In the Netherlands, two studies were performed to investigate the effectiveness of several alternative follow-up strategies in terms of patient-reported outcomes (health-related quality of life and satisfaction), and to address economic considerations in breast cancer follow-up care. This chapter describes the economic evaluation of four follow-up strategies after breast cancer treatment. As such, it provides an example of the application of economic methods to evaluate the relative value of breast cancer care. Whereas economic evaluation is outcome-focused, the process of care delivery is also a major determinant of patient value. Insight into patients’ preferences for outcome and process is crucial in order to tailor care to individual patients’ needs. Therefore, in a second study, patients’ preferences for the process of care delivery were evaluated.

scholarly journals PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy—Safety and Efficacy in Asian Patients

2017 ◽  
Vol 3 (4) ◽  
pp. 289-303 ◽  
Author(s):  
Hiroji Iwata ◽  
Seock-Ah Im ◽  
Norikazu Masuda ◽  
Young-Hyuck Im ◽  
Kenichi Inoue ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Asian Patients ◽  
Hormone Receptor Positive ◽  
Patient Reported ◽  
Epidermal Growth

Purpose To assess efficacy and safety of palbociclib plus fulvestrant in Asians with endocrine therapy–resistant metastatic breast cancer. Patients and Methods The Palbociclib Ongoing Trials in the Management of Breast Cancer 3 (PALOMA-3) trial, a double-blind phase III study, included 521 patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer with disease progression on endocrine therapy. Patient-reported outcomes (PROs) were assessed on study treatment and at the end of treatment. Results This preplanned subgroup analysis of the PALOMA-3 study included premenopausal and postmenopausal Asians taking palbociclib plus fulvestrant (n = 71) or placebo plus fulvestrant (n = 31). Palbociclib plus fulvestrant improved progression-free survival (PFS) compared with fulvestrant alone. Median PFS was not reached with palbociclib plus fulvestrant (95% CI, 9.2 months to not reached) but was 5.8 months with placebo plus fulvestrant (95% CI, 3.5 to 9.2 months; hazard ratio, 0.485; 95% CI, 0.270 to 0.869; P = .0065). The most common all-cause grade 3 or 4 adverse events in the palbociclib arm were neutropenia (92%) and leukopenia (29%); febrile neutropenia occurred in 4.1% of patients. Within-patient mean trough concentration comparisons across subgroups indicated similar palbociclib exposure between Asians and non-Asians. Global quality of life was maintained; no statistically significant changes from baseline were observed for patient-reported outcome scores with palbociclib plus fulvestrant. Conclusion This is the first report, to our knowledge, showing that palbociclib plus fulvestrant improves PFS in asian patients. Palbociclib plus fulvestrant was well tolerated in this study.

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