227 A Review of Clinical Endpoints and Use of Quality of Life Outcomes in Phase III Metastatic Breast Cancer Clinical Trials

2012 ◽  
Vol 48 ◽  
pp. S109
Author(s):  
R. Tatla ◽  
D. Landaverde ◽  
J.C. Victor ◽  
D. Miles ◽  
S. Verma
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Cancer Clinical Trials ◽  
Life Outcomes ◽  
Clinical Endpoints

A review of clinical endpoints and use of quality-of-life outcomes in phase III metastatic breast cancer clinical trials.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 129-129
Author(s):  
Raman Tatla ◽  
Denis Landaverde ◽  
Charles Victor ◽  
David Miles ◽  
Sunil Verma
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Clinical Endpoints ◽  
Phase Iii Clinical Trials ◽  
The Impact

129 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with most interventions intended to relieve disease symptoms, minimize treatment effects and prolong patient survival. The impact of disease and treatment on a patient's funcitonal abilities has led to an emphasis of incorporating quality of life (QoL) measures into clinical trials. The main objective of this study is to evaluate phase III clinical trials in MBC, and assess the inclusion of QOL as an endpoint, in addition to conventional efficacy endpoints. Methods: A structured PubMed search was conducted to identify phase III clinical trials published between Jan. 1990 and Aug. 2011, evaluating systemic treatment in MBC patients. Data pertaining to treatment regimens, study endpoints and clinical findings were collected, with a particular focus on progression-based (PB), overall survival (OS), and QoL endpoints. Results: Of 520 publications identified, 122 phase III MBC clinical trials met the inclusion criteria. Of these studies, 98.4% and 95.9% included PB and OS respectively, as clinical endpoints, while QoL was assessed in only 46 (37.7%) studies. While the inclusion of QoL was not associated with the significance of PB results, there was an association between the inclusion of QoL and OS results, with 59% of significant OS studies and 32% of non-significant OS studies including QoL as a clinical endpoint (p=0.016). When stratified by treatment arm, it was found that studies favouring standard therapy were more likely to include QoL (75%, p=0.045), compared to those favouring the intervention (56%), and those without significant differences (32%). Conclusions: Although the importance of QoL is often emphasized in MBC management and treatment decisions, only one-third of identified phase III clinical trials included an assessment of QoL. About half of these trials showed no statistically significant differences in the QoL endpoint; of not, instruments of varying validity were utilized. There needs to be a greater emphasis on the evaluation of QoL, with the use of standard and validated QoL tools in MBC clinical trials, especially as we increasingly focus on progression-based endpoints.

A review of clinical endpoints and use of quality of life outcomes in phase III metastatic breast cancer clinical trials.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16547-e16547
Author(s):  
Raman Tatla ◽  
Denis Landaverde ◽  
Charles Victor ◽  
David Miles ◽  
Sunil Verma
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Clinical Endpoints ◽  
Phase Iii Clinical Trials ◽  
The Impact

e16547 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with therapy used to relieve disease symptoms, minimize treatment effects and prolong survival. The impact of disease and treatment on patients has led to an emphasis of quality of life (QoL) measures in clinical trials. This study’s primary objective is to evaluate phase III clinical trials in MBC, and assess the inclusion of QoL as an endpoint. Methods: A PubMed search was conducted to identify phase III clinical trials published from Jan 1990 to Aug 2011, which evaluated systemic therapy in MBC patients. Data pertaining to treatment regimens, study endpoints and clinical findings were collected, with a focus on progression-based (PB), overall survival (OS), and QoL endpoints. The instrument(s) used to evaluate QoL were also noted (if applicable). Results: Of 520 publications identified, 122 phase III MBC clinical trials met the inclusion criteria. Of these studies, 98.4% and 95.9% included PB and OS respectively, as clinical endpoints, while QoL was assessed in only 46 (37.7%) studies. 14 instruments were identified as QoL tools among the studies, with EORTC QLQ-C30 and FACT-B accounting for 54.7% of the instruments used. While the inclusion of QoL was not related to the significance of PB results, there was an association between the inclusion of QoL and OS results, with 59% of significant OS studies and 32% of non-significant OS studies including QoL as an endpoint (p=0.016). Stratification by treatment arm found that studies favouring standard therapy were more likely to include QoL (75%, p=0.045), compared to those favouring the intervention (56%), and those without significant differences (32%). Conclusions: Although the importance of QoL is often emphasized in MBC management, only one-third of identified phase III clinical trials included its assessment. Half of these trials showed no statistically significant differences in QoL endpoint; of note, instruments of varying validity were utilized. There needs to be greater emphasis on the evaluation of QoL, with the use of standard and validated QoL tools in MBC clinical trials, especially as we increasingly focus on progression-based endpoints.

Phase III Trial of Doxorubicin, Paclitaxel, and the Combination of Doxorubicin and Paclitaxel as Front-Line Chemotherapy for Metastatic Breast Cancer: An Intergroup Trial (E1193)

2003 ◽  
Vol 21 (4) ◽  
pp. 588-592 ◽  
Author(s):  
George W. Sledge ◽  
Donna Neuberg ◽  
Patricia Bernardo ◽  
James N. Ingle ◽  
Silvana Martino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response ◽  
Phase Iii ◽  
Global Quality Of Life ◽  
Intergroup Trial

Purpose: Between February 1993 and September 1995, 739 patients with metastatic breast cancer were entered on an Intergroup trial (E1193) comparing doxorubicin (60 mg/m2), paclitaxel (175 mg/m2/24 h), and the combination of doxorubicin and paclitaxel (AT, 50 mg/m2 and 150 mg/m2/24 h, plus granulocyte colony-stimulating factor 5 mg/kg) as first-line therapy. Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression. Patients and Methods: Patients were well balanced for on-study characteristics. Results: Responses (complete response and partial response) were seen in 36% of doxorubicin, 34% of paclitaxel, and 47% of AT patients (P = .84 for doxorubicin v paclitaxel, P = .007 for v AT, P = .004 for paclitaxel v AT). Median time to treatment failure (TTF) is 5.8, 6.0, and 8.0 months for doxorubicin, paclitaxel, and AT, respectively (P = .68 for doxorubicin v paclitaxel, P = .003 for doxorubicin v AT, P = .009 for paclitaxel v AT). Median survivals are 18.9 months for patients taking doxorubicin, 22.2 months for patients taking paclitaxel, and 22.0 months for patients taking AT (P = not significant). Responses were seen in 20% of patients crossing from doxorubicin → paclitaxel and 22% of patients crossing from paclitaxel → doxorubicin (P = not significant). Changes in global quality-of-life measurements from on-study to week 16 were similar in all three groups. Conclusion: (1) doxorubicin and paclitaxel, in the doses used here, have equivalent activity; (2) the combination of AT results in superior overall response rates and time to TTF; and (3) despite these results, combination therapy with AT did not improve either survival or quality of life compared to sequential single-agent therapy.

scholarly journals Hellenic Alliance for Metastatic Breast Cancer: A Platform of Support, a Platform for Life

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 165s-165s
Author(s):  
A. Tarampikou ◽  
Z. Saridaki ◽  
S. Kolokotroni ◽  
A. Christopoulou ◽  
S. Agelaki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Social Services ◽  
Metastatic Breast ◽  
Online Forum ◽  
Web Based ◽  
Medical Facilities

Background and context: W4O-Hellas (Women for Oncology-Hellas, a network of women professionals in oncology) and K.E.F.I. (an association of cancer patients) joined forces to create the “Hellenic Alliance for Metastatic Breast Cancer”, a project awarded through the SPARC initiative. The project is consisting among others, on creating, promoting and maintaining a Web-based platform of education, information, communication, advocacy and support for MBC patients in Greece. Aim: The aim of the platform is to provide education at patients and caregivers on various aspects concerning the disease, from diagnosis to palliative care, the available medical facilities, social services, benefits and allowances, clinical trials and issues concerning quality of life and psychological support. Strategy/Tactics: The development of an innovative Web-based tool was included in the “Hellenic Alliance for Metastatic Breast Cancer” project. It was overseen by a steering committee with W4O-Hellas and K.E.F.I. representatives, journalists, health economics advisors and state representatives. A support team was also created, to run and update the platform. Program/Policy process: The platform (“w4life.gr” reading “women for life” or “life for women with stage 4 disease”) is functional since June 2016 and was officially presented to the public on November 2016. The site´s structure is consisting of the main sections and an online forum. The sections contain information about the disease, the access to doctors, medical facilities, social services and patient groups, quality of life, nutrition and exercise issues, patient guidance and clinical trials available in Greece. The online forum is accessible 24 hours per day, and provides information and update about the network´s actions and upcoming seminars and forums. There is also a patient support direct line available on weekdays and access to other useful links. An online survey measuring quality of life data are running through the platform and the results will be presented in the near future. Since last year, a mobile application was also created aiming to an easier and user friendly access. Outcomes: By March 2018, the platform had 27,018 page views, 10,416 users who completed 13,020 sessions, with average session duration 2:23 minutes and bounce rate 74.54%. w4life received two awards from the Boussias-Health Care Business Awards-2017. The Gold Award, in the e-Health category digital applications for information and integrated patient care and a Silver Award for actions aimed at information, awareness, and prevention. What was learned: During the severe Hellenic socioeconomic crisis we have found that an alternative approach, as the above described, of dedicated oncologists toward their patients is needed, easy to use, helpful and sustainable and can provide important information and comfort to women with mBC their families and caregivers.

Impact of symptoms and toxicity on quality of life: Exploratory analysis of gemcitabine plus docetaxel vs capecitabine plus docetaxel in metastatic breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 682-682 ◽  
Author(s):  
P. Fumoleau ◽  
G. Romieu ◽  
S. Chan ◽  
J. Huober ◽  
M. Tubiana-Hulin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Serious Adverse Events ◽  
Distress Scale

682 Background: A recent phase III trial comparing gemcitabine-docetaxel (GD) with capecitabine-docetaxel (CD) for metastatic breast cancer (MBC) found comparable progression-free survival but patients (pts) on GD had less toxicity (Chan, ASCO 2005). To better understand how quality of life (QoL) is impacted by toxicity and symptoms, we conducted an exploratory analysis. Methods: The study had 305 pts who relapsed after anthracycline-based treatment either in (neo)adjuvant or first-line MBC. Pts were randomized to GD or CD for 21-day cycles until PD or unacceptable toxicity. QoL was assessed every cycle with Rotterdam Symptom Checklist (RSCL). Only pts with RSCL data were included in the QoL analysis. Comparison between arms of changes from baseline in RSCL dimensions at each cycle were analyzed using analysis of co-variance (ANCOVA). Because the physical symptom distress scale (PSDS) includes symptom- and toxicity-related items, distributions of responses to each item were explored. Results: 302 pts received treatment (GD 152; CD 150); median number of cycles was 6 for both arms. 267 pts (88%) had baseline RSCL data; compliance ranged from 79%-88% for the first 6 cycles. Baseline RSCL scores were comparable between arms. No statistical differences between arms were seen for any of the RSCL dimensions (p>.05 at all cycles). Both arms had worsening in the PSDS (median increases of 3–6.8 on 69-point scale). Numerical differences were seen in some PSDS items rated as “quite a bit” or “very much.” By cycle 3, more GD pts reported tiredness (58% v 47%), lack of energy (45% v 38%), back pain (19% v 9%), and by cycle 2, alopecia (76% v 66%). By cycle 1, more CD pts reported tingling hands/feet (15% v 7%) and burning/sore eyes (14% v 3%). Conclusions: Preliminary analysis indicated no QoL differences between GD and CD; however, further exploration shows that physical distress is explained by different symptoms and toxicities in each arm. Results, particularly at later cycles, should be cautiously interpreted because of pt attrition and different reasons for discontinuation (eg, more CD than GD pts discontinued due to serious adverse events [28% v 13%]). Further analysis incorporating clinical outcomes may better explain QoL outcomes [Table: see text]

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