scholarly journals Health-related quality of life from the FALCON phase III randomised trial of fulvestrant 500 mg versus anastrozole for hormone receptor-positive advanced breast cancer

2018 ◽  
Vol 94 ◽  
pp. 206-215 ◽  
Author(s):  
John F.R. Robertson ◽  
Kwok-Leung Cheung ◽  
Shinzaburo Noguchi ◽  
Zhimin Shao ◽  
Arnold Degboe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Hormone Receptor ◽  
Randomised Trial ◽  
Phase Iii ◽  
Health Related Quality ◽  
Hormone Receptor Positive ◽  
Related Quality ◽  
Health Related

scholarly journals Health-related quality of life in premenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer treated with ribociclib plus endocrine therapy: results from a phase III randomized clinical trial (MONALEESA-7)

2020 ◽  
Vol 12 ◽  
pp. 175883592094306
Author(s):  
Nadia Harbeck ◽  
Fabio Franke ◽  
Rafael Villanueva-Vazquez ◽  
Yen-Shen Lu ◽  
Debu Tripathy ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Advanced Breast Cancer ◽  
Hormone Receptor ◽  
Phase Iii ◽  
Health Related Quality ◽  
Hormone Receptor Positive ◽  
Related Quality ◽  
Health Related

Background: This analysis evaluated patient-reported outcomes (PROs) to assess health-related quality of life (HRQoL) in the phase III MONALEESA-7 trial, which previously demonstrated improvements in progression-free survival (PFS) and overall survival (OS) with ribociclib (cyclin-dependent kinase 4/6 inhibitor) + endocrine therapy (ET) compared with placebo + ET in pre- and perimenopausal patients with hormone-receptor-positive, HER2-negative (HR+/HER2−) advanced breast cancer (ABC). Methods: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire C30 (QLQ-C30) and the EQ-5D-5L were used to evaluate HRQoL. Results: EORTC QLQ-C30 assessments were evaluable for 335 patients in the ribociclib arm and 337 patients in the placebo arm. Adherence rates at baseline and ⩾1 postbaseline time point were 90% and 83%, respectively. Patients treated with ribociclib + ET had a longer time to deterioration (TTD) ⩾ 10% in global HRQoL {hazard ratio (HR), 0.67 [95% confidence interval (CI), 0.52–0.86]}. TTD ⩾ 10% in global HRQoL was delayed in ribociclib-treated patients without versus with disease progression [HR, 0.31 (95% CI, 0.21–0.48)]. TTD ⩾ 10% in pain was longer with ribociclib + ET than with placebo + ET [HR, 0.65 (95% CI, 0.45–0.92)]. Patients who received a nonsteroidal aromatase inhibitor experienced similar benefits with ribociclib versus placebo in global HRQoL and pain. Conclusion: HRQoL was maintained longer in patients who received ribociclib + ET versus placebo + ET. These data, combined with previously reported improvements in PFS and OS, support a strong clinical benefit-to-risk ratio with ribociclib-based treatment in pre- and perimenopausal patients with HR+/HER2− ABC.

Health-related quality of life from a phase 3 randomized trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1048-1048 ◽  
Author(s):  
John Forsyth Russell Robertson ◽  
Kwok-Leung Cheung ◽  
Shinzaburo Noguchi ◽  
Zhimin Shao ◽  
Arnold Degboe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Hormone Receptor ◽  
Health Related Quality ◽  
Phase 3 ◽  
Hormone Receptor Positive ◽  
Related Quality ◽  
Health Related ◽  
Scale Range

1048 Background: The Phase 3 randomized FALCON trial (NCT01602380) demonstrated improved progression-free survival with fulvestrant 500 mg (F) vs anastrozole 1 mg (A) in postmenopausal women with hormone receptor-positive (HR+) locally advanced or metastatic breast cancer (BC) without prior endocrine therapy (hazard ratio [HR] 0.797, 95% confidence interval [CI] 0.637-0.999; p = 0.0486; Robertson et al. Lancet 2016). Overall health-related quality of life (HRQoL) was maintained and similar for F and A. There was no evidence of a detriment with F vs A in time to deterioration for both Trial Outcome Index (TOI; HR 0.90, 95% CI 0.70-1.15; p = 0.4008) and Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) total score (HR 0.84, 95% CI 0.66-1.07; p = 0.1594). We present additional analyses of patient (pt)-reported HRQoL outcomes from FALCON. Methods: Women with HR+ BC were randomized 1:1 to F (Days 0, 14, 28, then every 28 days) or A (daily) until disease progression or discontinuation. HRQoL was assessed by FACT-B questionnaire (TOI [summary of physical and functional well-being and breast cancer subscale scores] and FACT-B total score) at randomization and every 12 weeks during treatment. HRQoL data post-treatment (with or without progression) were also collected. Results: 462 pts were randomized (F, n = 230; A, n = 232). Compliance to FACT-B during treatment ranged from 84.6-100.0%. Mean change from baseline in TOI (scale range 0-92) and FACT-B total score (scale range 0-144) remained broadly stable (approximately ±3 points to Week 132) and similar between arms during treatment. HRQoL was also maintained in FACT-B subscales. Approximately one third of pts had improved TOI (≥ +6 points) and FACT-B (≥ +8 points) total scores from baseline up to Week 144 of treatment with F (ranges 26.4-45.0%, and 20.0-35.8%, respectively) and A (ranges 18.6-32.9%, and 22.7-37.9%, respectively). Conclusions: Compliance to the FACT-B questionnaire on treatment with F and A for HR+ BC in the FALCON trial was good; mean change from baseline in TOI and FACT-B total score was maintained, and similar proportions of pts had improved TOI and FACT-B total score in both arms. Clinical trial information: NCT01602380.

scholarly journals Physical activity, health‐related quality of life, and adjuvant endocrine therapy–related symptoms in women with hormone receptor–positive breast cancer

Cancer ◽  
2020 ◽  
Vol 126 (17) ◽  
pp. 4059-4066
Author(s):  
Vanessa B. Sheppard ◽  
Chiranjeev Dash ◽  
Sarah Nomura ◽  
Arnethea L. Sutton ◽  
Robert Lee Franco ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Physical Activity ◽  
Hormone Receptor ◽  
Health Related Quality ◽  
Hormone Receptor Positive ◽  
Related Quality ◽  
Health Related ◽  
Positive Breast Cancer

CLO19-059: A Systematic Review and Meta- Analysis of Randomized Controlled Trials to Evaluate the Risk of Health-Related Quality of Life Events in Patients With Hormone Receptor-Positive HER2-Negative Metastatic Breast Cancer Treated With CDK 4/6 Inhibitors

2019 ◽  
Vol 17 (3.5) ◽  
pp. CLO19-059
Author(s):  
Rachana Yendala ◽  
Kyaw Thein ◽  
Sriman Swarup ◽  
Anita Sultan ◽  
Somedeb Ball ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Meta Analysis ◽  
Hot Flushes ◽  
Health Related Quality ◽  
Randomized Controlled ◽  
Hormone Receptor Positive ◽  
Related Quality ◽  
Health Related

Background: Pain, fatigue, hot flushes, and rash significantly contribute to quality of life in breast cancer patients undergoing chemotherapy. Hormone receptor-positive breast cancer is a common entity among women worldwide. In cancer cells, CDK4/6 activity is over expressed, which can lead to amplification or overexpression of the genes encoding for CDK 4/6 or the cyclin D, ultimately leading to endocrine therapy resistance. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of health-related quality of life (HRQOL) events associated with CDK 4/6 inhibitors. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018. RTCs that mention HRQOL events as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95%CI. Random effects model was applied. Results: 8 RCTs (7 phase III and 1 phase II) with a total of 4,557 patients were eligible. The study arms used palbociclib/ribociclib/abemaciclib with letrozole or anastrozole or fulvestrant or other hormonal agent while the control arms utilized placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agent. The RR of all-grade side effects were as follows: fatigue, 1.226 (95% CI: 1.079–1.393; P=.002); back pain, 0.971 (95% CI: 0.844–1.117; P=.681); arthralgia, 0.978 (95% CI: 0.830–1.152; P=.790); headache, 1.046 (95% CI: 0.928–1.179; P=.459); alopecia, 2.635 (95% CI: 1.966–3.533; P<.001); hot flushes, 0.901 (95% CI: 0.766–1.060; P=.210); and rash, 2.068 (95% CI: 1.604–2.666; P<.001). The RR of high-grade side effects were as follows: fatigue, 3.487 (95% CI: 1.765–6.889; P<.001); back pain, 1.364 (95% CI: 0.695–2.679; P=.367); arthralgia, 1.148 (95% CI: 0.509–2.593; P=.740); headache, 0.807 (95% CI: 0.303–2.147; P=.667); and rash, 3.018(95% CI: 0.954–9.554; P=.060). Conclusions: Our study showed that the risk of developing all grades of fatigue and any-grade alopecia and rash was significantly with CDK 4/6 inhibitors. Prompt intervention with good supportive care is required.

Sign in / Sign up

Export Citation Format

Share Document