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

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 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.

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