Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer

Modi, Natansh D.; Danell, N.O.; Perry, R.N.A.; Abuhelwa, Ahmad Y.; Rathod, Akash; Badaoui, Sarah; Haseloff, M.; Shahnam, Adel; Swain, Sandra M.; Welslau, Manfred; Sorich, Michael J.; Hopkins, Ashley M.

doi:10.1016/j.esmoop.2022.100475

Cited by 8 publications

(6 citation statements)

References 41 publications

(67 reference statements)

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“…The necessity of addressing PROs as an essential endpoint of clinical trials has been increasingly emphasized by international societies and guidelines. 75 QoL questionnaires have been the most common tool implemented in decision-changing studies to evaluate PROs. Specifically, the Functional Assessment of Cancer Therapy-Breast (FACT-B) has been one of the most widely administered questionnaires in HER2 ABC clinical trials.…”

Section: Toxicities Associated With the Treatment And Patient-reporte...mentioning

confidence: 99%

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HER2-Directed Therapy in Advanced Breast Cancer: Benefits and Risks

Mandó¹,

Waisberg²,

Pasquinelli³

et al. 2023

OTT

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Around 20% of breast cancers are associated with amplification or overexpression of human epidermal growth factor receptor 2 (HER2). In this setting, anti-HER2-targeted agents are the cornerstone of cancer therapeutic strategies. This includes monoclonal antibodies, tyrosine kinase inhibitors (TKIs) and, recently, antibody–drug conjugates (ADCs). With the advent of these new alternatives, the decision-making process has become more complex, especially with regard to the treatment sequence possibilities. In spite of the fact that overall survival has significantly improved accordingly, resistance to treatment remains a challenge in HER2-positive breast cancer. The introduction of new agents has created awareness regarding new potential specific adverse events, and consequently, their increasing application pose major challenges in daily patient care. This review describes the therapeutic landscape for HER2-positive advanced breast cancer (ABC) and evaluates its benefits and risks in the clinical setting.

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Section: Toxicities Associated With the Treatment And Patient-reporte...mentioning

confidence: 99%

“…Importantly, PROs according to the FACT-B scale have been identified as an independent prognostic factor for OS and PFS, considering a pooled analysis of some of the largest HER2-positive ABC clinical trials, such as CLEOPATRA, EMILIA, and MARIANNE. 75 …”

Section: Toxicities Associated With the Treatment And Patient-reporte...mentioning

confidence: 99%

HER2-Directed Therapy in Advanced Breast Cancer: Benefits and Risks

Mandó¹,

Waisberg²,

Pasquinelli³

et al. 2023

OTT

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“…The link between depression and anxiety status and cancer outcomes has been well investigated. Psychological distress is related to higher cancer-specific mortality and poorer cancer survival in patients with breast cancer ( 2 – 4 ). Both, low levels of psychological distress and low fatigue are independently correlated with longer periods of recurrence-free survival and overall survival ( 3 , 4 ).…”

Section: Introductionmentioning

confidence: 99%

App-based support for breast cancer patients to reduce psychological distress during therapy and survivorship – a multicentric randomized controlled trial

Wolff,

Seidel,

Wuelfing

et al. 2024

Front. Oncol.

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IntroductionThe negative impact of unmanaged psychological distress on quality of life and outcome in breast cancer survivors has been demonstrated. Fortunately, studies indicate that distress can effectively be addressed and even prevented using evidence-based interventions. In Germany prescription-based mobile health apps, known as DiGAs (digital health applications), that are fully reimbursed by health insurances, were introduced in 2020. In this study, the effectiveness of an approved breast cancer DiGA was investigated: The personalized coaching app PINK! Coach supports and accompanies breast cancer patients during therapy and follow-up.MethodsPINK! Coach was specifically designed for breast cancer (BC) patients from the day of diagnosis to the time of Follow-up (aftercare). The app offers individualized, evidence-based therapy and side-effect management, mindfulness-based stress reduction, nutritional and psychological education, physical activity tracking, and motivational exercises to implement lifestyle changes sustainably in daily routine. A prospective, intraindividual RCT (DRKS00028699) was performed with n = 434 patients recruited in 7 German breast cancer centers from September 2022 until January 2023. Patients with BC were included independent of their stage of diseases, type of therapy and molecular characteristics of the tumor. Patients were randomized into one of two groups: The intervention group got access to PINK! over 12 weeks; the control group served as a waiting-list comparison to “standard of care.” The primary endpoint was psychological distress objectified by means of Patient Health Questionnaire-9 (PHQ-9). Subgroups were defined to investigate the app’s effect on several patient groups such as MBC vs. EBC patients, patients on therapy vs. in aftercare, patients who received a chemotherapy vs. patients who did not.ResultsEfficacy analysis of the primary endpoint revealed a significant reduction in psychological distress (least squares estimate -1.62, 95% confidence interval [1.03; 2.21]; p<0.001) among intervention group patients from baseline to T3 vs, control group. Subgroup analysis also suggested improvements across all clinical situations.ConclusionPatients with breast cancer suffer from psychological problems including anxiety and depression during and after therapy. Personalized, supportive care with the app PINK! Coach turned out as a promising opportunity to significantly improve psychological distress in a convenient, accessible, and low-threshold manner for breast cancer patients independent of their stage of disease (EBC/MBC), therapy phase (aftercare or therapy) or therapy itself (chemotherapy/other therapy options). The app is routinely available in Germany as a DiGA. Clinical Trial Registration: DRKS Trial Registry (DRKS00028699).

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“…Generating further evidence in research of psycho-oncological interventions and digital behavioral coaching is one of the main goals of this project. The current status of research clearly shows that increased psychological well-being and health-related quality of life are associated with better treatment responses and significant improvement of disease-free survival rates [3, 4]. Psychological well-being and patient empowerment are complex and very individual factors in patients with a serious disease such as breast cancer.…”

Section: Introductionmentioning

confidence: 99%

App-Based Lifestyle Coaching (PINK!) Accompanying Breast Cancer Patients and Survivors to Reduce Psychological Distress and Fatigue and Improve Physical Activity: A Feasibility Pilot Study

Wolff,

Wuelfing,

König

et al. 2023

Breast Care

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This pilot study aimed to investigate the effects of using an app-based certified medical product named PINK! on breast cancer patients and survivors. The objectives were to measure psychological distress, physical activity and therapy-related fatigue of patients using PINK! to identify trends and develop a study design for a subsequent multicentric proof of efficacy RCT. Materials and Methods PINK! offers individualized, evidence-based therapy and side-effect management, mindfulness-based stress reduction, nutritional and psychological education, physical activity tracking and motivational exercises to implement lifestyle changes sustainably in daily routine. A prospective, intraindividual RCT was performed with n=60 patients in 2021 at Comprehensive Cancer Center Munich. Patients with BC were included independent of stage of disease. The intervention group got access to PINK! over 12 weeks. Control group served as waiting list comparison to “standard-of-care”. Results Primary efficacy variable analysis revealed a relative average decrease of 32.9 % in psychological distress which corresponds to a statistically significant reduction (p<0.001) within 12 weeks compared to the control group. Linear regressions within usage groups showed a correlation of high app usage and reduction of psychological distress. Fatigue data presented a statistically significant anti fatigue efficacy (p<0,001) and physical activity increased by 63,9%. Conclusion App-based supportive care offers a promising, low-threshold and cost-efficient opportunity to improve psychological well-being, quality of life, fatigue and physical activity. More research is needed to implement eHealth solutions in clinical cancer care.

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Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer

Cited by 8 publications

References 41 publications

HER2-Directed Therapy in Advanced Breast Cancer: Benefits and Risks

HER2-Directed Therapy in Advanced Breast Cancer: Benefits and Risks

App-based support for breast cancer patients to reduce psychological distress during therapy and survivorship – a multicentric randomized controlled trial

App-Based Lifestyle Coaching (PINK!) Accompanying Breast Cancer Patients and Survivors to Reduce Psychological Distress and Fatigue and Improve Physical Activity: A Feasibility Pilot Study

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