scholarly journals Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials

2017 ◽  
Vol 35 (27) ◽  
pp. 3113-3122 ◽  
Author(s):  
Poornima Saha ◽  
Meredith M. Regan ◽  
Olivia Pagani ◽  
Prudence A. Francis ◽  
Barbara A. Walley ◽  
...  

Purpose To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results For 240 human epidermal growth factor receptor 2–negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer–free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2–negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion In women younger than 35 years with hormone receptor–positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.

2009 ◽  
Vol 1 ◽  
pp. CMT.S3410
Author(s):  
Julie Price ◽  
Quincy Siu-chung Chu

Lapatinib is an oral dual inhibitor of epidermal growth factor receptor (HER1/ErbB1/EGFR) and human epidermal growth factor receptor 2 (HER2/ErbB2) which was approved for use in patients with metastatic breast cancer in 2007. In this review, we discuss the quality of life (QOL) results for patients on clinical trials of lapatinib. Six clinical trials, including 4 phase III and 2 phase II trials, were identified for which QOL outcomes have been reported. The trials generally showed stability of QOL during lapatinib therapy with no trial showing a detrimental effect of lapatinib on QOL. With these results, a discussion of the role of QOL assessments in patients with breast cancer is presented.


2016 ◽  
Vol 34 (19) ◽  
pp. 2221-2231 ◽  
Author(s):  
Meredith M. Regan ◽  
Prudence A. Francis ◽  
Olivia Pagani ◽  
Gini F. Fleming ◽  
Barbara A. Walley ◽  
...  

Purpose Risk of recurrence is the primary consideration in breast cancer adjuvant therapy recommendations. The TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor–positive breast cancer, testing exemestane plus ovarian function suppression (OFS), tamoxifen plus OFS, and tamoxifen alone. We examined absolute treatment effect across a continuum of recurrence risk to individualize endocrine therapy decision making for premenopausal women with human epidermal growth factor receptor 2 (HER2) –negative disease. Patients and Methods The TEXT and SOFT hormone receptor–positive, HER2-negative analysis population included 4,891 women. The end point was breast cancer–free interval (BCFI), defined as time from random assignment to first occurrence of invasive locoregional, distant, or contralateral breast cancer. A continuous, composite measure of recurrence risk for each patient was determined from a Cox model incorporating age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. Subpopulation treatment effect pattern plot methodology revealed differential treatment effects on 5-year BCFI according to composite risk. Results SOFT patients who remained premenopausal after chemotherapy experienced absolute improvement of 5% or more in 5-year BCFI with exemestane plus OFS versus tamoxifen plus OFS or tamoxifen alone, reaching 10% to 15% at intermediate to high composite risk; the benefit of tamoxifen plus OFS versus tamoxifen alone was apparent at the highest composite risk. The SOFT no-chemotherapy cohort—for whom composite risk was lowest on average—did well with all endocrine therapies. For TEXT patients, the benefit of exemestane plus OFS versus tamoxifen plus OFS in 5-year BCFI ranged from 5% to 15%; patients not receiving chemotherapy and with lowest composite risk did well with both treatments. Conclusion Premenopausal women with hormone receptor–positive, HER2-negative disease and high recurrence risk, as defined by clinicopathologic characteristics, may experience improvement of 10% to 15% in 5-year BCFI with exemestane plus OFS versus tamoxifen alone. An improvement of at least 5% may be achieved for women at intermediate risk, and improvement is minimal for those at lowest risk.


2020 ◽  
Vol 22 (1) ◽  
pp. 33-46
Author(s):  
LAURA CALVO

Introducción: Los inhibidores del Receptor del Factor de Crecimiento Epidérmico (Epidermal Growth Factor Receptor, EGFR) son fármacos antineoplásicos que actúan de forma dirigida sobre mecanismos implicados en el crecimiento celular neoplásico. No obstante, se asocian con efectos adversos que afectan a la piel, pelo y uñas. Objetivo: Evaluar el efecto de la toxicidad cutánea en la calidad de vida de los pacientes del Hospital de Día Oncológico del HUBU que reciben el tratamiento anti- EGFR. Material y método: Estudio descriptivo, transversal, y de tipo cuantitativo. Los 17 pacientes completan un cuestionario, Functional Assessment of Cancer Therapy (FACT), que evalúa la calidad de vida en dominios: físico, emocional, social y funcional. Resultados y discusión: El dominio que más influye en la calidad de vida es el físico, seguido del emocional, funcional y social. Las mujeres presentan peor calidad de vida en todos los dominios con respecto los hombres. Los pacientes que han suspendido algún ciclo del tratamiento presentan mayor afectación del RPP que los pacientes que no han suspendido ningún ciclo. La enfermería resulta vital para la identificación y tratamiento de los efectos adversos. Conclusión: La calidad de vida de los pacientes oncológicos se ve afectada negativamente por los efectos adversos. ABSTRACT Background: Epidermal Growth Factor Receptor (EGFR) inhibitors are antineoplastic drugs that act in a targeted manner on mechanisms involved in neoplastic cell growth. However, they are associated with adverse effects that affect the skin, hair and nails. Objective: To evaluate the effect of dermatological toxicity on the quality of life of HUBU patients that receiving the anti-EGFR treatment. Material and method: Descriptive, transversal and quantitative study. The 17 patients complete a questionnaire, Functional Assessment of Cancer Therapy (FACT), which evaluates the quality of life in domains: physical, emotional, social and functional. Results and discussion: The domain that most influences in the quality of life is the physical, followed by the emotional, functional and social domain. Women presented worse quality of life in all domains with respect to men. Patients who have discontinued a treatment cycle  have a greater involvement of the RPP than patients who have not stopped any cycle. Nursing is vital for the identification and treatment of the adverse effects. Conclusion: The quality of life of cancer patients is affected negatively by the adverse effect.


Sign in / Sign up

Export Citation Format

Share Document