Feb 16, 2016
Few prospective studies have compared the quality of life (QOL) and symptoms experienced by women who receive adjuvant endocrine therapies (ETs), including aromatase inhibitors (AIs) and tamoxifen, to the experience of women who do not receive endocrine therapy.
To address this gap, a study in the Journal of Clinical Oncology (JCO), published online ahead of print, January 19, 2016, examined 186 women, age 21 to 65, with newly diagnosed breast cancer shortly after they completed primary treatment (surgery, with or without radiation or chemotherapy), but before they started ET. The patients were asked to report on their physical and mental health, ET-related symptoms, depression, fatigue, and sleep quality before they started adjuvant ET and then at 6 and 12 months from baseline. The participants were enrolled in the prospective observational Mind-Body Study (MBS).
Side effects from primary treatment resolve, those from endocrine therapy continue
The study found significant differences in the physical health component of QOL between women who received ETs and those who did not (123 out of the 186 women on the study received ETs, with half receiving AIs and half receiving tamoxifen). In terms of physical health, at baseline, before initiation of therapy, the ET group did not differ from the non-ET group (both groups reported health-levels below that of the general population). However, at the 12-month mark, the women in the AI group had significantly lower physical health scores. In terms of mental health, both groups had scores within the normal range at baseline, and this pattern did not change over time.
When it came to the severity of ET-related symptoms, such as hot flashes, musculoskeletal symptoms, vaginal problems, and cognitive problems, significant differences emerged between groups, with some variable patterns: Women who did not undergo ET experienced either stable or declining severity of symptoms over time, whereas women who received ET often experienced increased severity over time. When the ET group was separated out into those who received an AI and those who received tamoxifen, the AI group reported significantly more severe musculoskeletal symptoms, vaginal problems, cognitive problems, and hot flashes at either the 6- or 12-month mark, or both, compared to the non-ET group. The women in the tamoxifen group reported higher levels of cognitive problems, hot flashes, and bladder problems compared to the non-ET group.
Acknowledging symptoms and offering early intervention
According to first author Patricia A. Ganz, MD, the study shows that doctors have an opportunity to speak with patients about side effects and how these can be managed.
“A lot of times patients report symptoms to their physicians and nurses and are told, ‘It’s going to get better’ or ‘We expect that,’” said Dr. Ganz. “But for several symptoms—for instance, fatigue and sleep disturbance, which are pretty common—the severity is at a high level at the end of primary treatment and does not get better over time…. It’s our responsibility to address these issues from a quality-of-life standpoint.”
Dr. Ganz added that early intervention is especially important for patients receiving ET, considering that women must continue to take the medication—and face ongoing symptoms—over many years.
“Endocrine therapy is often taken for 5 years or more, and as the study shows, symptoms are associated with this treatment and do not necessarily get better,” said Dr. Ganz. “Trying to find a way to address some of these symptoms early on could be very important in terms of making sure women stay on their therapy.”
Side effects might guide choice between AIs and tamoxifen
AIs have been the standard adjuvant therapy treatment for postmenopausal women with breast cancer since a 2002 landmark study showed that patients who received the AI anastrozole had a significantly greater disease-free survival benefit compared to tamoxifen. However, AIs may cause troublesome symptoms, including musculoskeletal or joint pain and greater vaginal dryness, especially compared to tamoxifen. A 2014 ASCO guideline suggests that clinicians and patients should weigh these side effects when deciding between AIs and tamoxifen; this new study sheds light on which side effects patients and doctors should anticipate and discuss.
“These symptoms are important to consider, particularly when we have a choice of which drug to use,” said Dr. Ganz. “If we had a patient who was already having a lot of arthritis and muscle pain or sexual difficulties, we might recommend tamoxifen. If our goal is to ensure that women take their endocrine therapy, we need to consider the tolerability of medication and use these symptom findings to help in making treatment decisions.”
Patricia Ganz, MD, FASCO is a medical oncologist and the Leader of Patients and Survivors Program Area at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles (UCLA), where she also directs the Center for Cancer Prevention and Control Research. She is also a professor of Health Policy and Management at the UCLA Fielding School of Public Health. An ASCO member since 1980, Dr. Ganz has volunteered in a variety of capacities for the Society. She was a member of the Board of Directors from 2003 to 2006, serving on the Executive Committee from 2005 to 2006. She has served on numerous ASCO committees (Survivorship, Prevention, Awards, Program, Education), and as Chair of the Personnel Committee, Quality of Care Committee, and Publications Committee. She is a current member of the Cancer Communications Committee and the Value Task Force. She was the 2008 recipient of the ASCO-American Cancer Society Award for her contributions to the prevention and management of cancer. She was also awarded the Conquer Cancer Foundation 2010 Comparative Effectiveness Research Professorship in Breast Cancer. Dr. Ganz is the 2016 recipient of ASCO’s first annual Joseph V. Simone Award and Lecture for Excellence in Quality and Safety in the Care of Patients with Cancer in recognition of her work in improving the quality of cancer care from prevention through survivorship. She is a Fellow of the American Society of Clinical Oncology.
Abstract of the original JCO article.
PDF of the original JCO article.
Ganz PA, Petersen L, Bower JE, et al. Impact of adjuvant endocrine therapy on quality of life and symptoms: observational data over 12 months from the Mind-Body Study. J Clin Oncol. Epub 2016 Jan 19.
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@ 2016 American Society of Clinical Oncology