By Beth Gilbert HealthDay Reporter
The annual San Antonio Breast Cancer Symposium was held from Dec. 5 to 9 in San Antonio, with attendees including medical oncologists, radiation oncologists, researchers, and other health care professionals. The conference highlighted recent advances in the risk, diagnosis, treatment, and prevention of breast cancer, and presentations focused on emerging treatments in hard-to-treat patient populations, including patients with metastatic breast cancer.
In the phase 3, double-blind randomized HER2CLIMB-02 study, Sara A. Hurvitz, M.D., of the Fred Hutchinson Cancer Center at the University of Washington in Seattle, and colleagues found that adding tucatinib to trastuzumab emtansine (T-DM1) extends the length of time a patient can live without their breast cancer progressing.
The study was designed to determine whether adding tucatinib, an oral drug that selectively targets human epidermal growth factor receptor 2 (HER2), to an antibody drug conjugate, T-DM1, benefits patients with HER2-positive, locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane in any setting. The study met its primary end point by demonstrating that the addition of tucatinib to T-DM1 significantly improved median progression-free survival, from 7.4 to 9.5 months, thereby reducing the relative risk for progression or death by 24 percent. This benefit was seen across all prespecified patient subgroups. Importantly, benefit was seen in patients with brain metastases, a subgroup that comprised 44 percent of enrolled patients. The median progression-free survival for patients with brain metastases was 7.8 months in the tucatinib arm and 5.7 months in the control arm. A statistical difference in overall survival was not observed in this interim analysis.
“At this time, these results are not practice-changing, as this regimen is not yet U.S. Food and Drug Administration approved,” Hurvitz said. “It does, however, validate that tucatinib has significant activity in HER2-positive metastatic breast cancer, especially in those with brain metastases, and in the future, this may be a regimen that patients could use for their disease.”
The study was funded by Seagen, the manufacturer of tucatinib.
In the PREFERABLE-EFFECT study, Anne May, Ph.D., of the Julius Center for Health Sciences and Primary Care at the University Medical Center in Utrecht, Netherlands, and colleagues found that a supervised resistance and aerobic exercise intervention results in beneficial effects on fatigue, health-related quality of life, and other clinically relevant outcomes for patients with metastatic breast cancer.
The authors investigated the effects of exercise in patients with metastatic breast cancer. Patients from eight centers in five European countries and Australia were randomly assigned to either a nine-month supervised exercise intervention or a usual care control group. The exercise intervention consisted of endurance, muscle strengthening, and balance training. The investigators observed positive effects of the exercise intervention on both primary outcomes. Patients in the exercise intervention group had lower levels of fatigue and a better quality of life compared with the control group. In addition, the researchers observed positive effects on physical fitness and functioning, as well as functioning in their social life (with family and friends and at work). Patients also reported fewer symptoms of pain and shortness of breath.
“Importantly, some patients with metastatic breast cancer worry that exercise might worsen their fatigue and pain, but this study shows that exercise can actually improve these outcomes,” May said. “We recommend exercise to patients with metastatic breast cancer with stable bone metastases. If patients are interested in exercising, I recommend talking to their treating doctor or nurse first, and to search for an exercise trainer who is trained in guiding people with (metastatic) cancer.”
In the multicenter prospective cohort IDEA study, Reshma Jagsi, M.D., of the Emory University School of Medicine in Atlanta, and colleagues found that five-year breast cancer recurrence is extremely low among younger postmenopausal women with early-stage, biologically favorable disease who do not receive radiation therapy.
The authors wanted to see if the choice to consider omitting radiation therapy may be possible for some younger postmenopausal women, and they enrolled patients with early-stage, biologically favorable disease who agreed to receive the same treatment. Lumpectomy was followed by endocrine therapy, but not radiation treatment, for these selected women, who were all postmenopausal and 50 to 69 years of age with unifocal invasive breast cancer. The cancer was up to 2 cm in size without spread to the lymph nodes and was removed with breast-conserving surgery. Tumors were estrogen receptor-positive, progesterone receptor-positive, and HER2-negative, with an Oncotype DX 21-gene Recurrence Score ≤18 (biologically favorable on a commonly used genomic assay). The researchers found that five-year freedom from any recurrence was 99 percent. Crude rates of ipsilateral breast events for the entire follow-up period for patients aged 50 to 59 and 60 to 69 years were 3.3 and 3.6 percent, respectively.
“Rates of recurrence were very low at five years, suggesting that this is worth ongoing investigation, including in trials like the NRG BR007 DEBRA trial that is currently open for patients similar to those on IDEA,” Jagsi said. “But something I really want to emphasize is the fact that although this is a study about avoiding radiation therapy, and radiation therapy does have expense, toxicity, and burden, these downsides have been mitigated by many advances in radiation delivery in recent years. Patients like those on IDEA can be treated in five days with radiation regimens that are generally very well tolerated.”
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