Heartland’s Contributions to Research Presented at ASCO 2018
At the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO), National Cancer Institute (NCI) Director Norman Sharpless, MD, announced $10 million in new funding for the National Clinical Trials Network (NCTN).
The NCTN consists of five U.S. research bases that develop and conduct cancer clinical trials. Heartland Cancer Research NCORP is a member of four of these research bases- Alliance, SWOG, ECOG-ACRIN, and NRG Oncology. These research bases allow Heartland the opportunity to offer clinical trials to patients in our communities.
This additional funding ensures NCI’s continued commitment to clinical trials, which expand our knowledge of cancer and offer the best treatment options for many patients. Dr. Sharpless also highlighted the need to address cancer research challenges such as poor enrollment rates, inability to enroll patients who don’t meet certain criteria, and the fact that each person’s cancer is different. This funding is key to providing clinical trial access to more patients.
ASCO wants to give even more patients the chance to participate in these trials, which are fundamental to making continued progress in cancer treatment and prevention. Heartland’s participation in clinical trials has enabled our physicians to be “early adopters” of new innovations. This is known to be an important advantage of involvement in the NCORP. As a result, there were few presentations at the 2018 ASCO meeting that will change clinical practice in Heartland institutions. However, we wanted to highlight for you the results of the major studies that will change practice for many physicians and in which we were proud to have participated:
TAILORx : Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score.
This trial is highlighted elsewhere on the Heartland NCORP website.
TEXT and SOFT trials: Absolute improvements in freedom from distant recurrence with adjuvant endocrine therapies for premenopausal women with hormone receptor-positive HER2-negative breast cancer
The TEXT and SOFT trials assigned women who were not yet menopausal and who had a type of early breast cancer that was identified to be potentially sensitive to hormone therapy to either the usual type of hormone therapy (the drug Tamoxifen) or to a treatment that would turn off the ability of their ovaries to produce hormones—in effect making them post-menopausal.
Among those women who were assigned to “ovarian function suppression,” they were further assigned to either take tamoxifen pills or an oral medication called “exemestane.” Exemestane is only effective in women who have gone through a menopause. Since these women had been made “post-menopausal” by the blockade of their ovarian function, they had become eligible to take exemestane, instead of tamoxifen.
Therefore, these studies aimed to determine whether
(1) ovarian function suppression lowered the relapse rate of the women’s breast cancers and
(2) whether exemestane was superior to tamoxifen among those women who had been made post-menopausal by the ovarian function suppression.
The 8-year results of these interventions were presented.The analysis found that among young women whose cancers were judged to have a high recurrence risk, the combination of ovarian function suppression and exemestane produced up to a 10-15% improvement in relapse rates in comparison with the standard treatment, (Tamoxifen pills alone). The benefits were less for those women whose tumors had an intermediate risk of recurrence (4-5%). For those at low risk, 97% were recurrence-free at 8 years, regardless of which form of hormone therapy they received.
These studies confirmed that suppression of ovarian function in young women with this type of breast cancer improves outcome. However, ovarian function blockade is not for all patients—- it should be discussed with each patient in terms of the expected benefit and anticipated side effects.
Z1071 trial: Factors associated with lymphedema in patients/women with node positive breast cancer treated with neoadjuvant chemotherapy and axillary dissection on a prospective clinical trial.
Lymphedema (arm swelling) is a known complication of breast cancer surgery. Through the years, we have made great progress lowering the risk of lymphedema. This study reported the factors associated with lymphedema after pre-surgical chemotherapy and axillary node removal in patients with breast cancer that had already spread to axillary lymph nodes (i.e., the lymph nodes in the under-arm area) at the time their breast cancer was diagnosed. This is a group of women who might be expected to have an especialy high risk of arm swelling.
The study found that the incidence of arm swelling was higher in obese patients and in patients with chemotherapy durations of longer than 3.5 months prior to surgery. Patients in these groups may benefit from closer surveillance for lymphedema to allow early intervention with physical and occupational therapy.