SWOG Spotlights High-Impact Research at ASCO

At ASCO 2019, SWOG investigators will report on 16 group-led trials, one jointly-led study, and another 12 involving partners. Presentation topics illustrate SWOG’s wide-ranging portfolio, with talks and posters on treatment or prevention of bladder, breast, colorectal, lung, pancreatic, prostate, and rare cancers, as well as melanoma and multiple myeloma. SWOG investigators will make a particularly strong showing in symptom control, survivorship, and quality of care trials.

“Some of our best work focusing on quality of life and quality of care issues is being presented at ASCO,” said SWOG Chair Charles D. Blanke, MD. “From text messaging to financial toxicity, this work is innovative and relevant – and it will have a major, positive impact on cancer research, cancer care, and patients with cancer.”

Here are SWOG highlights at ASCO 2019:

• Dawn Hershman, MD, will deliver two oral presentations based on SWOG trial data. A vice chair at SWOG and a breast cancer physician at NewYork-Presbyterian and Columbia University Irving Medical Center, Hershman will present the results of a multi-center randomized trial testing the effectiveness of text message reminders to improve adherence to hormone therapy for breast cancer. This is the first long-term, prospective trial to evaluate an intervention to improve cancer medication adherence. Hershman wanted to determine whether text reminders would persuade breast cancer patients to continue taking aromatase inhibitors, once-a-day estrogen-blocking pills. Due to the drug’s side effects, such as severe joint pain, a substantial number of women do not complete the five-year recommended treatment. Hershman and her team randomized patients into two groups – one that received a text twice a week for 36 months and one that did not. Hershman and her team found substantial non-adherence in all patients, and no difference in adherence rates between women who did and did not receive the texts. This was true no matter how adherence was measured – through urine biomarkers, patient self-reporting, or provider reports. Hershman said the data shows that simple, one-way texts are not an effective way to persuade patients to continue taking their cancer drugs. She concluded that improving long-term drug adherence will require personalized, sustained behavioral interventions, as well as symptom management and support.
   
• Hershman will give a second oral presentation on results of the first study to explore the effects that cardiovascular disease risk factors have on healthcare use and healthcare costs. Hershman will present data showing that patients with underlying cardiovascular disease risk factors, like hypertension, diabetes, and high cholesterol, have a substantially higher risk of an unplanned hospitalization during treatment. Hershman and her team reviewed data from 708 SWOG breast cancer patients over the age of 65 enrolled in 12 years’ worth of trials. They found that diabetes, high blood pressure, high cholesterol levels, and coronary artery disease were all associated with an increased risk of hospital admissions and emergency room visits. Women with hypertension had more than a three-fold risk. Across the board, women with cardiovascular disease risk factors also paid higher medical bills – particularly elderly women with diabetes. Hershman said the results illustrate the need for better patient monitoring and better models of patient care to keep women from being hospitalized and to reduce their medical bills.
   
• Thomas Flaig, MD, will present first-ever results from S1314, a phase II chemotherapy trial studying whether COXEN, a new type of gene expression model, can predict patient response to the two chemotherapy regimens used to treat muscle-invasive bladder cancer. Flaig, a SWOG investigator from the University of Colorado School of Medicine, said the oral presentation has attracted interest because results could inform preoperative treatment decisions for patients with bladder cancer. The trial is also testing COXEN, a unique method which uses cell cultures rather that tumor tissue samples to generate biomarkers and could be used on other cancer types.
   
• SWOG statistician and health services researcher Joseph Unger, PhD, will present results that show that gender plays a significant role in whether cancer patients receiving chemotherapy, biologics and immunotherapy, and targeted therapies experience severe adverse events, the types of side effects that often require hospitalization or medical intervention. Women reported more serious adverse events – regardless of type of treatment and regardless of whether the events were self-reported or objectively measured. To complete his study, Unger, from Fred Hutchinson Cancer Research Center, mined three decades of SWOG clinical trial data that included 36,397 patients, 297 trials, and more than 500,000 adverse events – making it one of the largest adverse events studies ever conducted using data from federally-funded cancer trials. The results provide provocative hypotheses for further study. In particular, the study identified large gender disparities for patients receiving immunotherapies – indicating that studying the effects of these popular new agents is a research priority.
   
• Two SWOG presentations focus on osteonecrosis of the jaw (ONJ), a bone disease that can occur from treatment with bisphosphonates, a class of drugs often prescribed for women with breast cancer. ONJ is considered an uncommon side effect of cancer treatment. However, in an oral presentation, Catherine Van Poznak, MD, of the University of Michigan will present study results that show that 1 in 40 patients who received the bisphosphonate zoledronic acid for bone metastases developed ONJ – making it a fairly common side effect. The findings come from the analysis of data from S0702, a SWOG prospective study of ONJ that enrolled over 3,000 people diagnosed with a variety of cancers. The highest incidence of ONJ was found in patients with multiple myeloma. Results can help physicians identify risk factors for ONJ, and S0702 has created a wealth of trial data to mine in future research.
   
• SWOG investigator Darya Kizub, MD, of Everett Clinic will give the other ONJ presentation using data from SWOG breast cancer trial S0307. That trial randomized 6,097 post-surgery breast cancer patients to receive one of three different types of bisphosphonates. Results showed all three drugs – zoledronic acid, clondronate, and ibandronate – were equally effective in preventing bone metastases. However, zoledronic acid use carries the highest risk of ONJ, with the biggest ONJ risk factors being gum disease, hardened tartar, and moderate to severe infections around the teeth. Kizub said the two other drugs, clondronate and ibandronate, are likely better options for patients with poor dental health – but they are not currently available for use in the U.S.
   

A member of the NCI’s National Clinical Trials Network (NCTN), SWOG collaborates on trials with its network partners. One of those multi-group studies, Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, captured international attention at last year’s ASCO meeting. TAILORx was designed and managed by the ECOG-ACRIN Cancer Research Group and is the largest adjuvant breast cancer treatment trial ever conducted. This year, the TAILORx presentation will focus on clinical risk of breast cancer recurrence, and whether it, along with the 21-gene recurrence score, will help physicians select the best treatments. SWOG investigators Daniel Hayes, MD, a former ASCO president from the University of Michigan Comprehensive Cancer Center, and Kathy Albain, MD, the Huizenga Family Endowed Chair in Oncology Research at Loyola University Chicago Stritch School of Medicine, are on the TAILORx team.