WON Open Protocols
The Wisconsin Oncology Network currently has the following open studies available for participation:
UW15068: UWCCC Molecular Tumor Board Registry
UW16112: A Phase II Study of Neoadjuvant Weekly Carboplatin/Paclitaxel followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients with Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer
UW16086: Bendamustine + obinutuzumab induction chemoimmunotherapy with risk-adapted obinutuzumab maintenance therapy in previously untreated mantle cell lymphoma
For more information about this network, or to learn how you can get involved, please contact the WON Affiliate Coordinator by email or (608) 265-2867.
WON Successes
For many patients with advanced cancer, pain rarely occurs on its own. Instead, pain forms clusters with other symptoms such as fatigue and sleep disturbance. Dr. Kristine Kwekkeboom received funding from the National Institute of Nursing Research to study if treatment strategies including relaxation, distraction and guided imagery could reduce pain and related symptoms and improve patients’ quality of life.
In the study, patients are randomized into two groups. In one group, patients listen to recordings of cancer educational materials. In the other, they listen to audio-guided exercises to help control symptoms, such as deep breathing or imagining changes in their pain sensations and draining pain from their body like sand draining from a sandbag. Each recorded exercise lasts up to 20 minutes. Patients are asked to practice the exercises at least once a day for up to nine weeks. They also fill out a weekly log and complete pain and symptom questionnaires every three weeks.
Kwekkeboom expects this study will determine if patients benefit from these non-drug treatment strategies. She is examining changes in patients’ symptom ratings, their perceptions of stress, and biological inflammatory markers and stress hormones in blood and saliva. Importantly, this study should help explain individual differences in how well these symptom management strategies work for patients, allowing her to identify who is likely to benefit with these specific interventions and how to improve treatments for all patients.
She reached out to the Wisconsin Oncology Network (WON) to expand the diversity of the patient population beyond just those patients treated in Madison at the UW Carbone Cancer Center. For this study, the team recruited patients from Mercy Health System in Janesville, ProHealth Care in Waukesha and Swedish American Regional Cancer Center in Rockford, IL.
Nikki Meanovich, RN, a clinical research nurse currently at University Hospital but who previously coordinated the study at Mercy Health, said, “Our site chose this study because we truly believed that it provided a great benefit to our patients and that many different patients with different disease sites could participate. Quality of life is so important in oncology, and our patients at Janesville turned this study into a way of life and an outlet on how to improve their quality of life. By the end of October, when I left Mercy, we literally had our whole chemo room listening to an mp3 player, whether or not they were on the study, just from all of the positive talk going on in the chemo room from patients that were on it.”
Mantle Cell Lymphoma Remission Increase
Mantle cell lymphoma (MCL) is a rare subtype of non-Hodgkin lymphoma. Despite its name, MCL behaves differently than many lymphomas and, consequently, needs to be treated differently. The first line of therapy, known as R-CHOP, can cure some types of lymphoma, but it is not curative for MCL. After treatment, MCL patients see an average first remission of 18 months.
“Your first remission is always your best, and its length can be extremely telling for how the disease is going to behave” said Dr. Julie Chang, a hematologist with the University of Wisconsin Carbone Cancer Center and lead author of the study. “Each successive treatment will give shorter and shorter remissions, so the goal of this particular trial was to give a little bit more intensive first-line therapy and hopefully help these people stay in remission a little bit longer.”
In this study, which was initiated in 2005 and closed to accrual in 2008, Chang and colleagues gave MCL patients the same combination of chemotherapy drugs as in R-CHOP but in higher doses. They added another drug, Bortezomib (Velcade™), that has been FDA-approved for treatment of MCL. After treatment, they gave patients five years of maintenance therapy with rituximab (Rituxan™).
“We initially published results of the trial in 2011, 63 percent of patients were still in remission three years after treatment,” Chang said. “We followed patients on the trial until this year, and now eight years after the last person accrued on the trial, 50 percent of patients are still in remission, indicating that there was a remarkably small margin of people who relapsed after three years. In fact, everyone who was in remission after five years was still in remission after eight.”
The trial was run through WON, a network of regional clinics that allows patients throughout the state to participate in UWCCC clinical trials. Four sites outside of Madison accrued patients to the trial. Chang said the benefit of using WON is evident when working with such a rare disease.
“The study had 30 patients, which doesn’t seem like a lot, but MCL is a very uncommon disease,” Chang said. “Yet between the UW and WON we were able to accrue to the study and get meaningful data.”
Based on the results first published in 2011, the WON treatment protocol was developed for a larger Eastern Cooperative Oncology Group (ECOG) trial (ECOG E1405). That study is currently being analyzed, and the results are expected to be reported in 2017. Chang said if the ECOG trial’s results agree with those of the WON trial, then the combined results will be a major factor in deciding if this intermediate-intensity chemotherapy moves forward for the treatment of MCL.
Whether by choice or by financial need, many cancer patients continue to work during their treatment. A study by the UW Carbone Cancer Center and the Wisconsin Oncology Network is looking for ways to reduce the effects of cancer treatment on work ability. It may also help to more quickly identify those patients who are most at risk for a poor recovery and provide them with earlier interventions.
“One of our research team’s primary missions is to mitigate the impact of cancer diagnosis and treatment on survivors,” said Amye Tevaarwerk, MD, who led the study. “We wanted to know, who’s at risk for work limitations? Whose work ability actually changes? When do we need to intervene?”
Before this study, U.S. data on work limitations during treatment were obtained years after treatment had ended. This study, then, was opened to current patients at University Hospital who were working at the time of diagnosis and who indicated they intended to work after their treatment ended. However, after the first 20 or so patients enrolled, the researchers found their study sample in Madison was not representative of the U.S. population as a whole with respect to education, race or income level.So they turned to the Wisconsin Oncology Network (WON). Participants were recruited from six WON sites: Fox Valley Hematology and Oncology in Appleton; Marshfield Clinic in Weston; Mercy Health Systems in Janesville; Aspirus Regional Cancer Center in Wausau; Gundersen Lutheran Medical Center in La Crosse; and Columbia St. Mary’s in Milwaukee.
“We were able to capture a much broader socioeconomic demographic working through WON,” Tevaarwerk said. “We wanted to capture a wider range of patients, including those who worked desk jobs and those who had extremely physical jobs, and those whose household incomes were less than $35,000 or over $150,000. We couldn’t have done it without WON.”
Participants were asked to complete a questionnaire with 100 questions related to their jobs and their ability to work. Seven questions asked specifically about work limitations, such as how much of the time they were able to use hand-held equipment like keyboards or drills.
By the end of treatment, the group as a whole scored higher for work limitations. Six months after they completed treatment, three-quarters of the patients had recovered to their baseline levels, though a small minority of patients did not show much if any recovery. Tevaarwerk noted that neither finding is surprising, but says this is the first time this type of study has been done on U.S. cancer patients in the workforce. She presented this first part of the study at the Cancer Survivorship Symposium in January 2017.
“Next we’ll be using the information in the remainder of the questionnaires to figure out if we can do anything to improve that increase in work limitations during treatment even a little bit,” Tevaarwerk said. “And for those people who continue to struggle with decreased work ability, we’d like to find if there was anything we could do that would identify them earlier to help reverse that or to help provide them with services to, say, transition to disability.”