TAILORx - made
I feel so blessed. The clinical trial gave me so much more confidence in my decision. "
- Brigette Stovall, breast cancer survivor
Clinical trial helps local cancer survivor make individualized treatment decisions
Brigette Stovall says 3 has always been her lucky number.
"I'm slightly superstitious," laughed the Reno resident, now 30, who was diagnosed with invasive ductal breast cancer in 2008 - at the age of 28. "It sounds weird, but my boyfriend, his son and I make up a family of three. I shop in threes. It's just kind of our number."
But the number's significance now carries even greater weight, as 3 is also her Oncotype DX Assay Recurrence Score (RS).
"This is a score, on a scale from 0 to 100, that correlates to a specific likelihood of breast cancer recurrence within 10 years of initial diagnosis," said Beth Ahart-Valk, RN, OCN, lead research nurse for Renown Institute for Cancer. "Oncotype Dx is used for women with early stage breast cancer whose tumors are estrogen and/or progesterone positive, Her2 negative and lymph node negative."
Knowing her RS - which she discovered through a clinical trial - helped Stovall make an important decision.
Stovall was weighing whether or not to undergo chemotherapy after her lumpectomy and radiation therapy. While chemotherapy has been shown to slow or stop breast cancer's steady progression, it can have side effects: nausea, hair loss and fatigue among them. And for Stovall, there was another consideration.
"Brigette is a young woman who was hoping to have children someday," Ahart-Valk explained. "A potential side effect from chemotherapy in young women includes ovarian suppression, which in some cases can be permanent after treatment. This would mean she would not be able to become pregnant, a risk she really did not want to take."
But because of her youth and type of cancer, Stovall's oncologist was encouraging her to undergo chemotherapy.
"I had a hard time trying to make this decision by myself," Stovall said. "I am much more a fan of naturalistic forms of treatment, and I didn't want to go through chemo if it wasn't entirely necessary."
So she researched her options on the Internet and discovered the TAILORx clinical trial, which stands for "Trial Assigning Individualized Options for Treatment (Rx)" and is being conducted by the National Cancer Institute.
The main purpose of the clinical trial is to determine which patients fall in the "primary study group" and would be more likely to benefit from chemotherapy. The trial uses the Oncotype DX to identify and assign treatment to more than 10,000 breast cancer patients.
Patients enrolled in the TAILORx trial with an RS between 0 and 10 receive hormonal therapy only, as patients with a low RS have been found to be at a very low risk of recurrence. Patients with an RS above 25 receive both hormonal therapy and standard chemotherapy. And the patients between 11 and 25, the primary study group, are put into two treatment groups - one receiving hormonal and standard chemotherapy, the other receiving only hormonal therapy. Patients within this range have an elevated risk of recurrence in which chemotherapy would be typically recommended, but there is insufficient evidence demonstrating chemotherapy is beneficial.
"This trial is an example of how we're beginning to individualize treatment for our patients," Ahart-Valk said.
The study tracks all patients - whether in the low, middle, or high RS range - and their recurrence within 10 years of initial diagnosis.
"As a result of this study, we hope that future breast cancer patients will have more information to help make tough treatment decisions," Ahart-Valk said. "Women with an RS of 11-25 can choose a treatment option tailored to their specific situation and genetic profile."
For Stovall, her score of 3 was another tool to help her make an informed decision.
"I didn't want to make a decision as important as that (undergoing chemotherapy) without knowledge," she said. "So I enrolled in the study, deciding I'd leave it in the hands of fate. If the score came back high, I knew I'd do the chemo; if it was low, I'd feel better about my choice."
She said that the day before the score came in was one of her lowest ever.
"My boyfriend and I spent the whole day depressed, trying to wrap our minds around everything that had happened, because it all came at us so fast," she said. "So that day, we mutually decided the number was going to be 3. We both mentally committed to that number."
And 3 it was. Based on the trial methodology, prescribed treatment was hormone therapy only.
"I feel so blessed," Stovall said. "The clinical trial gave me so much more confidence in my decision. It showed me how important it is to listen to your doctor but also look within yourself to make decisions, because those decisions can change your whole life."
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