Reshma Jagsi, MD, DPhil, Lawrence W. Davis Professor, chair, 

Dr Jagsi on the Implications of the IDEA Trial For Patients With Breast Cancer

Department of Radiation Oncology, Emory University School of Medicine, Winship Cancer Institute, discusses the implications of the IDEA trial (NCT02400190) for patients with breast cancer.

The overarching message Jagsi wishes to convey is her immense pride in being a part of a community of researchers who have diligently prioritized centering patients' experiences. This collective effort aims to enhance the quality of care oncologists provide, ensuring equity and acknowledging the vast heterogeneity within breast cancer, she explains. This diversity presents an opportunity for oncologists to personalize treatments, tailoring them to the individual patients’ needs, Jagsi adds.

She goes on to express her gratitude to the numerous women who have participated in clinical trials, starting from the landmark studies of the 1970s comparing mastectomy with breast-conserving surgery. It's truly remarkable to contemplate the bravery of patients facing a breast cancer diagnosis who willingly allow chance to determine whether they would retain their breast, Jagsi states. Their courage has paved the way for advancements that benefit future generations of women, and their contributions to research are a gift to society, she notes.

The IDEA trial is a prospective, multicenter cohort study exploring the safety of excluding radiation therapy after breast-conserving surgery in the treatment of younger postmenopausal patients by incorporating a genomic assay alongside traditional selection criteria. From June 2015 to October 2018, 200 patients 50 to 69 years of age with stage I unifocal invasive breast cancer were enrolled across 13 collaborating sites. The trial’s primary analysis occurred 5 years after the completion of surgery for the last enrolled patient.

Results, based on a median follow-up of 5.2 years for 186 patients with at least 56 months of clinical follow-up, revealed both overall and breast cancer–specific survival rates of 100%. Additionally, the 5-year rate of freedom from any recurrence was 99% (95% CI, 96%-100%).

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Reshma Jagsi, MD, DPhil, discusses the implications of the IDEA trial for patients with breast cancer.

Dr Jagsi on the Implications of the IDEA Trial for Radiotherapy Omission in Breast Cancer  

Reshma Jagsi, MD, Dphil, Lawrence W. Davis Professor, chair, Department of Radiation Oncology, Emory University School of Medicine, Winship Cancer Institute, discusses caveats when interpreting long-term results from the IDEA trial (NCT02400190) evaluating radiotherapy omission when administering breast conserving surgery plus endocrine therapy to postmenopausal patients with breast cancer.

The prospective, multicenter cohort trial aimed to assess the feasibility and safety of omitting radiation therapy in younger postmenopausal patients, incorporating 21-gene recurrence score alongside traditional selection factors. Data from the primary analysis of the trial revealed a low 5-year risk of recurrence when utilizing a genomic assay in conjunction with selecting classic postmenopausal patients under the age of 60 based on clinical and biological characteristics. This approach represents a significant advancement in tailoring treatment strategies for this specific patient population.

When discussing the implications of omitting radiotherapy in certain contexts, Jagsi says it is important to clarify that these data do not imply that radiation treatment is inherently undesirable or ineffective. Radiation therapy has undergone significant advancements, making it more efficient and less toxic than ever before, she explains. For many patients with breast cancer, it remains a vital component of curative treatment, often well-tolerated with minimal adverse effects and no severe long-term complications.

The goal of exploring radiotherapy omission therefore is not to discourage its use, but rather to empower patients to make informed decisions about their treatment options, Jagsi emphasizes, adding that this approach aligns with broader efforts in breast cancer care to provide patients with agency in their treatment journey. Similar efforts have been made in medical oncology with the development of tools like the 21-gene recurrence score, which aids in chemotherapy decision-making based on individual patient characteristics.

Ultimately, the goal of this research is to offer patients a range of options and involve them in decision-making processes that align with their values and preferences, ensuring they receive the most appropriate and personalized care for their breast cancer journey, Jagsi concludes.

Reshma Jagsi, MD, Dphil, discusses caveats when interpreting long-term results from the IDEA trial of radiotherapy omission in breast cancer.

Dr Jagsi on the Feasibility of Radiation Omission Following Surgery in Breast Cancer Care  

Reshma Jagsi, MD, Dphil, Lawrence W. Davis Professor, chair, Department of Radiation Oncology, Emory University School of Medicine, discusses 5-year findings from the IDEA trial (NCT02400190) evaluating the feasibility of breast conserving surgery followed by endocrine therapy without radiotherapy in postmenopausal patients with breast cancer.

The prospective, multicenter cohort trial was conducted to investigate the safety of omitting radiation therapy in the treatment of younger postmenopausal patients, adding a genomic assay to classic selection factors. In the study, investigators provided patients with a thorough understanding of the individual risks of breast cancer recurrence, allowing for informed decision-making regarding treatment options.

A total of 200 patients between the ages of 50 and 69 with stage I unifocal invasive breast cancer were enrolled onto the study from June 2015 to October 2018 across 13 collaborating sites. This primary analysis was conducted 5 years after the last patient enrolled completed surgery.

Results showed that after a median follow-up of 5.2 years, the overall and breast-cancer specific survival rates in the 186 patients with clinical follow-up of at least 56 months were both 100%. Moreover, 5-year freedom from any recurrence was 99% (95% CI, 96%- 100%), Jagsi reports. Two patients experienced disease recurrence before 5 years, both of whom were compliant with endocrine therapy, Jagsi notes. Another 6 patients recurred later than 5 years after breast-conserving surgery, 3 of whom were endocrine therapy compliant. Notably, no distant recurrences were observed, she adds.

Jagsi emphasizes that it's essential to approach these results with caution, especially for younger postmenopausal women, considering the limited follow-up period of 5 years. Accordingly, longer-term follow-up of this and other trials can help assess the durability of these outcomes beyond 5 years and help determine whether the option of avoiding initial radiotherapy can be offered to a broader group of women, Jagsi explains.

Findings from this preliminary study have also provided the foundation for the ongoing, phase 3 NRG-BR007/DEBRA trial (NCT04852887), Jagsi details. The trial is evaluating the de-escalation of breast radiation following breast-conserving surgery in stage 1, hormone receptor– positive, HER2-negative breast cancer. It aims to provide valuable insights into the de-escalation of breast radiation therapy and gather essential quality-of-life data through randomized treatment allocation, Jagsi concludes.Reshma Jagsi, MD, Dphil, Lawrence W. Davis Professor, chair, Department of Radiation Oncology, Emory University School of Medicine, discusses 5-year findings from the IDEA trial (NCT02400190) evaluating the feasibility of breast conserving surgery followed by endocrine therapy without radiotherapy in postmenopausal patients with breast cancer.

Findings from this preliminary study have also provided the foundation for the ongoing, phase 3 NRG-BR007/DEBRA trial (NCT04852887), Jagsi details. The trial is evaluating the de-escalation of breast radiation following breast-conserving surgery in stage 1, hormone receptor– positive, HER2-negative breast cancer. It aims to provide valuable insights into the de-escalation of breast radiation therapy and gather essential quality-of-life data through randomized treatment allocation, Jagsi concludes.

Reshma Jagsi, MD, DPhil, discusses 5-year findings from the IDEA trial assessing radiotherapy omission for postmenopausal patients with breast cancer.


	University of Michigan Comprehensive Cancer Center

	Professor, Medicine and Health Management and Policy

As genetic testing becomes increasingly available, there will be a growing gap between the wide availability of testing and the relative importance of results to treatment decisions. In the current environment, there’s more promise in precision medicine than practical applications in the exam room. Multigene panel testing is increasingly available, but we don’t fully understand how to best incorporate results into treatment recommendations for patients with breast cancer.

As a result, patients newly diagnosed with breast cancer and their doctors face a conundrum in the exam room: how to efficiently incorporate increasingly complex clinical information into treatment decision making.

The demand is growing for genetic testing. More than a quarter of patients newly diagnosed with breast cancer undergo genetic testing now. That rate has been increasing, and recent studies suggest it could be even higher.

Our study of 1536 breast cancer survivors published this year in the Journal of Clinical Oncology found that 35% of patients had a strong desire for genetic testing.

 Many of the women who reported strong interest were at low risk of having a mutation and might not be typical candidates for a discussion about genetic testing.

But whether results of genetic testing show a mutation or not, what does it mean for physicians recommending treatment options to patients and for patients trying to understand complex treatment options and risk to decide how to treat their cancer? We need to change both the way genetic tests results are reported and, more importantly, how results are incorporated into treatment deliberation for patients newly diagnosed with breast cancer. After diagnosis, patients face a rapid escalation of treatment decisions navigated by different specialists. We need to allow more time for deliberation and a better way to incorporate increasingly more complex genetic and genomic information into the process.

Germline genetic testing often requires discussions with genetic counselors. Patients need a stepwise approach to deliberation and ought not to rush the process. We don’t honor enough the process and time patients need for treatment decision making.

This can be seen in the recent uptick in women choosing contralateral prophylactic mastectomy (CPM). A 2014 study in 

found that 70% percent of women who have CPM have no clinical indications, such as a family history of breast or ovarian cancer or a mutation found on genetic testing.

 In fact, many of these women were candidates for breast conservation. It’s striking that so many women are receiving much more extensive surgery than needed to treat their disease.

Women diagnosed with breast cancer are naturally eager to do everything in their power to fight the disease. So many patients confide that they just want to do everything they can to be there for their children. It is up to us, as doctors, to make sure they understand which treatments are really going to do that, and which actions might seem heroic but are actually not expected to improve the outcomes for a typical woman with early-stage breast cancer.

Our team presented an abstract at the 2015 American Society of Clinical Oncology Annual Meeting that found nearly half of 1949 breast cancer survivors surveyed said they considered CPM.

 Of those who considered it, only 37% knew that the more aggressive procedure does not improve survival for women at average risk of a second cancer. Further, we found that women’s perceptions of their surgeon’s recommendation played a big role in the decision to have CPM. Only 4% of women who said their surgeon recommended against CPM had the procedure. But even among patients who did not have a genetic mutation or strong family history to motivate the decision for CPM, 23% who said their surgeon didn’t recommend for or against CPM went on to have the aggressive surgery.

This research indicates that patients are coming away with perceptions that really require adjustments. Doctors need to address the jaw-dropping gaps in patient knowledge of CPM benefits and the perception of what their surgeons told them.

The University of Michigan Comprehensive Cancer Center leads an interdisciplinary group of investigators from across the country seeking to understand and improve how patients and their providers communicate and make decisions about cancer treatments.

Research Team (CanSORT) has a grant from the National Cancer Institute, part of which includes building a decision tool to help women with breast cancer fully understand their treatment options and the risks involved.

Part of the issue is in how different healthcare providers frame information about risk. Typically, genetics experts focus on the cumulative risk of another cancer over a lifetime. This doesn’t incorporate comorbid conditions, such as heart disease, diabetes, or even the present cancer diagnosis. Meanwhile, oncologists recommending treatment for the current cancer talk about 5- to 10-year survival rates and they do consider other health risks.

Patients are stuck in the middle, trying to make sense of it all. As healthcare professionals, we need to do a better job of framing this discussion in a patient-centered, coherent way. CanSORT investigators are currently in the midst of a survey called iCanCare, and are beginning to analyze responses from 7500 breast cancer survivors on issues related to treatment decision making. The team is also completing an agreement that would involve looking at patterns of genetic testing among a very large sample of patients with breast cancer. Going forward, we believe breast cancer will be the tracer condition to show how genetic testing can influence treatment decision making and improve patient health.

			Jagsi R, Griffith KA, Kurian AW, et al. Concerns about cancer risk and experiences with genetic testing in a diverse population of patients with breast cancer. J Clin Oncol. 2015;33(14):1584-1591.

			Hawley ST, Jagsi R, Morrow M, et al. Social and clinical determinants of contralateral prophylactic mastectomy. JAMA Surg. 2014;149(6):582-589.

			Jagsi R, Kurian AW, Griffith KA, et al. Genetic testing decisions of breast cancer patients: results from the iCanCare study. J Clin Oncol. 2015;(suppl; abstr 1541).

Articles

As genetic testing becomes increasingly available,
there will be a growing gap between
the wide availability of testing and the relative
importance of results to treatment decisions.

Reshma Jagsi, MD, DPhil

Articles

Dr Jagsi on the Implications of the IDEA Trial For Patients With Breast Cancer

Dr Jagsi on the Implications of the IDEA Trial for Radiotherapy Omission in Breast Cancer

Dr Jagsi on the Feasibility of Radiation Omission Following Surgery in Breast Cancer Care

How Genetic Testing Impacts Breast Cancer Treatment Decisions