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What happens when the old best practices no longer apply?

October 13, 2020

When COVID-19 hit, a lot of usual activities were put on pause. Much of life didn’t feel “normal.” But cancer diagnoses and treatment could not be put on hold.

Breast cancer doctors and researchers from Baystate Health talk about the impact of the pandemic on breast cancer care and research – and how the breast care community came together to address the challenges.

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New Best Practices in Breast Cancer Surgery

Dr. Holly Mason, Breast Surgeon

The pattern of breast cancer care feels like a pendulum, sometimes swinging slowly and other times quickly. With the publication of William Halsted’s outcomes of the radical mastectomy in 1894, patients’ main option for care for over 80 years was a massive operation with significant risks. Fortunately, the last half century has seen an evidence based-transition away from the radical mastectomy toward breast preservation and away from an axillary node dissection (removing all nodes) to the sentinel node biopsy (removing one or two nodes) or even the avoidance of node removal altogether. Even the last five years have brought about tremendous change but the change was navigated through our multidisciplinary team-based approach to cancer care.

Then the COVID-19 pandemic arrived, and now we needed to rapidly reassess for new best practices as the old best practices may no longer apply.

In a time when many elective surgeries have been put on hold, breast cancer surgery falls into a gray area. It is not elective but it is not emergently life threatening, like trauma. Some feel that it falls into the “urgent” category, but others would say it is “non-emergently life threatening.” Regardless, the breast surgery community needed to come together with our multidisciplinary colleagues in medical oncology and radiation oncology to figure out how to care for our patients, and thus the concept of COVID-19 Prioritization Strategies was born.

At Baystate Health, we came together within one week of Massachusetts’ closure of routine surgery to develop a strategy that made sense to us based on the evidence in the literature. We set up a weekly strategy conference call to discuss all patients with either breast cancer or atypia (benign lesions that are higher risk) to discuss what the options for care were in cases where surgery must be deferred. Many patients were temporized, (helping to delay surgery), on endocrine therapy such as tamoxifen or an aromatase inhibitor. Only those patients for whom temporizing measures could not be used proceeded to surgery. We felt that this was the best balance that could be found at this time of crisis.

Fortunately, the American Society of Breast Surgeons (ASBrS), National Accreditation Program for Breast Centers (NAPBC), National Comprehensive Cancer Network (NCCN), and American College of Radiology and Commission on Cancer together published a formal strategy on April 16, 2020, and our “on-the-fly” strategy fell in line with this consensus strategy. The fact that five societies could formalize a policy within one month of a pandemic state of emergency being declared in the United States is truly remarkable. Now, we could care for our patients and reassure them that our recommendations to delay surgery and temporarily treat them with endocrine therapy when possible was safe and in line with national organizations. These were very difficult discussions to have with patients, but our patients were remarkable in their understanding of the situation and willingness to accept the recommended plan.

We wonder what is next. The country is trying to re-open in whatever form that takes. We hope to resume our usual care for our patients in which surgery is often the first step of treatment, but we may have a different strategy once research on the effects of the current strategy that is occurring nationally and internationally is completed. We may also see that outcomes for patients with cell abnormalities who did not have surgery in the usual time frame may not be any different than if we did surgery as usual or perhaps there will be an impact. We hope that patients return to screening mammography protocols quickly but will there be further delays due to fear of COVID-19 transmission and what differences will we see?

We hear frequently about the “new normal” and we are anxious to see what that new normal is. Breast surgery and breast care may look completely different in this new world. I suspect that we will see an acceleration of the trend toward de-escalation that we were already seeing, so instead of trends changing over years, we may now be talking about months. That very well may be the new normal.

Weighing the risks of cancer treatment

Dr. Grace Makari-Judson, Medical Oncologist

Cancer cannot be quarantined. COVID-19 hit but patients with cancer were still in need of treatment.

The gut-wrenching decision-making was without precedent. How do we weigh the risks of cancer treatments against the risks of COVID-19? In the beginning of the pandemic, concern was raised that cancer patients undergoing chemotherapy and other treatments that may suppress the immune system could have a higher risk of contracting and dying from COVID-19. The Baystate Regional Cancer Program leadership jumped into action.

How do we protect existing patients?

We immediately initiated precautions at the D’Amour Center for Cancer Care and our other facilities in Greenfield and Ware. To limit potential exposures, visitors were no longer allowed in the building. Each individual entering the building, whether patient or staff member, was screened for any symptoms and had their temperature checked. Everyone was required to wear masks and sanitize hands. Staff members took additional precautions for safety and cleaning to protect our patients. Patients who needed curative therapy stayed on schedule. When selecting chemotherapy options for patients, we kept in mind side effects in the hopes of limiting possible complications, like fever, that might lead to the need to go to the emergency room.

We carefully reviewed the treatment plans of patients who needed chemotherapy or immunotherapy to keep cancer under control and reviewed implications of delaying treatment.

We quickly assessed who needed to come into the building and who could wait. Many breast cancer patients who had completed active treatment and were being monitored had appointments rescheduled.

We ventured into telehealth with both virtual and telephone visits for patients who did not need to be examined. This was a particularly effective modality for all of our patients needing genetic counseling and testing since we can counsel over the phone and then mail the test kit.

How do we care for new breast cancer patients?

As if the COVID-19 pandemic was not stressful enough, imagine the anxiety associated with a new breast cancer diagnosis in the midst of all this. Our multidisciplinary team came together to provide a consistent approach to best support our new patients. To supplement our weekly multidisciplinary breast pathology conference, we promptly initiated a new conference each Tuesday to review “strategy” for each newly diagnosed patient as the availability of the operating rooms diminished. We often give a treatment first before surgery in order to shrink the cancer to make the surgery easier or to allow for more time to make decisions about type of surgery. Most of the time when we talk about “pre-operative therapy” we are referring to chemotherapy. A span of 12 to 20 weeks of chemotherapy can markedly reduce the cancer size and in some cases, no residual cancer is found at the time of surgery. This can be predictive but also help to select the need for additional treatments after surgery.

For cancers that are ER positive (hormone receptor positive), we don’t consider pre-operative endocrine therapy as often. This may be because we don’t like to wait. Endocrine therapy, like tamoxifen or an aromatase inhibitor, can takes six months or longer to shrink a cancer. We do use this strategy in specific situations but generally patients with these cancers go straight to surgery.

When COVID-19 struck, this strategy of temporarily giving anti-estrogen endocrine therapy while waiting for surgery made sense. It is a proven strategy for hormone receptor positive cancers – just not one that we use as frequently. It was appropriate to consider prior to surgery since the majority of cancers, whether invasive or not (like DCIS), are hormone sensitive. Cancers that are hormone negative or that over-express HER2/neu are generally treated with chemotherapy first prior to surgery.

When questions are raised about over-treatment of early stage breast cancer, the replies focus on how we predict which cancers may need treatment and which may never cause harm. The challenges brought on by the COVID-19 pandemic have also brought with them unique opportunities to answer questions about the biology of cancer. The opportunity to look at the surgical tissues of a cohort of patients treated first with endocrine therapy could help to provide insight into this question. To do this, we relied on consenting and tissue procurement protocols that are part of the Rays of Hope Breast Research Registry.

So, are breast cancer patients more susceptible to COVID-19, or do they have a higher risk of serious infection if they are receiving cancer treatment?

Thankfully, this has not been the case. Deaths worldwide from COVID-19 and cancer were more likely attributed to advancing age and other health problems. At Baystate Health, to date, our strategies of screening individuals entering our facilities, universal mask wearing, and cleaning protocols have kept our patients and our staff members safe with lower than anticipated rates of COVID-19. Our staff and patients have all shown resilience in the face of this enormous challenge. In the end, I hope that we may learn from this experience to bring benefit to our community in new ways.

Treatment Planning to Ensure Safety

Dr. Seth Kaufman, Radiation Oncologist

Those of us in the Division of Radiation Oncology at Baystate Health have worked since March to balance the need for cancer treatment with the novel threat of the coronavirus pandemic. While many elective patient care areas within Baystate Health have appropriately suspended all in-person activity, our division has remained open as an essential service. Through the early days of the pandemic in Massachusetts (in March and April), we worked closely with our colleagues in Medical Oncology and Surgery to determine which patients needed to begin radiotherapy immediately, and whose treatment could be safely delayed until the risks of infection could be lowered. These determinations were made in accordance with national guidelines from the American Society for Radiation Oncology, and were based not only on the specifics of a person’s cancer, but on their entire health status and social setting. For example, someone with a less aggressive cancer but with advanced lung disease such as emphysema and no one to care for them at home would be someone for whom we would have looked to delay treatment.

For women with breast cancer, many have early stage tumors that respond to endocrine therapy. For these folks, the oncology team was able to delay radiotherapy and even surgery through March, April, and May. This both allowed our patients to stay safely at home and at the same time freed up needed medical resource and staffing for the initial surge of the pandemic. For those with higher risk breast cancers, we took the additional step (again, in conjunction with national guidelines) to deliver the radiotherapy in fewer visits over three to four weeks rather than the traditional five to six weeks. This has been the national standard and our practice at the D’Amour Center for Cancer Care for several years in cases of early stage breast cancer. However, in the setting of node positive disease (with a more complicated arrangement of radiation beams) the standard practice in the United States has largely remained the five to six week course (although research is ongoing that may help change this in the near future). Balanced against the risk of the pandemic, we felt it appropriate to shift our practice to limit patient exposure as much as possible.

In June, as the rate of new cases in the region slowed, widespread testing became available, and much needed personal protective equipment was obtained, we were able to safely and carefully resume treatment for all our patients. Certainly if you come to the D’Amour Center for Cancer Care today, you will notice significant changes from only a few months ago. Only those with appointments will be allowed entrance to the building (except for those who require assistance due to a medical incapacity, in which case one caretaker will be admitted as well). Everyone is required to wear a facemask, and one will be provided for those who do not have their own. All are required to sanitize their hands upon entry, and to be screened for their temperature as well as any symptoms associated with the virus. These requirements hold for our staff members and physicians, as well as our patients. Our waiting areas have been adjusted for appropriate distancing between seats. Our treatment machines are cleaned between each patient, and our staff keep physical contact to a minimum (i.e., only when needed for examination or set up on a treatment machine).

Today, the Radiation Oncology Division continues to work daily with our colleagues in Medical Oncology and Surgery to assess the prevalence of the virus in the area and to keep the facility safe. Should there be another wave of infections requiring us to curtail treatment again, we will take the appropriate steps. We want everyone to know our top priority is your welfare. If you have any questions concerning the safety of the environment here or the appropriateness of your treatment in the midst of the pandemic, please feel free to speak with your physician or health care provider. We are here for you!

Learning from Clinical Challenges

With Dr. Joseph Jerry, Scientific Director of the Pioneer Valley Life Sciences Institute and Co-Director of the Rays of Hope Center for Breast Cancer Research and Dr. Grace Makari-Judson, Medical Oncologist

Preparations for COVID-19 have meant that many surgical procedures, including those for breast cancer diagnosis and treatment, have been delayed or moved from Baystate Medical Center to other Baystate hospitals. Baystate investigative teams from the D’Amour Cancer Center, Department of Pathology, and Pioneer Valley Life Sciences Institute (PVLSI) worked closely with the Baystate Institutional Review Board to quickly allow the research use of tissue specimens from patients going to surgery at Noble Hospital.

“To set up this study, we relied on consenting and tissue procurement protocols that are part of the Rays of Hope Breast Research Registry,” said Baystate’s Dr. Grace Makari-Judson. “However, with surgeries redeployed to other Baystate hospitals, this required swift actions to make it possible. Thanks to the team of oncologists, surgeons, pathologists, and scientists at Baystate working with the Cancer Services Clinical Research team and the Baystate Health Institutional Review Board, protocols were revised and reviewed within 48 hours and processes were modified, allowing collections to be initiated.”

The challenges of the COVID-19 pandemic have also provided unique opportunities to answer important clinical research questions. Because of COVID-19, breast cancer surgeries for low risk patients have been delayed. These patients are being treated with anti-estrogen therapies while waiting for surgery, a strategy that is well described but underutilized. This approach offers a cohort of patients to test responses to these treatments. This research will help us understand which early stage breast cancers need immediate treatment and which may never cause harm, with important implications that can reduce the over-treatment of early stage breast cancer. See breast cancer clinical trials.

COVID-19 has clearly demonstrated Baystate’s nimbleness in adapting successfully to clinical challenges to create opportunities for investigations to improve cancer care.

“This would not have been possible in the past,” added Joseph Jerry, PhD, Scientific Director of the Pioneer Valley Life Sciences Institute. “It is a resounding demonstration that Baystate is research-ready!”

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