Patients with newly diagnosed metastatic breast cancer and the healthcare providers (HCPs) that treat them reported difficulties finding the necessary materials and programs to address the psychosocial and educational needs of patients, according to research presented at the 2020 San Antonio Breast Cancer Symposium.

Both parties expressed a desire for an increased availability of plain language, evidence-based information to accompany diagnosis.

“Patients and HCPs need information to help explain key clinical topics such as understanding diagnosis and treatment planning, treatment side effects and management, expectations for survival, and mental health and coping strategies,” Stephanie Washburn, manager of healthcare provider outreach at Living Beyond Breast Cancer (LBBC), who spearheaded the study, said during the presentation. “HCPs prefer information that is evidence-based, credible, and conveyed in plain language.”

A total of 352 surveys were completed by HCPs across the United States. From those surveys, 50% of respondents were social workers, 46% were nurse navigators or nurse practitioners, and 4% of respondents were physicians or other.

The surveys were developed following discussions with 2 patient focus groups (14 participants) and 2 HCP focus groups consisting of nurses and social workers (15 participants).

According to respondents, the most frequently requested clinical topic (47% of patients) by patients with newly diagnosed metastatic breast cancer was plain language information to aid with understanding their diagnosis. Other frequently requested clinical topics were as follows:

Treatment side effects and management (44%)

Mental health and coping strategies (44%)

Seventy-six percent of respondents stated that their preferred educational format was printed materials such as brochures and booklets, with 58% expressing a desire for materials that can be downloaded and printed.

The majority of survey respondents (57%) were from community-based cancer centers, with 20% coming from NCI designated Comprehensive Cancer Centers and 12% based in an academic or university cancer center setting.

Financial concerns (74%) and family or relationship concerns (45%) were identified as the biggest issues for patients, with employment issues (34%), discussing a diagnosis with children (28%) and insurance coverage (25%) also cited as important practical and daily living tips needing to be addressed.

Both patients and providers alike noted that a reliable online hub of information and resources regarding metastatic breast cancer was needed. Patients with newly diagnosed metastatic breast cancer who were Black, or under the age of 45 reported that they felt underrepresented in the existing content, with content gaps identified for spouses and partners, along with family members and caregivers.

“Using this data, LBBC is developing a model outreach program to assist HCPs in meeting the needs of their newly diagnosed MBC patients,” said Washburn. “As a first step, LBBC has developed 2 online information hubs to provide easy access to key content for people living with newly diagnosed MBC.”

Ormerod CL, Washburn S, Swiger KD, O’Neill C. Developing an Outreach Model to Healthcare Providers Treating Newly Diagnosed Metastatic Breast Cancer Patients. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-11. Poster PS9-31.

Articles

Recent research highlighted the need for reliable information to address the educational and psychosocial needs of patients with newly diagnosed metastatic breast cancer.
 

Study Shows Need for Evidence-Based, Educational Material for Providers and Patients with Metastatic Breast Cancer

Nurse navigators play an important role in coordinating and providing timely care, as well as educating and improving the emotional wellbeing of newly diagnosed patients with breast cancer in the oncology clinic, according to a poster presented at the 2020 San Antonio Breast Cancer Symposium (SABCS).

Lead author Tianyi Wang, AB, noted that while past research indicates that nurse navigators, or registered nurses who can serve as patient advocate, educator, and care coordinator, can help empower patients to receive the best care possible, data is lacking when evaluating the effect of nurse navigation on newly referred oncology patients.

Wang and colleagues set out to evaluate the efficacy of nurse navigation on 50 patients before their breast oncology appointment in three main areas: patient knowledge, care coordination, and emotional wellbeing. A mixed-method approach to assessing these areas was used, involving a quantitative survey and qualitative feedback.

All 50 patients, at the UCSF Breast Cancer Center, were given an 8-question survey before their initial appointment:

Did you have any contact with a nurse during any of these times of your treatment?

Do you feel informed going into your meeting with the doctor?

The initial questions I had were answered to my satisfaction prior to my visit.

My care is being coordinated effectively in the Breast Care Center.

Did speaking with a nurse improve your patient experience?

Did speaking with a nurse help you better deal with stressful emotions or anxiety?

Speaking with a nurse would improve my patient experience.

Speaking with a nurse would help you better deal with stressful emotions?

After completing the survey, patients were then asked to participate in a 5- to-15-minute, open-ended interview, where they were able to provide feedback on their patient experience in the waiting room or appointment room. Twenty-two patients were provided navigation, while 28 were not.

Upon survey analysis, Wang and her team found that a statistically greater proportion of patients who had initial contact with a nurse felt informed before going into their appointment and agreed that their care was effectively coordinated when compared to those who did not have nurse contact before their appointment.

Of note, 17 patients who received navigation (77.3%) agreed that their initial questions were answered in a satisfactory way, compared to 8 (28.6%) who did not receive navigation.

Qualitative findings also showed that patients had an appreciation for the preliminary knowledge their nurse navigator provided, as well as the humanistic care they received. As one patient response in particular noted: “Some patients need hand-holding as well as information on where to seek information…Nurses can provide additional general information which affects

what questions a patient has to ask doctor…like a tree to drive questions.”

These findings led the researchers to conclude that the role of nurse navigators extends beyond simply providing information and timely care coordination, but also provides a “human touch” that could contribute to alleviating negative emotions.

Wang T, Huilgol Y, Black J et al. Nurse navigation in the ambulatory oncology clinic: Patient-centered findings from a survey of 50 breast cancer patients. Presented at: 2020 San Antonio Breast Cancer Symposium. Poster PS9-17.

Nurse Navigators Play a Vital Role for Breast Cancer Patients in the Oncology Clinic

Chemotherapy-induced nausea/vomiting (CINV) is a common adverse event for patients undergoing treatment for breast cancer. While it can be treated, there is potential for CINV to return, especially for patients for whom CINV treatment did not work the first time around, according to new research.

Rudolph Navari, MD, PhD, FACP, of the World Health Organization Cancer Care Program, presented his team’s findings at the 2020 San Antonio Breast Cancer Symposium (SABCS). At the event, he explained that many prior studies evaluated CINV prevention strategies, but there is a research gap when it comes to a subsequent bout of CINV.

“We sought to evaluate individual patients’ risk for repeat CINV,” Navari said, explaining that this particular study was looking at how CINV risk changes with each chemotherapy cycle for patients with breast cancer.

The research team gathered data from a prospective, 4-cycle CINV prophylaxis trial involving netupitant/palonosetron (NEPA) plus dexamethasone for patients with breast cancer who are receiving anthracycline and cyclophosphamide (AC) chemotherapy. A post-hoc analysis was also performed on a 2006 trial evaluating ondansetron plus aprepirant (APR).

When patients did not experience CINV — defined as vomiting or the use of rescue medication with 5 days after chemotherapy – they were deemed to have a complete response. Other patients were deemed to have CINV prophylaxis treatment failure (TF).

A total of 402 patients and 1299 AC chemotherapy cycles were evaluated. Three-fourths (75.4%) had a complete response, while 24.6% experienced TF. Over 4 cycles, there was a total of 253 TFs, though it should be noted that for the 303 patients who had a complete response in cycle 1, the majority (between 93% and 98%) had a complete response in subsequent cycles.

In the patients with TF in the first cycle, subsequent failure rates were higher, at 49.8% failing at some point between cycles 2 through 4. 

In the APR study (including 433 patients over 1537 cycles), nearly half (49.2%) of patients experienced TF in cycle 1, and 46.7% had TF at any point between cycles 1 through 4.

As also seen in the NEPA group, patients who had a CR in cycle 1 had an increased chance (between 80.5% and 92.7%) of CR in later cycles. Similarly, patients who had TF in cycle 1 also had an increased chance (between 72.2% and 74.8%) of TF in subsequent cycles as well.

“Patients with treatment failure in cycle 1 did face a higher repeat failure rate,” Navari summarized. “These findings strongly suggest an individual patient [with CINV on] cycle 1 predict CINV in subsequent cycles.” 

Navari RM, Binder G, Roeland EJ, et. al. Chemotherapy-induced nausea and vomiting (CINV) risk after prior breakthrough CINV: unmasking the false average. Presented at: 2020 SABCS Annual Conference. Dec. 8-11, 2020. 

Patients who experienced breakthrough CINV in their first chemotherapy cycle were more likely to have the adverse event in later cycles too, recent research found.
 

Prior CINV May Increase Occurrence in Later Cycles of Cancer Treatment

Patients from Asian countries with hormone receptor (HR)—positive, HER2-negative breast cancer may have a higher risk of disease recurrence than those from non-Asian countries, suggesting that this population may benefit from additional adjuvant treatment with abemaciclib (Verzenio), according to additional data from the phase 3 monarchE trial that were presented during the ESMO Asia Virtual Congress 2020.

Results from the analysis of baseline characteristics of patients from Asia who were enrolled on the trial showed that this population of patients were younger than those from non-Asian countries, they were more commonly premenopausal, and they had a higher incidence of 4 or more positive nodes.

“These characteristics suggest that patients with HR-positive, HER2-negative early breast cancer from Asian countries may have a higher risk of recurrence than patients from non-Asian countries and would benefit from additional adjuvant treatment beyond the current standard of care,” In Hae Park, MD, of the Center for Breast Cancer of the National Cancer Center in Korea, said during an oral presentation on the data.

Approximately 20% of patients with HR-positive, HER2-negative early breast cancer will experience disease recurrence within the first 10 years of diagnosis. It has been demonstrated that specific high-risk clinical or pathological features could potentially increase risk of recurrence.

The open-label, phase 3 monarchE trial enrolled 5637 patients with HR-positive, HER2-negative, high-risk early breast cancer. To be eligible for enrollment, patients had to have 4 or more positive axillary lymph nodes (ALN) or 1 to 3 ALN and a tumor that was 5 cm or larger, grade 3 disease, or a centrally tested Ki67 of 20% or higher.

In the trial, participants were randomized 1:1 to receive either abemaciclib at a twice daily dose of 150 mg for up to 2 years in combination with endocrine therapy for 5 to 10 years as clinically indicated or endocrine therapy alone for the same duration. A total of 1155 patients were randomized from Asian countries, including China, Japan, Korea, Taiwan, Singapore, and Hong Kong. Stratification factors included prior chemotherapy (yes vs no), menopausal status (pre vs post), and region (North America/Europe vs Asia vs other).

The primary end point of the trial was invasive disease-free survival (iDFS) per STEEP criteria, while key secondary end points comprised distant relapse-free survival (DRFS), overall survival, safety, patient-reported outcomes, and pharmacokinetics.

Results from monarchE presented during the 2020 ESMO Virtual Congress demonstrated that the addition of abemaciclib to endocrine therapy resulted in a significant 25.3% reduction in the risk of invasive disease compared with endocrine therapy alone in this patient population (HR, 0.747; 95% CI, 0.598-0.932; 2-sided P = .0096).2 Moreover, the iDFS rate at 2 years was 92.2% in the abemaciclib arm versus 88.7% in the endocrine-alone arm; this translated to an absolute improvement of 3.5%.

The addition of abemaciclib to standard-of-care endocrine treatment also significantly impacted DRFS across all prespecified subgroups analyzed, with patients in the investigational arm experiencing a 28.3% reduction in the risk of distant recurrence (HR, 0.717; 95% CI, 0.559-0.920; P = .0085). At 2 years, the DRFS rate was 93.6% in the abemaciclib arm versus 90.3% in the endocrine-alone arm, which translated to an absolute improvement of 3.3%. Ninety-two patients in the investigational arm experienced distant recurrence versus 142 patients in the endocrine-alone arm.

In the analysis presented during the ESMO Asia Virtual Congress 2020, Park shared data on the differences in patient demographics between patients from Asian countries versus those from non-Asian countries. Moreover, patients from Asian countries were observed to be younger than those from non-Asian countries, with a median age of 48 years versus 52 years, respectively. Additionally, more patients from Asian countries were found to be premenopausal at the time of diagnosis compared with patients from non-Asian countries, at approximately 59% versus approximately 40%.

“Fifty-five percent of patients received prior chemotherapy, indicating the high-risk nature of this study population,” noted Park.

When examining high-risk disease characteristics, approximately 65% of patients from Asian countries had 4 or more positive ALN compared with approximately 58% of those from non-Asian countries. With regard to histological grade, pathologic tumor size, central Ki-67 index, and progesterone receptor status, characteristics were observed to be similar between the 2 groups.

Approximately 34% of patients from Asian countries had 1 to 3 positive nodes versus about 41% of those from non-Asian countries. In the former group, 6.5% had tumors that were 5 cm or greater upon pathology, 4.9% had tumors that were 5 cm or greater upon imaging, 18.4% had histologic grade 3 disease, and 8.8% had central Ki-67 of 20% or greater. In the latter group, these rates were 9.2%, 5.7%, 23.1%, and 7.9%, respectively.

Additionally, 39.9% of patients from Asian countries received tamoxifen as their first on-study endocrine therapy versus 29.2% of those from non-Asian countries; 12.5% and 6.4% of patients, respectively, also received ovarian suppression. No patients from non-Asian countries received toremifene versus 1.45% of those from Asian countries.

Moreover, 58.7% of patients from Asian countries received aromatase inhibitors compared with 70.8% of patients from non-Asian countries. Letrozole was the most commonly used agent in both groups, at 33.6% versus 39.5%, respectively. Other agents included anastrozole (15.0% vs 23.8%, respectively) and exemestane (10.2% vs 7.6%).

“As expected, we saw an increased incidence of premenopausal patients [from Asian countries] so we also saw an increase in the proportion of patients who received ovarian suppression in combination with endocrine therapy,” added Park. In those who received aromatase inhibitors, 22.5% of patients from Asian countries also received ovarian suppression versus 12.2% of those from non-Asian countries.

Lastly, fewer patients from Asian countries received concomitant therapy with bone-modifying agents versus those from non-Asian countries, at 9.0% versus 16.4%, respectively.

“To our knowledge, these are the first reported baseline characteristics data in patients from Asian countries with HR-positive, HER2-negative, node-positive, high-risk early breast cancer in a CDK4/6 inhibitor trial,” Park concluded.

1. Jiang Z, Nakayama T, Nakamura S, et al. Baseline characteristics of patients from Asia enrolled in monarchE, evaluating abemaciclib in high risk early breast cancer. Presented at: ESMO Asia Virtual Congress 2020; November 20-22, 2020; Virtual. Abstract LBA1.

2. Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high risk, early breast cancer (monarchE). Ann Oncol. 2020;31(suppl 4):1143-1144. doi:10.1016/j.annonc.2020.08.2238

This article was originally published on OncLive as, "

Asian Patients With HR+, HER2- Breast Cancer Have Higher Risk of Recurrence, May Benefit From Additional Adjuvant Abemaciclib.

Patients from Asian countries with hormone receptor (HR)–positive, HER2-negative breast cancer may have a higher risk of disease recurrence than those from non-Asian countries, suggesting that this population may benefit from additional adjuvant treatment with abemaciclib (Verzenio).

Asian Patients With HR+, HER2- Breast Cancer Have Higher Recurrence Risk

The FDA granted an accelerated approval to pembrolizumab (Keytruda) plus chemotherapy for the treatment of patients with locally recurrent, unresectable or metastatic triple-negative breast cancer (TNBC) with PD-L1 expression is CPS ≥10, according to the agency.

The approval was based off findings from the multicenter, double-blind KEYNOTE-355 trial. In the trial, eligible patients were randomized 2:1 to receive either 200 mg on day 1 every 3 weeks of pembrolizumab plus chemotherapy or a placebo plus chemotherapy (paclitaxel protein-bound or paclitaxel, or gemcitabine plus carboplatin).

The primary outcome was progression-free survival (PFS) according to RECIST 1.1 criteria. In the group with CPS ≥10, average PFS was 9.7 months in the pembrolizumab arm, compared with 5.6 months in the placebo arm.

Recommended dosing is 200 mg every 3 weeks or 400 mg every 6 weeks, given prior to chemotherapy treatment. This should be administered until disease progression, unacceptable toxicity, or for 24 months.

Paclitaxel protein bound, when administered with pembrolizumab, should be 100 mg/m2 on days 1, 8 and 15 every 28 days, or paclitaxel 90 mg/m2 on days 1, 8 and 15 every 28 days, or gemcitabine 1000 mg/m2 plus carboplatin AUC 2 mg/mL/min on Days 1 and 8 every 21 days is administered via intravenous infusion. 

Common adverse events, which occurred in 20% or more of patients receiving pembrolizumab, were fatigue, nausea, diarrhea, constipation, vomiting, alopecia, rash, cough, decreased appetite, headache. The most common laboratory abnormalities were anemia, leukopenia, neutropenia, lymphopenia, thrombocytopenia, elevated ALT and AST, hyperglycemia, hypoalbuminemia, increased alkaline phosphate, hypocalcemia, hyponatremia, hypophosphatemia, and hypokalemia.

The FDA also approved a companion diagnostic, PD-L1 IHC 22C3 pharmDx to determine which patients should receive pembrolizumab treatment.

FDA Approves Pembrolizumab Plus Chemo for TNBC

In 2020, the FDA approved more than 50 new cancer treatment regimens, bringing 19 new drugs to the market. While the majority of those drugs are given orally, there were also subcutaneous or intravenous therapies that were approved, too.

It is crucial that oncology nurses keep up with these new developments in the oncology space and know what kind of adverse events to look out for, according to R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA.

Harvey recently gave a pharmacology update at the 38

 Annual CFS Virtual, Interactive Meeting.

Harvey discussed belantamab mafodotin (Blenrep), an antibody drug conjugate that was approved for patients with multiple myeloma who had 4 or more prior lines of therapy and a autologous transplant.

The FDA approved the drug at the 2.5 mg/kg dose after trials showed that amount was noninferior to a higher 3.4 mg/kg dose.

While many patients on the trial reported little or no symptoms, many of them experienced vision changes, such as blurred vision or loss of acuity, when seen by an ophthalmologist, as the trial mandated. Therefore, oncology nurses should discuss potential issues with sight for patients who are on this treatment.

“The overall response rate was about 31%,” Harvey said. “But the big issue, I think, that’s really valuable with this agent is that in those people who did respond, it was quite durable. So even if patients had to stop the drug, if they had a response, their durability was maintained for more than 6 months and over in almost three-quarters of people.”

Tafasitamab-cxix (Monjuvi), an anti—CD-19 monoclonal antibody, was approved for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

The drug, which is usually given in combination with lenalidomide (Revlimid) is given with more frequent dosing upfront, and then frequency slows down as treatment progresses.

“And what's happening is you're really clearing out the disease by giving these doses quickly in a relatively short period of time,” Harvey explained.

When administering tafasitamab-cxix, nurses need to look out for cytopenia, neutropenia, and diarrhea. “Patients have to be monitored carefully for [blood] counts, ideally weekly, if not early on, and then can be perhaps spread out as patients tolerate therapy,” Harvey said.

Patients with metastatic small cell lung cancer who did not respond to chemotherapy gained a new second-line treatment option this year with the FDA approval of lurbinectedin (Zepzelca).

While the drug proved to be efficacious, more than 20% of patients reported constipation and diarrhea. The agent is also highly emetogenic.

“Patients [experienced] nausea and vomiting prophylaxis, and there certainly can be myelosuppression, which you would expect with alkylating agents,” Harvey said, emphasizing that there is a possibility for liver toxicities, so nurses should monitor patients for that as well.

Finally, Harvey discussed sacituzumab govitecan (Trodelvy), which was approved for the treatment of patients with metastatic triple-negative breast cancer (TNBC).

This antibody drug conjugate targets the Trop-2 protein, which is commonly overexpressed in patients with TNBC.

Clinicians should look out for vomiting, infusion reactions, cytopenia, fatigue, hair loss, abdominal pain, and appetite loss in patients taking this agent.

“Like many of the other drugs I’ve mentioned today, it’s going to be evaluated in earlier stage disease and in different combinations, depending on other therapies,” Harvey said

A pharmacist provides an overview of new intravenous cancer therapies that were approved in 2020.
 

A Rundown of New Infusion Therapies

Beyond single-agent chemotherapy, few effective treatment options are available for metastatic triple-negative breast cancer (TNBC), according to Candace Mainor, MD, but several approaches comprised of immunotherapy, antibody-drug conjugates (ADCs), and PARP inhibitors are shifting standards of care and eliciting impressive response rates in heavily pretreated patients.

“There are some exciting new therapies for the treatment of both early and metastatic disease. In the early setting, we see that the addition of immunotherapy to neoadjuvant chemotherapy can improve the pathologic complete response [pCR] rate, regardless of PD-L1 status,” said Mainor. “In the metastatic setting, we have seen how ADCs have improved progression-free survival [PFS] and overall survival [OS] in a patient population that has historically had few treatment options available besides single-agent chemotherapy.”

The phase 3 IMpassion130 trial showed that the addition of the PD-L1 inhibitor atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) resulted in a 40% reduction in the risk of progression or death versus nab-paclitaxel alone in patients with metastatic TNBC.

 Moreover, the combination resulted in a clinically significant improvement in OS in a subset of patients with PD-L1 positivity, according to Mainor. These data led to the March 2019 FDA approval of the combination for those with unresectable locally advanced or metastatic PD-L1—positive TNBC. 

The addition of ADCs has also generated excitement in the field, according to Mainor. Results from the phase 3 ASCENT trial showed that the ADC sacituzumab govitecan-hziy (Trodelvy) improved PFS versus standard-of-care single-agent chemotherapy, at 5.6 months versus 1.7 months, respectively (HR, 0.41; P < .0001).

 Sacituzumab govitecan also resulted in improved median OS versus chemotherapy, at 12.1 months and 6.7 months, respectively (HR, 0.48; P < .0001) and a more favorable overall response rate, at 35% and 5%, respectively (P < .0001). These data led to the April 2020 accelerated FDA approval of the agent in patients with TNBC who have received at least 2 prior lines of therapy for metastatic disease.

Although the role for PARP inhibition in the neoadjuvant setting remains unclear, data from the phase 3 OlympiA&#8239;trial are anticipated to shed light on the benefit of this approach in the adjuvant setting. “Overall, [investigators] have been looking at PARP inhibitors in the early setting, particularly in the neoadjuvant setting,” said Mainor. “However, to date, there is no clear role for the use of PARP inhibition with chemotherapy in that setting. It'll be interesting to see whether there's a role for PARP inhibition in the adjuvant setting.”

, during the 2020 Institutional Perspectives on Cancer webinar on Breast Cancer, Mainor, a medical oncologist specializing in the diagnosis and treatment of early and metastatic breast cancer at MedStar Georgetown University Hospital, discusses novel approaches that are generating excitement in metastatic TNBC.

:&#8239;What does the current standard of care for TNBC look like?

The current standard of care for early TNBC includes neoadjuvant chemotherapy, usually with dose-dense anthracycline and&#8239;cyclophosphamide followed by a taxane. Then, patients go on to complete their local therapy with surgery and radiation. However, at the time of surgery, if residual disease is noted, we now [prefer] that those patients go on to receive additional therapy, either [through] a clinical trial or with [adjuvant] capecitabine [based on] the&#8239;CREATE-X data.&#8239;In the metastatic setting, the current standard of care is still sequential single-agent chemotherapy; however, ADCs such as sacituzumab govitecan are quickly changing the field.

What was the significance of the IMpassion130 trial? How did it impact the standard of care for metastatic disease?

This trial was exciting. In this study, patients with metastatic TNBC were randomized to receive either atezolizumab plus nab-paclitaxel or placebo and&#8239;nab-paclitaxel. They continued treatment until either disease progression or unacceptable toxicity. In the study, we saw prolonged PFS in the group who received atezolizumab/nab-paclitaxel compared with those given placebo/nab-paclitaxel.

In addition, we believe there is likely a clinically meaningful survival advantage in the patients who are PD-L1 positive. However, we note that formal testing of OS in this population was not able to be completed due to the prespecified statistical analysis planned for this study.&#8239;Based on these data from&#8239;IMpassion130, patients whose tumors are positive for PD-L1 are going on to&#8239;receive&#8239;atezolizumab and nab-paclitaxel in the first-line setting.

ADCs have emerged as a key development for those with metastatic disease. Could you speak to the promise of sacituzumab govitecan?

ASCENT was a phase 3 study in which patients with metastatic TNBC whose disease had progressed through 2 lines of chemotherapy were randomized to either&#8239;sacituzumab govitecan&#8239;or single-agent chemotherapy. In the study, we saw a marked improvement in PFS in addition to OS and response rate. The safety profile of this drug is known from the previous phase 1/2 studies and no new safety signals were observed.

What are the next steps for these agents?

ADCs, as a whole, offer promising and exciting treatments for patients with TNBC, particularly in the metastatic setting, since the main treatment options are still single-agent sequential chemotherapy. We've seen exciting results from&#8239;sacituzumab govitecan, and in reference to&#8239;ladiratuzumab vedotin (SGN-LIV1A), early phase 1 data have shown an impressive response rate in a heavily pretreated population. Fleshing out these data in confirmatory studies and in phase 3 studies is the best next step for research.

PARP inhibitors are also under exploration. Could you speak to the objectives of the phase 3&#8239;OlympiA&#8239;trial? Do you believe these agents will have a role in the adjuvant setting?

In the phase 3 study, [investigators are] looking at the use of PARP inhibitors in the post-neoadjuvant or adjuvant setting. In this trial, patients who have germline BRCA mutations and who have received all of their neoadjuvant or adjuvant systemic therapy and local therapy will then be randomized to olaparib (Lynparza)&#8239;for 12 months versus no olaparib. The whole [goal] is to see whether there is any improvement. The primary end point for that study is invasive disease-free survival.

What are some of the promising PARP combinations under investigation?

To date, PARP inhibitors are indicated for patients with metastatic TNBC who have&#8239;deleterious or suspected deleterious germline&#8239;BRCA&#8239;mutations and HER2-negative disease. Two PARP inhibitors are approved for use, [and they offer serve as] another treatment option for patients. The combination of PARP inhibitors plus immunotherapy could be an exciting [area of research]. We believe that PARP inhibitors alter the tumor microenvironment and may have some synergy with immunotherapy.

Patients with this disease, particularly those with metastatic TNBC, still have a poor prognosis. The therapies that are available, particularly the chemotherapy [regimens], still offer a short PFS.

Anything that can be done to improve the targeted therapies and improve those outcomes is important. In addition, identifying biomarkers that will help [determine] who will benefit from which therapies and at which point in their treatment schema is important to improve the survival of these patients.

1. Schmid P. IMpassion130: Results from a global, randomised, double-blind, phase 3 study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC). In: Proceedings from the 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract LBA1_PR.

2. Bardia A, Tolaney SM, Loirat, et al. ASCENT: a randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020; Virtual. Accessed October 29, 2020. https://bit.ly/2HPRzqQ

Immunotherapy, ADCs, PARP Inhibitors Make Waves in Metastatic TNBC

Triple-Negative Breast Cancer Treatments Continue to Evolve

As the number of cancer survivors continues to grow, it is imperative that clinicians closely monitor therapy-related cardiac toxicity after patients finish their treatment. In particular, survivors who were treated with anthracyclines and/or trastuzumab (Herceptin) may be at an increased risk.

“As advanced practice nurses, it’s important to understand current clinical guidelines for cancer survivors in order to educate and support survivors,” said Jacqueline B. Vo, PhD, RN, MPH, a cancer prevention fellow at the National Cancer Institute, in a presentation at the 

“Both anthracyclines and trastuzumab can cause left-sided heart failure. The risk of heart failure increases significantly when both of these drugs are given together,” she said.

In her research, which was presented at the 2020 ONS Bridge Virtual Meeting, Vo analyzed survivorship guidelines regarding cardiovascular care of cancer survivors. She looked at the blueprints laid out from 5 leading organizations: The American Society for Clinical Oncology (ASCO); The American Cancer Society (ACS); the European Society for Medical Oncology (ESMO); the National Comprehensive Cancer Network (NCCN); and the American Heart Association (AHA).

AHA, ASCO and ESMO all recommended baseline echocardiograms of the left ventricular ejection fraction for patients who received anthracyclines and/or trastuzumab. Additionally, the NCCN deemed low baseline ejection fraction (under 55%) as a risk for developing cardiac toxicity.

During treatment, the AHA, ASCO, and ESMO all recommend screening every 3 months while patients are undergoing cardiotoxic treatment, and AHA, ASCO, ESMO, and the NCCN all recommended screening 1 year after a patient completes treatment.

The ASCO/ACS survivorship guidelines reference NCCN cardiotoxicity guidelines, which focuses on monitoring lipid levels, cardiovascular monitoring, and patient education on healthy lifestyles.

Only one organization — ESMO – recommended the long-term monitoring.

Vo said that nurses can play a key role in ensuring that their patients get echocardiograms, when recommended or necessary. It is also important for them to understand not only the treatments that patients received, but also heir individual lifestyles that can contribute to the development of heart problems down the line.

“We also want to provide survivorship care that is tailored to the patient, including modifying the risk factors and also educating the patient on risk factors,” Vo said. These factors can include smoking cessation, maintaining a health weight, and getting enough physical activity.

Cardio-oncology is a growing field, and as more clinicians understand the impact that cancer treatment has on the heart, better interventions and prevention strategies can be crafted.

There are also ongoing studies examining lifestyle interventions such as physical activity and diet, as well as pharmacologic studies looking at drugs such as angiotensin-converting enzyme (ACE) inhibitors in preventing cardiotoxicity.

“With this discipline, there’s a growing quantity of cardio-oncology clinics, specifically in academic medical centers,” Vo said. “With this, there’s also a need for nurses to be trained in cardiology and cardio-oncology as well.”

Vo JB. Clinical cardiovascular guidelines for adult cancer survivors: implications for oncology nursing practice. Presented at: 2020 ONS Bridge Virtual Conference. September 8, 10, 15, and 17. 2607356/vo_reviewing-clinical-cardiovascular-guidelines-for-adult-cancer-survivors-implications-for-oncology-nursing-practice-self-recording-on-demand 

Oncology nurses are key players in promoting health heart practices after a patient finishes cancer treatment.
 

Nurses' Role in Cardiotoxicity in Cancer Survivors

Lauren Chatalian, LMSW, Women & Children’s Program Manager at CancerCare

At the start of the COVID-19 outbreak, it was unclear how cancer treatments would transpire and how the length of time the pandemic would be impacting those diagnosed with cancer. Individuals diagnosed with cancer have faced many obstacles in receiving care. While COVID-19 continues to present much uncertainty for many people, those diagnosed with breast cancer are faced with unique challenges in navigating continued treatment.

Because of the pandemic, people diagnosed with breast cancer may have experienced adjustments in their treatment regimen. Some may have begun neoadjuvant treatments due to postponed surgeries, while others have transitioned to oral treatments rather than receiving consistent infusion treatments at one’s treatment center.

 Clinical trials have also been adjusted with enrollment briefly paused. However, those who were in a clinical trial were able to continue to receive treatment (most likely delivered to one’s home)

. While many precautions have been put in place, many concerns have arisen in accessing necessary cancer care. Treatment approaches are on a case-by-case basis, as each diagnosis may exhibit different concerns

. It is important for patients to know that research continues and medical professionals are exploring ways to balance the concern of breast disease progression and COVID-19.

Unfortunately, due to COVID-19, many surgeries and procedures have been postponed. This specifically causes concern for individuals diagnosed with breast cancer who may have been scheduled for a lumpectomy or mastectomy. When someone is newly diagnosed with breast cancer and awaiting tumor removal, it may be difficult to comprehend the precautions necessary to ensure that surgical staff can continue to provide these services. While procedures have been termed elective, these surgeries may not appear to be elective for those diagnosed. They are still medically necessary and, in some cases, time sensitive even if they are not considered emergencies. Nevertheless, precautions must be taken. Surgical procedures and recovery may be different than initially expected due to COVID-19

Reconstructive surgery procedures may continue to be delayed until the pandemic is over. Preparing patients for these possible changes can help to alleviate uncertainty. Open communication and continued education about one’s diagnosis as well as COVID-19 is particularly vital during this time.

Individuals diagnosed with breast cancer may also be unsure if going into the hospital or treatment center poses a risk to their health. During a time of heightened anxiety, it is necessary to inform patients who they can contact if any concerns arise. For example, if it is possible for a patient to experience skin irritation due to radiation, and it could be useful to know ahead of time how to treat this or what specific circumstances require medical attention. If there is someone on the medical team that could be the point person for a patient to contact, this may offer a sense of comfort and reassurance throughout a breast cancer treatment, especially during COVID-19. There may be a nurse helpline through one’s medical insurance that could also be helpful.

Telemedicine, or telehealth, has become increasingly useful throughout COVID-19 to provide remote health care services. If patients express hesitancy, explaining the benefits of this option could provide a new perspective. Telehealth could offer a more flexible schedule, limit physical contact with others, and reduce the stress of traveling to and from medical appointments. In addition, explaining how to prepare for these appointments, as well as sharing what an appointment entails, may help to put a patient’s mind at ease. Step-by-step instructions for the video platform being used may be requested, and so healthcare professionals should consider having reading material on hand that patients can refer to, such as 

It may be helpful to consider a patient’s worries and stress. Throughout the pandemic, individuals diagnosed with breast cancer may experience increased feelings of isolation and a limited sense of community. Strong emotions when first diagnosed with breast cancer may be amplified throughout the pandemic. Oncology support staff may engage with individuals diagnosed with breast cancer regularly; however, this is a very new experience for many patients. Whether an individual is diagnosed during the pandemic or is navigating ways to continue treatment throughout these difficult times, patients are attempting to manage several stressors and may feel overwhelmed. It is imperative for patients to have a sense of security with their medical team to feel supported throughout his or her treatment.

As those impacted by a breast cancer diagnosis are faced with much uncertainty during COVID-19, financial strain may be an additional and powerful concern for many individuals. The loss of a job or loss of medical insurance poses increased stress for those in the cancer community. Connecting patients with the financial department, hospital social worker or patient navigator at the treatment center can help patients and families become aware of options available to them. Non-profit organizations, such as 

, may be helpful in connecting with financial resources, support services and educational workshops, including 

. During a time when people feel increased loneliness, connecting with others who may understand what he or she may be experiencing can be extremely beneficial. This could be through support groups, peer matching or individualized counseling. It is important to continue to address the emotional and practical concerns of a breast cancer diagnosis throughout one’s treatment and care, especially during a pandemic.

Citgez, B., Yigit, B., Capkinoglu, E., & Yetkin, S. G. (2020). Management of Breast Cancer during the COVID-19 Pandemic. 

Bauchner H, Fontanarosa PB. Randomized Clinical Trials and COVID-19: Managing Expectations. 

 2020;323(22):2262—2263. doi:10.1001/jama.2020.8115

Chia, C. L. (2020). Being a surgeon in the pandemic era. 

Journal of the American College of Surgeons

While COVID-19 continues to present much uncertainty for many people, those diagnosed with breast cancer are faced with unique challenges in navigating continued treatment.

Navigating Breast Cancer Care During a Pandemic

Recent years have brought many changes to the treatment of patients with HER2-positive metastatic breast cancer.

Breast Cancer