This week top oncologists and researchers from around the world attended the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, one of the largest oncology research conferences of the year. Researchers presented breakthrough clinical trial data including new treatment options, symptom management and research in cancer care equity. We’ve highlighted a few major takeaways from the conference. If you have any questions after reading our wrap up, you can ask our medical team via the “Ask” tab in the Outcomes4Me App.

Treatment Advancements

Metastatic breast cancer

New data shows T-DXd (Enhertu) increases overall survival in HER2-low metastatic breast cancer patients

HER2 low or HER2 negative patients partook in a phase 3 trial DESTiNY 4, testing the efficacy of trastuzumab-deruxtecan (T-DXd), also known as Enhertu®. The study involved 540 patients, with 480 presenting hormone receptor positive (HR+) and 60 that were hormone receptor negative (HR-) and determining the efficacy of Enhertu® versus standard treatments. When compared to standard treatments, this study saw overall survival increase by nearly six and a half months for both HR+ and HR- patients. Comparing Enhertu® with standard treatments, Enhertu® also saw higher rates of efficacy and progression free survival. Receiving a standing ovation from those in attendance, the hope is for this trial to become the new standard of care for those patients who are HER2 low. Read the full publication in The New England Journal of Medicine here.

Enhertu® shown to be more effective in stage III trial for patients with HER2+ metastatic breast cancer

Enhertu® (trastuzumab-deruxtecan) is also being studied in HER2+ tumors. Enhertu® was compared against trastuzumab emtansine (Kadcyla®) in the second line setting for patients that were already exposed to trastuzumab and pertuzumab. At twelve months, the overall survival for Enhertu® was 8.5% higher than patients on the Kadcyla® arm. Long analysis is expected in the future to delve further into the overall efficacy of Enhertu®, but signs are promising for this subset of patients.Read the full publication in The New England Journal of Medicine here.

Phase II study for second line treatment of hormone receptor positive, HER2- patients metastatic breast cancer

Hormone receptor positive, HER2- patients with unresectable tumors, who experience progression while on hormone therapy and a CDK 4/6 inhibitor may soon have another option for second line treatments. MAINTAIN, a phase II trial, looked to see whether ribociclib plus endocrine therapy would benefit such patients, with promising results. Progression free survival for patients receiving ribociclib was found to be double at six months and three times as high at twelve months when compared to patients on the placebo arm. Ribociclib side effects were manageable, with fatigue, neutropenia, anemia, and thrombocytopenia being the most common. The results from this study show that using ribociclib in combination with endocrine therapy has significant benefits for patients in need of a second line CDK 4/6 inhibitor. Read the full publication here.

Breast cancer patients with brain metastases receive what is being called the new Standard of Care 

Breast cancer patients with brain metastases partook in the HER2CLIMB study, which aimed to determine the benefit of a new drug combination therapy. The study added tucatinib to capecitabine and trastuzumab and patients were randomized to arms containing either tucatinib or placebo. Patients who received tucatinib saw a median overall survival increase of nearly 10 months (21.4 months for tucatinib arm vs. 11.8 months for placebo arm). 47% of patients taking trastuzumab also saw a response in their brain metastases while on the placebo arm 20% of patients saw a response. Further follow-up was done to find alternatives if tucatinib is unavailable and study TBCRC 022 found that targeted therapy Neratinib had results that were comparable to tucatinib. Read the full publication in The New England Journal of Medicine here.

Early stage breast cancer

Low risk luminal A patients who have undergone breast conserving surgery may be able to omit radiation therapy

Radiation therapy following breast conserving surgery is common for patients with local breast cancer. For years, the standard practice for low-risk early stage breast cancer has been breast conserving surgery followed by radiation therapy.The LUMINA study looks to see if patients with luminal A tumors less than 11mm in size could omit radiation therapy without increasing their recurrence risk. Five hundred patients under 60 years of age, diagnosed luminal A cancer were followed for five years in this single arm study. The results show that though patients did not receive radiation treatment, there was not a significant increase in the rate at which patients were found to have local recurrence. Read the full publication here.

KEYNOTE study shows that early triple negative breast cancer patients receiving pembrolizumab have better overall results

Patients on the KEYNOTE study (N=1174) were given either pembrolizumab plus chemotherapy or placebo plus chemotherapy in the neoadjuvant setting, with adjuvant pembrolizumab/placebo plus chemotherapy following surgery. Results showed that patients who received pembrolizumab had a significantly higher rate of event-free survival, with 85% of patients receiving pembro experiencing event-free survival and only 77% of patients on the placebo arm experiencing similar results. This data confirms that patients receiving pembrolizumab in the neoadjuvant and adjuvant setting will have notably better results.Read the full publication in The New England Journal of Medicine here.

Young women with hormone sensitive breast cancer found to have better disease free survival with ovarian function suppression

A study out of South Korea looked at the long term follow-up of adding ovarian function suppression (OFS) to treatment for young women with hormone sensitive breast cancer. Patients were given either Tamoxifen alone or with OFS and were followed for 8 years. Results showed that while there was no significant difference in overall survival, the rate of disease free survival between groups was 5.2% in favor of patients receiving both treatments. This shows that there is indeed a benefit for young women to receive ovarian function suppression treatment, even if overall survival was not impacted. Read the full publication in the Journal of Clinical Oncology here.

Long term follow-up for HR+ patients taking hormone therapy with focus on bone health

Aromatase inhibitors are commonly used as an endocrine treatment for postmenopausal, hormone receptop-positive (HR+) breast cancer patients. One common side effect is bone density degradation, which leads to increased rates of fractures. One drug tested for long-term effectiveness was denosumab. This drug was given to patients in comparison to a placebo arm in conjunction with endocrine therapy. The initial results, released several years ago, showed a significant decrease in fractures among patients taking denosumab. Long term follow-up has shown that patients receiving denosumab had a 20% better overall survival rate and a 25% decrease in fractures even if the patient discontinued medication. Read the abstract of the study here.

Study finds evidence that detection of ctDNA may be able to detect future recurrence in breast cancer

Patients in remission for hormone receptor positive, HER2 negative breast cancer enrolled in the CHiRP study. This study sought to detect circulating tumor DNA (ctDNA) and determine if it could be used as a predictor for future recurrence. 75% of patients who were found with ctDNA in their blood eventually recurred. ctDNA was detected up to 37 months prior to the detection of recurred cancer. These results have followed the thoughts that many researchers around the country have wondered, whether finding ctDNA blood is an accurate predictor for metastatic recurrence. Current and future research is being performed across cancer types including breast cancer to further investigate the utility of ctDNA screening and more efficiently perform these tests. Read the full publication in the Journal of Clinical Oncology here.

Improving Clinical Trials

BECOME project studies how to increase black patient participation in metastatic breast cancer clinical trials

For researchers to understand how cancer treatments work across different patient populations, clinical trials need to reflect the diversity of the general population. However, black breast cancer patients are consistently underrepresented in these trials. While 15% of cancer patients are black, only 4-6% of clinical trial participants are black. After conducting a patient survey (N=424), researchers found that 83% of black respondents would consider trial participation, but 40% of them said no one on their care team discussed clinical trials with them. The study shows that black patients with metastatic breast cancer are willing to consider clinical trials, but providers need to do more to enhance awareness, build deeper trust, and help patients find trials relevant to them. Learn more here.

Real world data could have the potential to replace control group for some clinical trials

Clinical trial studies typically have two cohorts or “arms”: the group who receives new treatment and the group who receives  standard of care.  Real World Data (RWD) could have the potential to replace the standard of care  arm in some studies. RWD is patient health data that is collected outside of a typical clinical trial setting. RWD can come from a variety of sources such as electronic health records, registry data or insurance claims. Dr. Jennifer Lund from the University of North Carolina at Chapel Hill explains that instead of randomizing patients to the two different arms, researchers could put all patients in the new treatment arm and then identify external patients from real world data who have taken the comparable standard of care. It is important to note that this method may introduce some study biases that researchers must be aware of before conducting research. 

Access and Equality

Age based discrimination may lead to overtreatment in older adults with cancer

Unfortunately, ageism in cancer care can lead to overtreatment, poor communication, and poorer outcomes in older adults with cancer. Ageism in cancer care includes biases from providers, ageist communication, biased clinical decisions and exclusion from clinical trials. Integrating geriatric assessment tools which capture age-related functional, cognitive and psychosocial changes can improve patient satisfaction, communication and decrease overtreatment in older patients. Additionally, older adults with cancer, especially those from historically marginalized backgrounds, must be represented in cancer research like clinical trials to address inequities and ensure the safety of new cancer treatments in this population.

Symptom Management 

Placebo may be able to help improve cancer related fatigue in advanced cancer patient

Cancer related fatigue is one of the most common symptoms in patients and can have a significant impact on a patient’s quality of life. Recent studies have shown that placebos given without deception can be effective in reducing cancer related fatigue symptoms in cancer survivors. From this prior research, researchers wanted to test the placebo effect in patients with advanced cancer to see if it could help decrease fatigue symptoms. Results showed that patients receiving the placebo reported improved fatigue symptoms as compared to patients who did not receive a placebo after 1 week and this improvement continued after 4 weeks. Researchers are investigating further studies to see how the placebo effect may be utilized to help improve cancer-related fatigue. Read the abstract here.

Acetaminophen may have negative impact on efficacy of immunotherapy

Acetaminophen is commonly used to manage mild-to-moderate pain in patients with cancer. However, some evidence has shown that acetaminophen can negatively affect how your body regulates its immune system. A study presented this week aimed to assess acetaminophen’s impact on the efficacy of immunotherapy in cancer patients. Researchers found that patients with detectable levels of acetaminophen being treated with immune checkpoint blockers (such as pembrolizumab) in their plasma at treatment onset had a 43% increased risk of disease progression as compared to patients who did not have detectable levels of acetaminophen in their plasma. Based on these results, the researchers recommend patients and providers use acetaminophen with caution in patients being treated with immune checkpoint blockers. Further studies are needed to confirm the results. Learn more here.

In addition to making up to date research available, our medical team is here to help you understand the latest insights about breast cancer topics. If you have any questions or comments about this research–how it relates to your medical care, or wish to better understand the overall research on a particular topic, you can reach out to us via the “Ask” tab in the Outcomes4Me App.

References:

1. Modi, Shanu (2022, June 3-7) Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
2. Cortes, Javier (2022, June 3-7) Integration of Innovative Therapies in the First and Second Line. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
3. Kalinsky, Kevin (2022, June 4) A randomized, phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor–positive (HR+), HER2-negative metastatic breast cancer (MBC): MAINTAIN trial. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
4. Lin, Nancy U. (2022, June 3) Prevention and Treatment of Brain Metastases. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
5. Whelan, Timothy Joseph (2022, June 7). A prospective trial omitting radiotherapy (RT) following breast conserving surgery (BCS) in T1N0 luminal A breast cancer (BC). [Oral Abstract Session]. 2022 ASCO Annual Meeting.
6. Pusztai, Lajos (2022, June 7). Event-free survival by residual cancer burden after neoadjuvant pembrolizumab + chemotherapy versus placebo + chemotherapy for early TNBC: Exploratory analysis from KEYNOTE-522. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
7. Kim, Hee Jeong (2022, June 7). Adding ovarian function suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or resume menstruation after chemotherapy: 8-year follow-up of the randomized ASTRRA trial. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
8. Gnat, Michael (2022, June 7). Long-term outcomes of adjuvant denosumab in breast cancer: Fracture reduction and survival results from 3,425 patients in the randomized, double-blind, placebo-controlled ABCSG-18 trial. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
9. Lipsyc-Sharf, Marla (2022, June 4) Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer (CHiRP) [Oral Abstract Session]. 2022 ASCO Annual Meeting.
10. Walker, Stephanie (2022, June 3). Increasing Black patient participation in metastatic breast cancer clinical trials: The BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) project. [Poster Discussion Session]. 2022 ASCO Annual Meeting.
11. Lund, Jennifer (2022, June 5). Real-World Data: Promises and Pitfalls in Turning Data to Evidence. [Education Session]. 2022 ASCO Annual Meeting.
12. Wallington, Sherrie (2022, June 3). Health Equity for Older Adults With Cancer. [Education Session]. 2022 ASCO Annual Meeting.
13. Yennu, Sriram (2022, June 6). Open-labeled placebo for the treatment of cancer-related-fatigue in patients with advanced cancer: Results of a randomized controlled trial. [Oral Abstract Session]. 2022 ASCO Annual Meeting.
14. Bessede, Alban (2022, June 6) Impact of acetaminophen on the efficacy of immunotherapy in patients with cancer. [Oral Abstract Session]. 2022 ASCO Annual Meeting.