MD Anderson Research Highlights: ASCO 2022 Special Edition

ABSTRACTS 6502, 6504, 9505, 9506, 12004, 12006

CHICAGO ― The University of Texas MD Anderson Cancer Center’s Research Highlights provides a glimpse into recent basic, translational and clinical cancer research from MD Anderson experts. This special edition features upcoming oral presentations by MD Anderson researchers at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting focused on quality improvement, health services research, new treatments for skin cancers, and symptoms and survivorship advances. More information on ASCO content from MD Anderson can be found at MDAnderson.org/ASCO.

In addition to the studies summarized below, forthcoming press releases will feature groundbreaking research on:

• Combining ibrutinib with chemoimmunotherapy as a first-line treatment for older patients with mantle cell lymphoma (Abstract LBA7502)
• Neoadjuvant immunotherapy for certain soft-tissue sarcomas (Abstract LBA11501)
• Cellular therapy approaches for lymphoma and multiple myeloma (Abstracts 7509, 7518, 8009)
• Gut microbiome signatures and immunotherapy responses (Abstracts 2006, 2511)
• Early-stage clinical results of novel investigational therapies (Abstracts 2501, 3003, 3008) 

Interdisciplinary goals of care program improved hospital outcomes during COVID-19 pandemic (Abstract 6502)

Comprehensive goals of care (GOC) programs provide opportunities to align treatment plans with patient preferences. In response to the COVID-19 pandemic, MD Anderson launched a multicomponent, interdisciplinary GOC program to align care teams and patients on care planning, communication, palliative care options and more. A team led by David Hui, M.D., and Eduardo Bruera, M.D., evaluated the effects of this GOC program on patient outcomes by comparing an eight-month period pre-implementation (May-December 2019) and post-implementation (May-December 2020). After launching the GOC program, there was a 6.3% reduction in intensive care unit (ICU) mortality, a reduction in length of ICU stay by 1.4 days, and in-hospital mortality dropped by 0.9% — all statistically significant. There also were significant increases in the percentage of patients with care-planning documents, such as do-not-resuscitate orders and medical powers of attorney, and these documents were filed earlier during care. The findings suggest the GOC program was associated with improved outcomes and care plan documentation during the COVID-19 pandemic at a comprehensive cancer center. Hui will present the findings on June 4.

Oral targeted cancer therapies associated with increased costs for patients with Medicare (Abstract 6504)

Oral targeted therapies have benefitted many patients with a variety of cancer types, but they are associated with rising costs that may disproportionately affect certain patients, such as those on Medicare plans. To evaluate financial burdens from oral targeted therapies for Medicare beneficiaries with cancer, a team led by Meng Li, Ph.D., and Ya-Chen Tina Shih, Ph.D., analyzed information from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. The researchers evaluated patients aged 65 and older who were enrolled in Medicare Part D with one primary cancer diagnosis between 2011 and 2016, excluding those with low-income subsidies. Over that time, oral targeted therapy use increased from 3.6% to 8.9%, and the percentage of patients receiving targeted therapies who reached the level of catastrophic coverage — designed to protect against high out-of-pocket (OOP) costs —increased from 54.6% to 60.3%. Among those reaching catastrophic coverage, average total spending on oral targeted therapy in the catastrophic phase increased more than $48,000 and average OOP spending rose by nearly $2,000. Based on these results, the authors suggest policies are needed to regulate prices and OOP spending. Li will present the results on June 4. 

Novel immunotherapy combination improved survival in patients with metastatic melanoma (Abstract 9505)

Combination immunotherapy treatment with anti-PD-1 and anti-CTLA-4 checkpoint inhibitors has proven effective as a front-line option for many patients with metastatic melanoma, but it is associated with toxicity rates of more than 50%. Therefore, additional therapeutic approaches are needed to maximize outcomes and improve patient quality of life. In a Phase II/III trial led by Hussein Tawbi, M.D., Ph.D., researchers evaluated a novel third-generation checkpoint inhibitor, relatlimab, which targets the immune checkpoint LAG-3. Patients with untreated, metastatic melanoma received either relatlimab plus nivolumab (anti-PD-1) or nivolumab alone. A previous report showed that the combination doubled progression-free survival over nivolumab alone with a manageable safety profile. The current analysis demonstrates the combination achieved an overall response rate of 43% relative to 33% for nivolumab alone. Median overall survival had not yet been reached in the combination arm, but results continue to show a meaningful improvement over nivolumab alone, albeit not statistically significant. The findings suggest that the relatlimab and nivolumab combination offers improved outcomes and supports approaches targeting LAG-3 as a novel immunotherapy approach. Tawbi will present updated results and subgroup analyses on June 5.  

Targeting p53 pathway shows promise for patients with Merkel cell carcinoma (Abstract 9506)

Merkel cell carcinoma (MCC) is a rare and aggressive form of skin cancer caused by the Merkel cell polyomavirus. Patients who do not respond to immune checkpoint inhibitors have a median survival of just four months, highlighting the need for new treatment options. In patients without TP53 mutations, viral proteins activate MDM2 to block p53 function, preventing normal cell death. In a Phase Ib/II trial led by Michael K. Wong, M.D., Ph.D., researchers evaluated navtemadlin, a targeted therapy against MDM2, in MCC patients without TP53 mutations. The study enrolled 31 patients that previously received anti-PD-1/L1 therapies, randomly assigned to different dose levels. The putative recommended Phase II dose achieved a 25% confirmed overall response rate and a 63% disease control rate. This dose level was well-tolerated, with fewer dose reductions and longer treatment duration than higher doses. Grade 3/4 treatment-related adverse events were seen in 68% of patients across all dose levels, while hematologic side effects were most common. The findings suggest this therapeutic approach warrants further study for patients with MCC. Wong will present updated findings on June 5.

Acupuncture improves chronic radiation-induced dry mouth for patients with head and neck cancer (Abstract 12004)

Most head and neck cancer patients treated with radiation therapy develop long-term treatment-related dry mouth, or xerostomia, which can negatively impact quality of life (QOL) and oral health. Available therapies offer limited benefit and are associated with additional side effects, necessitating new treatment options. Previous studies suggested acupuncture during radiation treatment may reduce the severity of xerostomia symptoms, but large trials were needed to evaluate the approach for chronic xerostomia. A Phase III trial led by Lorenzo Cohen, Ph.D., demonstrated that true acupuncture (TA) was more effective in treating chronic xerostomia and improving QOL than sham acupuncture (SA) or a waitlist control (WLC) group receiving standard oral hygiene. The study enrolled 258 patients across 33 sites that are part of the Wake Forest Community Oncology Research Program Research Base. Participants were experiencing xerostomia for at least one year post-radiation therapy — the average was four years — and were randomized to either TA, SA or WCL. During the 12-week follow-up, significant group differences between the TA and WLC groups emerged, but no differences between SA and WLC. Twelve weeks after treatment, patients receiving TA had statistically and clinically significant improvements in QOL over SA and WLC, with no differences between SA and WLC. The findings suggest that acupuncture should be considered as a treatment option for chronic radiation-induced xerostomia. Cohen will present the findings on June 6.

Open-label placebo treatment reduces cancer-related fatigue in patients with advanced cancers (Abstract 12006)

Cancer-related fatigue (CRF) is the most common symptom in patients with cancer, and there are limited effective treatments available. Fatigue has the potential to have significant physical, emotional and familial effects, and can even impact a patient’s ability to receive cancer treatment. Clinical trials investigating medicines to treat CRF often find no improvements over placebo, suggesting the placebo effect may be affecting outcomes. To investigate the potential for an open-label placebo to treat CRF, Sriram Yennu, M.D., and colleagues led a Phase II/III trial evaluating placebo treatment for patients with advanced cancers and a diagnosis of CRF. Ninety patients were randomized to receive either a placebo with a message about the treatment or to be enrolled in a waitlist control group. Study results demonstrated that the open-label placebo treatment offered significant reductions in CRF as measured by several established fatigue scales, and these improvements in fatigue were maintained for the entire four weeks of the study period. The findings suggest that further studies to evaluate this treatment approach are justified. Yennu will present the findings on June 6.

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