University Hospitals Seidman Cancer Center at ASCO 2022

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Innovations in Cancer | Summer 2022

Implementation of a PREcision meDICine Thoracic (PREDICT) service using reflex testing in a large academic-community practice network

A precision medicine service implemented for patients with stage IV non-small cell lung cancer (NSCLC) being treated at UH Seidman Cancer Center has led to significantly higher rates of next-generation sequencing, a critical component in treating these patients. The service, dubbed PREDICT, consists of system-wide reflex testing of newly diagnosed stage IV NSCLC patients by an in-house solid tumor focused assay (hybrid DNA/RNA next-generation sequencing panel) and PD-L1 testing, a PREDICT navigator, a molecular tumor board and an integrated information portal for real-time updates on samples processing, results and treatment recommendations by the molecular tumor board. UH Seidman thoracic oncologist Debora Bruno, MD, who presented the results of the program recently at ASCO, says that launching this initiative has also resulted in significantly shorter turnaround times for both next-generation sequencing and PD-L1 test results. PREDICT led to detection rates of actionable alterations that can be targeted in the first-line setting, compared to prior to this initiative.

Estimating survival benefit of adjuvant chemotherapy in postmenopausal women with pT1-2N0 early stage breast cancer and Oncotype DX recurrence score > 26: a National Cancer Database (NCDB) analysis

UH Seidman Cancer Center research fellow Lifen Cao, MD, PhD, mentee of Alberto Montero, MD, MBA, and UH Seidman colleagues analyzed data from the National Cancer Database to determine how adding adjuvant chemotherapy to endocrine therapy (CET) would affect overall survival in women with hormone receptor positive ER+/HER2- node negative early-stage breast cancer with a recurrence score on OncoType DX of 26 or higher, compared with endocrine therapy (ET) alone, given that CET is more beneficial in women age 50 and younger. Results show that that women over 50 who fit this profile had significantly superior five-year overall survival when receiving adjuvant chemotherapy, providing a measurable benefit that should be discussed with these post-menopausal patients. Dr. Cao presented these results recently at ASCO.

Longitudinal immunological responses of COVID-19 vaccination in solid tumor patients on active treatment: a pilot study

A team at UH Seidman Cancer Center is a launching a pilot study to assess immune B and T cell responses to COVID-19 vaccination over 12 months in solid tumor patients who receive chemotherapy or non-immunosuppressive therapy for cancer, compared to healthy individuals without cancer. The CANVAX trial recently demonstrated that short term immune responses to COVID-19 vaccines are modestly impaired in patients with cancer— particularly those who receive myelosuppressive chemotherapy. However, little is known regarding longitudinal antibody or T-cell responses in cancer patients who receive cytotoxic chemotherapy or non-myelosuppressive targeted systemic therapy. The study, outlined recently at ASCO by UH Seidman research fellow Lifen Cao, MD, PhD, mentee of Alberto Montero, MD, MBA, will enroll 100 patients; 37 have already enrolled.

Adjuvant Chemotherapy is associated with an overall survival benefit regardless of age in ER+/HER2- breast cancer pts with 1-3 positive nodes and Oncotype DX recurrence score 20 to 25: An NCDB Analysis

A team from UH Seidman Cancer Center recently used the National Cancer Database to attempt to replicate the RxPonder trial, which found that post-menopausal women over age 50 with estrogen receptor (ER)+ breast cancer, 1-3+ nodes and a 21-gene Oncotype DX recurrence score of 25 or less did not benefit from receiving adjuvant chemotherapy. Using a larger sample size with real-world data, the goal was to determine whether a threshold with recurrence scores exists where adjuvant chemoendocrine therapy (CET) is beneficial regardless of age. Results of the analysis show that among women with ER+/HER2- breast cancer with 1–3 positive nodes, and recurrence score of 20-25, CET was associated with an overall survival benefit in women regardless of age – contrary to the findings of the RxPonder trial. UH Seidman research fellow Lifen Cao, MD, PhD, mentee of Alberto Montero, MD, MBA,  recently presented the UH Seidman group’s analysis at ASCO.

Survival in Elderly Patients with Breast Cancer With and Without Autoimmune Disease

This study investigated the association between autoimmune disease and survival in breast cancer using a national database of cancer patients.  Results show that patients with breast cancer have higher rates of certain autoimmune conditions, including rheumatoid arthritis and inflammatory bowel disease. In addition, patients with late-stage breast cancer affected by autoimmune disease lived about six months longer than patients without autoimmune disease. These results suggest that that anti-tumor immunity plays an important role in late-stage breast cancer, and could be potentially exploited to improve the effectiveness of immunotherapy. Further research into the relationship between autoimmunity and breast cancer is warranted. Demitrios Dedousis, MD, a combined internal medicine and genetics resident at UH Cleveland Medical Center, recently presented the results of this study at ASCO on behalf of his UH research group.

An open-label, multicenter, phase 2 study of the safety and efficacy of navtemadlin (KRT-232) in patients with TP53 wild-type relapsed/refractory small cell lung cancer

Afshin Dowlati, MD, Rosalie and Morton Cohen Chair in Lung Cancer and Lucile and Robert H. Gries Endowed Director of the Center for Cancer Drug Development at University Hospitals, is leading a team of national and international experts in small cell lung cancer (SCLC) to launch a global clinical trial of navtemadlin (KRT-232) as a potential treatment for patients with the TP53 wild-type form of the disease. Approximately 15% of patients have a TP53 wild-type (TP53WT) gene. In patients with extensive-stage SCLC, TP53WT is associated with an inferior response to chemotherapy. Thus, the presence of TP53WT may help identify a small subset of patients with an even greater unmet need. Navtemadlin is a potent, selective, orally available MDM2 inhibitor that restores function of the p53 tumor suppressor protein to drive apoptosis of TP53WT malignancies. The primary endpoint of the Phase 2 navtemadlin trial is objective response rate per RECIST v1.1. Secondary endpoints include duration of response, progression-free survival, overall survival, disease control rate, and safety. This trial, recently presented by Dr. Dowlati at ASCO, is ongoing and will enroll patients at approximately 40 global sites.

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