Researchers with the ECOG-ACRIN Cancer Research Group will present a wide range of research findings at the annual meeting of the American Society of Clinical Oncology (ASCO), occurring virtually May 29-31. The presentations include late-breaking data in two plenary sessions and several oral abstract presentations. National Cancer Institute, part of the National Institutes of Health, funded these studies.
Breast cancer and myeloma
In LBA2 of the plenary session, first author Seema A. Khan, MD (Northwestern University), will present the results of the randomized phase three trial E2108 (NCT01242800), evaluated the use of surgery after initial systemic therapy in patients with newly diagnosed metastatic breast cancer.
In LBA3, first author Shaji K. Kumar, MD (Mayo Clinic), will present the results of myeloma study E1A11 or ENDURANCE (NCT01863550). This randomized phase three trial compared bortezomib, lenalidomide, and dexamethasone with carfilzomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma.
Largest ever breast cancer treatment trial
Abstract 7004: Previous studies suggest that up to 50% of women with breast cancer do not adhere to the full five years of recommended adjuvant hormone therapy. A subgroup of 954 TAILORx (NCT00310180) women was assessed by clinical report for early discontinuation of hormone therapy, less than four years from initiation, for reasons other than death or recurrence. The study found that women below the age of 40 are at risk for early discontinuation, and modifiable characteristics (health-related quality of life and history of depression) are potential risk factors.
First author, Betina R. Yanez, PhD (Northwestern University): "These results support systematic screening for health-related quality of life and depressive symptoms to identify women at risk for discontinuation of hormone therapy."
Abstract 7041: Cancer patients often face unpredictable or unmanageable costs that may lead to care nonadherence. This study sought to identify correlations between insurance status and early discontinuation of hormone therapy, less than four years from initiation, for reasons other than death recurrence, in 9,475 TAILORx women (mean age: 55.6; 84% white; 9% Hispanic). Early discontinuation rates were highest among self-pay (18.7%) and Medicaid patients (18%).
First author, Gelareh Sadigh, MD (Emory University): "Insurance status plays an important role in adherence to adjuvant hormone therapy, with high rates among uninsured and underinsured patients. Early identification of patients at risk and enrollment in insurance optimization programs may improve adherence to therapy."
Head and Neck Cancer
The first presentation in the Head and Neck Oral Abstract Session
Abstract 6500: E3311 (NCT01898494) is a randomized phase two trial that examined transoral robotic surgery followed by low-dose or standard-dose intensity-modulated radiation therapy (IMRT) in patients with human papillomavirus (HPV) positive, stage III to IVA, oropharynx cancer. The primary endpoint was progression-free survival (PFS). For patients with low-risk disease, two-year PFS was favorable without post-operative therapy. Reduced-dose (50Gy) radiation therapy without chemotherapy appears sufficient for those patients with uninvolved surgical margins, <5 involved nodes, and <1mm extranodal extension.
First author, Robert L. Ferris, MD (University of Pittsburgh): "Transoral resection followed by low-dose radiation is safe in patients with intermediate-risk locally advanced oropharynx cancer, with very good oncologic outcomes. These results present a promising de-intensification approach."
The first presentation in the Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Oral Abstract Session
Abstract 9000: Immune checkpoint inhibition with chemotherapy is a first-line treatment for extensive-stage small-cell lung cancer. The randomized phase two study, EA5161 (NCT03382561), evaluated nivolumab (anti-PD1) in combination with platinum-etoposide (CE) as first-line treatment in these patients. Nivolumab plus CE significantly improved progression-free survival, the primary endpoint, compared with CE alone. The secondary endpoint of overall survival was also improved with nivolumab plus CE versus CE alone.
First author, Ticiana Leal, MD (University of Wisconsin): "EA5161 demonstrated improved progression-free survival and overall survival with the addition of nivolumab to chemotherapy for small-cell lung cancer. These results support the role of immune-chemotherapy in front line treatment of patients with small-cell lung cancer."
Latest data from the largest precision medicine cancer trial
Abstract 3506: NCI-MATCH (EAY131) is a platform trial that enrolls patients with solid tumors, lymphomas, or multiple myeloma to single-arm phase two studies of targeted therapies based on matching genomic alterations of interest (NCT02465060). Arm Z1F evaluated copanlisib, a highly selective, pan-Class 1 PI3K inhibitor with predominant activity against PIK3CA mutations (PTEN loss allowed), in 28 patients. The overall response rate, the primary endpoint, was 11%. Partial responses were seen in uterine cancer, clear cell carcinoma of anterior abdominal wall, and liposarcoma. Six patients had more than six months of stable disease, and the clinical benefit rate was 32% (9/28). Two patients remained on treatment at the time of abstract submission.
First author, Senthil Damodaran, MD, PhD (MD Anderson Cancer Center): "While the study did not meet its primary endpoint, copanlisib showed meaningful clinical activity in select tumors with PIK3CA mutation in the late-line refractory setting, warranting further study either alone or in combinations."
Web-based Genetic Education
Care Delivery and Regulatory Policy Oral Abstract Session
Abstract 2008: The COMET (COMunication and Education in Tumor Profiling) trial (NCT02823652) evaluated a web-based intervention to increase genetic knowledge and decrease distress among patients with advanced cancer about to undergo tumor genetic testing. The majority of the 594 patients in this study were being treated at hospitals and cancer centers participating in the NCI Community Oncology Research Program. They were randomized to web-intervention versus usual care. Those randomized to the web intervention had better knowledge improvement than those randomized to usual care (conversations with physicians and staff and information from typical resources).
First author, Angela R. Bradbury, MD (University of Pennsylvania): "Web-based education before receipt of tumor genetic test results increases patient understanding of tumor genetic testing. While the intervention did not significantly reduce distress, results suggest that women who received the intervention had lower cancer-specific distress than those with usual care."
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. ECOG-ACRIN comprises nearly 1100 member institutions in the United States and around the world. Approximately 12,000 physicians, translational scientists, and associated research professionals from the member institutions are involved in Group research, which is organized into three scientific programs: Cancer Control and Outcomes, Therapeutic Studies, and Biomarker Sciences. ECOG-ACRIN is supported primarily through National Cancer Institute research grant funding, but also receives funding from private sector organizations through philanthropy and collaborations. Its headquarters are in Philadelphia, Pa. For more information, visit http://www.ecog-acrin.org, follow us on Twitter @eaonc, Facebook, and LinkedIn, or call 215.789.3631.