Trial Results: ECOG-ACRIN Research Round-Up

News in Brief
News in Brief, August 2023
August 25, 2023
Trial Spotlight: Efrat Dotan Gives an Update on the EA2186/GIANT Study for Older Adults with Pancreatic Cancer
August 25, 2023
  • Breast Cancer – The latest findings from the landmark TAILORx trial show racial and ethnic differences in 8-year locoregional recurrence rates among women with hormone receptor-positive (HR+) and node-negative early-stage breast cancer. Recurrence rates were highest among Asian and non-Hispanic Black women (4%) compared with Hispanic (3%) and non-Hispanic White women (2%). These differences occurred despite high treatment receipt rates and similar access to care. Kantor O. JAMA Surgery. April 2023
    • Also, note the accompanying editorial by Newman LA, “Race and Ethnicity as a Sociopolitical Construct That is Biologically Relevant in Breast Cancer.”
  • Breast Cancer – Translational scientists continue to explore biomarkers to predict the development of peripheral neuropathy (nerve damage in the hands and feet). This painful and dose-limiting side effect is common among breast cancer patients receiving paclitaxel chemotherapy. Using tumor samples and associated data from a previous trial (E5103), this report is Part Two of an exploration of a cluster of 267 single nucleotide polymorphisms (SNPs). Lustberg M. Support Care Cancer. February 2023
  • Breast Cancer – Also using specimens and data from the E5103 trial (see above), this analysis found that rare variants in cytochrome P450 oxidoreductase (POR) predicted an increased risk of severe taxane-induced peripheral neuropathy in breast cancer patients of European ancestry. Shen F. Clin Cancer Res. July 2023
  • Cardiotoxicity – VEGF (vascular endothelial growth factor) inhibition therapy is often used alone or with other medicines to treat cancer in adolescents and young adults (AYAs) aged 15-39. Researchers evaluated cardiovascular toxicities associated with this therapy, such as hypertension and left ventricular systolic dysfunction, in AYAs who participated in the E2805 trial for patients with renal cell carcinoma. Bottinor WJ. J Natl Compr Canc Netw. July 2023
  • Deep Learning – The role of calibration in uncertainty-based referral for deep learning is the subject of this report, whose authors include ECOG-ACRIN Group Statistician Constantine A. Gatsonis, PhD. Zang R. Stat Methods Med Res. April 2023
  • Deep Learning, Head and Neck Cancer – This publication demonstrates the capability of a deep learning algorithm in the post-surgery setting to assess the stage of disease more accurately using standard CT scans. In a cohort of newly diagnosed patients in the E3311 trial at high risk for recurrence by standard assessment, a neural network algorithm outperformed expert radiologists in measuring the extent of cancer spread. Kann BH. Lancet Digit Health. June 2023
  • Esophageal Cancer – The addition of cixutumumab to paclitaxel chemotherapy in second-line treatment of patients with metastatic esophageal cancer or gastroesophageal junction (GEJ) cancer was well tolerated but did not improve clinical outcomes relative to standard of care. This is one of the findings from the randomized phase 2 trial E2208. Cixutumumab is an insulin-like growth factor-1 receptor monoclonal antibody. Stockton S. Oncologist. April 2023
  • Head and Neck Cancer – Researchers with ECOG-ACRIN and those from Yale University and the University of North Carolina have identified two new subtypes of HPV-associated head and neck squamous cell carcinoma, each with unique characteristics and treatment responses. The discovery opens new opportunities for treatment personalization. Shrank TP. Proc Natl Acad Sci USA. July 2023
  • Immunotherapy – For patients with advanced hematologic malignancies, immunotherapy medicines can be effective yet possibly have life-threatening side effects. Thus, patients may require informal caregivers to stay close during treatment to help manage physical care and provide emotional support. This report aims to improve understanding of the psychosocial characteristics of patients undergoing cellular immunotherapies and their caregivers across time, including distress, coping, and caregiver burden. Kirtane K. Leuk Lymphoma. February 2023
  • Kidney Cancer – The phase 2 trial E1308 was the first and largest randomized trial of cytotoxic therapy for patients with advanced renal cell carcinoma with sarcomatoid features—a particularly aggressive and deadly form of the disease. The trial evaluated the effectiveness and safety of sunitinib, an oral tyrosine kinase inhibitor, with or without gemcitabine chemotherapy in 47 patients. The study found that sunitinib alone met the pre-set threshold for success. Researchers state that cytotoxic chemotherapy is only useful in limited clinical scenarios in this population of patients. Carthon BC. Clin Genitourin Cancer. July 2023
  • Leukemia – Somatic mutations in isocitrate dehydrogenase (IDH) genes occur frequently in adults with acute myeloid leukemia (AML) and less commonly in children with AML. ECOG-ACRIN researchers, with colleagues from the Children’s Oncology Group and the SWOG Cancer Research Network, report the characteristics and prognostic impact of IDH mutations in adult and pediatric AML. This cohort included 3,141 patients across several trials. Sarnegar-Lumley S. Blood Adv. June 2023
  • Leukemia – Obesity (body mass index [BMI] ≥30 kg/m2) is an important epidemiological risk factor for adults to develop acute myeloid leukemia (AML), leading to this evaluation. It compared obesity versus non-obesity among 1,088 patients receiving intensive remission induction and consolidation therapy in two randomized prospective clinical trials (E1900 and E3999). The authors state that this study demonstrates that obesity is not a factor in survival, and strict adherence to body surface area–based dosing is unnecessary because dose adjustments do not affect outcomes. Foran JM. Cancer. April 2023
  • Lymphoma – Harnessing data from more than 5,000 patient cases in the Hodgkin Lymphoma International Study for Individual Care (HoLISTIC) Consortium, ECOG-ACRIN researchers are part of a broad effort to develop a modern clinical prediction model for advanced-stage classic Hodgkin Lymphoma to replace an outdated prognostic scoring system. This publication describes the development and validation of the new model. An online calculator was created for individualized point-of-care use. Rodday AM. J Clin Oncol. April 2023
  • Myelodysplastic Syndromes – This observational study explored health-related quality of life and vulnerability among people with myelodysplastic syndromes (MDS). Participants are from The National MDS Study, an ongoing multicenter prospective cohort study in the United States that enrolls and banks samples from patients with cytopenia undergoing a workup for suspected MDS or myeloproliferative neoplasms (MPN). The National Heart, Lung, and Blood Institute sponsors the study. Abel GA. Blood Adv. July 2023
  • Myeloid Malignancies – Also from The National MDS Study (see above), is a publication on the utility of targeted gene sequencing to differentiate myeloid malignancies from other cytopenic conditions. A two-stage classifier was built to discriminate the presence of a myeloid malignancy or MDS in 1,298 patients using mutations in 53 genes. DeZern AE. Blood Adv. July 2023
  • NCI-MATCH – Trametinib is an inhibitor of MEK1/2 and was first approved for clinical use based on activity in BRAF-mutant melanoma. This report combines the results of two NCI-MATCH treatment arms: S1 and S2. Trametinib was evaluated in 50 patients, of which 46 had neurofibromatosis 1 (NF1) mutations and four had GNA11/Q altered tumors. Although these arms did not meet the primary endpoint for objective response rate, there were significant responses or prolonged stable disease in some disease types that warrant further investigation. Wisinski KB. JCO Precis Oncol. April 2023
  • Prostate Cancer – Which patients with metastatic hormone-sensitive prostate cancer benefit from docetaxel? This publication is a systematic review and meta-analysis of 2,261 patients across three randomized clinical trials: CHAARTED (E3805), GETUG-AFU15, and STAMPEDE. It found that docetaxel plus hormone therapy best suits patients with poorer prognoses based on high tumor volume and potentially the bulkiness of the primary tumor. There was no evidence of meaningful benefit for patients with metachronous, low-volume disease who should therefore be managed differently. These results have the potential to change international practice and improve patient outcomes. Vale CL. Lancet Oncol. July 2023
  • Smoking Cessation – Little is known about the use of alternative tobacco products, such as smokeless tobacco, cigars, and e-cigarettes, among cancer survivors. Researchers investigated the prevalence of these products and cigarette smoking among 756 cancer patients enrolled in nine national ECOG-ACRIN clinical trials (2017-2021). While cigarettes were the most prevalent tobacco product reported, the authors recommend that cancer care providers routinely assess the use of alternative tobacco products, including multiple tobacco product use. Streck JM. J Cancer Epidemiol Prev. July 2023

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