Trial Results: ECOG-ACRIN Research Round-Up

News in Brief
News in Brief, October 2022
October 13, 2022
Couple speaking to doctor
Trial Results: ECOG-ACRIN Completes the First Randomized Phase 3 Clinical Trial of Neoadjuvant Immunotherapy in Patients with Kidney Cancer
October 13, 2022

Trial Results: ECOG-ACRIN Research Round-Up

Research definition

NCI-MATCH – As a result of the NCI-MATCH trial, the US Food and Drug Administration (FDA) recently approved dabrafenib and trametinib in combination for treating patients with nearly any type of advanced solid tumor with a BRAF V600E mutation. The approval is based on data from NCI-MATCH's Arm H and other studies.

Anal Cancer – For patients with early-stage squamous cell carcinoma of the anal canal or perianal skin, researchers in ECOG-ACRIN's Gastrointestinal Cancer Committee and Radiation Oncology Committee have developed the first guidelines to customize radiation therapy (RT). They aim to reduce harmful side effects by providing anatomic, clinical, and technical instructions to guide the delivery of RT that targets tumors but spares healthy tissue. Previous guidelines delineated target volumes similarly, regardless of disease stage. The new guidelines were developed for the EA2182 / DECREASE trial (currently enrolling patients) but are now available for routine clinical use. Damico N. Pract Radiat Oncol. July 2022

Breast Cancer – The ACRIN 6657 component of the I-SPY trial proved the value of magnetic resonance imaging (MRI) to predict response to neoadjuvant chemotherapy treatment in women with locally advanced (stage 3) breast cancer (Hilton NM. Radiology. June 2012). The I-SPY1 Trial data is publicly available to researchers via The Cancer Imaging Archive. However, it is not yet accessible to evaluate recently discovered radiomic biomarkers that can potentially expand MRI capability to characterize the molecular features of breast cancer in individual patients. (Broadly defined, radiomics is the extraction of high-throughput visual and sub-visual cues derived from medical imaging.) Imaging researchers from ECOG-ACRIN are co-authors of a proposal to expand the I-SPY1 Trial data collection by adding uniformly curated data, tumor annotations, and quantitative imaging features for the ACRIN 6657 component, making it accessible for radiomics research. A particular interest is in the use of MRI to study the biology of breast cancer and its progression mechanisms. Chitalia R. Sci Dat. July 2022

Breast Cancer – Long-term cancer survivors have identified help managing fear of recurrence (FoR) as their most pressing unmet need. FoR is linked to poor health-related quality of life, anxiety, depression, symptom burden, and maladaptive health behaviors that increase the risk for poorer clinical outcomes. FoR may be exacerbated by avoidance coping, in which individuals make cognitive and behavioral efforts to minimize or avoid dealing with stressors. Researchers in ECOG-ACRIN's Cancer Control and Outcomes Program are putting a spotlight on the topic of avoidance coping due to its role in perpetuating FoR. They report that telecoaching is a promising eHealth modality for supporting survivors with therapeutic interventions to help address avoidance coping. Hall DL. J Behav Med. August 2022

Leukemia – The FDA approves using ibrutinib and rituximab (IR) in combination for the frontline treatment of patients age 70 and younger with chronic lymphocytic leukemia (CLL). This approval is based on the practice-changing randomized phase 3 trial E1912. Not only did E1912 find that IR provides better leukemia control, but it also prolongs life and has fewer side effects than previous standard chemo-immunotherapy, fludarabine, cyclophosphamide, and rituximab (FCR) (Shanafelt TD. N Engl J Med. 2019). As a result, E1912 eliminated the need for chemotherapy in these patients. Now, long-term outcomes are available. After a median follow-up of 6 years, IR led to superior progression-free survival (PFS) compared to FCR and excellent overall survival. In addition, most CLL patients tolerate continuous ibrutinib therapy beyond 5 years. Shanafelt TD. Blood. July 2022

Melanoma Skin Cancer – After years of research, many exciting and effective new combination treatments exist for patients with advanced melanoma. As a result, patients and their physicians often find themselves with multiple treatment options but few answers to questions surrounding how and when to use these new approaches. In addition, melanoma can be highly aggressive, and existing treatments often stop working. Final results are now available for the randomized phase 3 trial DREAMseq (EA6134) for melanoma patients with a BRAF V600 tumor gene mutation. DREAMseq showed that starting treatment with immunotherapy (nivolumab and ipilimumab), followed by targeted therapy (dabrafenib and trametinib) if there is disease progression, is the preferred treatment approach. "I think the standard of care should immediately change because these are FDA-approved regimens," said lead researcher Michael B. Atkins, MD (Georgetown University Lombardy Comprehensive Cancer Center). Atkins MD. J Clin Oncol. September 2022

Prostate Cancer – Androgen deprivation therapy (ADT) on its own is no longer the standard of care for men with a new diagnosis of metastatic hormone-sensitive prostate cancer. Alicia K. Morgans, MD, MPH (Dana-Farber Cancer Institute) and co-authors write about the CHAARTED (E3805) trial, which found in 2014 that adding early chemotherapy to ADT improved survival. Since then, several phase 3 studies also clearly demonstrated that combination treatments lead to superior disease control and improved quality of life compared to ADT alone. Morgans AK. J Clin Oncol. March 2022

Symptom Management – The current approaches to assessing patients for their ability to tolerate cancer treatment only capture a part of the total picture. They also miss opportunities to focus on the patient, according to ECOG-ACRIN Cancer Research Advocates Committee Chair Mary Lou Smith, JD, MBA (Research Advocacy Network), and ECOG-ACRIN PRO Working Group Chair John Devin Peipert, PhD (Northwestern University), on behalf of the EVOLV study team. This team recommends that physicians assess treatment tolerability in a new way. "In addition to patient experience, we suggest assessment of patients' disposition toward staying on treatment," say the authors. "To do so, we must tap the patient's preferences and attitudes about treatment, including willingness to stay on treatment while enduring side effects. This captures the essence of tolerability, at least as viewed from the patient perspective." Peipert JD. Support Care Cancer. January 2022 (updated July 2022)


Leave a Reply

Your email address will not be published. Required fields are marked *