Researchers with the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) presented a wide range of study results at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and online June 3-7. Read the summaries below and click on the abstract number to review the data.

Highlights

• Pancreatic and Neuroendocrine Tumors—Selected for Best of ASCO®—The E2211 randomized phase II study in patients with advanced progressive pancreatic neuroendocrine tumors met its primary endpoint of progression-free survival (PFS). The group of patients who received the oral chemotherapy temozolomide and capecitabine had a significantly longer median PFS (22.7 months) than those who received only temozolomide (14.4 months). Pamela L. Kunz, MD (Yale School of Medicine), presented the final efficacy analysis and new data showing that a deficiency of the DNA repair enzyme methylguanine methyltransferase (MGMT) was significantly associated with greater odds of objective response. Oral Abstract 4004
• Melanoma—Until recently, little prospective data existed to guide the choice of initial therapy or sequence in patients with BRAF V600 mutant metastatic melanoma. The randomized phase III trial DREAMseq (EA6134) showed that starting treatment with immunotherapy (nivolumab and ipilimumab), followed by targeted therapy (dabrafenib and trametinib) if there was disease progression, led to a clinically meaningful 20% improvement in estimated 2-year overall survival from the start of treatment when compared to the opposite treatment sequence (72% vs. 52%, respectively). The results were considered practice-changing upon their original presentation at the Inaugural ASCO Plenary Series (November 2021). Michael B. Atkins, MD (Georgetown-Lombardy Comprehensive Cancer Center), presented an update. Abstract 356154 | ASCO Plenary Series: Rapid Abstract Updates
• Melanoma—This quality of life (QOL) and symptom analysis relates to the DREAMseq (EA6134) trial (see above). Half of the trial participants started treatment with immunotherapy (nivolumab and ipilimumab), and the other half began with targeted therapy (dabrafenib and trametinib). Patients completed the PROMIS^® Profile 29 questionnaire at baseline, week 12, and week 24, reporting symptoms that include: sleep disturbance, pain interference, and physical function. Researchers also collected patient-reported adverse events. Roxanne Jensen, PhD (National Cancer Institute), presented QOL trends within and between the initial therapies through 24 weeks. Abstract 9559 | Poster 152
• Prostate Cancer—With a median follow-up of nearly eight years, the CHAARTED (E3805) randomized phase III trial continues to demonstrate that androgen deprivation therapy (ADT) plus docetaxel chemotherapy significantly improves overall survival (OS) in men with metastatic hormone-sensitive prostate cancer, compared to ADT alone. Primary results were reported previously (Sweeney CJ. N Eng J Med. 2015). Abhishek Tripathi, MD (University of Oklahoma Health Sciences Center), presented the long-term survival data. Median overall survival was 60.4 months with ADT plus docetaxel vs. 47.2 months with ADT alone. The main finding related to patient care is the benefit of early docetaxel was most pronounced and maintained in patients with high volume disease. Abstract 5081 | Poster 264 
• Head and Neck Cancer—This analysis shows patient outcomes by tobacco history from participants in the completed E3311 trial. Participants with intermediate-risk disease who were current smokers or had a history of >10 pack-years had favorable 3-year progression-free survival and overall rates that were not significantly worse than those with <10 pack-years histories. Ranee Mehra, MD (University of Maryland), presented the data, which show that outcomes did not appear to be influenced by smoking status. Abstract 6077 | Poster 69
• Health Equity—State-mandated Medicaid coverage of the routine costs of trial participation was associated with a short-term increase in the proportion of Black trial participants in study EAY20YD1. These preliminary findings suggest that Medicaid policies have the potential to improve the representation of racial minority groups in cancer clinical trials and support recent federal legislation mandating state Medicaid programs to cover trial participation. The author is Samuel U Takvorian, MD, MS (Perelman School of Medicine, University of Pennsylvania). Oral Abstract 1501

Other Presentations

• Breast Cancer—For women with hormone receptor-positive (HR+) early breast cancer who are through menopause, 5-10 years of hormonal therapy with an aromatase inhibitor (AI) is standard following initial treatment (surgery, radiation if recommended, and chemotherapy). However, AIs carry high premature discontinuation rates due to the development of painful musculoskeletal symptoms (MSS), e.g. severe joint pain. An innovative new finding from the E1Z11 trial, the first racially diverse study of MSS in this population (Stearns V. ASCO 2021), shows that patient reports of moderate to high treatment bother PRIOR to beginning anastrozole were associated with a higher risk of stopping anastrozole early, except in Asian patients. The author is Fengmin Zhao, PhD (Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston). Abstract 12094 | Poster 340
• Care Delivery—The reproductive health needs of pre-menopausal women with a new cancer diagnosis have been poorly addressed. The EROS (E1Q11) trial shows the effectiveness of a reproductive health program to help align women’s reproductive goals and needs with cancer treatment. The trial included a racially diverse group of 434 women aged 15-55 treated at community practices in the NCI Community Oncology Research Program (NCORP). A total of 17 sites were randomized to deliver the intervention vs. usual care. The trial found that women treated at the eight sites that implemented the reproductive health care algorithm were twice as likely to receive reproductive health care than women treated at nine other community practices that delivered usual care. Younger age (</=35) and good physical health (ECOG Performance Status 0) were statistically associated with higher odds of receiving reproductive health management. Author Ashlesha Patel, MD, MPH (Cook County Health), reported that the EROS findings support the broad implementation of this intervention to optimize cancer survivorship. Abstract 1519 | Poster 113 | Discussion Session
• Care Delivery—The cancer care delivery study EAQ162CD shows an assessment of the financial burden that patients with newly diagnosed colorectal cancer carried due to treatment costs. Patients at NCI Community Oncology Research Program (NCORP) practices were surveyed using the FACIT-COST (Comprehensive Score for Financial Toxicity) survey at baseline, 3, 6, and 12 months. Author Sheetal Mehta Kircher, MD (Northwestern Medicine),  reported that increasing age, income, self-efficacy, and neighborhood socioeconomic status predicted a higher COST score, indicating greater financial well-being. Chemotherapy receipt, insurance type, and treatment at a safety-net hospital did not predict COST score. Abstract 6597 | Poster 378 | Discussion Session
• Head and Neck Cancer—Researchers propose a new model for determining overall survival prognosis in patients receiving first-line chemotherapy treatment for recurrent or metastatic squamous cell carcinoma of the head and neck. The new model uses four independent factors: ECOG Performance Status (1 vs. 0), prior radiation, primary region (non-oropharynx vs. oropharynx), and the presence of bone or liver metastasis. Athanassios Argiris, MD (Thomas Jefferson University), and colleagues examined a large patient dataset from the completed phase III trial E1305, whereas the previous model was based on data from older trials. Abstract 6026 | Poster 18
• Health Equity—Tobacco use is a modifiable risk factor for adverse outcomes among patients diagnosed with cancer. Yet, we know very little about socioeconomic contexts that influence access and utilization of tobacco cessation counseling. Using surveys completed by cancer patients enrolled in 10 ECOG-ACRIN clinical trials, study EAQ16T shows relationships between neighborhood socioeconomic disadvantage and tobacco assessment and cessation assistance. The author is Angela Wangari Walter, PhD, MPH, MSW (University of Massachusetts Lowell). Abstract 6514 | Poster 297 | Discussion Session
• NCI-MATCH—Mismatch repair (MMR)-deficient cancers have impaired DNA damage repair. Arm Z1D of the NCI-MATCH precision medicine cancer trial evaluated the PD-1 inhibitor nivolumab in MMR-deficient tumors across several histologies other than colorectal. Arm Z1D met its primary endpoint with an objective response rate of 36%. The 6-month progression-free survival rate was 51% (Azad NS. J Clin Oncol. 2020). In this correlative study, Jonathan D. Schoenfeld, MD (Dana-Farber Cancer Institute), and colleagues evaluated genomic and tissue predictors of clinical benefit. Abstract 2616 | Poster 271
• NCI-MATCH—Arm T of the NCI-MATCH precision medicine trial evaluated vismodegib in patients with SMO or PTCH1 mutated tumors. Although the primary endpoint was not reached, vismodegib was well-tolerated with mostly grade 1-2 toxicities, and substantial responses were seen in patients with SMOPro641Ala and PTCHGlu947Ter alterations. Anne S. Tsao, MD (The University of Texas MD Anderson Cancer Center), and colleagues report that further study of the impact of concomitant molecular alterations may yield additional insights into vismodegib mechanisms of response. Abstract 3010 | Poster 2 | Discussion Session
• Pancreas or Gastrointestinal Tract Neoplasms—The randomized phase II study EA2142 is one of the first prospective trials conducted for patients with advanced, high-grade (G3) non-small cell gastroenteropancreatic neuroendocrine neoplasms. Temozolomide and capecitabine (CAPTEM) chemotherapy was not superior to standard chemotherapy (platinum and etoposide) as a front-line treatment for these patients—even though CAPTEM demonstrated a more favorable toxicity profile. The author is Jennifer R. Eads, MD (University of Pennsylvania, Abramson Cancer Center). Abstract 4020 | Poster 8 | Discussion Session 

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