Trial Results: ECOG-ACRIN Research Round-Up

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Trial Results: ECOG-ACRIN Research Round-Up

Research definition

Below are summaries of recently published analyses of studies led by the ECOG-ACRIN Cancer Research Group. Click on the shortened citation to access the publication.

Breast Cancer – Breast cancer patients who are Black or of African ancestry have a higher risk of experiencing side effects from chemotherapy, especially peripheral neuropathy. Thus, they have a higher risk of discontinuing treatment, resulting in higher recurrence rates and worse survival rates. Study EAZ171 was a prospective trial that aimed to improve outcomes for these patients. The trial found that Black patients with early-stage breast cancer who received docetaxel chemotherapy every 3 weeks had less drug-induced peripheral neuropathy and fewer dose reductions compared to those who received weekly paclitaxel. This is ECOG-ACRIN's first trial to focus specifically on enrolling Black patients. Schneider BP. J Clin Oncol. June 2024

Colorectal Cancer – E7208 was a randomized phase 2 study of irinotecan and cetuximab with or without ramucirumab in treating patients with KRAS wild-type colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy. Ramucirumab is in a class of medications called monoclonal antibodies. It is a type of targeted therapy drug known as an angiogenesis inhibitor. Trial E7208 demonstrated that the addition of ramucirumab to irinotecan and cetuximab is feasible and effective. The finding paves the way for further evaluation of the combination in phase 3 trials. Hochster HS. J Natl Cancer Inst. May 2024

Kidney Cancer—PROSPER RCC (EA8143) is ECOG-ACRIN's first randomized phase 3 trial of neoadjuvant immunotherapy in patients with kidney cancer. The study found that priming the immune system with nivolumab before surgery and then continuing nivolumab did not improve recurrence-free survival in patients with high-risk renal cell carcinoma. PROSPER RCC is a unique study that will help inform future research through ongoing radiomic, pathomic, and other biomarker analyses. Allaf ME. Lancet Oncol. June 2024 (subscription required)

Leukemia – Previous studies have shown that adults with acute myeloid leukemia (AML) who remain in long-term remission after a stem cell transplant have a shorter life expectancy than the general population. However, we know very little about the survival of those treated with chemotherapy alone without a transplant. Here, ECOG-ACRIN researchers indicate the life expectancy of adults with AML who did not undergo a transplant by compiling data from patients enrolled across nine consecutive phases 2 or 3 ECOG-ACRIN-led trials. They state that, taken together, these data strongly suggest that prior chemotherapy for the underlying AML is a major contributing factor for the known shortened life expectancy post-transplant. Ganzel C. Bone Marrow Transplant. May 2024

Leukemia – Researchers in the ECOG-ACRIN Leukemia Committee collaborated with pediatric oncology researchers to investigate inherited noncoding genetic variation impacting the pharmacogenomics of childhood acute lymphoblastic leukemia (ALL) treatment. The goal was to define genetic factors impacting chemotherapy failure to help to better predict response and identify drug resistance mechanisms. Such information has the potential to improve outcomes for patients with relapsed or refractory AML. Bhattarai KR. Nature Communications. May 2024

Lymphoma – While initial therapy for mantle cell lymphoma (MCL) is not standardized, bendamustine-rituximab (BR) is commonly used in older patients. Rituximab (R) maintenance following induction is often utilized. E1411 was a randomized phase 2 trial in patients aged 60 and above with previously untreated MCL. It tested two questions: 1) Does the addition of bortezomib to BR induction (BVR) and/or 2) the addition of lenalidomide to rituximab (LR) maintenance improve progression-free survival (PFS) in patients with treatment-naïve MCL? The trial found that adding bortezomib to BR induction did not prolong PFS, and LR maintenance was not associated with longer PFS. The authors conclude that the > 5-year median PFS outcomes in this prospective trial indicate the efficacy of BR followed by rituximab maintenance as a highly effective initial therapy for older MCL patients. Smith MR. Blood. May 2024 (subscription required)

Prostate Cancer – The randomized phase 3 CHAARTED trial (E3805) demonstrated that androgen deprivation therapy (ADT) plus docetaxel chemotherapy significantly improves overall survival in men with metastatic hormone-sensitive prostate cancer, compared to ADT alone. Primary results were reported previously (Sweeney CJ. N Eng J Med. 2015). Here, researchers evaluated trial participants' patient-reported quality of life (QOL) and survival outcomes. They found that patients with the poorest QOL at baseline and 3 months had longer survival if they received ADT plus docetaxel rather than ADT alone. In contrast, patients with the best QOL at baseline and 3 months had comparable survival with or without docetaxel being added to ADT. The authors suggest that close tracking of QOL could help patients and clinicians make decisions about the appropriate treatment in this setting. Sentano-Lledo D. Eur Urol Oncol. April 2024

Symptom Management – In this survey study with 1058 participants in the E1A11 trial, with newly diagnosed multiple myeloma, a single question from the Functional Assessment of Cancer Therapy ("I am bothered by side effects of treatment"), asked during treatment, was significantly associated with subsequent discontinuation of treatment due to adverse events. The authors suggest that brief, single-question assessments accurately reflect patients' ability to tolerate treatment and may be an efficient way to asses risk for treatment discontinuation due to adverse event or compare tolerability of different treatments. Peipert JD. JAMA Netw Open. March 2024

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