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News in Brief, February 2025
February 19, 2025
The Value of Patient-Reported Outcomes in Enhancing the Relevance of Clinical Trials
February 19, 2025Top Trial Results of 2024: A Year of Significant Advancements in Cancer Treatment
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Below, we feature seven studies with key findings reported during 2024 by researchers with ECOG-ACRIN Cancer Research Group and PrECOG. These discoveries generated great interest throughout research and patient communities for having significant and immediate clinical impacts on cancer treatment and care.
Brain Cancer – A striking survival improvement for adults with slow-growing brain tumors
- Common treatments for adults with grade 2 glioma include radiation and temozolomide, a type of chemotherapy in pill form. The randomized phase 3 trial E3F05, which followed patients for more than 10 years, found that combining temozolomide with radiation therapy resulted in a 10-year survival rate of 70%, compared to only 47% for radiation alone. It is the first evidence from a randomized phase 3 trial showing that temozolomide chemotherapy enhances long-term survival for these patients. Temozolomide is a less toxic chemotherapy pill, making it easier for patients to tolerate and more manageable for oncologists to administer than other chemotherapies used for these patients. Read the press release.
Breast Cancer – First large trial to show that CDK4/6 inhibitors may slow progression of HR+, HER2+ metastatic disease and improve clinical outcomes
- About 10% of breast cancers are hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+), often referred to as double-positive breast cancer. These patients need better treatment options due to the development of resistance to current therapies. The randomized phase 3 PATINA trial assessed palbociclib, a targeted drug therapy already approved by the FDA to treat HR+, HER2+ metastatic breast cancer. Results show that adding palbociclib to standard anti-HER2 and endocrine treatment led to an increased progression-free survival—44.3 months for those receiving the drug compared to 29.1 months for those who did not. Read the press release.
DCIS Breast Cancer – Tamoxifen significantly reduces recurrence risk for 'good-risk' patients
- For patients with ductal carcinoma in situ (DCIS), the risk of recurrence is a key consideration when choosing therapy options after breast-conserving surgery. Current guidelines recommend considering tamoxifen post-surgery, regardless of radiation therapy. However, a patient's individualized risk of recurrence and other factors can influence which therapy options they prefer to pursue. This study compared outcomes in higher-risk and 'good-risk' DCIS patients—defined as grade 1 or 2, 2.5 cm or smaller, and having clear surgical margins of 3 mm or greater. It found that tamoxifen significantly reduced the risk of recurrence in the same breast. The estimated 15-year recurrence risk was 11.4% for those on tamoxifen compared to 19% for those who were not. This finding is from an analysis of combined data from two trials: ECOG-ACRIN E5194 and NRG/RTOG 9804. Read the press release.
Geriatric Oncology – The ground-breaking GIANT trial is offering new approaches
- The GIANT trial (EA2186) is ECOG-ACRIN's first trial exclusively for older patients. Broadly speaking, GIANT is leading the way in geriatric oncology, providing a trial framework to guide and stimulate researchers to design more clinical trials specifically for older patients—who have historically been underrepresented. GIANT is also ground-breaking for another reason: Researchers developed a new clinical tool to better assess geriatric patients, and this resource is now available for other elderly-specific clinical trials regardless of cancer type. In terms of specific trial results, GIANT is the first study aimed at defining the optimal treatment approach for older patients with newly diagnosed metastatic pancreas cancer. Before this trial, evidence-based data was lacking to guide the care of these patients, resulting in extrapolation of the treatment approach utilizing data from younger patients. Preliminary results showed no difference in the effectiveness of one treatment approach compared with the other; therefore, the trial was stopped early. Since the side effects were also similar in both groups, GIANT reinforced that both treatment regimens may be used for this patient population. Watch Dr. Dotan discuss the study.
Leukemia – Phase 3 trial leads to FDA approval of a new treatment for patients with B-ALL
- In June 2024, the FDA approved BLINCYTO® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. The approval was based primarily on the phase 3 E1910 trial. The final statistical analysis of overall and relapse-free survival was published in the New England Journal of Medicine in July 2024. Read the press release.
Nose and Sinus Cancer – First evidence that chemotherapy helps spare patients from debilitating eye and bone removal
- Striking results have emerged from the only prospective multi-center randomized trial to examine the effects of chemotherapy before surgery to shrink tumors and reduce the amount of normal tissue that surgeons need to remove. Surgery is required for patients diagnosed with advanced squamous cell-type cancer of the nose or sinus—but at a high physical cost. Patients enrolled in the EA3163 trial had signs that surgery would result in loss of the eye, the base of the skull bone, or both. The trial demonstrated that patients who received chemotherapy before surgery had a 50% chance of structure preservation. In contrast, patients having surgery, the usual treatment, had only a 15% chance of preserving both the eye and the base of the skull bone. Read the press release.
Mantle Cell Lymphoma – First evidence that some patients may be able to rely on highly effective standard treatments and avoid the rigors of a stem cell transplant
- Mantle cell lymphoma (MCL) is an incurable blood cancer more common in older men. Advances in therapies have improved patient outcomes, with remissions lasting 8-10 years or longer. Treatment options include intensive chemotherapy, immunotherapy, targeted drugs, and BTK inhibitors. Rituximab, a targeted immunotherapy drug, is one option. Patients under age 70 may also receive an autologous stem cell transplant (ASCT) if they are physically fit enough to withstand the difficult procedure, which involves high-dose chemotherapy followed by re-infusion of the patient's own blood stem cells. However, the benefits of ASCT are heavily debated due to outdated trial data. Study EA4151 is the first randomized trial to assess ASCT for MCL patients in the current era of highly effective treatments. It was stopped early, after an interim analysis found that ASCT did not improve survival for MCL patients in the first complete remission with no detectable minimal residual disease (MRD). Read the press release.
Notable Accolade in Melanoma
- In January 2024, a team of ECOG-ACRIN melanoma researchers was honored with the 2023 Paper of the Year distinction by the Journal of Clinical Oncology. This recognition signified that the paper had the greatest impact and reach among all the journal's papers in 2023. The DREAMseq (EA6134) randomized phase 3 clinical trial showed an optimal treatment sequence for combination therapy in patients with advanced melanoma with a BRAF V600 tumor gene mutation. The sequence beginning with immunotherapy, followed by targeted therapy if there was disease progression, resulted in a 20% absolute improvement in 2-year overall survival compared with the reverse sequence. Read the press release.