E-News - February 2026
Spotlight on Clinical Trial Results


Advancing Cancer Treatment: Recent Publications from Alliance

Recent publications from Alliance investigators are delivering practice-changing insights that directly improve patient care. Featured in leading journals—including the New England Journal of Medicine, Journal of Clinical Oncology, and JAMA Oncology—these studies are shaping treatment strategies for prostate cancer, meningioma, lung cancer, and colon cancer.

Below is a selection of these recent publications.

Journal of Clinical Oncology: Alliance A222001: Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Patients Receiving Androgen-Deprivation Therapy for Prostate Cancer
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Overview: Results of Alliance A222001 have found that oxybutynin, a drug used to treat overactive bladder symptoms, reduces hot flashes compared to the placebo in men receiving hormone therapy for prostate cancer.

“Oxybutynin demonstrated clear and clinically meaningful improvements in both hot flash frequency and quality of life for men undergoing hormone therapy for prostate cancer,” said Bradley J. Stish, MD, the study’s lead investigator from the Mayo Clinic.

The phase II randomized, double‑blind, placebo‑controlled trial evaluated whether two doses of oxybutynin (2.5 mg twice daily and 5 mg twice daily) could improve hot flash symptoms compared with placebo over six weeks. The study enrolled 88 men from 15 academic and community cancer centers; 81 participants were eligible for final analysis. The average age of the participants was 68.5.  

In this trial, both doses of oxybutynin substantially improved hot flash symptoms compared to the placebo over the six‑week treatment period. Men receiving placebo experienced an average reduction of 2.15 hot flashes per day and a 4.85‑point drop in daily hot flash severity scores, whereas those taking 2.5 mg of oxybutynin twice daily reported reductions of 4.77 hot flashes per day and a 9.94‑point decrease in severity, and those receiving 5 mg twice daily experienced the largest improvements, with 6.89 fewer hot flashes per day and a 13.95‑point reduction in severity.

Improvements occurred quickly, often during the first week of treatment, and were sustained throughout the study. The proportion of patients achieving at least a 50 percent reduction in hot flash scores was also markedly higher with oxybutynin: 57 percent in the 2.5 mg group and 79 percent in the 5 mg group, compared with 32 percent taking placebo. Treatment was well tolerated overall. Dry mouth was the most common side effect reported.

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Nature Medicine: Abemaciclib in Meningiomas with Somatic NF2 or CDK Pathway Alterations: The Phase II Alliance A071401 Trial
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Overview: The primary analysis of Alliance A071401 published in Nature Medicine found that abemaciclib may slow tumor growth in patients with aggressive meningiomas that have specific genetic mutations.

Meningiomas, tumors that grow in the membranes that surround the brain and spinal cord, are the most common primary brain tumors. While most are benign or treatable, aggressive meningiomas with mutations in genes like NF2 and alterations in the CDK pathway can be fatal.

“Patients with recurrent or progressive high-grade meningiomas have historically had very few treatment options,” said senior author Priscilla Brastianos, MD, with Mass General Brigham Cancer Institute and co-chair of the Alliance Neuro-Oncology Committee.

Alliance A071401 trial followed patients with grade 2 or 3 meningiomas whose tumors carried NF2 mutations or CDK pathway alterations. All patients evaluated had previously received surgery, radiation therapy, or both. Patients received an average number of nine cycles of abemaciclib, a CDK inhibitor that is currently approved for certain breast cancers.

Of the first 24 patients treated with abemaciclib, 58% had high-grade tumors that didn’t progress within the six months after they started therapy. There was no control arm in the study, due to the lack of standard treatment options available for patients with high-grade tumors after surgery and radiation. The results compare favorably to previous studies that found that, on average, 0%-29% of patients with grade 2 or 3 meningiomas had cancer that wasn’t progressing within six months from the time they started their experimental treatment.

The median progression-free survival was 10 months, and the median overall survival was 29 months. Common side effects included diarrhea, fatigue, headache, and nausea/vomiting. About a quarter of patients had a severe side effect (grade 3 or grade 4) that was possibly or likely related to treatment.

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New England Journal of Medicine: AFT-38 (PATINA) - Palbociclib for Hormone-Receptor–Positive, HER2-Positive Advanced Breast Cancer
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Overview: Published in the New England Journal of Medicine, the results of Alliance Foundation Trial PATINA study (AFT-38) marked a major milestone for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer (ABC). The results showed that the addition of the CDK4/6 inhibitor palbociclib to standard first-line maintenance therapy significantly prolongs progression-free survival (PFS) by more than 15 months compared with standard therapy alone.

“The ability to meaningfully extend progression-free survival with a well-tolerated regimen offers new hope for individuals living with this challenging subtype of advanced breast cancer,” said Otto Metzger, MD, Principal Investigator of PATINA with the Dana-Farber Cancer Institute.

The PATINA study evaluated whether adding palbociclib to anti-HER2 therapy and endocrine therapy after four to eight cycles of induction chemotherapy could delay disease progression. The study found that patients receiving palbociclib experienced a meaningful improvement in median PFS, with no new signals.

The trial enrolled 518 patients across 109 clinical sites in the U.S., Europe, New Zealand, and Australia. Participants who had no prior treatment in the advanced setting beyond induction were randomly assigned to receive either palbociclib with anti-HER2 and endocrine therapy (n=261) or anti-HER2 and endocrine therapy alone (n=257). Findings demonstrated an extension of progression-free survival (PFS) of more than 15 months (median PFS increased from 29.1 to 44.3 months) with the addition of palbociclib to anti-HER2 and endocrine therapy in this patient population.

Safety and tolerability findings in the PATINA study were consistent with the known safety profile of palbociclib in HR+, HER2-negative ABC, with no new safety signals identified.

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JAMA Oncology: Predictive Role of Circulating Tumor DNA in Stage III Colon Cancer Treated With Celecoxib: A Post Hoc Analysis of the CALGB (Alliance)/SWOG 80702 Phase 3 Randomized Clinical Trial
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A blood test could help doctors decide which patients with colon cancer should receive anti-inflammatory medication along with chemotherapy after surgery, according to new study in JAMA Oncology based results from on CALGB (Alliance) 80702. 

Researchers have suspected that the anti-inflammatory properties in nonsteroidal anti-inflammatory drugs (NSAIDs) like celecoxib could prevent colon cancer from coming back since inflammation plays a role in cancer growth. However, clinical trials have not shown a clear benefit for all patients, leaving doctors unsure who should take them.

This new analysis offers insight. Researchers looked at circulating tumor DNA (ctDNA), tiny fragments of cancer DNA that can remain in the blood after surgery. Patients who tested positive for ctDNA after surgery were much more likely to have their cancer return. For these high-risk patients, adding celecoxib to chemotherapy significantly improved survival. Patients without ctDNA did not benefit, meaning they could avoid taking extra medication unnecessarily. To measure ctDNA, clinicians take a simple blood test from the patient and use gene sequencing to analyze the sample.

“We’ve known that NSAIDs may help prevent recurrence in some patients with colon cancer, but until now, we didn’t know how to identify them. Measuring circulating tumor DNA levels after surgery using this blood test has the potential to change that,” said lead study author George Q. Zhang, MD, MPH, with Brigham and Women’s Hospital.

“The main goal of CALGB (Alliance) 80702 was to determine if adding celecoxib to chemotherapy after surgery for colon cancer improved survival,” said study chair Jeffrey Meyerhardt, MD, MPH, with the Dana-Farber Cancer Institute. “The initial trial didn’t definitively confirm our hypothesis; however, we saw that some patients did benefit from adding celecoxib and we then sought to identify them. This study identified a subset of patients that had detectable ctDNA after surgery as a group that benefited from adding celecoxib to chemo after surgery.”

CALGB (Alliance) 80702 enrolled more than 2,500 patients with stage III colorectal cancer who had initially had surgery to remove their tumor. This study looked at the ctDNA biospecimens of 940 individuals – 767 of whom were ctDNA negative and 173 that were ctDNA positive. In patients who tested ctDNA positive, the addition of celecoxib compared to placebo nearly doubled disease-free survival over three years, 41% compared to 22.6%. Over five years, the overall survival for patients who were ctDNA positive was 61.6% for those who received celecoxib, compared to 39.9% in those in the placebo group. 

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Clinical and Translational Science: Association of SULT2A1 Locus With Abiraterone Clearance in the Alliance A031201: Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer

Overview: A secondary analysis of Alliance A032201 published in Clinical and Translational Science has uncovered a genetic factor that may inform how to optimize the dosing of abiraterone, a widely used hormone treatment for advanced prostate cancer.

“This study is the first to show how an individual’s genetics can impact how abiraterone is metabolized. These findings could lead to optimized dosing strategies in the future, rather than giving the same dose of the drug to everyone, as we do now,” said author Michael Morris, MD, the Steven A. Greenberg Chair in Prostate Cancer Research at Memorial Sloan Kettering Cancer Center in New York.

A phase III trial, Alliance A031201 enrolled 1,311 men with metastatic castration-resistant prostate cancer and randomized them to enzalutamide, another hormonal therapy, either alone or with abiraterone.

As part of this study, researchers collected genetic data and measured drug levels in the blood to see if certain genes influence how these medications are metabolized. That genomic data was analyzed for this current research.

“We discovered that men who carry a specific version of the gene SULT2A1 clear abiraterone from their bodies more slowly,” said lead author Nadine Norton, PhD, Associate Professor of Cancer Biology for the Mayo Clinic in Jacksonville, FL. “This means the drug stays in the system longer, which could affect how well it works and whether side effects occur.”

The study did not find any similar genetic effect for enzalutamide, suggesting that this discovery is unique to abiraterone. This finding opens the door to more personalized care. In the future, doctors may be able to test for this gene variant (found in about 15% of people of European descent) and adjust abiraterone doses to make treatment safer and more effective.

 

 

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