More Results: SWOG Trials That Keep on Giving

S1216
SWOG’s S1216 phase 3 trial compared androgen deprivation therapy (ADT) plus orteronel to ADT plus bicalutamide, in patients with metastatic hormone-sensitive prostate cancer. The study missed its primary target of a 33 percent improvement in overall survival (OS), but it has generated a growing catalogue of important results from secondary and exploratory analyses that are helping shape the design of the next generation of clinical trials in this space.

These have included the following findings:

• baseline circulating tumor cell counts in S1216 patients were highly prognostic of progression-free survival (PFS) and OS (at ASCO 2023)
• equitable access to care, often a benefit of participating in a clinical trial, may reduce historical racial differences in PFS and OS outcomes (at ASCO 2023)
• in patients with metastatic hormone-sensitive prostate cancer, prostate-specific antigen (PSA) levels at 3 months and 7 months after starting treatment are prognostic for OS (in European Urology Oncology)
• in patients newly diagnosed with metastatic prostate cancer, elevated levels of selected biomarkers of bone turnover are associated with shorter lifespans (in European Urology)

This year’s American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) featured yet another in this growing set of secondary findings from the S1216 study: “Bone pain as a prognostic marker for survival for men with metastatic hormone-sensitive prostate cancer (mHSPC): Patient level analysis of SWOG 1216 trial.”

Presenting these results at 2024 ASCO GU, Dr. Georges Gebrael reported that in men with metastatic hormone-sensitive prostate cancer, baseline bone pain was significantly associated with lower PFS and OS, even after adjustment for other prognostic variables such as treatment, disease burden, Gleason score, and age. Patients without bone pain, Gebrael’s team found, had significantly longer median PFS (3.7 years versus 1.3 years) and OS.

The authors suggest that patients with bone pain at baseline in this disease may warrant prioritization for clinical trial enrollment, and that bone pain might be included as a factor in future prognostic models of metastatic hormone-sensitive prostate cancer.
 

S1609 DART
In the category of “trials that keep on giving,” it’s hard to out-do SWOG’s S1609 DART study. This basket trial tested the combination of nivolumab plus ipilimumab against a broad range of rare cancers – enrolling roughly 800 patients to some 53 separate cohorts, each representing a distinct rare tumor type. Several times a year, the DART team (led by Drs. Razelle Kurzrock, Sandip Patel, and Young Kwang Chae), reports results from yet another of these cohorts. Previously, DART researchers have detailed positive results in the following rare cancers:

• metaplastic breast cancer
• neuroendocrine tumors
• angiosarcoma
• thyroid carcinomas
• gynecologic cancers

DART’s most recent set of significant results was delivered at the 2024 American Association of Cancer Research annual meeting (AACR 2024): “A phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: sarcomatoid carcinoma of lung (cohort 11).”

DART enrolled 14 evaluable patients with sarcomatoid carcinoma lung tumors. In four of these 14 patients (28.6 percent), the disease showed an objective response to the dual immunotherapy treatment – one complete response (lasting at least 32 months) and three partial responses. Of the three patients with a partial response, one showed 100 percent regression, one 92 percent regression, and one 52 percent regression. Among the 14 patients in Cohort 11, the overall clinical benefit rate (the percentage of patients who had gone at least six months without disease progression) was 50 percent.

As Dr. Kurzrock, abstract co-author and chair of SWOG’s early therapeutics and rare cancer committee stated, these DART findings represent “a potential breakthrough for patients with this rare cancer.”

With every publication or presentation from DART or S1216 – or any of our other trials – we advance our mission of significantly improving lives through cancer clinical trials and translational research. And, stay tuned for info on trials we will present at ASCO. You may see those again as well.

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Trial of the Week

S2108CD: A Cluster Randomized Trial Comparing an Educationally Enhanced Genomic Tumor Board (EGTB) Intervention to Usual Practice to Increase Evidence-Based Genome-Informed Therapy

S2108CD is a unique cancer care delivery study that asks whether providing physicians guidance from a genomic tumor board of experts, augmented with targeted educational materials, can lead to more patients with cancer receiving evidence-based genome-informed treatment.

It uses a cluster-randomized design, with the study intervention administered at the recruitment center level rather than the physician or patient level. Eighteen NCORP recruitment centers, together comprising more than 80 individual sites, are participating – nine incorporating the genomic tumor board intervention, nine continuing their standard practice.

Patients with a wide range of advanced or recurrent solid tumors may be enrolled to the study (and they may be co-enrolled on other trials).

Secondary objectives of S2108CD include measuring the relative impact of such an intervention on physicians’ confidence in using genomic tumor testing results with their patients. The study team will also assess how sites implement such testing and how their use of it evolves over the course of the study.

Led by Drs. Jens Rueter, of The Jackson Laboratory, and Meghna S. Trivedi, of Columbia University, S2108CD was opened in summer of 2022 and is now about 80 percent of the way to its ultimate accrual target of 1,182 enrolled patients. The Essentia Health Cancer Center and the Carle Cancer Center are the top accruing institutions on the trial.

Learn more on the SWOG S2108CD page or the CTSU S2108CD page. I also recommend checking out my Front Line introduction to the study, posted soon after activation.

And when you next present the study to a patient, remember to use S2108CD’s patient-friendly summary to help tell the story (also available en español).