SWOG Research Demonstrates the Special Role of Federal Sponsorship

Our 2022 publication (Unger, et al, JCO 2022) on the population, clinical, and scientific impact of four decades of cooperative group treatment trials found they had saved 14.2 million life-years (estimated to climb to 19 million by 2025) at a total federal investment of just $326 per life-year saved (I just love citing this).

A significant addition to this body of work on the benefits of public funding is an oral abstract Joseph M. Unger, PhD and colleagues presented at the ASCO Quality Care Symposium (and an ASCO press briefing) earlier this month in Chicago.

“The Special Role of Federal Sponsorship in the Design and Conduct of Drug or Biological Agent Cancer Treatment Clinical Trials” (oral abstract 94) analyzed 16 years of registry data from ClinicalTrials.gov, looking at more than 10,000 industry funded or federally sponsored U.S.-based trials that featured a drug or biological agent for cancer treatment.

As you might expect, the federally sponsored trials were much more likely than the industry trials to combine a drug or other agent with one or more other therapy modalities, such as surgery, radiation, or transplant.

In fact, although roughly 83 percent of the trials examined were industry funded (8,431 of 10,142 trials), among trials that included radiation, surgery, or both, more than one half were federally sponsored.

Rare cancers were more than 50 percent more likely to be studied in federal trials than in industry studies, pediatric cancers were more than three times as likely, and drug de-escalation trials (think RxPONDER) were more than eight times as likely to be federally sponsored. 

Dr. Unger’s Chicago presentation highlighted the complementary missions of these sponsors, with industry trials focused on testing new, single-agent treatments and federal studies extending treatment discovery to more complex, multi-modal regimens and meeting the needs of less commercially viable patient populations such as children and those with rare cancers.

Quantifying the role of federal sponsorship in this way provides essential information for policymakers in an era in which government support for biomedical research is increasingly called into question (the work of Dr. Unger and his team was itself funded in significant part by The Hope Foundation for Cancer Research).

I want to highlight a few other SWOG abstracts presented recently that demonstrate this essential function of federal sponsorship in our cancer research ecosystem.

• Our S1417CD trial reported in 2022 that roughly three-fourths of a group of 380 patients being treated for advanced colorectal cancer had faced major financial hardship within 12 months of their diagnosis, even though almost all of them (98 percent) had health insurance. 
  
  A secondary analysis from that trial, presented at last week’s ASCO Quality Care Symposium, found that more than one-half of the caregivers of those S1417CD patients themselves faced significant detrimental effects on their finances (such as needing to take out loans or declare bankruptcy) and/or on their work life (such as having to cut hours or take leave) during that 12-month period. Perhaps not surprisingly, caregivers with children still at home and those with lower income were particularly hard hit.
  
  Hannah R. Abrams, MD, presented the results (“Finance and Work Changes among Caregivers of Patients with Metastatic Colorectal Cancer (mCRC): Secondary Analysis of SWOG S1417CD” – abstract 297).

• At the American Society for Radiation Oncology (ASTRO) Annual Meeting late last month in San Francisco, Reshma Jagsi, MD, PhD, presented results from the SWOG S1706 trial. That study in patients with inflammatory breast cancer added olaparib to standard radiotherapy for purposes of radiosensitization.
  
  Looking at treatment-related adverse events among these patients in her ASTRO presentation, Dr. Jagsi reported a clinically relevant increase in toxicity when olaparib was given concurrently with radiotherapy, even with low doses of the drug (“Acute Toxicity in SWOG 1706, a Randomized Trial Comparing Radiotherapy for Inflammatory Breast Cancer with and without Concurrent Olaparib” – oral abstract 68808).

• And just this week, the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin heard long-term follow-up data from the S1801 trial, which compared adjuvant-only immunotherapy (IO) to IO begun before surgery (neoadjuvant + adjuvant) in patients with high-risk melanoma. 
  
  Back at the 2022 ESMO Congress, Sapna P. Patel, MD, chair of SWOG’s melanoma committee, had made a splash reporting primary S1801 findings showing that starting IO before surgery resulted in longer event-free survival.
  
  This week’s presentation reported that, after a median follow-up of 3.7 years, the neoadjuvant-plus-adjuvant regimen maintained an EFS benefit over adjuvant-only IO. Data on overall survival (OS) are still maturing, but they show a trend toward an OS benefit as well from starting IO before versus after surgery. Vernon K. Sondak, MD, past SWOG melanoma chair, presented the results (“3-Year Survival with Neoadjuvant-Adjuvant Pembrolizumab from SWOG S1801” – proffered paper 1601O).

There we are: important results in cancer care delivery research, in assessment of a multimodal treatment regimen, and in identifying the most efficacious timing for treatment – all great examples of the types of oncology research Dr. Unger and his colleagues just highlighted in Chicago. Yet more evidence of the special – and likely irreplaceable – role of federal sponsorship in the design and conduct of cancer clinical trials. 

I remain extraordinarily proud to lead a group dedicated to public-powered oncology research.