SWOG Studies Highlight Biostatistical Expertise in Bladder Cancer and Hodgkin Lymphoma
Key Insights
A phase 3 study revealed that extended lymphadenectomy does not improve survival in muscle-invasive bladder cancer (search) patients, challenging current high-volume institutional practices.
Nivolumab plus AVD chemotherapy showed promising results for stage 3 or 4 classic Hodgkin lymphoma (search), potentially becoming a primary treatment option for adolescents and adults.
The SWOG Statistics and Data Management Center (SDMC) at Fred Hutch plays a crucial role in designing and executing impactful cancer research studies.
Two recent studies published in the New England Journal of Medicine highlight the critical role of biostatistics in cancer research, with significant contributions from the SWOG Statistics and Data Management Center (SDMC) at Fred Hutchinson Cancer Center. These studies address surgical approaches for bladder cancer (search) and novel treatment combinations for Hodgkin lymphoma (search), potentially reshaping clinical practices.
Challenging Surgical Standards in Bladder Cancer
A phase 3 study, with Catherine M. Tangen, DrPH, as the lead biostatistician, compared standard versus extended lymphadenectomy in nearly 600 patients with localized muscle-invasive bladder cancer (search). The study aimed to determine if a more aggressive surgical approach of removing more lymph nodes improved disease-free and overall survival. Contrary to common practice in many high-volume centers, the research found that extended lymphadenectomy did not provide a survival benefit and was associated with higher rates of perioperative morbidity and mortality.
"The most important part of the biostatistician’s role is to be involved at the early stages of designing a study in order to get convincing results at the end," said Tangen. The study design involved defining the research question, determining sample size, and designing tools for data collection.
Promising Results for Hodgkin Lymphoma Treatment
Another significant study, with Michael LeBlanc, PhD, as the lead biostatistician, investigated the efficacy of nivolumab plus AVD chemotherapy (N+AVD) compared to brentuximab vedotin plus AVD in adolescents and adults with newly diagnosed stage 3 or 4 classic Hodgkin lymphoma (search). The trial enrolled 970 patients across 256 sites in the U.S. and Canada.
The results indicated that patients receiving N+AVD had a significantly lower risk of disease progression or death and experienced better treatment tolerance. "This study is unusual because there aren’t many phase 3 studies in which we have a significant cohort of kids along with adults — multiple ages being treated essentially the same way," said LeBlanc. The findings suggest that N+AVD could become a primary treatment option for this patient population, and Bristol-Myers Squibb (search) intends to seek FDA approval for this indication.
The Role of SWOG SDMC
The SWOG SDMC, co-located at Fred Hutch and Cancer Research and Biostatistics (CRAB), plays a vital role in these studies. Their contributions span study design, data management, quality assurance, and statistical analysis. With a team of over 100 staff members, the SDMC supports approximately 100 active SWOG studies at any given time.
"The SDMC has stayed here for four decades in part because Fred Hutch is Fred Hutch: it’s historically strong in both biostatistics and cancer prevention, both interests of SWOG. That’s part of the long-term success," said LeBlanc.
The success of these studies underscores the importance of rigorous biostatistical input and data management in generating reliable evidence to inform and improve cancer care.