Stephen B. Williams, MD, chief, division of Urology, associate professor, Robert Earl Cone Endowed Professorship, director, Urologic Oncology, co-director, Department of Surgery Clinical Outcomes Research Program, University of Texas Medical Branch, discusses the rationale for the phase 3 SunRISE-2 trial (NCT04658862) in muscle-invasive bladder cancer (MIBC).

Oftentimes, patients with MIBC have a poor prognosis and are at a high risk of death, Williams explains. The standard-of-care approach for this patient population is neoadjuvant platinum-based chemotherapy, followed by radical cystectomy, which is associated with high treatment burden. However, previous studies have shown that a large portion of patients with MIBC receive no definitive treatment, Williams adds.

The intent of the SunRISE-2 trial was to explore the combination of TAR-200 (GemRIS) plus cetrelimab in patients with MIBC to determine whether it can improve outcomes, Williams adds. TAR-200 is a novel intravesical drug delivery system that enables sustained release of gemcitabine into the bladder and has demonstrated clinical benefit with favorable toxicity in this patient population, according to Williams.

Cetrelimab is an investigational immunoglobulin g4 antibody that targets the PD-1 receptor, blocking signaling for both PD-L1 and PD-L2, Williams says. Moreover, the study will specifically assess this modality of treatment vs concurrent chemoradiotherapy, Williams concludes.

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Stephen B. Williams, MD, discusses the rationale for the phase 3 SunRISE-2 trial in muscle-invasive bladder cancer. 


Dr. Williams on the Rationale for the SunRISE-2 Trial in Muscle-Invasive Bladder Cancer 

From the onset of our medical training, and continuing into residency, we are exposed to academic medicine. Seldom do we have any interaction or experience with private practice. After residency, many of us choose to enter a fellowship program for additional specialized training. Others, including myself, decide to enter private practice. Many fellows are disgruntled, as they believe their colleagues who opted for private practice are making a substantially greater income and “getting on with their lives.”

My path is unique. I decided to pursue private practice upon graduation from residency. However, after a couple of years of practice, I realized that I missed research and teaching and returned to academic medicine by entering a fellowship program. I completed my training in urology in the Harvard Program in Urology at Brigham and Women’s Hospital in Boston, Massachusetts. Additionally, I accumulated over 60 publication credits, which included numerous presentations primarily dedicated to urologic oncology and supported my interest in pursuing fellowship after residency. Many of these presentations were delivered during national and sectional American Urological Association (AUA) annual meetings.

I also interviewed with fellowship programs in urologic oncology, with the intention of accommodating my wife’s desire to move closer to family. However, some programs not located in close proximity to family also interested me. While pondering this dilemma of whether to pursue my academic interests or satisfy family obligations, an opportunity emerged to enter community practice in Southern California. I interviewed with the practice and after considering the balance between work and family interests, I decided to pursue community practice. Community practice offered the clinical appeal of managing my own patients and encountering diverse types of clinical urology cases. During my time in practice, I treated a variety of urologic conditions, from stone management to female urology; however, I enjoyed urologic oncology cases the most. From the initial diagnosis, to treatment, to patient follow-ups, I found great joy in managing prostate, bladder, kidney, and testicular cancers. I also kept track of my patient outcomes and quickly realized there was a void in practice that I wanted to address.

I approached the administration at St. Joseph Hospital to ask if I could become involved with committees and organizations to help improve the quality of care provided to our patients. I found this opportunity satisfying, as it allowed me to embrace not just my own practice, but also practices in other disciplines in and around the community. After working on several fund-raising events, I was elected to the Foundation Board of Directors at St. Joseph, and received the hospital’s support in hosting a Los Angeles-based radio show, “The Men’s Health Hour.” A weekly, hour-long talk show, it featured discussions on relevant men’s health topics ranging from urinary disorders related to benign prostatic hypertrophy to prostate cancer.

Despite the amazing opportunities I was offered and the wonderful relationships I developed while in private practice, I greatly missed the investigative research and teaching components of academic medicine. While clinical practice was intriguing, it often left me wondering what more I could do to improve medicine. One evening, while I was reviewing my billing (which should be the highlight of the day and why we put forth all of our hard work), I remember saying to myself, “I would rather be writing a manuscript or contemplating my next research project.” In that instant, I realized that I did not want to continue my career in private medical practice. Rather, I decided, I wanted to get back into academic medicine. I was torn between continuing at my current practice or pursuing my academic interests. During my time in Boston and thereafter, I had stayed in contact with colleagues who respected my intention to pursue opportunities outside of academia.

These colleagues recognized my work ethic and were aware of my contributions to a variety of publications. Naturally, this made it easy for one of them to call my bluff when a fellowship opportunity at a leading urologic oncology program opened up. After some serious thought and discussion with my family and previous mentors (including the chairman from my residency), I decided to leave community practice and enter fellowship at The University of Texas MD Anderson Cancer Center in Houston.

Fellowship has been a wonderful experience thus far, especially in light of being in practice for some time, as my time in practice allowed me to identify areas that I want to improve clinically. I have engaged in several clinical and molecular epidemiology-related research projects that are satisfying my research appetite, and I’ve since had the opportunity to present at the Society of Urologic Oncology, Genitourinary Cancers-American Society of Clinical Oncology (ASCO), and AUA meetings. I’ve received several awards, including the ASCO Merit Award and the Comparative Effectiveness Research on Cancer in Texas research scholar award.

The second award led to a current research grant that supports my population-based comparative effectiveness research in prostate cancer. I have also extended my prior epidemiology research in prostate cancer into molecular epidemiology in bladder cancer, as MD Anderson has a wealth of resources dedicated to this field of research. Recently, I realized how my prior and current work has contributed to the field of urologic oncology and health policy decision making. I have been invited to speak at the Institute of Medicine in Washington, DC, to discuss my prior comparative effectiveness research in prostate cancer, which specifically evaluated the appropriate utilization of treatments. I see this as one of my greatest accomplishments, and I see it as a tremendous opportunity to support my current research and to help direct health policy decisions in order to optimize cancer care and decrease costs to our healthcare system. As I look back, I’m thankful that I decided to head back into academic medicine, and more importantly, I thank my amazing wife and family for allowing me to pursue my dreams.

There is no magic door to walk through at the end of our training (whether that be residency or fellowship) that leads to the perfect job. We are human. The decision to pursue a career in academic medicine or private practice is complex and is based on numerous factors of varying importance. My only advice to fellows and young physicians is to never have regrets and to always pursue your dreams.

Both you and your family have worked very hard to make your pursuit of a career in medicine possible. Pursuing your dreams is beneficial to both you and your patients.

Articles

There is no magic door to walk through at the
end of our training (whether that be residency or
fellowship) that leads to the perfect job.

Stephen Williams, MD

Articles

Dr. Williams on the Rationale for the SunRISE-2 Trial in Muscle-Invasive Bladder Cancer

My Path to Fellowship: Slightly Different From Most