Plenary: Next Frontier, Monday

Plenary: Next Frontier

PNFLBA-10: Late-Breaking Abstract - A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Non-Muscle Invasive Bladder Cancer: SWOG S0337

Monday, May 15
10:40 AM - 10:45 AM
Location: BCEC: Ballroom East

Presentation Authors: Edward Messing*, Rochester, NY, Cathy Tangen, Seattle, WA, Seth Lerner, Houston, TX, Deepak Sahasrabudhe, Rochester, NY, Theresa Koppie, Portland, OR, David Wood, Royal Oak, MI, Philip Mack, Sacramento, CA, Robert Svatek, San Antonio, TX, Christopher Evans, Sacramento, CA, Khalid Hafez, Ann Arbor, MI, Daniel Culkin, Oklahoma City, OK, Timothy Brand, Tacoma, WA, Lawrence Karsh, Denver, CO, Jeffrey Holzbeierlein, Kansas City, KS, Shandra Wilson, Aurora, CO, Guan Wu, Rochester, NY, Melissa Plets, Seattle, WA, Nicholas Vogelzang, Las Vegas, NV, Ian Thompson, San Antonio, TX

Introduction: Gemcitabine (G) is a frequently used and effective systemic agent for advanced urothelial cancer (UC). However, its utility for low grade (LG) non-muscle invasive (NMI) disease when administered intravesically has not been studied extensively. This trial tested the impact of one instillation of G (2 gm/100 ml saline) versus saline (S) alone (100 ml), held for one hour immediately following transurethral resection of bladder tumor (TURBT), on time to recurrence (TTR).

Methods: Patients had suspected LG NMI UC based on cystoscopic appearance. Patients could not have a prior history of muscle invasive, upper tract or prostatic urethral UC, non-UC bladder cancer or prior HG UC or > 2 UC episodes within 18 months before index TURBT. Patients were followed quarterly with cystoscopies for 2 years, then semiannually for 2 more years. Design: Primary endpoint: TTR. Randomize 340 eligible patients, one-sided α=0.025, 89% power to detect a hazard ratio (HR) of 0.65 (G vs S) for time to recurrence. Participants were stratified by new vs recurrent tumor and 1 vs > 1 lesion(s).

Results: From July 2007 to August 2012, 416 (406 eligible) patients were randomized to G or S. Median age was 66 yrs, 85% were male, 91% were white, 37% had recurrent disease, and 68% had one lesion at entry. 33 patients assigned to G and 28 to S did not receive instillation, primarily because of complications at TURBT or patient refusal. In the primary ITT analysis (n=406), there was a significant 34% reduction in risk of recurrence in the G arm compared to S (HR=0.66, 95% CI 0.48, 0.90, p=0.010). For the per-protocol target population, LG NMI UCs, TTR even more strongly favored G (HR 0.50 95% CI 0.33, 0.76; p=0.001). Few muscle invasive events (G 2.5%, S 4.9%) or deaths from any cause (G 8.5%, S 12.2%) occurred. Adverse events (AEs) were infrequent. There were no Grade 4 or 5 complications, and no difference in Grade 3 AEs (G 2.4%, S 3.4%).

Conclusions: Immediate post TURBT intravesical instillation of G was safe, well tolerated and significantly reduced recurrence of LG NMI UC in these participants.

Source Of Funding: Support: NIH/NCI grants CA180888, CA180819 and in part by Eli Lilly and Company

Clinical Trials.gov Registry Number: NCT00445601

Edward Messing, MD

University of Rochester Medical Center

Dr. Messing is the Winfield W. Scott Professor and Chairman of Urology, Professor of Oncology at the University of Rochester. Prior experiences include: Interim Director, James P. Wilmot Cancer Center, University of Rochester; Professor, Surgery/Human Oncology, University of Wisconsin Medical School; Chief, Urologic Oncology, Division of Urology, Department of Surgery, University of Wisconsin School of Medicine and Clinical Assistant Professor of Urology, Tulane University School of Medicine.

He is a former President of the Society of Urologic Oncology (SUO) and former co-leader of the GU Committee of the Eastern Cooperative Oncology Group (ECOG) and is currently co-leader of the Renal Cancer Subcommittee of the Southwest Oncology Group (SWOG). In 2013 he was awarded the prestigious Presidential Citation from the American Urological Association (AUA) for his work on bladder cancer research and urologic education.

He has received several honors and awards. His research includes: early detection, prevention, and treatment of urologic malignancies.

Dr. Messing is a busy clinician and a renowned surgeon for urologic cancers and related diseases. Dr. Messing strongly believes research is an integral part of the practice of medicine and is necessary to provide patients with the best possible care. His research interests (he has been an NIH funded investigator for over 25 years) range from basic science investigations into the molecular underpinnings of cancers of the bladder, kidney and prostate, to translational research which has adopted laboratory findings and has brought them to the care of patients, to carrying out large scale studies on screening for, and prevention of these cancers. Furthermore, he has designed and conducted large clinical trials on the treatment of bladder, renal and prostate cancer. His work is often quoted in medical publications, and he is frequently asked to be a visiting professor at other research and educational institutions

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PNFLBA-10: Late-Breaking Abstract - A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Non-Muscle Invasive Bladder Cancer: SWOG S0337



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