suo 2015 pre-convention newsletter

12
1 Society of Urologic Oncology, Inc. Society of Urologic Oncology Newsletter 2015 Pre-Convention IN SIDE this issue Message from the President 2015 – 2016 Board of Directors Listing 2015 Winter Meeting Update 2016 Spring Meeting Update SUO: Past, Present and Future SUO-CTC Update SUO Treasurer’s Report Fellowship Committee Update Young Urologic Oncologists Committee Update Large Urology Group Practice Representative Report 1 3 5 4 7 9 Message from the President Leonard G. Gomella, MD, FACS 6 9 I assumed the presidency of a strong and growing Society of Urologic Oncology this past May during the 2015 AUA in New Orleans. Having served as SUO treasurer and president elect under the outstanding leadership of our SUO Past President Dr. Brantley Thrasher, I would like to take a moment to share with our membership the accomplishments of Dr. Thrasher’s tenure as SUO president from 2013 to 2015. Dr. Thrasher led a Five-Year Strategic Initiative that includes membership expansion of individuals interested in urologic oncology. He crafted a thoughtful yet cautious approach to future discussions concerning Certificate of Added Qualifications for our specialty. He formalized the leadership nomination process and made accommodations to ensure all candidates were qualified and able to assume a leadership role in the SUO if asked to serve. Dr. Thrasher crafted a memorandum of understanding with the AUA guidelines committee for our organization to more closely collaborate on Prostate and Bladder Cancer Guidelines. The new Rapid Response Committee will allow us to quickly address important issues that arise between our board meetings. Three research scholarship grants were established in collaboration with the SUO including one specific to a SPORE project. For this and many other accomplishments Dr. Thrasher has left a lasting legacy and strengthened our organization as he assumes his new role and responsibilities as SUO past president. We also wish him well as he prepares to serve as upcoming President of the AUA. I would like to welcome several new positions and new members to the SUO Executive Committee. Dr. Chris Evans who has served admirably as secretary is our new president elect while Dr. Jeff Holzbeierlein takes over as secretary. Dr. Bruce Malkowicz is our new membership chair replacing Dr. Badar Mian. Our new Bylaws Committee chair is Dr. Sia Daneshmand replacing Dr. Badrinath Konety. Our new member-at-large is Dr. Ed Trabulsi with another to be chosen at our upcoming election replacing Dr. Surena Matin. Replacing Dr. Steve Campbell as OKAT chair will be Dr. Sam Chang. The role of spring program chair, a major undertaking handled by Dr. David Jarrad will be assumed by Drs. Stephen Boorjian and Alexandre Zlotta. As the Clinical Trials Consortium President Dr. Rob Uzzo is the new chair of the CTC. I thank everyone for the past service and look forward to their continued engagement with the SUO. There are major changes in store for the coming years concerning our two major SUO meetings. Everyone should be aware of the new location for the 2015 Annual Winter Meeting that will be held at the Renaissance Washington DC Downtown Hotel from December 2 to 4, 2015. This relocation into the District of Columbia from suburban Bethesda should address some of the transportation issues raised by our members and allow expansion of the program attendance. I encourage you to review the three days of the 2015 Annual Winter Meeting scientific program chaired by Drs. Surena F. Matin and Brett Carver. In addition to mini symposia on rare cancers and upper tract urothelial carcinoma, the meeting features programs for our Young Urologic Oncologists and the presentation of the SUO Huggins Award to SUO Past President Dr. Jay Smith from Vanderbilt University. All members should also take note in the change of our SUO Annual Business Meeting. Traditionally continued on following page 10 11

Upload: society-of-urologic-oncology

Post on 24-Jul-2016

239 views

Category:

Documents


1 download

DESCRIPTION

 

TRANSCRIPT

Page 1: SUO 2015 Pre-Convention Newsletter

1

Society of Urologic Oncology, Inc.

Society of UrologicO n c o l o g y Newsletter

2015 Pre-Convention

INSIDEthis issue

Message from the President

2015 – 2016 Board of Directors Listing

2015 Winter Meeting Update

2016 Spring Meeting Update

SUO: Past, Present and Future

SUO-CTC Update

SUO Treasurer’s Report

Fellowship Committee Update

Young Urologic OncologistsCommittee Update

Large Urology Group Practice Representative Report

1

3

5

4

7

9

Message from the PresidentLeonard G. Gomella, MD, FACS

6

9

I assumed the presidency of a strong and growing Society of Urologic Oncology this past May during the 2015 AUA in New Orleans. Having served as SUO treasurer and president elect under the outstanding leadership of our SUO Past President Dr. Brantley Thrasher, I would like to take a moment to share with our membership the accomplishments of Dr. Thrasher’s tenure as SUO president from 2013 to 2015.

Dr. Thrasher led a Five-Year Strategic Initiative that includes membership expansion of individuals interested in urologic oncology. He crafted a thoughtful yet cautious approach to future discussions concerning Certificate of Added Qualifications for our specialty. He formalized the leadership nomination process and made accommodations to ensure all candidates were qualified and able to assume a leadership role in the SUO if asked to serve. Dr. Thrasher crafted a memorandum of understanding with the AUA guidelines committee for our organization to more closely collaborate on Prostate and Bladder Cancer Guidelines. The new Rapid Response Committee will allow us to quickly address important issues that arise between our board meetings. Three research scholarship grants were established in collaboration with the SUO including one specific to a SPORE project. For this and many other accomplishments Dr. Thrasher has left a lasting legacy and strengthened our organization as he assumes his new role and responsibilities as SUO past president. We also wish him well as he prepares to serve as upcoming President of the AUA.

I would like to welcome several new positions and new members to the SUO Executive Committee. Dr. Chris Evans who has served admirably as secretary is our new president elect while Dr. Jeff Holzbeierlein takes over as secretary. Dr. Bruce Malkowicz is our new membership chair replacing Dr. Badar Mian. Our new Bylaws Committee chair is Dr. Sia Daneshmand replacing Dr. Badrinath Konety. Our new member-at-large is Dr. Ed Trabulsi with another to be chosen at our upcoming election replacing Dr. Surena Matin. Replacing Dr. Steve Campbell as OKAT chair will be Dr. Sam Chang. The role of spring program chair, a major undertaking handled by Dr. David Jarrad will be assumed by Drs. Stephen Boorjian and Alexandre Zlotta. As the Clinical Trials Consortium President Dr. Rob Uzzo is the new chair of the CTC. I thank everyone for the past service and look forward to their continued engagement with the SUO.

There are major changes in store for the coming years concerning our two major SUO meetings. Everyone should be aware of the new location for the 2015 Annual Winter Meeting that will be held at the Renaissance Washington DC Downtown Hotel from December 2 to 4, 2015. This relocation into the District of Columbia from suburban Bethesda should address some of the transportation issues raised by our members and allow expansion of the program attendance. I encourage you to review the three days of the 2015 Annual Winter Meeting scientific program chaired by Drs. Surena F. Matin and Brett Carver. In addition to mini symposia on rare cancers and upper tract urothelial carcinoma, the meeting features programs for our Young Urologic Oncologists and the presentation of the SUO Huggins Award to SUO Past President Dr. Jay Smith from Vanderbilt University.

All members should also take note in the change of our SUO Annual Business Meeting. Traditionally

continued on following page

10

11

Page 2: SUO 2015 Pre-Convention Newsletter

2

STILL TIME TO REGISTER!16th Annual Meeting of the Society of Urologic Oncology

Extraordinary Opportunities for DiscoveryDecember 2 – 4, 2015

Renaissance Washington DC Downtown HotelWashington, DCwww.suonet.org

held during the AUA Annual Meeting, the SUO business meeting will now be held on Friday morning of our Winter Meeting. Please make every effort to make your voice heard and vote on important issues facing our organization.

We are excited to announce a pilot program for this year’s Annual Meeting in Washington, DC. The SUO Board has authorized videotaping of our major plenary presentations. This will allow our outstanding presentations to be available to those who cannot attend this year’s meeting. Also please stand by as we prepare to reveal our new and improved SUO website through the efforts of our professional service organization WJ Weiser & Associates.

SUO Past President and Chair of the Rapid Response Committee Dr. Ed Messing has circulated a questionnaire on the BCG shortage to our membership and how it has impacted patient care. We look forward to his final report and analysis of how this has impacted our clinical care.

After a successful start of the SUO-CTC and six years of leadership under Dr. Colin Dinney, Dr. Rob Uzzo has assumed the presidency. The SUO-CTC has been a highlight of one of SUO’s newer initiatives and continues to develop high impact clinical trials to serve our patients and members.

Long term planning is already underway for the SUO meeting at the 2016 AUA Annual Meeting in San Diego. Dr. Alex Zlotta from the University of Toronto and Dr. Steve Boorjian from the Mayo Clinic will serve as program directors for the traditional Saturday afternoon session on May 7, 2016. Please also keep in mind a relatively new AUA session that focuses on basic science and our urology-centric SPORE programs. This AUA Office of Research sponsored Urologic Oncology Symposium is entitled “Forging New Paths in Research to Advance Urologic Oncology” and will be held all day on Friday, May 6, 2016, and is led by Drs. Aria Olumi and Carolyn Best.

I am proud to begin my service as SUO president as we begin our 31st year. As a reminder the mission of the SUO is to: “Enable qualified members primarily interested in the care of patients with malignant GU diseases to meet for the purpose of discussion, development and implementation of ideas to improve care.” Through the actions of our many members, the SUO board, and the SUO-CTC we continue to achieve the stated goals of our mission.

Please feel free to contact me directly concerning your ideas on ways to improve and expand our organization. On behalf of the SUO Board and our meeting organizers we all look forward to seeing you at our new winter meeting location in our nation’s capital this December.

Page 3: SUO 2015 Pre-Convention Newsletter

3

2015 – 2016Board of Directors Listing

Society of Urologic Oncology, Inc.

OFFICERS

PresidentLeonard G. Gomella, MD, FACS

Past PresidentJ. Brantley Thrasher, MD

President-ElectChristopher P. Evans, MD, FACS

SecretaryJeffrey M. Holzbeierlein, MD, FACS

TreasurerMichael S. Cookson, MD, MMHC

MEMBERS AT LARGEJeffrey M. Holzbeierlein, MD, FACSDavid F. Jarrard, MDEduoard J. Trabulsi, MD, FACS

STANDING COMMITTEE CHAIRS

AJCC RepresentativeStephen A. Boorjian, MD

AUA RepresentativeJ. Brantley Thrasher, MD

Awards Committee ChairJ. Brantley Thrasher, MD

Bylaws Committee ChairSia Daneshmand, MD

Clinical Trials CommitteeRobert G. Uzzo, MD

Fellowship Committee ChairPeter E. Clark, MD

Large Urology Group Practice RepresentativeNeal D. Shore, MD

Membership ChairS. Bruce Malkowicz, MD

NCI LiaisonW. Marston Linehan, MD

Nominating Committee ChairJ. Brantley Thrasher, MD, FACS

OKAT RepresentativeSteven C. Campbell, MD, PhD

Publications Committee ChairMichael J. Droller, MD

Spring Scientific Program Co-ChairsStephen A. Boorjian, MDAlexandre Zlotta, MD

Winter Scientific Program Co-ChairsBrett S. Carver, MD Surena F. Matin, MD

WUOF LiaisonLaurence H. Klotz, MD

Young Urologic Oncologists RepresentativeDaniel A. Barocas, MD, MPH

HEADQUARTER OFFICE1100 E Woodfield Road, Suite 350Schaumburg, Illinois 60173(847) 264-5901

Executive Office, General ManagerWendy J. Weiser

Executive DirectorPam Murphy

Page 4: SUO 2015 Pre-Convention Newsletter

4

As co-chairs of the 16th Annual Meeting of the Society of Urologic Oncology, we are very pleased to see the outstanding program put together by this year’s program chairs. This year the SUO Annual Winter Meeting will be held on December 2 – 4, 2015, at the Renaissance Downtown Hotel in Washington, DC. With this meeting we continue to usher notable changes in response to feedback from our members and under the guidance of SUO leadership.

A brief outline of this year’s meeting with notable changes, and more detailed description of the agenda follow:

• The new meeting venue in Washington, DC represents a major change, and represents a response to input from membership.

• The meeting will again start on Wednesday at noon with two special programs: “Clinical and Histologic Variants,” followed by the “2nd Symposium on Upper Tract Urothelial Carcinoma.”

• The first poster session will be following these Wednesday special programs at 4:30 p.m., prior to the Young Urologic Oncologist’s (Y.U.O) Dinner.

• Last year we had an extended welcome reception on Thursday afternoon, in lieu of the SUO dinner. Given the positive responses, we will again be holding the reception from 6:00 p.m. – 7:30 p.m., which is included in the registration fee. This will allow for group social gathering and announcements prior to everyone’s dinners, and we highly encourage attendance.

• The SUO Business Meeting will now be held during the Annual Winter Meeting, and this year is scheduled to occur at 7:30 a.m. Friday morning.

• Similar to last year, an earlier start on Wednesday allows the meeting to conclude on Friday by 3:15 p.m., allowing many to get home to their families before the weekend.

We are very excited of continuing the trend of kicking off the meeting with special programs on Wednesday, alternating between SPORE programs and under-represented areas of urologic oncology. This year, Drs. Vivek Arora and John Cheville have put together an insightful agenda on clinical and histologic variants in urologic oncology, bringing attention to these often overlooked and vexing issues in our field.

We are also honored this year with an outstanding, world class state-of-the-art lecturer. Dr. Lewis Cantley is currently the director of the Weill Cornell Medical College Cancer Center. He was recently one of the inaugural recipients of the Breakthrough Prize in Life Science for his discovery and study of the enzyme PI3K. He has played a critical role in characterizing the up- and down-stream signaling of the PI3K pathway which is frequently

2015 Winter Meeting Update

Brett S. Carver, MD, and Surena F. Matin, MD, Winter Program Co-Chairs.

active across a variety of malignancies. He has also developed and evaluated a variety of inhibitors of this pathway that have entered clinical trials in patients with advanced malignancies.

Thursday’s scientific program starts with a bladder cancer session, chaired by Dr. Rosenberg, focusing on muscle invasive bladder cancer, cystectomy and the impact of ERAS. The second bladder cancer session on Friday will highlight the current and future role of immune checkpoint inhibitors, targeted drugs and optimal trial designs for NMIBC.

In addition, we also have an SUO-CTC session on Thursday morning, led by Dr. Colin Dinney who will be speaking about emerging therapies for patients with bladder cancer.

This year also marks the return of two biannual sessions. The session on health services, organized and led by Dr. John Wei, will provide an update on the AQUA registry, surgical coaching for performance improvement, and patient centered outcomes research. The session on penile cancer, organized and led by Dr. Viraj Master, will provide an update on the INPACT trial, and the role of radiotherapy, imaging and pelvic lymphadenectomy will be highlighted.

The prostate cancer sessions this year are chaired by Dr. Sumanta Pal who has organized sessions addressing the use of genomic platforms and their clinical relevance in patients with prostate cancer, the advancing role of systemic therapies for the management of metastatic prostate cancer, and the impact of prostate cancer therapy on quality of life for prostate cancer survivors.

Dr. Jodi Maranchie has organized a thoughtful program for the kidney cancer session, addressing timely issues on adjuvant therapy for RCC, designing the next generation of clinical trials, and the rationale for combination checkpoint inhibition.

The second poster session will conclude the Thursday sessions.

The Friday morning program will be kicked off by the YUO program, chaired by Dr. Daniel Barocas. The kidney and prostate cancer sessions will follow, along with the Oral Abstract session, moderated by Dr. Alon Weizer. The meeting will conclude in the afternoon following the final bladder and prostate cancer sessions.

As in past years, changes to this year’s program reflect feedback from our attendees. We are very grateful for this feedback and hope that the current program will not only keep you engaged but as well have a positive impact on your research and clinical care. We are honored to have had the opportunity to help organize this terrific program, and are very much looking forward to seeing you on December 2.

Page 5: SUO 2015 Pre-Convention Newsletter

5

2016 Spring Meeting Update

Stephen A. Boorjian, MD & Alexandre Zlotta, MD, Spring Scientific Program Co-Chairs, Afternoon Session; Christopher P. Evans, MD, Spring Scientific Program Co-Chair, Morning Session (with SBUR)

The Annual Spring Meeting for the Society of Urologic Oncology will be held this year on Saturday, May 7, 2016, at the American Urological Association Meeting in San Diego, CA. This year’s morning meeting, held in conjunction with the Society of Basic Urologic Research and the American Urological Association is themed “Therapeutic Resistance in Urologic Oncology.” This session will bring together an outstanding group of multi-disciplinary clinicians and basic scientists in urologic oncology to discuss new research developments regarding mechanisms of therapeutic resistance, biomarker to identify resistance and strategies to overcome resistance. The meeting will be moderated by Dr. Christopher Evans and Dr. Hari Koul, president-elects of the SUO and SBUR, respectively.

The morning session will begin with a session on “Identification and Targeting Resistance in Castration-Resistant Prostate Cancer.” Timothy Thompson, PhD will speak on “Mechanisms of Castration Resistance,” and Emmanuel Antonarakis, MD will discuss “Biomarkers of Resistance and Therapeutic Implications.” The second session is on “Resistance and Options in Urothelial Cancer,” with Michael O’Donnell, MD speaking on “New Approaches Post-BCG,” and Chong Pan, MD addressing “Microdosing for Chemo-Therapeutic Response in Advanced Urothelial Cancer.” In the renal cancer resistance session, Dr. Marston Linehan will present “Mechanisms of Therapeutic Resistance in Renal Cancer: Moving Past TKI’s in Renal Cancer,” and Rajvir Dahiya will speak on “Role of Non-Coding RNA in Renal Cancer.” The morning session will end with the Annual Donald Coffey Lecture given this year by Dr. Carlo Croce from Ohio State University.

The SUO afternoon session will be themed “Balancing the Risks of Overtreatment Versus Undertreatment,” and will begin with the presentation and delivery of the Whitmore Lecture by this year’s awardee. Following this, the first session will examine the importance of avoiding undertreatment of the high-risk prostate

cancer patient, and will detail the role of local therapy in patients with locally-advanced and/or relapsed disease. Talks include the implications of race in the decision for active surveillance, the long-term safety of active surveillance as a management strategy, the value of treating the prostate for patients with cN+ disease, the role of prostatectomy in M1 prostate cancer, and the evolving concept of image-guided local treatment for pelvic nodal relapse. A case-based discussion to review management options for patients with high-risk disease will follow.

The bladder cancer session will include an assessment of selection criteria for initial cystectomy in patients with T1 bladder cancer. Current non-surgical management options for patients with BCG-refractory disease will then be discussed. An important and timely discussion on the value of extended lymph node dissection will then be undertaken. Following this will be a talk on the value of adjuvant chemotherapy, and then a debate on the value of oncologic surveillance following radical cystectomy with urinary diversion. The final session will examine controversies in kidney cancer, inclusive of early and late stages of disease. This session will begin with a talk on novel imaging modalities for the solid renal mass as a means of “radiographic biopsy.” A debate on the importance of renal ischemia during partial nephrectomy will follow, with moderator-prompted questions. There will then be a talk providing a critical assessment of the existing guidelines for surveillance after treatment among patients with kidney cancer, providing an opportunity for a future individualized approach to surveillance that maximizes capture of recurrences and makes the most efficient use of medical resource allocation. An update on checkpoint blockade agents in metastatic renal cell carcinoma follows that talk, and the session will conclude with a debate on optimal sequencing of treatments for the patient with newly-diagnosed metastatic kidney cancer.

We look forward to seeing you at the Annual Spring Meeting of the SUO at the AUA!

“...There will then be a talk providing a critical assessment of the existing guidelines for surveillance after treatment among patients with kidney

cancer, providing an opportunity for a future individualized approach to surveillance that maximizes capture of recurrences and makes the most

efficient use of medical resource allocation...”

Page 6: SUO 2015 Pre-Convention Newsletter

6

At the SUO Board of Directors meeting this past Spring, Dr. J. Brantley Thrasher recounted some of the Society’s most notable accomplishments over its 30 years, and outlined some of the most important goals for its future. We’ve included them in the newsletter so that all members can share in the Society’s success and mission.

Thank you, Dr. Thrasher, for your service to the Society!

Thank you for allowing me the honor of serving as the President of an organization that I love, serving a group of colleagues that I truly respect and, a debt of gratitude for all that Wendy, Pam and a host of others do for this organization.

Past, Present and FutureJ. Brantley Thrasher, MD, FACS, Immediate Past President of the SUO

PAST: SUO MILESTONES• 1984: the Society of Urologic Oncology is founded• 1986: The first summer meeting, focusing primarily

on clinical needs• 2000: The first winter meeting, covering more

universal topics.• 2000: The SUO Fellowship program is created

to standardize fellowship program in urologic oncology, so that trainees will receive a superior experience and achieve a level of expertise that will allow them to coordinate and participate in multi-disciplinary care in an academic or private practice setting.

• 2007: Began the Oncology Knowledge Assessment Test (OKAT), which assists uro-oncology program directors in evaluating the strengths and weaknesses of the education of their training program, as well as the performance and progress of individual fellows.

• 2008: Founding of the SUO sub-group, the Clinical Trials Consortium, to improve the implementation and conduct of multi-institutional trials.

• 2014: SUO celebrated its 30th anniversary!

PRESENT• Started 5-Year Strategic Initiative to generate goals

and objectives to better identify the Society’s future• Created Finance and Rapid Response Committees • Began a combined initiative with the AUA for the

summer meeting• Entered into MOU with PGC on Prostate and Bladder

Guideline developments• Created three Research Scholarships for the Urology

Care Foundation Research Scholar Program• Created the Nomination Committee and nomination

process

• Placed Certificate of Added Qualifications (CAQ) on hold until an unspecified time

• Changed the theme of the Annual Winter Meeting Banquet to honor a SUO Past-President

FUTURE• CAQ: Funding, six-core competencies, NAS,

milestones, surgery logs, testing, benchmarks for graduation, CPT Codes, etc.

• Voted to expand membership with a more inclusive vs. exclusive developmental strategy

• Voted to increase fellowship committee, tighten guidelines and potentially limit numbers

• Fund three Research Scholars (one preferential to SPORE sites) but no further at this time

• Further discuss patient advocacy/survivorship

PARTING THOUGHTS• Revisit CAQ in the next 5 years.-principle to this:

buy-in of the fellowship directors• Continue collaborations with the AUA• Stress inclusive strategy of membership with the

oncologic emphasis of our mission• Continue to solidify our fellowship programs and

stress a more rigorous/unified curriculum• Monitor Research Scholarship program before

further change• Major capital initiatives should be vetted by the

Finance Committee prior to vote to ensure the financial security of the SUO for years to come

• Use the new nominating process to bring new points-of-view to the Board of Directors and Committees

Page 7: SUO 2015 Pre-Convention Newsletter

7

SUO-CTC Update - Winter 2015 Robert G. Uzzo, MD, President - Clinical Trials Committee Chair

The SUO-CTC continues to work with a variety of sponsors on protocols for group-wide participation. A brief summary is provided below with a more in-depth discussion planned for the upcoming SUO winter business meeting in Washington DC. The organization maintains a positive financial statement independent of the SUO budget. In 2015 the organization recruited disease state medical oncology advisors to work with the three organ site committees on future clinical trials.The advisors include:

Bladder Committee• Elizabeth Plimack Fox Chase Cancer Center • Matthew Galsky Mount Sinai Medical Center • Noah Hahn Johns Hopkins University

Prostate Committee• Sumanta K. Pal City of Hope • Ana Molina Weill Cornell Medical Center • Christopher Ryan Oregon Health Sciences

University Renal Committee

• Evan Yu University of Washington • Lauren Harshman Dana Farber Cancer

Institute

SUO-CTC 2015 CLINICAL TRIAL INITIATIVES

ACTIVE TRIALS:

Prostate Cancer

PRO-IMPACT (GenomeDx)– “PROspective Study of the IMPACT of a Genomic Test (Decipher) on Physician and Patient Treatment Consideration and Decisions following Radical Prostatectomy” (N= 300) sponsored by GenomeDxSUO-CTC PI – Daniel Lin, MD and John Gore, MD

This is a prospective clinical utility study to evaluate urologists’ treatment recommendations before and after reviewing Decipher TM results for eligible patient cases. The SUO-CTC is the major contributor as 90 percent of the sites selected for this trial are SUO-CTC members.

Patient cases are defined as follows: • Arm A - In the adjuvant setting: within six-months after

surgery (in the absence of PSA rise or BCR) • Arm B - In the salvage setting: post RP with evidence of

PSA rise or BCR (defined as PSA detectable and rising on two or more subsequent determinations)

Patient Accrual from 19 SUO-CTC sites as of September 2015• Total Subjects Enrolled 258

o Arm A 158o Arm B 100

HS410-101 (Heat Biologics) – “A Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response and Clinical Activity of HS-410 in Patients with Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)” N=110SUO-CTC PI Larry Karsh, MD Study Design Summary

Primary Objective: Phase 1: To characterize the safety and tolerability of low dose monotherapy vaccination with vesigenurtacel-L in patients with non-muscle invasive bladder cancer.

Phase 2: Arms 1, 2, and 3: To evaluate 1-year disease-free survival in patients with non-muscle invasive bladder cancer treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo).

Arm 4: To evaluate 1-year disease-free survival in patients with non-muscle invasive bladder cancer treated with high dose vesigenurtacel-L monotherapy.

Phase 2 Patient Accrual from 13 SUO-CTC sites as of September 2015• Total Subjects Enrolled 53

o Randomized to Arms 1,2,or 3 = 49o Arm 4 = 4

PLANNED TRIALS UNDER CONTRACT

Bladder Cancer1. FKD Sponsor

Phase III – “A Phase III, Open Label, Study to Evaluate the Safety and Efficacy of INSTILADRIN (rAd-IFN/Syn3) Administered Intravesically to Subjects with High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)” - N=120

•Pending final site selection

2. BioCancell Sponsor #301 – “Treatment with BC-819/PEI in Patients

with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to or Intolerant of BCG” - N=120

•Pending final site selection

#302 – “Treatment with BC-819/PEI and BCG versus BCG only in Intermediate to High-risk Non-Muscle Invasive Bladder Cancer (NMIBC) Patients who Failed BCG” (note: this trial will be conducted under a SPA with FDA) - N=470

•Pending final site selection

continued on following page

Page 8: SUO 2015 Pre-Convention Newsletter

8

COMPLETED TRIALS:

Renal Cell Carcinoma

ADAPT – “A Phase 3 Open-Label Randomized Study Testing the Safety and Activity of AGS-003 in Combination with Sunitinib versus Sunitinib Alone in Subjects with Newly Diagnosed Advanced Stage RCC” (N= 450) sponsored by Argos TherapeuticsSUO-CTC PI – Brian Lane, MD and Robert Uzzo, MD

This trial closed to patient accrual in mid-July and is the largest cytoreductive nephrectomy trial ever conducted with over 1100 patients undergoing tumor collection. Patients randomized to treatment remain on study receiving standard of care therapy with or without investigational vaccine. The SUO-CTC is the major contributor to this trial including:

40% of Active Sites (53) 62% of Tumor Collections (N=712) 61% of Patients Randomized to Treatment

(N=283)Data collection continues for patients who were randomized to treatment continue on therapy with AGS-003 in combination with standard targeted therapy, or on standard therapy alone.

Bladder Cancer

rAd-IFN-CS-002 “A Phase II, Randomized, Open Label, Parallel Arm Study to Evaluate the Safety and Efficacy of rAd-IFN/Syn3 Following Intravesical Administration in Subjects with High Grade, BCG Refractory, Relapsed or Resistant Non-Muscle Invasive Bladder Cancer (NMIBC)” (N =40) sponsored by FKD Therapies OySUO-CTC PI - Colin Dinney, MD and Robert Svatek, MD

This manuscript is in development; abstract presented at the AUA 2015 (Abstract # 15-2375) - “Randomized Phase II trial of intravesical adenoviral mediated interferon-α gene therapy with the excipient Syn3 (rAd-IFNα/Syn3) in patients with BCG refractory or relapsing high grade (HG) non muscle invasive bladder cancer (NMIBC)”Daniel Canter*, Elkins Park, PA, Stephen Boorjian, Rochester, MN, Kenneth Ogan, Atlanta, GA, Neal Shore, Myrtle Beach, SC,Trinity Bivalacqua, Baltimore, MD, Bernard Bochner, New York City, NY, Tracy Downs, Madison, WI, Leonard Gomella,Philadelphia, PA, Robert Grubb III, St. Louis, MO, Brant Inman, Durham, NC, Ashish Kamat, Houston, TX, Larry Karsh, Denver, CO,Tracey Krupski, Charlottesville, VA, Seth Lerner, Houston, TX, Yair Lotan, Dallas, TX, Matthew Milowsky, Chapel Hill, NC, Mark Schoenberg, Bronx, NY, Robert Svatek, San Antonio, TX, Michael Woods, Chapel Hill, NC, Colin Dinney, Houston, TX conducted exclusively with the SUO-CTC:

MEMBERSHIP SUMMARY• Physician membership= 336

o Academic - 70%o Community – 28%

LUGPA – 9%o Military/VA – 2%

• Clinical Trial Sites = 186o 171 US / 11 Canadao Academic – 54%o Community – 42%

LUGPA – 14%o Military/VA – 4%

SUO Winter Meeting CTC PresentationThursday 12/3/1511:15 -11:45 AM

“Emerging Therapies for Patients with Bladder Cancer”Colin P. N. Dinney, MD MD Anderson Cancer Center

“Emerging Therapies for Patients with Bladder Cancer”Colin P. N. Dinney, MD MD Anderson Cancer Center

Page 9: SUO 2015 Pre-Convention Newsletter

9

The overall financial position of the SUO remains strong, and I am pleased to report that our assets have grown over the last five years, in spite of the financial market instabilities. A full report will be delivered at the 16th Annual Meeting of the Society of Urologic Oncology in Washington, DC. Until then, there are several important new financial developments and areas of growth that I would like to highlight.

The administrative support provided by WJ Weiser & Associates has continued to be outstanding. Their sound management principles, close interaction with the Board of Directors and the ability to consistently identify external support and cost saving opportunities has contributed greatly to our financial health.

In 2015, the SUO Annual Meeting moves to Washington, DC, at the Renaissance Washington DC Downtown Hotel. This location still offers close proximity to the National Institutes of Health in Bethesda, MD, while allowing SUO to expand opportunities for meeting support, as well as satellite symposia and significant cost-saving considerations from the facility.

The SUO’s investment portfolio continues under the wealth management company of BDF (Balasa/Dinverno/Foltz, LLC), based out of Chicago, IL. As SUO is a nonprofit corporation, they have provided special consideration to our Society’s unique investment needs. Their advice has been to maintain investments at a 60/40 split of stocks/bonds and this strategy has been successful to date.

Last year, the SUO Finance Committee was created, whose purpose is to align the goals and initiatives of the SUO as outlined in its five-year strategic plan with its fiscal policies. Accordingly, the committee is responsible for overseeing SUO finances, developing and implementing a fiscal plan to support

SUO Treasurer’s Report - Fall 2015 Michael S. Cookson, MD, MMHC, SUO Treasurer

the present and future needs of the society. Members of this committee include Leonard Gomella, MD (SUO president); Badrinath Konety, MD, MBA (Strategic Planning Committee Chair); Sam Chang, MD, MBA (SUO member) and Todd Morgan, MD (SUO and YUO member).

Also, the SUO-CTC has been a positive activity, both scientifically and economically. Through the leadership of SUO-CTC chair, Robert Uzzo, MD; current member-at-large, Colin Dinney, MD; associate director, Joan Chiavello; and the SUO-CTC board and disease site committees, the return on the investment remains robust. I am pleased to announce that the clinical trials portfolio is growing and the society underwriting continues to decline as the SUO-CTC proves a healthy investment for the organization.

The American Urological Association (AUA) and the SUO have recently partnered resources to secure two new research scholars. The Research Scholars Program, now part of the Urology Care Foundation, promotes urologic advances by funding program participants with essential support for research. These innovative researchers will build upon the base of experience and knowledge gained during their fellowships and contributes to expand the field of knowledge in urologic oncology research that will lead to new treatments and cures. Through this generous partnership, the AUA and the SUO have now invested in the future of urologic oncology research scholars for years to come!

All of the above factors, combined with strong and steady growth in our membership over the last five years, have all contributed to our financial growth as an organization. It is a pleasure and privilege to serve as your SUO Treasurer and a member of the SUO Board of Directors.

Fellowship Committee Update Peter E. Clark, MD, Fellowship Committee Chair

The Fellowship Committee of the SUO has been actively reviewing SUO fellowship programs for reaccreditation as well as site visits for new program applications. In the last year, six of the seven programs reviewed have successfully undergone the reaccreditation process, including two programs that merged into one joint program. In addition, the program at the University of Iowa was approved as the latest SUO oncology fellowship program while two programs voluntarily withdrew their accreditation. At the AUA Annual Meeting in New Orleans,

Drs. Jonathan Coleman and Erik Busby completed their terms of service on the Committee. The Committee would like to thank them both for their commitment, leadership, and dedication over the last several years. The Fellowship Committee welcomed the addition of Drs. Sia Daneshmand, Andrew Stephenson and David Jarrard.

continued on following page

Page 10: SUO 2015 Pre-Convention Newsletter

10

The SUO Fellowship Program successfully completed the Match Process in June of this year. There were a total of 70 registered applicants (compared to 71 the year prior) to fill a total of 50 vacancies (compared to 49 vacancies the prior year) in 29 fellowship programs (the same number as the year prior). There were a total of nine unfilled positions at programs who registered for the match and 29 applicants who submitted a match list but did not get a position for an overall 41 percent non-match rate (compared to 35 percent the year prior).

The OKAT examination will be given on November 21, 2015. As always, all fellows and program directors (or their designee)

are required to take the examination. The deadline to register for the OKAT examination was in August. If for any reason a fellow or fellowship director cannot take the test, it is important that a written request be submitted within six weeks of the test to Janel Angeles ([email protected]) at the SUO office. We highly encourage all urologic oncology faculty, in addition to the fellows and program directors, to take the examination. We will be holding the annual program directors’ meeting at the SUO Winter Meeting. This will take place on Thursday, December 3 from 11:45 a.m. -12:45 p.m. in Meeting Room 12-14 of the Renaissance Downtown Hotel.

2017 Urologic Oncology Fellowship Matching Program

Match Schedule

Nov.23 2015 – April 29, 2016 Online registration process. Please register at: http://www.auanet.org/eforms/SUO/

April 29, 2016 Registration deadline for both applicants and programs.

May 2, 2016 Preference list phase begins.

May 31, 2016 Deadline for receipt of all online preference lists. (You will receive e-mail instructions on how to submit your list.)

June 10 – 17, 2016 The Match is performed, using all possible safeguards to ensure accuracy and confidentiality.

June 20, 2016 Match results sent out via e-mail.

Dear Society of Urologic Oncology Members,

The Young Urologic Oncologists (YUO) members consist of those within seven years of completion of training, including fellows with a dedicated post-graduate and ongoing focus to urologic oncology. The YUO proudly supports a platform for meaningful academic exchange, networking, awarding high-quality scientific contributions, all highlighted annually during an informative, contemporary and practical evening program at the SUO Annual Winter Meeting.

There are currently 242 YUO members, and in 2014, we had 171 attendees at the YUO meeting, which consisted of a lively debate regarding physician ownership of ancillary services. The debate included Brent Hollenbeck, MD, from the University of

Michigan (“Urologist Ancillary Services Ownership: Financially Conflicted or Much Ado About Nothing?”) and Carl Olsson, MD, from Integrated Medical Professionals in New York (“Physician Ownership and Self-Referral: Clinical Care and Health Policy Implications”), and was moderated by David F. Penson, MD, MPH, from Vanderbilt University Medical Center. This debate garnered a huge amount of interest from the audience and was clearly well-received.

The past year also saw the successful publication of a manuscript spear-headed by Scott Eggener, MD (immediate Past President of the YUO) and Will Lowrance, MD, MPH (YUO Executive

Young Urologic Oncologists Committee Update

Daniel A. Barocas, MD, MPH, President, Young Urologic Oncologists Committee

continued on following page

Page 11: SUO 2015 Pre-Convention Newsletter

11

Large Urology Group Practice Representative Report

Neal D. Shore, MD

Board member). The paper, “Gleason 6 Prostate Cancer: Translating Biology into Population Health,” was published in The Journal of Urology (J Urol. 2015 Sep;194[3]:626-34). This is a triumph not only because it publicizes the relevance of Gleason 6 prostate cancer from the point of view of the upcoming generation of urologic oncologists, but also because it represents a successful coordination and collaboration among the members of the YUO.

Todd Morgan, MD, from our group also assisted with updating the YUO components of the website during the SUO website renovation.

For the coming year, we are pleased to have an outstanding evening program, which will focus on workforce issues in urologic oncology, which is a hot topic among our membership. Our speakers will be Dr. Raj Pruthi, chairman of urology at UNC and researcher in workforce issues, and Dr. Peter Clark, Fellowship Committee Chair for the SUO.

As in past years, our group will be charged with judging the posters submitted by YUO members, and prizes will be awarded for the top three posters in each of the two poster sessions. In addition, we have selected the top three abstracts submitted, and these will be presented in the main meeting on Friday morning. As a new feature this year, we are planning to award one urologic oncologist for “Best Paper of the Year” for a

paper representing outstanding work completed during training and published within a year of completing training. We secured some funds from Nature Clinical Practice Urology, which will be used for the poster prizes, so that the poster money can be used to support the travel award and cash prize for Best Paper. This avoids a potential conflict of having a specific journal support the Best Paper award.

I will be rotating off as President of the YUO. I am grateful for the contributions of the Executive Committee, which consists of Todd Morgan, MD, University of Michigan (rising President); Alex Kutikov, MD, Fox Chase Cancer Center (President-Elect); Matthew J. Resnick, MD, MPH, Vanderbilt University Medical Center; John L. Gore, MD, MS, University of Washington; and Will Lowrance, MD, MPH, University of Utah. A recent election for positions on the Steering Committee generated significant interest and a large volume of highly-qualified applicants. Two new members will be selected in time for the Annual Winter Meeting, with an eye toward enhancing the diversity of our Executive Committee and maintaining the strong interest in our group.

It is a privilege to represent this organization of talented and productive individuals, national leaders in caring for patients with urologic cancers. We continue to welcome suggestions as we strive to provide value to our membership and look forward to seeing you in Washington, DC.

LUGPA continues to advance urology group practices in the United States and now represents more than a quarter of the nation’s practicing urologists. LUGPA and its member practices are committed to best practices and research that allow and encourage independent practices to flourish under a value-based care model. Through data collection and benchmarking initiatives, LUGPA works to promote quality clinical outcomes. Due to LUGPA’s unwavering commitment to high quality and cost-effective, value-based medicine, the association has expanded impressively since its founding seven years ago.

This year, LUGPA has grown its activity in the public policy arena. From engaging our members to contact and build relationships with their member of Congress, to providing the Centers for Medicare and Medicaid Policy (CMS) comments on both the Physician Fee Schedule and the Hospital Outpatient Prospective Payment Schedule regarding proposals affecting independent urology, LUGPA’s involvement in health policy continues to expand.

Among LUGPA’s key initiatives this year, I wanted to highlight the following:

• Membership Expansion: LUGPA modified its bylaws to welcome practices with five or more physicians to allow more urologists to benefit from its growing network. Member practices’ model of care is enhanced by the revised membership and national presence expansion, as the association is dedicated to helping practices grow within their communities, thus engaging both existing and prospective patients.

• First-Ever CEO: In late September, LUGPA announced their first Chief Executive Officer, Celeste Kirschner. Kirschner comes to the organization with more than 20 years of experience in medical society management including American Society of Anesthesiologists (ASA) and the American Medical Association (AMA). We look forward to continued growth and innovation under Kirschner’s leadership.

continued on following page

Page 12: SUO 2015 Pre-Convention Newsletter

12

• Amplified Advocacy: In a win for the entire independent practice community, LUGPA physicians, staff and patients generated thousands of phone calls, emails and faxes in support of the Sustainable Growth Rate (SGR) repeal. LUGPA’s efforts received special recognition by House leadership for its exemplary role in rallying support for the repeal that ended the cycle of patchwork fixes to the deeply flawed formula.

• Regional Outreach: To accommodate member practices throughout the country, LUGPA has introduced regional meetings at convenient airport hubs beginning in spring 2016. Regional meetings will allow practices to network and share best practices outside of the Annual Meeting and foster new practice relationships.

LUGPA also continues a series of collaborative communication efforts with the American Urological Association (AUA) and the American Association of Clinical Urologists (AACU) to help align the urologic community and develop a cohesive message from our specialty. As the three largest urology associations, the AUA, AACU and LUGPA continue to voice unified support the USPSTF Transparency and Accountability Act of 2015. The legislation, introduced by Representatives Marsha Blackburn

and Bobby Rush, aims to reform the process by which the U.S. Preventive Services Task Force (USPSTF) reviews and develops recommendations for clinical preventive services. We look forward to working with the AUA and AACU to advance this important legislation.

LUGPA continues to work its partners, such as SUO and AUA to enable urology practices to flourish during this era of transformative health care. In April, LUGPA shared the bacillus Calmette-Guerin availability letter with membership through its weekly Media Monitor report and posted it on the LUGPA website. This letter included updates from the AUA and the SUO on the limited supplies of this critical drug impacting urology practices and patients.

LUGPA looks forward to fostering its relationship with all stakeholders to strengthen practice networks and advance quality urology care. Together with the SUO, LUGPA remains focused on several policy initiatives that lie ahead and will continue to work to protect independent integrated practices and allow patients to receive care at the site of their choosing.

“It is a privilege to represent this organization of talented and productive individuals, national

leaders in caring for patients with urologic cancers. We continue to welcome suggestions as we strive to

provide value to our membership...”