The Weill Cornell Medicine and NewYork-Presbyterian Genitourinary Oncology Program is proud to announce that our physicians have been identified as Castle Connolly 2017 Top Doctors for cancer in the United States and in the New York Metro area. This further validates our long-standing commitment to patient care and the advancement of medicine.
Each year, Castle Connolly, an established healthcare research company located in New York, bases its selection through a peer-review process, extensive research and screening of nearly 100,000 nominations. This nomination shows that not only do our physicians have a great reputation, but they are also recognized by other doctors who can attest to their commitment to the field of genitourinary oncology.
“Within the Genitourinary Oncology Program, we are dedicated to providing cutting-edge care and access to clinical trials for people with all stages and types of prostate, kidney, bladder and testicular cancer,” said Scott Tagawa, MD, Medical Director of the Genitourinary Oncology Research Program at Weill Cornell Medicine.
Diagnosing and using the latest technologies to molecularly characterize and find the right treatment for each patient is an individualized process. Physicians in the Genitourinary Oncology Program, as well as other cancer experts throughout Weill Cornell Medicine and NewYork-Presbyterian, utilize an approach to treatment known as precision medicine that assesses individual variability in the tumor’s genes and microenvironment. This allows our physicians and researchers to better understand and predict which treatment approach will work best for each patient, without using a “one-size-fits-all” approach.
According to Dr. Tagawa, “Patient care is our utmost priority and winning this prestigious Castle Connolly Top Doctors award is a testament to our dedication to improving the lives of our patients. I’m honored to be part of such a comprehensive and multidisciplinary team.”
Congratulations to the GU physicians on this outstanding achievement!
About Castle Connolly and America’s Top Doctors
The mission ofCastle Connolly Medical Ltd.is to help consumers find the best healthcare. They publish a variety of books including the “Top Doctors” series, the most popular of which is America’s Top Doctors®. Doctors who are among the very best in their specialties and in their communities are selected for inclusion.
Each year, the American Society of Clinical Oncology (ASCO) Annual Meeting brings together more than 30,000 oncology professionals. At this year’s meeting in Chicago, physicians and scientists presented the latest research findings in an effort to bring the best cancer treatments to patients across the United States and the world. We’ve outlined some of the genitourinary (GU) oncology highlights, broken down by disease type.
At this year’s meeting, there was also some important research presented related to communication, quality of life and survival. In a study that involved patients with GU cancers, as well as those with other types of tumors, patients were randomized to two groups: 1) a control group of standard care 2) a group to utilize a web-based patient-reported outcome questionnaire between visits. Results from any answers completed in the online system were sent to the treatment team in real time. In this study, the patients that were randomized to the online questionnaire group experienced better quality of life. In addition, these patients lived longer, with a 17% improvement in survival simply by using the online tracker reporting symptoms to their treatment team between visits. While the study was only conducted at a single institution, it underscores the importance of communicating and relaying any symptoms to your treatment team members responsible for your medical care (generally physicians, nurses and advanced practitioners).
The results from two large phase 3 clinical trials will lead to a change in the standard of care treatment for men with advanced prostate cancer. The LATITUDE and STAMPEDE trials investigated the addition of abiraterone and low dose prednisone to standard androgen deprivation therapy (ADT) for men with advanced prostate cancer. Similar to the unprecedented results presented at ASCO in 2014 (CHAARTED) and 2015 (STAMPEDE) with the use of docetaxel chemotherapy, a major improvement in overall survival was demonstrated, improving length of life by nearly 40%. The results from these studies will provide an additional treatment option for men presenting with advanced prostate cancer.
For men with metastatic castration-resistant prostate cancer (mCRPC), a randomized phase 2 trial demonstrated no significant differences in the efficacy, or effectiveness, of abiraterone or enzalutamide, two of the leading treatments for prostate cancer that is resistant to hormonal therapy. This research finding was consistent with most clinicians’ belief that either drug may be utilized, allowing physician and patient choice. Importantly, the study incorporated a number of interesting biomarkers using circulating tumor cell (CTC) DNA from a liquid biopsy, and the data gleaned from the DNA revealed prognostic insights about disease aggressiveness and biology. Another study showed a lack of utility to continue enzalutamide after disease progression, confirming the current practice of switching treatments after cancer growth.
Additional data was presented on genomic signatures from prostate tissue, which in combination with clinical data, are more powerful in indicating prognosis in men who receive treatment for clinically localized (low stage / early) prostate cancer.
Prostate cancer acquires resistance to systemic treatment as a result of tumor evolution and selection, but repeat biopsies to study how cancers evolve are challenging, invasive, and may be confounded by tumor heterogeneity. Dr. Himisha Beltran evaluated a non-invasive approach: whole exome sequencing of circulating tumor DNA in the blood. Additional data utilizing circulating tumor cell (CTC) counts as an early indicator of response may speed drug development. Clinical trials are currently evaluating measuring circulating tumor cell counts as a biomarker for whether or not treatments are working. This may be a better indicator than measuring levels of prostate specific antigen (PSA), the current indicator for response.
Dr. Scott Tagawa presented a trial-in-progress update about the clinical trial he is leading at Weill Cornell Medicine and NewYork-Presbyterian utilizing the small molecule lutetium 177Lu-PSMA-617 to target prostate-specific membrane antigen (PSMA). PSMA is a protein abundantly expressed in 85-90 percent of metastatic prostate cancer cells, and this is the first U.S. trial of its kind. Learn more about this radionuclide therapy-based clinical trial and the eligibility criteria.
Additionally, there were many research updates presented in the area of neuroendocrine prostate cancer (NEPC), an aggressive subtype of prostate cancer that is resistant to many traditional treatment types. Dr. Loredana Puca received a Merit Award from the Conquer Cancer Foundation for her research examining the potential use of antibody-drug conjugate rovalpituzumab tesirine for treatment of NEPC. View the abstract and learn more about our open clinical trial using this antibody-drug conjugate. Dr. Himisha Beltran highlighted the significance of the loss of tumor suppressor ZFP36 in prostate cancer patients.
Prostate cancer was the first tumor type to have a cancer vaccine (sipuleucel-T) lead to longer survival, but the drug’s activity may be limited on its own. In a randomized phase 2 trial, receiving sipuleucel-T in combination with indoximod – a drug with the potential to improve immune response – kept the cancer at bay more than twice as long compared to those who received sipuleucel-T plus a placebo. This was an exciting research update showing promise for patients with prostate cancer.
New research using tumor and liquid (blood-based) biopsies demonstrated that a majority of tumors and circulating tumor cells in men with metastatic castration-resistant prostate cancer express a protein called Trop-2, justifying a targeted treatment approach. With this knowledge, we are now evaluating the safety and efficacy of IMMU-132, an immunotherapy-based drug that targets Trop-2, in an open clinical trial for men with prostate cancer.
Bladder Cancer and Other Urothelial Cancers:
Dr. Bishoy Faltas was invited to present at the ASCO Clinical Science Symposium entitled “Expanding the Actionable Landscape: Bladder Cancer Genomics — Unlocking the Genome: Insights Into Risk and Response in Bladder Cancer.”
During this session, Dr. Faltas discussed the genomics of urothelial cancer, and highlighted the latest research describing new data on the frequency of inherited (germline) mutations as well as tumor (somatic) genomics and relationship to response to chemotherapy and immunotherapy. Patients with “upper tract” urothelial cancer (tumors arising in the kidney or ureter) in particular have a higher chance of harboring an inherited mutation. Different genomic alterations in the tumors may be separated into groups that are associated with better responses to chemotherapy and immunotherapy. This is becoming more clinically relevant as we can test for these genes and the number of treatment options is expanding.
Additionally, updated results of the KEYNOTE-045 study confirmed the overall survival benefit of the anti-PD1 immune checkpoint inhibitor pembrolizumab (Keytruda) compared to second-line chemotherapy in patients with prior platinum-based chemotherapy. Importantly, this was the first head-to-head trial to demonstrate the superiority of immunotherapy over chemotherapy in urothelial cancer.
Several different combination studies for the treatment of advanced renal cell carcinoma (RCC) were presented at the 2017 ASCO Annual Meeting. While some studies demonstrated promising response data, significant toxicity of some combinations underscored the importance of clinical trials and the recommendation to avoid combinations outside of the research setting, which is regulated and in which these types of side effects can be monitored. Several randomized phase III trials testing combination therapy are ongoing with results anticipated to lead to changes in standard of care.
Unfortunately, despite imaging that indicates no evidence of cancer metastases (spread), many patients are not cured with surgery alone. Treatment of many cancers incorporate the use of systemic (medical) therapy in addition to surgery to increase cure rates. For the most part, this strategy has not been overwhelmingly successful in the setting of renal cell carcinoma (RCC). Unfortunately, another “negative” phase III trial showed that the addition of pazopanib (Votrient) to surgery did not improve cure rates for patients with RCC. Additional data was presented utilizing either clinical or genomic biomarkers that may assist physicians in choosing patients that might benefit from the addition of the oral drugs following surgery. We continue to await the results of additional completed studies and some currently enrolling studies utilizing immunotherapy before/after surgery.
Beginning a clinical trial is a lot like preparing for a wedding or another large celebratory event with many details and different people working together. In the case of starting a clinical trial, the “big day” is your first day of treatment. Planning a wedding entails coordination with multiple vendors – venues, florists, catering – all within a set period of time. Similarly, there is a set timeline for determining eligibility and enrolling on a clinical trial. We call this process “screening” and everyone who is interested in starting a clinical trial must go through screening prior to enrolling on the trial. The screening process requires collaboration with:
Physicians and nurses who work directly with you to perform specific procedures and tests necessary for eligibility
Lab technicians who process your blood or other samples according to study specific protocols
Sponsors (such as pharmaceutical companies) to verify your eligibility for the trial
Pharmacists to ensure you are dispensed the proper drug and dose
Federal oversight (such as the FDA) to ensure proper safety reporting for you as well as past and future patients exposed to the treatment
Coordination can be difficult. That’s where I come in.
Just as a wedding planner assists brides, as a study coordinator, I assist patients. I work diligently behind the scenes with a range of health care providers and clinical research colleagues to ensure that each step of the screening process is feasible for patients to complete, and to help ensure that there are no delays in starting treatment.
IT’S LIKE A CLOCK COUNTING DOWN
So what exactly is screening? Here are three things to know:
Screening begins the moment you enroll (most often by signing a consent document) It’s a checklist of items that must be completed within certain windows of time to verify your eligibility for a trial. The timeline varies depending on the study protocol, but on average, scans and labs must be completed within 28 days of receiving the first treatment. Sometimes, labs must be completed within 14 days prior to starting a clinical trial.
Screening does not guarantee eligibility It’s not enough to complete a test. Sometimes, your test results must fall within a certain range. Often, this is for safety reasons, but it can also be because the drug is only thought to work in certain populations or with certain pre-established disease parameters.
The biggest challenges are coordination and accommodation In reality, completing this checklist is not always simple, but we do our best to simplify it and accommodate you.
Screening consists of standard-of-care procedures – tests you’ve likely completed from previous visits with your provider, like blood tests to determine white blood cell count, hemoglobin levels, etc. – and study specific procedures – tests that are normally not conducted, but that the trial would like to test, such as magnesium, phosphorous or amylase.
If you have had standard of care procedures prior to consenting that we can use to verify your eligibility, we will use them, but depending on when they happened, this may decrease the amount of time we have to complete the other required tests, since all testing must occur within a certain window of time.
IT REQUIRES SUPPORT
Beginning a clinical trial can be a daunting task, but rest assured that in addition to the support of your family and your healthcare team, you also have a network of clinical trial personnel cheering you on during each step of the way.
Aileen Lee is a genitourinary (GU) cancer clinical trial coordinator. Through the Weill Cornell Medicine and NewYork-Presbyterian Joint Clinical Trial Office (JCTO), Aileen screens patients interested in participating in a clinical trial for kidney, bladder, prostate or testicular cancer. She also contributes to Dr. Molina’s Kidney Cancer Support Group. She is an Oregon native, violinist and aspiring physician.