Tag: Clinical Trials

A Meeting of the Minds in Prague

prague-aua-programLast week, approximately 100 of the leading experts in genitourinary (GU) cancer research and treatment converged in Prague in the Czech Republic for the 114th Annual American Urology Association (AUA) Meeting. The AUA’s mission is “to promote the highest standards of urological clinical care through education, research and in the formulation of health care policy.”

The AUA has over 22,000 members from across the country, and many of the Weill Cornell Medicine/NewYork-Presbyterian GU physicians serve as members of the New York chapter. At this year’s meeting, doctors David Nanus, Jim Hu, and Scott Tagawa were invited to present on the latest standards in screening and treatment for prostate, bladder and kidney cancers.

jim-hu_aua-prague-2016On Thursday, September 15th, Dr. Jim Hu spoke about the screening controversy surrounding the early detection of prostate cancer and how this influences present day practice and the medical care men are receiving. We have a number of different screening tools available to detect prostate cancer and distinguish between aggressive and non-aggressive sub-types. One of the most common and least invasive ways to screen for prostate cancer is through Prostate Specific Antigen (PSA) testing, but this is controversial because some argue that it leads to false positives, or the detection of cancers that are very slow growing and may never need treatment. Most physicians and scientists agree that PSA testing isn’t perfect, but research shows that it can be a very good screening indicator when used in conjunction with physical exams, biomarkers and imaging tools. In addition, analysis of a recent study demonstrated that surveillance remains an option for some men with little difference in 10-year survival in those that choose treatment with either surgery or radiation, though there are tradeoffs in terms of a higher likelihood of developing advanced cancer in those that avoid more aggressive treatment.

Later that day, Dr. Scott Tagawa provided an update on the impact of chemotherapy in treating prostate cancer – a modality that was once thought to be a treatment last-resort. Chemo is now a standard much earlier on during cancer care and people are living longer, and feeling better as a result. In particular, the earlier use of a short course of chemotherapy at the time that men initially present to the clinic with advance prostate cancer leads to a significant increase in survival combined with better overall quality of life in the longer-term. The two taxane chemotherapy drugs proven to be successful in prostate cancer are docetaxel and cabazitaxel, and the latest research on these drugs seeks to answer questions regarding for whom and when these treatments will be benefit. At Weill Cornell/NYP we are leading the field in this research and developing hi-tech biomarkers to determine sensitivity and resistance.

Dr. David Nanus presented on Friday and highlighted the latest advances in treating urothelial cancers of the kidney and bladder. After nearly three decades with no new FDA drug approvals for bladder cancer, in 2016 we witnessed great treatment advances for bladder cancer. With immunotherapy, chemotherapy and genomics, we’re now on the cusp of precision medicine. The combination of these approaches with novel treatments is improving the lives of many of our patients with advanced urothelial carcinoma. We are now able to offer complete tumor and germline (inherited) genomic analysis as part of research studies that in the near term will translate to selecting the optimal treatment strategy for each individual patient.

Is Surgery Critical for Advanced Kidney Cancer?

Drs. Ana Molina, Jim Hu and David Nanus address key issues in an editorial published this week in the Journal of Clinical Oncology

Surgical HandsUntil the last decade, there was much debate on the standard of care treatment for patients with metastatic renal cell carcinoma (mRCC), commonly referred to as advanced kidney cancer. Some physicians believed that the best treatment was to surgically remove the kidney, a process called cytoreductive nephrectomy (CN), while others argued that surgery did more harm than good.

In 2001 and 2004, two randomized clinical trials compared the two approaches (cytokine therapy alone vs. surgery plus cytokine therapy) in a controlled, side-by-side fashion and demonstrated a survival benefit for patients who had surgery followed by cytokine therapy. Cytokines are man-made versions of naturally occurring proteins that can enhance the immune response to cancer. This research found that patients that underwent surgery in addition to being given the cytokine interferon medication showed an average survival of 13.6 months, compared with 7.8 months for those who only received the interferon treatment, demonstrating a 31% reduced risk of death. Based on this study, urologists and oncologists continued to recommend surgery, seeing major improvements in disease-free and overall survival in patients who had their primary kidney tumors surgically removed.

Over the past ten years, there have been critical advancements in the treatment of kidney cancer and targeted therapies (i.e. vascular endothelial-growth factor inhibitors) have replaced cytokine therapy as the standard of care. Targeted therapies block the growth and spread of cancer by interfering with specific molecular targets associated with cancer. The role of surgery has become unclear since the introduction of targeted therapy. Of note, nearly 90% of patients enrolled in the early studies examining targeted therapies had undergone nephrectomy.

Retrospective studies suggest that surgery improves outcomes and reduces the risk of death from cancer by more than 50%. Despite possible improved outcomes, we have seen a decline in the use of surgery. A recent study sought to evaluate current utilization rates of surgery and examined the survival benefit of surgery compared with no surgery. They noted that currently only three out of 10 patients receiving targeted therapy undergo surgery. In addition, socioeconomic and racial disparities were associated with these declines. Younger, white people with private insurance and earlier stage cancer are more likely to have their tumors removed. These declines are also more significant at community hospitals than academic centers. This is important to point out because research also shows that African Americans with metastatic kidney cancer have a poorer prognosis than white patients, and inferior survival is more pronounced in black patients who do not undergo surgery.

Two large, phase 3 randomized clinical trials (CARMENA and SURTIME) will provide answers about the role of surgery in the era of targeted therapy. The CARMENA study is enrolling patients in France and comparing the outcomes of surgery followed by targeted therapy versus targeted therapy alone. The European SURTIME study is comparing the impact of patients undergoing immediate surgery and then receiving targeted therapy with patients first receiving targeted therapy and then deferred surgery. Until these two studies are completed and the results are available, we recommend that all medical oncologists and urologists carefully evaluate each patient and consider surgery when feasible.

Moonshot Summit: Changing Cancer As We Know it

DAVID NANUS, MD

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Photo credit: Ira Fox

On June 29, Weill Cornell Medicine and NewYork-Presbyterian Hospital joined more than 270 institutions across the country in holding a Moonshot Summit. These summits were held in conjunction with Vice President Biden’s Moonshot initiative to fight cancer. On this national day of action, cancer experts throughout our institution, survivors, and advocates came together to share their ideas for increased collaboration and cures.

The summit conversation started with a constructive dialogue about clinical trials and the unfortunate fact that for many cancer types, the “standard of care” chemotherapies are not good enough. At Weill Cornell Medicine and NewYork-Presbyterian, immunotherapies and precision medicine are opening new doors in cancer treatment, but sadly not all patients currently have access to these types of cutting-edge treatments.

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A packed room at the Weill Cornell Medicine/NewYork-Presbyterian Hospital Cancer Moonshot Summit (photo credit: Ira Fox)

Clinical trials may have gotten a bad rap in the past, but they are a powerful tool to access innovative treatments. The speakers agreed that clinical trials should be easily accessible to all patients, but at times there are obstacles. These range from lengthy forms that deter enrollment, to bureaucracy that slows the timeline for opening new clinical trials, to disinterest and concerns about the treatments’ effectiveness. On a global scale, there has been a lack of adult participation in cancer clinical trials, while for children we actually see the opposite trend – very high enrollment. What can we learn from this information?

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(L-R) Dr. Gail Roboz and Dr. Susan Pannullo speaking at the Cancer Moonshot Summit (photo credit: Ira Fox)

One of my colleagues Dr. Gail Roboz wisely stated, “I always tell my patients, be afraid of the disease, not the treatment.” She’s right in that we need to reframe the conversation to focus on making strides in increasing cure rates through new research that leads to new treatment breakthroughs across disease states.

We also talked about access to care. Not all patients are able to get a correct diagnosis quickly. This can be due to a variety of reasons including a lack of access to specialists, living in a rural area, or financial limitations. By increasing government research funding, as well as making it easier for patients to reach quality care, we can remove some of these barriers nationally. If we increase the number of people who are diagnosed with cancer early on, we can increase the cure rates. Additionally, as a country, we need to provide comprehensive care for patients and families and always put the interests of patients first. This includes offering supportive services beyond just the best medical care.

I felt so empowered by my colleagues and our patients’ great ideas about how we can overcome the challenges we face in cancer care. The Cancer Moonshot initiative is giving high hopes to many and will help ultimately change the world of cancer care as our country stands together with common goals and a renewed commitment to collaboration. By bringing everyone together at an event like this, we hear diverse perspectives and glean new insights. The fight against this terrible disease truly unites us all.

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Photo credit: Ira Fox