Breaking news today as, for the first time, a drug has been FDA-approved for cancer based on disease genetics rather than type. Developed from 30 years of basic research at Johns Hopkins and its Bloomberg~Kimmel Institute, pembroluzimab now can be used for colon, pancreatic, stomach, ovarian and other cancers if genetic testing reveals defects in so-called mismatch repair genes. Read more about the new approval.

Dung Le

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Patients and doctors received news this week of the FDA’s approval of the immunotherapy drug pembrolizumab in combination with platinum doublet chemotherapy as first-line therapy for all patients with non-small cell lung cancer, irrespective of patients’ tumor PD-L1 status.

Benjamin Levy, M.D.

Benjamin Levy, M.D.

The new approval follows the FDA’s decision last November to approve pembrolizumab as a first-line therapy for some patients with non-small lung cancer, but only if their tumors showed expression of a protein called PD-L1. The previous approval was based on an international trial led by the Kimmel Cancer Center’s Julie Brahmer, M.D.

This week’s approval was based on a small clinical trial of 160 patients, led by Corey Langer, M.D., director of thoracic oncology and professor of medicine at the University of Pennsylvania. The trial showed that the chemo-pembrolizumab combination can improve the response rates (meaning some evidence of tumor shrinkage) in more than 50 percent of patients with lung cancer compared with nearly 30 percent who received chemotherapy alone. There was a small average benefit of four months — referred to as a progression-free survival benefit — for patients who received the combination compared with those who received only chemotherapy.

However, there was no overall survival benefit of the drug combination. “Immunotherapy, at this point, doesn’t benefit all patients, and we need to be mindful of the drug’s costs and potential side effects,” says Benjamin Levy, M.D., clinical director of medical oncology and medical director of thoracic oncology for the Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital in northwest Washington, D.C. “This new drug approval provides a broader opportunity to consider the role of immunotherapy in the treatment of all of our patients with advanced non-small cell lung cancer.”

Watch a video of Levy: A Mission to Lead.

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On a weekend before a business trip, Ken Brothers noticed some blood in his urine. He wondered if it was related his recent loss of 40 pounds on a medically-supervised diet and emailed his doctor about it. Blood in the urine is a common symptom of bladder cancer, but its presence is not always associated with cancer. Infections, kidney stones and other conditions can cause bloody urine.

Ken Brothers (right) with his son at Machu Picchu in Peru.

Ken Brothers (right) with his son at Machu Picchu in Peru.

Ken’s doctor said that it was highly unlikely that his diet caused blood in the urine and suggested he see a urologist ASAP. Within a week, his local urologist diagnosed him with bladder cancer. Ken requested the tissue samples be reviewed by Hopkins’ pathologists, who identified it as muscle invasive micropapillary, one of the most aggressive types of bladder cancer.

As the fifth most common cancer in the U.S., bladder cancer affects mostly men older than 75, but Ken was only 49 when he was diagnosed. Bladder cancer in its earliest stages are highly curable, but even the smallest tumors tend to recur often, requiring invasive exams of the bladder every six months. Ken’s cancer had progressed to invade the muscle wall of the bladder. Doctors at four different institutions unanimously advised Ken to have chemotherapy, then surgery to remove the compromised bladder. Despite the chemotherapy, Ken’s cancer spread beyond his bladder. When his bladder was removed, metastatic cancer was found in 12 lymph nodes.

When bladder cancer metastasizes, survival rates plummet. For decades, doctors have struggled to find highly effective treatments for these “Stage IV” patients. Ken had a second type of chemotherapy, but the cancer continued to spread. In early 2015, Ken joined a Hopkins-led clinical trial for an immunotherapy drug. Ken had a complete response, and today has no evidence of disease.

The recent development and approvals of immunotherapy drugs have encouraged patients and doctors alike. “We believe that, in the near term, we’ll make major progress in being able to better manage bladder cancer,” says David McConkey, Ph.D., director of the Johns Hopkins Greenberg Bladder Cancer Institute.

The goal, McConkey says, is to quickly implement projects that integrate science with medicine. For example, the Greenberg Institute plans to sequence the genome of every bladder cancer patient who comes to Johns Hopkins. In a research environment, the costs for genome sequencing are low – approximately $300 per patient – and the costs are covered by the Institute.

Genomic sequencing in bladder cancer can help guide therapies now that recent research has identified genomic features that predict which patients may benefit the most from chemotherapy, immunotherapy and other targeted agents. For example, McConkey says that one subtype of bladder cancer already identified may benefit more from frontline chemotherapy given to patients before surgery to remove the bladder.

Collaborations between the Greenberg Institute and other cancer centers are underway to identify other genetic cues to guiding therapy, including mutations in genes that repair DNA and using blood tests to find bladder cancer-linked DNA that might indicate worsening cancer or whether immunotherapy or other drugs are working.

McConkey reviewed these advances and other bladder cancer research during a plenary session at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, Society of Urologic Oncology and the American Society for Radiation Oncology.

“We’ve had plenty of successes, but they’re not nearly enough to reduce the extensive monitoring and recurrences that most patients with early disease experience and create long-term regressions in most bladder cancer patients with advanced disease,” says McConkey.

Five years after his diagnosis of advanced bladder cancer, Ken credits his longevity to good advice from his doctors, immunotherapy drugs, his own self-advocacy, and good luck. He continues to write Ken’s Cancer Blog, aimed at inspiring and educating other cancer patients and their caregivers. In our next bladder cancer blog, we’ll hear from Ken with questions and answers about his experiences and advice.

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William Nelson, M.D., Ph.D.

William Nelson, M.D., Ph.D.

“There are an increasing collection of tests that sample other aspects of prostate cancer in urine, blood or tissue, including acquired gene defects in the disease and acquired changes that cancers display that normal cells don’t,” says William G. Nelson, M.D., Ph.D., director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. “I would argue that the collection of tests have just started. Some have just begun to get approval from the U.S. Food and Drug Administration, but none of them have yet been approved for screening purposes. In addition, there are modified PSA assays that increase the predictive value of PSA to diagnose higher-risk disease. The good news is that these screening processes are improving and will improve more as some of these new molecular tests become widely available.”

Watch an AACR Webinar about cancer screening.

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No matter how you respond to your diagnosis, it’s not unusual for cancer patients to feel the impact of spiritual pain and distress, says Rhonda Cooper, an oncology chaplain at the Johns Hopkins Kimmel Cancer Center in Baltimore.  Signs of spiritual distress for cancer patients may include:

  • Guilt or regrets about things you have done
  • Fear of dying
  • An inability to find comfort in prayer, worship or study in your faith
  • Feeling you are being punished
  • Losing hope

Cooper emphasizes that these are normal spiritual reactions to an unexpected crisis such as a cancer diagnosis. Your doctor, nurse or social worker can contact a chaplain for you, and you also can take advantage of the Bunting Interfaith Chapel on the main level/arcade of the Zayed Tower at Johns Hopkins, or the meditation room located in the Weinberg Building lobby, which are always open for prayer and reflection. Weekly worship services also are held throughout the hospital.

Chaplain Cooper explains more in this video about spiritual care for cancer patients at the center:

 

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William Nelson, M.D., Ph.D.

William Nelson, M.D., Ph.D.

“The best approach is to have a significant conversation with your physician about the risks and benefits of screening. It's shared decision making,” says William G. Nelson, M.D., Ph.D., director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. “People have different attitudes about what they’d like to do with their health. If someone had a brother who had prostate cancer and became very sick, that person may be very concerned about prostate cancer and may want to take maximum advantage of screening in an effort to reduce the chance that his life might be threatened by prostate cancer. If, on the other hand, a person knows two or three other men who have had bad side effects from treatment, they might not want to pursue screening. Still others are concerned about overtreatment for prostate cancer.”

Watch an AACR Webinar about cancer screening.

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“Don’t be shy. It is not a sign of weakness to want a person of faith by your side at a time like this,” says Rhonda Cooper, an oncology chaplain at the Johns Hopkins Kimmel Cancer Center in Baltimore.  If you are struggling to understand why you have cancer, are feeling a range of emotions from guilt to anger, or feel isolated from your faith community, our experts in spiritual and pastoral care can help you as well as your family members in a non-denominational setting. As you progress on your cancer journey, our chaplains can:

  • Make sure your religious traditions and practices are observed as fully as possible.  For example, Communion and Anointing of the Sick can be provided during your hospital stay.
  • Offer you comfort in times of spiritual distress and anxiety.  Listening to your concerns is at the heart of the Chaplain’s practice.
  • Pray with you during your treatment.  You may want to pray with a Chaplain, as a source of comfort and support during your treatment
  • Support your family and friends. Chaplains also are available to support your personal support team. You also can ask a chaplain to participate in physician-family conferences.
  • Talk with you about end-of-life decisions. Chaplains can assist you in completing advance directives, including a selection of a health care agent, treatment preferences (living will), and decisions about organ donation.

Your doctor, nurse or social worker can contact a chaplain for you. Here’s a video with Chaplain Cooper to get you started:

Find out more about the full range of spiritual support services at the Johns Hopkins Kimmel Cancer Center, and look for other useful resources in our Patient and Family Education pages.

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At the annual Research Matters conference yesterday, top scientists from the Johns Hopkins Kimmel Cancer Center and University of Maryland Greenebaum Cancer Center discussed research using advanced imaging methods to develop better ways pinpoint and track cancer cells — down to the microscopic level — and precisely target each cell with anti-cancer drugs. Experts also delivered presentations on advances in four types of cancer affecting Marylanders: pancreatic, lung, liver and mesothelioma, a cancer of the lining of the chest and abdomen.

Flip through following slideshow of tweets during the conference:

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William Nelson, M.D., Ph.D.

William Nelson, M.D., Ph.D.

Prostate-specific antigen (PSA)-based screening for prostate cancer has received mixed reviews from different organizations, says William G. Nelson, M.D., Ph.D., director of the Johns Hopkins Kimmel Cancer Center. Today, the United States Preventive Services Task Force has posted draft recommendations for prostate screening that encourage men ages 55 - 69 to make individual decisions about screening after talking with their doctors about potential harms and benefits.

Other organizations recommend that PSA-based screening should be offered to all men beginning at age 50-55; that PSA-based screening should be considered before age 50 for African-American men and for men with a strong family history of prostate cancer; and that all men at risk for prostate cancer should participate in shared decision-making with physicians to ensure that the benefits and harms of screening are well understood before pursuing PSA testing.

“Prostate cancer screening has become somewhat controversial in our society even though it works,” says Nelson. “The controversy stems from the belief that the reduction in prostate cancer deaths due to screening, although real, is small. Some also worry that the harms associated with the diagnosis and treatment of the cancers being detected are common, persistent and may actually be a hazard. They worry that the more men they screen, the harms will increase and the benefits won’t be as fully realized. So they conclude that the benefits don’t outweigh the harms."

“There are screening recommendations from many organizations. Almost all of them come down to the notion that screening can be effective, but there should be serious consideration of the risks and benefits for each individual through a discussion with their doctor and shared decision making to ensure that all the benefits and harms of screening are well understood before pursuing PSA testing or a screening strategy.”

"The increasing use of active surveillance, where many men with low- or very low-risk prostate cancers can avoid treatment and its side effects altogether, may reduce the potential harms of prostate cancer screening at a population scale.”

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*This blog post was written by the Kimmel Cancer Center's development specialist, Allison Rich.

Anyone who has ever heard the words “you have cancer” knows that no part of their life remains unaffected by the reality of this diagnosis. Yet even though we know this to be true, the traditional approach to cancer medicine has not always incorporated these multifaceted and all-encompassing impacts into the plan of care. Here at Johns Hopkins, Claire Snyder, Ph.D., is seeking to transform this traditional paradigm, ensuring that every aspect of functioning and well-being is taken into account throughout the course of a patient’s cancer treatment and beyond.

Dr. Snyder’s background in healthcare outcomes and quality of life began when she was an undergraduate. Upon returning to Duke University from a health policy internship on Capitol Hill, she took a course on value in healthcare. This course showed her that medicine as a whole was largely lacking an evidence-based approach to understanding how what we do and how we do it impacts the day-to-day lives of patients and families. The awareness she gained in this course deeply resonated with her, and she knew that this was something that she wanted to spend the rest of her life doing.

This revelation has in fact shaped the course of her entire career, and is what drove Dr. Snyder to go on to receive her Master of Health Science in Health Policy, and then her Ph.D. in Health Policy & Management, from the Johns Hopkins Bloomberg School of Public Health. Johns Hopkins is still her professional home today, where she holds appointments in Medicine, Oncology, and Health Policy & Management. Her work centers on two principle areas: improving communication between cancer care providers and primary care providers across the treatment continuum and into survivorship, and developing tools to help cancer care providers better monitor patient well-being during active treatment. Broadly speaking, Dr. Snyder describes her work as assessing “how we can we use the patient’s own voice to improve the quality of life they experience and the quality of care they receive.”

Currently, Dr. Snyder’s work in improving communication between cancer providers and primary care providers focuses on how to help cancer patients transition to survivorship when their initial treatment is complete. Her research and that of her colleagues has shown that many cancer survivors don’t receive the care that they should be getting – or, in some cases, even receive care that they don’t actually need. To remedy this issue, the National Academy of Medicine recommends that patients receive a “survivorship care plan,” or SCP, when they complete treatment. This document summarizes the therapies received and outlines the follow-up care needed, and is intended to be a tool for both survivors and primary care providers. Dr. Snyder is co-Principal Investigator of a randomized, controlled trial to investigate the best approaches for delivering SCPs in the most effective and efficient manner possible, with the goal of ensuring that survivors and their primary care providers are both on precisely the same page, without placing a burden on either the survivor or their oncology care team. As these plans are now required for accreditation by the American College of Surgeons Commission on Cancer, Dr. Snyder’s work is exceptionally relevant to creating a model which will ensure that patients and providers have access to this important document both here at Hopkins and at other cancer centers across the region.

For patients who have not yet concluded their treatment process, Dr. Snyder has also spearheaded efforts to, as she describes, “make quality of life assessment as routine a part of cancer care as laboratory values and imaging studies, so that when a patient is being seen by their cancer clinician, the clinician has in front of him or her the lab values, the imaging studies, and the patient’s own report of their feelings, functioning, and well-being.” Dr. Snyder and her colleagues hope that this effort will not only help clinicians identify issues that may have otherwise gone unnoticed, but will also give patients an open line of communication to discuss topics that are sometimes difficult to raise, such as sexual function. Since Dr. Snyder implemented this approach through an online portal called PatientViewpoint, patients and providers alike have expressed how beneficial it is to have the opportunity to readily discuss these issues. While clinicians reported that the portal allowed them to gain insight into elements of their patients’ health that may not have come up during a standard office visit, such as increased feelings of depression or life events conflicting with treatment schedules, patients revealed that the process made them feel that their oncology team truly cared about them not only as patients but as people, allowing them to voice concerns about topics such as body image that may otherwise have been forgotten between visits or pushed to the wayside in light of other medical concerns. For Dr. Snyder, comments such as these underscore the value of what she calls “putting the ‘care’ in cancer care.”

In addition to focusing on making sure the patient’s voice is heard across the entire cancer care spectrum, and providing a mechanism for this data to be included in the medical record in a systematic and routine way, Dr. Snyder also established a platform for Johns Hopkins faculty who are passionate about these same issues to come together and establish a research community, called the BLOCS program. BLOCS, which stands for Building Lifestyle, Outcomes, and Care Services Research in Cancer, created a home for researchers and clinicians who, like Dr. Snyder, believe strongly in finding ways to improve quality of life and care delivery for patients and their families. Currently, BLOCS has 30 members, including clinicians and researchers from multiple disciplines, and facilitates additional research advances through communication, collaboration, and connections that would be far more difficult to make were it not for BLOCS.

Since she first discovered its incredible importance as an undergraduate, Dr. Snyder has dedicated her career to learning how to best serve patients and families, whether they have just received a cancer diagnosis or are well on the road of survivorship. Whether the prognosis is fantastic or difficult, she and her colleagues, including the members of the BLOCS program, believe that honing the tools necessary to improve the quality of how we provide cancer care at Johns Hopkins is of paramount importance, allowing patients to feel that their personhood is never taken out of the equation, and that their entire care team is united in the effort to provide them with the best possible quality of life for as long as is feasible.

 If you are interested in learning more about Dr. Snyder’s work and opportunities for support, please contact Ashlyn Sowell at asowell2@jhmi.edu.

 

 

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