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Gene Therapy. A New Frontier in Medical Innovation

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Cancer is a disease that is experienced by young and old and by every economic and social segment of the world populace. At some point in everyone’s life, cancer will affect us individually, a member of our family or one or many of our friends and acquaintances. The American Cancer Society projects there will be 1,688,780 new cancer patients and 600,920 deaths due to cancer in 2017, for a disease that does not discriminate by race or national origin.

Cancer is where abnormal cell growths form in the body and interfere with normal, healthy body functions. Not new to the world stage, cancer dates back to ancient times. Today, after millennials of research and discovery, new treatments for a vast array of cancer types are being studied, many with promising results.  One such new treatment called chimeric antigen receptor T-cell therapy (CAR-T) involves taking samples of T-immune cells called T-cells from a patient, genetically engineering them, and putting them back in to fight the cancer. Co-developed with the drug giant Novartis, the therapy, CAR-T, genetically alters a patient’s own immune cells to target and destroy cancer cells.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Dr. Scott Gottlieb. The process takes about 22 days and begins with the extraction of a patients T cells, exposing them to the vector which genetically transforms them. They’re then expanded and frozen for shipment back to the patient. During the out-of-body processing of the cells, the patient receives chemotherapy to wipe out any remaining T cells to avoid interference with the, soon to be, newly implanted cells.

“This is a major advance, and is ushering in a new era,” said Malcolm Smith, a pediatric oncologist at the National Institutes of Health. The treatment appears to strengthen a patient’s immune system allowing their own body to fight the cancer. The treatment is recommended for cancer patients who have run out of options for traditional therapy. The new therapy is only currently available for patients 25 years or younger. Thus far, 83 percent of patients are experiencing positive survival results.

While overtly touting the success of gene therapy, researchers are tempering their enthusiasm after experiencing some significant life threatening side effects in 47 percent of the studies participants. These side effects have resulted in brain swelling and deaths, casting a shadow over the field. Seizures and hallucinations were also relatively common, but temporary. Though concerning, the side effects have been successfully managed with drugs. Quality control and how to standardize the potency and purity of living cells extracted from each patient are also a concern. Because of the risks, the treatment is only currently available at 20 US hospitals. The individualized nature and relatively small patient population both drive up the cost of the treatment for now.

“This is a big paradigm shift, using this living drug,” says Dr. Kevin Curran, a pediatric oncologist at Memorial Sloan Kettering Cancer Center that will soon be offering the treatment. “It will provide a lot of hope. This is the beginning.”

“The approval of CAR T-cell therapy for pediatric leukemia marks an important shift in the blood cancer treatment paradigm,” says the American Society of Hematology. “We now have proof that it is possible to eradicate cancer by harnessing the power of a patient’s own immune system. This is a potentially curative therapy in patients whose leukemia is unresponsive to other treatments and represents the latest milestone in the shift away from chemotherapy toward precision medicine. Today’s approval is the result of over a decade of hematology research, including research funded by the National Institutions of Health (NIH).”

Cancer Research: Not Always an Exact Science

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It is the question most frequently asked of doctors by patients who have just received a diagnosis of cancer, “Why me?” It is usually asked by those who thought they were living a healthy lifestyle and had little expectation of receiving the devastating news. Others may have been aware of near or distant family members who had a form of cancer.

While much progress has been made in the effort to understand multiple forms of cancer and the development of effective treatments, the answer to why some people get the disease and others do not remains predominately an elusive mystery. Cancer is known to be caused by changes, or mutations, to the DNA within cells that can cause the cell to stop its normal function and may allow a cell to become cancerous. Some faulty genes that increase the risk of cancer, known as inherited cancer genes, and genes that increase the risk of cancer called cancer susceptibility genes can be passed on from parent to child. But most of genetic mutations appear to occur after birth and aren’t inherited.

Environmental influences such as smoking, radiation, viruses, persistent exposure to cancer-causing chemicals (carcinogens), obesity, hormones, chronic inflammation and a lack of exercise has been proven to provide a more definitive answer to the “Why Me?”. Even with this accepted knowledge, some people who share one or more of these environment factors appear to avoid a cancer diagnosis altogether.

Why do some cancers spread and kill patients, while many remain docile?  Seeking the answer to this question has researchers redirecting their approach for answers from why some get cancer to why so many do not. Ruslan Medzhitov, an Immunobiologist at Yale, says “You can inject the same virus into different hosts and get vastly different responses.”

Diagnosis and treatment becomes art and science. Researchers continue to develop and identify predictive tests based on gene mutations and patterns of gene regulation.  These tests assist in targeting the right therapies and treatments for each patient.  Research related to the micro-environments in which the cancer lives and spreads will provide beneficial to the prevention and early detection of cancer.

The field of oncology remains focused on a holistic approach factoring in the environment, genetic factors, and physiology, in the hopes of finding a concrete, science based answer to the “Why Me?”

To learn more about the clinical trials and research that Gettysburg Cancer Center offers its patients, click here.

Support Groups Can Help Cancer Patients Regain Sense Of Normalcy

Receiving a cancer diagnosis can be one of the most traumatic and stressful moments of a lifetime. Often the unknown aspects of treatment and the potential outcomes can trigger strong emotional feelings of shock and anger. The sense of “why me” is often a common initial experience for many cancer victims when they are informed of their disease. The disruption of daily social patterns due to the regiment of treatments that follow diagnosis can add additional strain and stress to the patient and their immediate family members.

Daily routines, family roles and future plans will be determined by a regiment of treatments and medications that often pose additional physical symptoms and challenges to everyday living. The support of family and friends during this process is critical to help the patient regain a sense of normalcy and maintain emotional stability and can provide assistance to reduce distress that can play a critical role in determining the patient’s clinical outcome.

Formal support groups can help people with cancer feel less depressed and anxious about their disease, help them feel more hopeful and enable them to manage their emotions better. Support groups can be peer-led (facilitated by individual group members), professional-led (by trained counselors) or informational, led by doctors and professional facilitators who focus on providing disease related information. Some groups will be organized around the type of cancer, age of the patient or the stag of the disease. Some groups are also available for family members and care givers because a cancer diagnosis doesn’t only affect the patient but also their family and friends.

“Support groups can be effective in many ways,” says Claire J. Casselman, Social Work Coordinator and Complementary Therapies Clinician, University of Michigan Comprehensive Cancer Center in Ann Arbor, Michigan. “Meeting and talking with other people whose lives are affected by cancer can create a sense of community or commonness that helps relieve the stress of isolation that many people experience.”

For those who find the formal group setting uncomfortable or cumbersome, online support groups can offer group forums to those who live in rural areas, who are too ill to attend a meeting in person, those who are without access to transportation or patients who seek a certain amount of anonymity. Most online support groups are available 24-hours a day. When looking to the internet for a support group, a certain amount of due diligence should be exercised to verify their credibility.

Often the most effective emotional support comes from those who provide the care. As a teenager in 2015, Chandler Banko’s was diagnosed with advanced, stage 2 Hodgkin’s Lymphoma. A positive and outgoing personality, Chandler found treatment and personal emotional support he needed at the Gettysburg Cancer Center in Gettysburg, Pennsylvania. At Gettysburg Cancer Center, he found experienced professionals who were dedicated to treating not only the science of his disease but the personal emotional conditions that often accompany a cancer diagnosis and regiment of treatment. Chandler says of his battle with cancer, “No One Fights Alone.”

The Importance of Connecting Patients with Clinical Trials in Cancer Research

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Clinical Trials are at the heart of medical research and are critical to finding new paths to prevent, detect and advance new treatment methods and medications for debilitating diseases. Patients with an illness or disease participate in Clinical Trials in order to receive the benefits of the newest treatment options for recovering from their disease and to offer the best opportunity for researchers to find better treatments for others in the future. Treatments may involve new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe and may also investigate other aspects of patient care, such as improving the quality of life for people with chronic illnesses.

Providing information to patients, who have been diagnosed with a serious disease, about the specifics and availability of important Trials that may be of benefit to them is proving to be challenging.  ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants being conducted around the world and currently lists 247,989 studies with locations in all 50 States and in 201 countries. But accessing, understanding and utilizing this important data can be difficult and challenging for the average patient undergoing the emotional and physical experience of a recent diagnosis.

Former FDA commissioner Dr. Robert Califf recently delivered a talk, “Finding the Right Balance in Learning about Therapies”, at a conference in New York City. In his address he said, “Our country is experiencing an unprecedented divergence of health outcomes that mirrors gaps in wealth and education…wealthy, highly educated people are benefiting from information that allows them to lead longer, more functional lives, while others are suffering. The clinical trials enterprise has gone awry,” he said. “It’s become unnecessarily expensive, cumbersome and arcane” In his opinion the system has become so costly and onerous that most of the important questions go unasked. “Doctors are heavily conflicted between patients and the institutions they work for,” says Dr. Robert. “The rosy view that doctors and patients are discussing all options and making the best decisions flies in the face of all evidence.”

The research and pharma industry is attempting to create new pathways to connect patients with the data and, most importantly, help them understand which clinical trial is best for their particular disease. The “Innovation and Clinical Trial Tracking Factbook 2017”, is an Assessment of the Pharmaceutical Pipeline listing the thousands of new drugs currently under trial across the U.S. and around the world. VitalTrax taps into a global database of clinical trials and ultimately organizes the complex web of information into a platform that allows patients, physicians, caregivers, and families to search for relevant trials in relevant locations – in a language they can understand.

Zikria Syed, CEO of VitalTrax says his company is taking an “Open Table” approach to enrolling patients in clinical trials. “We’re making a big bet on the fact that patients would appreciate tools that put the information, and an ability to learn about clinical trials and enroll, in their own hands.”

In smaller communities around the country local oncology providers are shortening the gap of distance and time for patients seeking the benefits of clinical trials. At the Gettysburg Cancer Center (GCC), Clinical Trials are available to patients who want to participate in this important process. The localized opportunity voids the often long drive to large regional healthcare centers for Trial participants and enhances the patients understanding of the technical and practical elements of the process in a personalized but highly qualified environment.

GCC, a leader in Oncology Care across the Central Pennsylvania region since 1989, is actively involved in providing the latest in clinical trials to their patients throughout their community.

The Resulting Dread of Cancer Survival

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One of the most prolific progressions in research and development over the past decade has been the discovery and development of new treatments and drugs for cancer, for good reason. According to National Cancer Institute (NCI) statistics, cancer has a major impact on our society, both in the United States and around the world.  In 2016, an estimated 1,685,210 new cases of cancer were diagnosed in the United States and 595,690 people died from the disease. Nearly 39.6% of men and women will be diagnosed with cancer at some point during their lifetimes. It is rare to find anyone who has not dealt with the dreaded disease personally or had a family member or acquaintance suffer from one type or another of cancer.

To answer the call for action in defeating the disease, researchers, oncologist and drug companies have turned-up the pace of research and discovery. Over the past 5 years, 68 new cancer drugs have been approved for various cancers, many producing significant improvement in outcomes for patients. In just the last ten years, drug developers and regulators have successfully shortened the R&D path for approving new cancer drugs safely and efficiently. The global market for cancer immunotherapies, cancer drugs that enlist the body’s immune system to improve patient survival rates, are expected to grow more than fourfold globally by 2022. The number of new drugs in the cancer pipeline has swelled by 45% over the past decade alone.

With the increased activity and availability of promising new therapies for the masses suffering from cancer, one would expect that a downward trend in costs would be a positive result of the new competitive environment. But increased competition and quicker access to market is not producing the expected. In previous decades, new drugs might cost around $10,000 for a year’s treatment. However, according to one recent study, today’s newly approved cancer drugs can cost a patient a staggering $120,000 to $170,000 per year.

The result of this revolution appears to come at a high cost for patients. In the past decade patients paid just 5% of healthcare provider revenue. Today the shifting responsibility to patients for these costs has risen to 35%, and the trend is expected to continue as employers continue to transfer the high cost of healthcare insurance to their employees, the trend to higher insurance deductibles and rising operating and regulatory costs. The result is that too many Americans are struggling to afford the care. Many healthcare consumers are avoiding or delaying needed care or abandoning treatment because of concerns about their ability to pay.

In a system where the patient first learns of the price of their treatment after it has been rendered, many are shocked at the staggering high price and confused and amazed by a complicated and convoluted system of service codes and the seemingly unending list of often unseen providers.  The euphoria and promise of this revolution of discovery is leading many to dread the unfathomable price of recovery and survival.

Gettysburg Cancer Center takes pride in seeking alternative financial resources that can assist its patients in managing the costs of their cancer treatment. To learn more, please contact: Erin or Kasey by calling 717.334.4033 or visiting the website at http://gettysburgcancercenter.com/patients/patient-assistance/.

Cancer of the Vallecula Can be Difficult to Treat

The Vallecula is an anatomic term for a crevice, furrow or depression and while several vallecula can be located in several areas of the body the term is most commonly used to describe a depression just behind the root of the tongue between the folds in the throat. Cancers involving the vallecula are classified as oropharyngeal cancers.

When David Magee was diagnosed with cancer of the vallecula in March 2016, he learned that his cancer was particularly difficult to treat, given the close proximity of the vallecula to the base of the tongue and voice box. “I was particularly nervous going into it (treatment) for that reason, says David. Early stage cancers of the oropharynx are generally treated with radiation therapy because of the difficulty of surgical access. Squamous cell carcinoma of the oral cavity and pharynx accounts for over 48,250 cases per year in the United States with approximately 9,575 deaths per year. Symptoms of head and neck cancers include: persistent pain, difficulty swallowing, voice changes, mouth sores, dry mouth, changes in appearance, and/or taste changes. Patients with a history of tobacco and alcohol use are at a high risk for these cancers.

David sought treatment at Gettysburg Cancer Center in Gettysburg Pennsylvania, a small town in the central part of the state famous for the great Civil War battle. “I have recommended others to come over here to this Cancer Center who may have sought treatment elsewhere at places like John Hopkins or Hershey Medical Center or places like that. People don’t always realize that there are places with this kind of expertise right here in Gettysburg.”

“No one has been more scared about the treatment process than I was…right away I was put at ease…I always felt that I was in great hands,” Said David. “I had thirty-five radiation treatments which were a little intimidating, but everything went well and I actually began to miss the people here when I was finished with my treatments.”

For David’s complete thoughts on his cancer and experience at the Gettysburg Cancer Center click on https://www.youtube.com/watch?v=yWe0x6PCwmQ.

WHAT YOU NEED TO KNOW: CANCER AWARENESS MONTH

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Cancer awareness month has its origin in the 1980’s when a small grassroots organization, Susan G. Komen, was formed to raise money and public awareness for breast cancer. The group created the now famous pink ribbon in order to create “brand awareness” for breast cancer and to generate much needed funding for cancer research, early detection and ultimately the diseases eventual cure.

The breast cancer program’s success spawned an important and growing expansion of the awareness campaign to cancers across the diseases spectrum. Many non-profit cancer organizations have gravitated towards the goals of the program and have originated specific colors and month of the year to represent their individual identities. The month of May represents three brands of cancers; Brain Cancer, Melanoma/ Skin Cancer and Bladder Cancer.

Brain tumors are growths of abnormal cells in tissues which originate in the brain or spinal cord. Tumors may be benign or malignant and affect nearby areas of the head and neck but rarely spread to other parts of the body. Symptoms vary and are dependent upon where the tumor forms, its size, how fast it is growing, and the age of the patient. More than 150,000 people are living with brain cancer with less than one percent of men and women likely to experience brain and nervous system cancer in their lifetime. Nearly 34 percent of brain cancer victims can expect to survive five years or more with early detection and aggressive treatment. Brain cancer is an extremely complex disease requiring a team of multi specialists including oncologist, primary care physicians and radiation oncologist. Each patient treatment protocol depends on the location of the tumor, its size and type, the patient’s age, and the overall medical condition of the patient. Brain Cancer is represented by the color grey in the month of May.

Melanoma, represented by the color black, is the most dangerous form of skin cancer and is most often caused by over exposure to ultraviolet radiation from sunshine or tanning beds. Cancerous growths develop when unrepaired DNA damage to skin cells initiate mutations that multiply rapidly and form malignant tumors. Discovered in its early stages and treated, skin cancer is almost always curable. But left untreated it can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. Depending on the stage of the disease treatments may include; surgery, immunotherapy, targeted therapy, chemotherapy and radiation.

Bladder Cancer originates when healthy cells in the bladder lining change and grow rapidly forming a tumor. Malignant tumors may spread to other parts of the body if left untreated. The three most common types of bladder cancer are; Urothelial carcinoma, Squamous cell carcinoma and Adenocarcinoma. Represented by the awareness color Marigold/Blue/Purple, bladder cancers are most often detected in patients by the presence of blood in the urine, frequent or burning sensation when urinating or lower back pain. Treatment options include; surgery, chemotherapy, immunotherapy and radiation. Treatment protocols are dependent upon the stage of the cancer, patient’s health, treatment preferences and potential side effects.  Bladder cancer mostly affects older people with an estimated 79,000 adults expected to be diagnosed with bladder cancer in the United States each year. With early detection the 10 year survival rate for bladder cancer is 70 percent.

Increased awareness has had a proven and positive effect on early diagnosis and treatment of various cancers and has resulted in a better educated and prepared patient. Utilizing this marketing approach the stigma once associated with cancer has been greatly diminished.

Finding the Emotional Support You Need to Recover From Cancer

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The discovery that you have cancer comes with many intense emotions, not only for the patient but also for close family members and friends. After the initial emotional and psychological effects of the news subsides, there is a realization that everything in your life is about to change. Daily routines, family roles and future plans will be determined by a regiment of treatments and medications that often pose additional physical symptoms and challenges to everyday living.

The support of family and friends during this process is critical to help the patient regain a sense of normalcy and maintain emotional stability. Efforts such as pier group support and individual therapy can help reduce distress and help cope with the personal emotions that come with a cancer diagnosis. Such support can play a critical role in determining the your clinical outcome.

Musa Mayer, a cancer survivor and patient advocate says, “Belonging to a group where you can discuss anything and everything is very freeing. You can talk about everything from medical treatments to lack of sexual interest, to fury at someone who has cut you off while driving. The loneliness and isolation that so many feel when they are going through the breast cancer journey can be helped, if not erased.”

Your doctor and their professional associates and nursing staff will also play a central role in providing coordination and support during treatment and recovery. “We have to look at a person’s medical care from a holistic perspective,” says Terri Ades, MS, APRN-BC, AOCN, director of cancer information at the American Cancer Society in Atlanta. Nurses are a patient’s greatest advocate.” Whether an oncology nurse or a nurse practitioner, these specially trained medical professionals become an important facilitator in managing overall care.

At his Gettysburg Cancer Center in Gettysburg, PA, Dr. Satish Shah, Medical Oncologist/Hematologist provides all-encompassing oncology and hematology programs with a complete range of diagnosis, treatment, and follow-up care. “It is our educated staff that set us apart from many other cancer centers,” says Dr. Shah, “We understand that every person is unique, each with their own set of psychological, emotional, and spiritual needs. Our team is dedicated to providing a caring environment for each individual patient and their families to insure the best possible outcome for their cancer treatment.”

In addition to your professional caregivers, The American Cancer Society has programs and services to help people with cancer and their loved ones understand cancer, manage their lives through treatment and recovery, and find the emotional support you need.