Health
Understanding a Treatment Option for Advanced Kidney Cancer
(Family Features) When kidney cancer spreads or becomes advanced, it can be challenging to treat. Common signs and symptoms can include blood in urine, lower back pain on one side, a mass on the side or lower back, loss of appetite or unexplained weight loss.
While a diagnosis of advanced kidney cancer can be overwhelming, there are steps patients can take to feel more empowered as they face the disease, starting with learning about the treatments that may be available for them.
Exploring Your Options
When facing advanced kidney cancer, it’s important for patients and caregivers to have open communication with their healthcare team to understand the diagnosis and establish a treatment plan.
Asking questions to understand where the cancer has spread, what the expected prognosis is and the potential benefits of treatment – including the possibility to live longer – can be critical to aligning on a path forward.
Fortunately, there are several types of medicines available for advanced kidney cancer today, depending on the specifics of each patient’s disease. Chemotherapy, targeted therapy or immunotherapy are a few types of treatment that may be considered, sometimes in combination. Immunotherapy works differently than chemotherapy or targeted therapy, as it helps a person’s own immune system to fight cancer and can enable the immune system to find and attack cancer cells. For some patients, dual immunotherapy – or a combination of two immunotherapy treatments – may be recommended.
For example, Opdivo (nivolumab) + Yervoy (ipilimumab) is approved by the U.S. Food and Drug Administration (FDA) as a combination of two immunotherapies for certain newly diagnosed adults whose kidney cancer (also referred to as renal cell carcinoma) has spread. It is not known if Opdivo is safe and effective in children younger than 18 years of age. Opdivo (10 mg/mL) and Yervoy (5 mg/mL) are injections for intravenous use.
This combination of two immunotherapies has the potential to work with the immune system in different but complementary ways to help fight cancer. While Yervoy may stimulate the kind of cells that help fight cancer, Opdivo may help these cells find and fight the cancer cells again.
While doing so, this immunotherapy combination can also affect healthy cells. These problems can sometimes become serious or life threatening and can lead to death. These problems may happen anytime during treatment or even after treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when Opdivo is used in combination with Yervoy.
Opdivo and Yervoy can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; eye problems; problems in other organs and tissues; severe infusion reactions; and complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms. Please see additional Important Safety Information below.
Understanding Overall Survival
One of the most important considerations for choosing a treatment is the potential for survival, or the chance to live longer. Overall survival is sometimes reported as a survival rate, which is the percentage of people in a clinical trial who are still alive for a certain time period after being diagnosed with or starting treatment for a disease, such as cancer.
“After my cancer diagnosis, my wife and I prayed about our future and pursuing every avenue with that goal in mind,” said Terry Broussard, who has been living with advanced kidney cancer. “I wanted a treatment that may give me a chance to live longer in order to see my youngest child graduate high school.”
Broussard’s doctor recommended treatment with Opdivo + Yervoy, which has overall survival data at five years. The FDA approval of this dual immunotherapy in advanced renal cell carcinoma (RCC) was based on results from the CheckMate -214 clinical trial, which included 847 previously untreated patients with kidney cancer that had spread and with one or more risk factors.
In the primary analysis at two years (25.2 months), the length of time patients lived without tumors worsening was 11.6 months for this immunotherapy combination and 8.4 months for sunitinib. There was no meaningful difference between the two treatments.
Researchers also assessed the overall response rate, which is a measure of the percentage of patients whose cancer shrunk (partial response) or disappeared completely (complete response) after treatment.
At the two-year time point, 41.6% of patients treated with Opdivo + Yervoy (95% CI:36.9-46.5) responded to treatment (n=177/425) versus 26.5% (n=112/422) of those treated with sunitinib (95% CI:22.4-31.0). Partial tumor shrinkage occurred in 32.2% of the patients treated with this immunotherapy combination compared to 25.4% of those treated with sunitinib. Tumors disappeared completely in 9.4% of patients treated with this immunotherapy combination versus in 1.2% of patients treated with sunitinib. The disappearance of any measurable tumors in response to treatment does not necessarily mean the cancer has been cured. Opdivo + Yervoy will not work for everyone. Individual results may vary.
“Advanced kidney cancer is a complex disease with many treatment options, which can feel overwhelming for people facing a devastating cancer diagnosis,” said Ulka Vaishampayan, M.D., professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan. “The goal of treatment is to help patients live longer, and research like these five-year data gives us insight into what treatment with Opdivo + Yervoy may look like for patients from the trial over time.”
The most common side effects of Opdivo, when used in combination with Yervoy, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); constipation; decreased weight; and dizziness.
Establishing and Leaning on a Support System
From diagnosis to treatment and beyond, many patients find the support from family, friends and loved ones invaluable. Identifying a friend, spouse or caregiver who can join doctor appointments, ask questions and take notes can be a helpful way to track all the details that can often be overwhelming when facing cancer. “I’ve been incredibly lucky to have the support of my wife, children, nurses and doctors every step of the way,” said Broussard. “Even in the most challenging moments, knowing they were by my side gave me the hope and inspiration I needed to continue moving forward.”
To learn more, visit Opdivo.com.
Source: Bristol Myers Squibb
Photo caption: Terry Broussard and his wife, Tracy. Broussard is an actual patient who has been compensated by Bristol Myers Squibb for his time.
INDICATION AND IMPORTANT SAFETY INFORMATION
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with kidney cancer in certain people when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
Information provided in this article is not a substitute for talking with your healthcare professional. Your healthcare professional is the best source of information about your disease.
Important Safety Information for OPDIVO® (nivolumab) + YERVOY® (ipilimumab)
What is the most important information I should know about OPDIVO + YERVOY?
OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.
What are the serious side effects of OPDIVO + YERVOY?
Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:
- Lung problems: new or worsening cough; shortness of breath; chest pain
- Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdominal) pain or tenderness
- Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal
- Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heart beat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
- Kidney problems: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite
- Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in the mouth or nose, throat, or genital area
- Eye problems: blurry vision, double vision, or other vision problems; eye pain or redness.
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with OPDIVO and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
- Chest pain; irregular heart beat; shortness of breath; swelling of ankles
- Confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs
- Double vision; blurry vision; sensitivity to light; eye pain; changes in eye sight
- Persistent or severe muscle pain or weakness; muscle cramps
- Low red blood cells; bruising
Getting medical help right away may help keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. Your healthcare team may also need to delay or completely stop your treatment if you have severe side effects.
Possible side effects of OPDIVO + YERVOY
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
- See “What is the most important information I should know about OPDIVO + YERVOY?”
- Severe infusion reactions. Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; feel like passing out; fever; back or neck pain
- Complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications.
The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); constipation; decreased weight; and dizziness.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA- 1088.
Before receiving OPDIVO or YERVOY, tell your healthcare provider about all of your medical conditions, including if you:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if OPDIVO or YERVOY passes into your breast milk. Do not breastfeed during treatment with OPDIVO or YERVOY and for 5 months after the last dose of OPDIVO or YERVOY.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.
- You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of OPDIVO or YERVOY. Talk to your healthcare provider about birth control methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO or YERVOY. You or your healthcare provider should contact Bristol-Myers Squibb at 1-844-593-7869 as soon as you become aware of a pregnancy.
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY.
© 2023 Bristol-Myers Squibb Company. All Rights Reserved.
OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.
7356-US-2200719 2/23
SOURCE:
Bristol Myers Squibb
https://q5i.09c.myftpupload.com/category/lifestyle/health-and-wellness/
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Lifestyle
Clinical Trials Expand Patients’ Treatment Options
Clinical trials play a crucial role in developing effective treatments for chronic health conditions. They evaluate safety and efficacy, but low enrollment delays drug approvals, limiting patient options.
(Family Features) For health conditions with no cure, effective treatments are the next best option. However, in order to make medical interventions including new drugs, devices, vaccines and lifestyle modifications available, they must undergo a thorough evaluation process to demonstrate their benefits.
Clinical trials are an important part of this process because they provide data for researchers on the effectiveness of various treatments and interventions. However, many myths about clinical trials deter people from enrolling. In fact, more than 70% of clinical trials are delayed at least one month due to unfulfilled enrollment, according to the “Journal of Medical Internet Research.”
Delays create barriers to the drug approval process and result in fewer available treatments for chronic conditions like Crohn’s disease and ulcerative colitis. The experts at the Crohn’s & Colitis Foundation offer these facts about the importance of clinical trials:
- More patients can benefit from clinical trials While hundreds of participants may take part in a trial, the results can lead to new care and treatment options for an entire patient community.
- Clinical trials lead to better and improved medications. For a new treatment to be approved, it needs to demonstrate a meaningful benefit to patients, such as improved outcomes, treating a wider range of symptoms, fewer side effects or more convenience for patients.
- They provide information. Clinical trials provide evidence of a treatment’s effectiveness and safety that can be used to guide patient care.
- Trials test safety and efficacy. Clinical trials are conducted in four phases. During the first phase, the main objective is to assess the safety of a new treatment. Experimental treatments only advance to the next stages if they pass certain safety and efficacy standards
. - They help prevent bias. In a randomized controlled trial, the effects of treatment with a new drug are compared with that of a control group – either a placebo (a treatment that looks identical to the new drug but contains no active medicine) or the current standard of care. Treatment assignments are “randomized,” which means neither the trial doctors nor the participants choose which treatment each participant will receive.
How Clinical Trials Work
Before a clinical trial begins, a research team develops a clinical trial protocol. This is the research plan that describes who can join the trial, which treatments the participants will receive, what questions the researchers will try to answer, how long the trial will last and how participant privacy and safety will be protected.
Conducting clinical research relies on volunteer trial participants. Those interested in joining a clinical trial meet with clinical research professionals to discuss the trial, treatments, eligibility requirements and expectations.
Joining a Trial
If you are interested in participating in a clinical trial, do some research. Your doctor may not be aware of or proactively tell you about trials you may be eligible to join. If you find a clinical trial you may be interested in joining, discuss the trial with your doctor and other health care professionals on your research team.
Foundations supporting chronic conditions can be a good source of information. For example, you can learn more about trials affecting individuals with inflammatory bowel disease by exploring the Clinical Trials Community at crohnscolitisfoundation.org.
Photo courtesy of Shutterstock
SOURCE:
Crohn’s & Colitis Foundation
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Lucas A. Berenbrok, University of Pittsburgh; Michael Murphy, The Ohio State University, and Sophia Herbert, University of Pittsburgh
Neighborhood pharmacies are rapidly shuttering.
Not long ago, Walgreens, one of the nation’s biggest pharmacy chains, announced plans to close 1,200 stores over the next three years. That’s part of a larger trend that has seen nearly 7,000 pharmacy locations close since 2019, with more expected in the coming years.
Many community pharmacies are struggling to stay open due to an overburdened workforce, shrinking reimbursement rates for prescription drugs and limited opportunities to bill insurers for services beyond dispensing medications.
As trained pharmacists who advocate for and take care of patients in community settings, we’ve witnessed this decline firsthand. The loss of local pharmacies threatens individual and community access to medications, pharmacist expertise and essential public health resources.
The changing role of pharmacies
Community pharmacies – which include independently owned, corporate-chain and other retail pharmacies in neighborhood settings – have changed a lot over the past decades. What once were simple medication pickup points have evolved into hubs for health and wellness. Beyond dispensing prescriptions, pharmacists today provide vaccinations, testing and treatment for infectious diseases, access to hormonal birth control and other clinical services they’re empowered to provide by federal and state laws.
Given their importance, then, why have so many community pharmacies been closing?
There are many reasons, but the most important is reduced reimbursement for prescription drugs. Most community pharmacies operate under a business model centered on dispensing medications that relies on insurer reimbursements and cash payments from patients. Minor revenue comes from front-end sales of over-the-counter products and other items.
However, pharmacy benefit managers – companies that manage prescription drug benefits for insurers and employers – have aggressively cut reimbursement rates in an effort to lower drug costs in recent years. As a result, pharmacists often have to dispense prescription drugs at very low margins or even at a loss. In some cases, pharmacists are forced to transfer prescriptions to other pharmacies willing to absorb the financial hit. Other times, pharmacists choose not to stock these drugs at all.
And it’s not just mom-and-pop operations feeling the pinch. Over the past four years, the three largest pharmacy chains have announced plans to close hundreds of stores nationwide. CVS kicked off the trend in 2021 by announcing plans to close 900 pharmacy locations. In late 2023, Rite Aid said that thousands of its stores would be at risk for closure due to bankruptcy. And late in 2024, Walgreens announced its plans to close 1,200 stores over the next three years.
To make matters worse, pharmacists, like many other health care providers, have been facing burnout due to high stress and the lasting effects of the COVID-19 pandemic. At the same time, pharmacy school enrollment has declined, worsening the workforce shortage just as an impending shortfall of primary care physicians looms.
Why pharmacy accessibility matters
The increasing closure of community pharmacies has far-reaching consequences for millions of Americans. That’s because neighborhood pharmacies are one of the most accessible health care locations in the country, with an estimated 90% of Americans living within 5 miles of one.
However, research shows that “pharmacy deserts” are more common in marginalized communities, where people need accessible health care the most. For example, people who live in pharmacy deserts are also more likely to have a disability that makes it hard or impossible to walk. Many of these areas are also classified as medically underserved areas or health professional shortage areas. As pharmacy closures accelerate, America’s health disparities could get even worse.
So if your neighborhood pharmacy closes, what should you do?
While convenience and location matter, you might want to consider other factors that can help you meet your health care needs. For example, some pharmacies have staff who speak your native language, independent pharmacy business owners may be active in your community, and many locations offer over-the-counter products like hormonal contraception, the overdose-reversal drug naloxone and hearing aids.
You may also consider locations – especially corporate-owned pharmacies – that also offer urgent care or primary care services. In addition, most pharmacies offer vaccinations, and some offer test-and-treat services for infectious diseases, diabetes education and help with quitting smoking.
What to ask if your pharmacy closes
If your preferred pharmacy closes and you need to find another one, keep the following questions in mind:
• What will happen to your old prescriptions? When a pharmacy closes, another pharmacy may buy its prescriptions. Ask your pharmacist if your prescriptions will be automatically transferred to a nearby pharmacy, and when this will occur.
• What’s the staffing situation like at other pharmacies? This is an important factor in choosing a new pharmacy. What are the wait times? Can the team accommodate special situations like emergency refills or early refills before vacations? Does the pharmacist have a relationship with your primary care physician and your other prescribers?
• Which pharmacies accept your insurance? A simple call to your insurer can help you understand where your prescriptions are covered at the lowest cost. And if you take a medication that’s not covered by insurance, or if you’re uninsured, you should ask if the pharmacy can help you by offering member pricing or manufacturer coupons and discounts.
• What are your accessibility needs? Pharmacies often offer services to make your care more accessible and convenient. These may include medication packaging services, drive-thru windows and home delivery. And if you’re considering switching to a mail-order pharmacy, you should ask if it has a pharmacist to answer questions by phone or during telehealth visits.
Remember that it’s best to have all your prescriptions filled at the same pharmacy chain or location so that your pharmacist can perform a safety check with your complete medication list. Drug interactions can be dangerous.
Community pharmacies have been staples of neighborhoods for more than a century. Unfortunately, current trends in pharmacy closures pose real threats to public health. We hope lawmakers address the underlying systemic issues so more Americans don’t lose access to their medications, health services and pharmacists.
Lucas A. Berenbrok, Associate Professor of Pharmacy and Therapeutics, University of Pittsburgh; Michael Murphy, Assistant Professor of Pharmacy Practice and Science, The Ohio State University, and Sophia Herbert, Assistant Professor of Pharmacy, University of Pittsburgh
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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(Family Features) Clinical trials help researchers studying chronic conditions answer important questions about the diseases and their treatment options. However, uncertainty about what to expect and a lack of knowledge about how to get started can prevent patients from joining a clinical trial.
Choosing to take part in a clinical trial means helping a study team figure out if a new method of diagnosis, treatment or prevention is effective. If you live with a chronic condition, such as Crohn’s disease or ulcerative colitis, and want to help find answers for others who share your experience, a clinical trial is an option to consider.
Once you identify a study that interests you, you’ll want to talk with the professionals involved in your ongoing treatment, a clinical research coordinator and your family to gather information necessary to determine whether the clinical trial is a good fit.
To find additional information about clinical trials and begin exploring trials in your area, visit crohnscolitisfoundation.org, and consider these steps for participating in a trial.
1. Talking with Your Doctor
Your gastroenterologist and other care providers can help determine whether a clinical trial is right for you and may be able to help point you toward recommended trials. It’s important to ask if or how your doctor will continue to be involved in your care if you participate in a trial.
2. Finding a Study
If you need help beyond your care team in identifying clinical trial opportunities in your area, organizations dedicated to your condition can be a good resource. For example, the Crohn’s & Colitis Foundation offers an online Clinical Trial Finder for individuals with inflammatory bowel disease.
3. Talking with the Research Coordinator
A clinical trial research coordinator can provide details specific to your circumstances and needs. You can discuss potential benefits and risks, why the trial is being conducted and who is involved in the health care team. You can talk about past treatments and how this study may differ from your previous experiences. Other questions you might ask include what your options are if the trial doesn’t work, any costs you might expect and what your personal commitment will be.
4. Evaluating the Fit for You
Once you have the necessary information, you’ll be able to consider whether you’re ready to move forward with registering for the trial. You’ll want to weigh factors like your time commitment, travel distance and whether the trial will affect your personal or professional obligations.
Photos courtesy of Shutterstock
SOURCE:
Crohn’s & Colitis Foundation
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