Navigating advanced bladder cancer: One caregiver's journey

Sponsored by and provided by Astellas Pharma US, Inc. and Pfizer Inc.

Armando, a 71-year-old with an active lifestyle, was midway through a round of golf when a strange sensation crept into his abdomen after drinking water. It was just a fleeting moment; one he brushed off without much thought. But that small, odd feeling was the first sign that something was wrong.

As the discomfort lingered and grew over the next two days, Armando's concern deepened, leading him to the ER. He was admitted, but despite a week in the hospital and countless tests, the cause of his symptoms remained elusive. Desperate for answers, he was referred to a specialized health center. It was there that a biopsy uncovered the truth: Armando had Stage 4 metastatic urothelial carcinoma (mUC), also known as advanced bladder cancer.

Bladder cancer is a serious, challenging disease, particularly when not detected early. [1] If the cancer spreads to nearby tissues, it's classified as locally advanced cancer. If it reaches distant parts of the body, like lymph nodes or other organs, it's referred to as metastatic cancer. Advanced bladder cancer refers to cases where the disease has spread extensively or cannot be surgically removed. [2]

A Caregiver's Perspective on Diagnosis

A bladder cancer diagnosis is a life-altering moment not just for the patient but for their loved ones as well. For Laura, Armando's wife, the news of his Stage 4 diagnosis was overwhelming. "It felt like my brain just stopped," Laura recalls. "This diagnosis was a real shock to both of us. We thought we were still young. His mom is 103. Mine's 99."

Armando is the patriarch of a large family, with four sons and nine grandchildren. Determined not to give up, he and his family set out to explore potential treatment options.

Exploring PADCEV (enfortumab vedotin-ejfv) with pembrolizumab

Armando and Laura's daughter-in-law played a crucial role in exploring and identifying treatment options. After careful consideration and discussions with his doctors, she helped Armando navigate admission into a clinical trial evaluating the safety and effectiveness of PADCEV® (enfortumab vedotin-ejfv) combined with pembrolizumab (Keytruda®) for adults with advanced bladder cancer.

"Armando's doctors explained that PADCEV works differently than chemotherapy or immunotherapy," Laura shares. PADCEV is an antibody-drug conjugate (ADC) that delivers cell-killing medicine directly to certain cancer cells. [7] However, it can also affect normal cells and cause side effects. PADCEV is a prescription medicine that may be used with pembrolizumab for adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter, or urethra) that has spread or cannot be removed by surgery and who have not yet received treatment, including patients like Armando, who are eligible to receive cisplatin-containing chemotherapy. [7]

PADCEV may cause serious side effects, including skin reactions. Severe skin reactions have happened in people treated with PADCEV, and in some cases, severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle of treatment but may happen later. People who are treated with PADCEV will be monitored during treatment by their healthcare providers, who may stop their treatment with PADCEV completely or for a period of time (temporarily), or may change their dose or prescribe medicines if they get skin reactions. Please see Important Safety Information below and read the Patient Information for more information, including risk of Serious Side Effects. [7]

As a caregiver, Laura learned the importance of being vigilant about potential side effects. "After Armando started on treatment, we were told to be aware that neuropathy, or nerve problems, was one of the situations and also that his skin may change." When Armando began experiencing these side effects he told his doctor, who then began to address them immediately. Armando started walking regularly, squeezing tennis or rubber balls to keep his fingers active and reducing the distance he walked in flip-flops, as his skin became more susceptible to blisters.

The Importance of Support Networks

Navigating a bladder cancer diagnosis can be overwhelming, which is why developing a strong support network is vital. Support teams of family and friends can provide emotional and practical assistance, helping to manage the complexities of treatment decisions, noting side effects that should be reported to a healthcare professional and fostering resilience for both patients and caregivers.

Laura emphasizes the importance of communication and delegation. "I had a text thread specifically for all the adults in our family. I would update them on what the doctor said and what to expect. They would ask questions for me to pass on to the doctors, which was very helpful."

She also appreciates the support from her daughters-in-law during Armando's recovery. Laura recalls that "we were pretty much housebound when he got out of the hospital. Each of our daughters-in-law had their different strengths. One of them was baking us fresh wonderful sourdough bread and bringing it over with some soups and some meals."

While Laura expressed gratitude for the treatment Armando received, noting his fighting spirt, she also acknowledged her crucial role in managing everything behind the scenes to support her husband's treatment journey. "The advice I would give to caregivers would be to appreciate your situation, how difficult it is and try to delegate what you can to family members or people that you trust so that you don't have everything on your shoulders."

A Message of Hope

With the support of his entire family, Armando is hopeful about the future. "Looking back before the diagnosis, we thought everything was great. You don't think of being ill. You never know what's going to come around the corner. Just love all your family."

If you or a loved one is navigating an advanced bladder cancer diagnosis, visit PADCEV.com† to learn more about Armando and Laura's story and discover more about PADCEV with pembrolizumab as a potential option.

This is Armando's experience with PADCEV and may not be reflective of other individuals' experiences. Armando and Laura were compensated by Astellas and Pfizer to share their story. This was Armando's experience at the time of publication. Please see Important Safety Information below.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PADCEV?

PADCEV may cause serious side effects, including:

Skin reactions. Skin reactions including severe skin reactions have happened in people treated with PADCEV and may be more common when PADCEV is given with pembrolizumab. In some cases, these severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle of treatment but may happen later. Your healthcare provider will monitor you, may stop your treatment with PADCEV completely or for a period of time (temporarily), may change your dose, and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction:

• Target lesions (skin reactions that look like rings)
•  Rash or itching that continues to get worse
•  Blistering or peeling of the skin
• Painful sores or ulcers in mouth or nose, throat, or genital area
• Fever or flu-like symptoms
• Swollen lymph nodes

See "What are the possible side effects of PADCEV?" for more information about side effects.

Before receiving PADCEV, tell your healthcare provider about all of your medical conditions, including if you:

• Are currently experiencing numbness or tingling in your hands or feet.
• Have a history of high blood sugar or diabetes.
• Have liver problems.
• Are pregnant or plan to become pregnant. PADCEV can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PADCEV.
• Are breastfeeding or plan to breastfeed. It is not known if PADCEV passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after the last dose of PADCEV.

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with PADCEV.
• You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of PADCEV.

Males with a female sexual partner who is able to become pregnant:

• If your female partner is pregnant, PADCEV can harm the unborn baby.
• You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of PADCEV.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking PADCEV with certain other medicines may cause side effects.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

• Skin Reactions. See "What is the most important information I should know about PADCEV?"
• High blood sugar (hyperglycemia). An increase in blood sugar is common during treatment with PADCEV. Severe high blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes treated with PADCEV. Tell your healthcare provider right away if you have any symptoms of high blood sugar, including: frequent urination, increased thirst, blurred vision, confusion, it becomes harder to control your blood sugar, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, or stomach pain.
• Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. These severe problems may happen more often when PADCEV is given in combination with pembrolizumab. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.
• Nerve problems. Nerve problems, called peripheral neuropathy, are common during treatment with PADCEV and can sometimes be severe. Nerve problems may happen more often when PADCEV is given in combination with pembrolizumab. Tell your healthcare provider right away if you get new or worsening numbness or tingling in your hands or feet or muscle weakness.
• Eye problems. Certain eye problems are common during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, increased tearing, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.
• Leakage of PADCEV out of your vein into the tissues around your infusion site (extravasation). If PADCEV leaks from the injection site or the vein into the nearby skin and tissues, it could cause an infusion site reaction. These reactions can happen right after you receive an infusion, but sometimes may happen days after your infusion. Tell your healthcare provider or get medical help right away if you notice any redness, swelling, itching, blister, peeling skin or discomfort at the infusion site.

Your healthcare provider may decrease your dose of PADCEV, or temporarily or completely stop your treatment with PADCEV if you have severe side effects.

If your healthcare provider prescribes PADCEV in combination with pembrolizumab for you, also read the Medication Guide that comes with pembrolizumab for important information about pembrolizumab.

The most common side effects of PADCEV when used in combination with pembrolizumab include:

• Changes in liver function and kidney function tests
• Rash. See "What is the most important information I should know about PADCEV?"
• Increased sugar (glucose) in the blood. See "High blood sugar (hyperglycemia)"
• Numbness or tingling in your hands or feet. See "Nerve problems"
• Increased lipase (a test done to check your pancreas)
• Decreased white blood cell, red blood cell, and platelet counts
• Tiredness
• Decreased sodium, phosphate, and protein (albumin) in the blood
• Itching
• Diarrhea
• Hair loss
• Decreased weight
• Decreased appetite
• Increased uric acid in the blood
• Increased or decreased potassium
• Dry eye. See "Eye problems"
• Nausea
• Constipation
• Change in sense of taste
• Urinary tract infection

The most common side effects of PADCEV when used alone include:

• Increased sugar (glucose) in the blood. See "High blood sugar (hyperglycemia)"
• Changes in liver and kidney function tests
• Decreased white blood cell, red blood cell, and platelet counts
• Rash. See "What is the most important information I should know about PADCEV?"
• Tiredness
• Numbness or tingling in your hands or feet. See "Nerve problems"
• Decreased protein (albumin), sodium, and phosphate in the blood
• Hair loss
• Decreased appetite
• Diarrhea
• Nausea
• Itching
• Increased uric acid in the blood
• Dry eye. See "Eye problems"
• Change in sense of taste
• Constipation
• Increased lipase (a blood test done to check your pancreas)
• Decreased weight
• Stomach (abdominal) pain
• Dry skin

PADCEV may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of PADCEV.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

WHAT IS PADCEV?

PADCEV is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery.

• PADCEV may be used with pembrolizumab (also known as Keytruda®), or
• PADCEV may be used alone if you:
• have received an immunotherapy medicine and chemotherapy that contains platinum, or
• are not able to receive a chemotherapy that contains the medicine cisplatin and you have received 1 or more prior therapy.

It is not known if PADCEV is safe and effective in children.

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.

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†PADCEV.com

References

1. American Cancer Society. Can Bladder Cancer Be Found Early. https://www.cancer.org/cancer/types/bladder-cancer/detection-diagnosis-staging/detection. Accessed October 8, 2024.
2. NCI. Bladder Cancer Stages. https://www.cancer.gov/types/bladder/stages. Accessed July 9, 2024.
3. American Cancer Society. Key Statistics for Bladder Cancer. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html. Accessed July 9, 2024.
4. American Cancer Society. Bladder Cancer Risk Factors. https://www.cancer.org/cancer/types/bladder-cancer/causes-risks-prevention/risk-factors. Accessed July 9, 2024.
5. NIH. Cancer Stat Facts: Bladder Cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed October 22, 2024.
6. Patel VG, Oh WK, Galsky MD. Treatment of muscle-invasive and advanced bladder cancer in 2020. CA Cancer J Clin. 2020: 70: 404-423. https://doi.org/10.3322/caac.2163. Accessed August 20, 2024.
7. PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc.