Balancing compassion and reality when providing care for people with metastatic pancreatic cancer

Developed under the direction and sponsorship of Ipsen Biopharmaceuticals, 2025.
Featuring Kirsten Blue, PA-C
 

Pancreatic cancer is a difficult diagnosis – both for families receiving the diagnosis and care teams delivering the news. Advanced practice professionals, oncologists, pharmacists, psychiatrists, nutritionists and the many others who consult and provide direct care must meet families where they are with the knowledge of the cancer, the options available to them, and also considerations about daily life.

For patients, navigating this diagnosis brings emotional challenges related to the uncertainty and physical health changes to anticipate. For families, they may decide to take an active role in helping to make treatment decisions and caring for their loved one; but it’s also important that they balance their desire to help with ensuring the patient’s voice and needs are still at the center of each decision. For the healthcare team, leading with compassion means balancing hope with the difficult reality of the cancer, ensuring understanding of treatment goals and facilitating communication among the care team.

Kirsten Blue, a certified Physician Assistant at Moffitt Cancer Center, provides her perspective employing a compassionate approach to helping patients with metastatic pancreatic cancer live life on their own terms throughout their time in her care. Kirsten Blue, PA, was compensated for her time by Ipsen.

Building the foundation of trust

Typically, Blue spends time with a patient after their initial diagnosis. However, each patient comes with a different level of understanding and a different desire for information. Blue starts by asking for their personal preferencing on how much they wish to know. For some people, they may not even want to know the stage of the cancer, while others may be keen to understand everything about their tumor. This way, she can tailor education around treatment goals in accordance with each patient’s comfort level.

Patients or their families may ultimately turn to the internet for information, which results in some having preconceived notions that may or may not be accurate. “I always discourage patients from looking at statistics,” Blue shares. “Everyone’s journey will be different and comparing doesn’t do any good. Instead, I’d rather they focus on themselves. I always provide reputable educational materials and encourage patients to check out resources like PanCAN, which are backed by research.”

Another opportunity to build trust is by taking the time to explain how everyone fits into the care plan. Since pancreatic cancer often requires a multidisciplinary care team to ensure optimal care for different aspects of the disease, such as nutrition, pain, and mental health, Blue employs a sports metaphor to explain the team. “I always tell patients, ‘your medical oncology team is your quarterback. We’re here to help navigate your care journey, and also to connect you with other teams that will provide expertise in different areas, like counseling or nutrition.’ Although it can feel like a lot to navigate, there is a benefit to bringing in support from the experts.”

Making treatment decisions

It’s important for healthcare providers to understand the patient’s treatment goals. To support this process, Blue first gets to know their lifestyle preferences, including things they love to do. Following a metastatic pancreatic cancer diagnosis, in Blue’s experience, it’s extremely important that the patient be able to retain the ability to do the things that bring them joy, as much as is feasible – certain hobbies or social interactions can be key for morale and mental health.

Patients may not realize how a specific regimen will impact them, so it is important to ask a lot of questions to understand their priorities. Asking questions, like: What do you do for fun? Do you work? Do you have family close by? can help to provide insight into what is important to someone and then treatment decisions can be tailored accordingly.

“For example, I had a patient who loved to play the piano,” Blue shares. “Knowing this helped to guide the treatment plan, so we could consider potential medication side effects such as neuropathy.”

Coupling this knowledge with an understanding of how involved the patient wants to be in their care plan, Blue can educate and address questions about treatment decisions. She notes that patience can be key, along with revisiting aspects of the care plan. “Ensuring full comprehension can take time, as patients and their families absorb the information at their own pace.”

Blue also has firsthand understanding of how difficult it can be for caregivers and patients to understand the options available. When she was in college on the pre-med track, her mother was diagnosed with lung cancer and Blue took time off to care for her. Even with an expanding medical background, it was difficult to truly understand and absorb the options. She often reflects on that personal perspective being on the other end of the discussion when she speaks with patients and their families.

While the pancreatic cancer treatment landscape has not evolved as rapidly as other cancer types, there have been recent data in metastatic pancreatic ductal adenocarcinoma showing a regimen that may improve overall survival. Based on the efficacy and safety profile, ONIVYDE® (irinotecan liposome injection), as part of the NALIRIFOX regimen, was approved by the FDA for use in the first-line setting in February 2024.

ONIVYDE® (irinotecan liposome injection) is indicated, in combination with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma.

ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

Limitations of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma.

WARNING: SEVERE NEUTROPENIA AND SEVERE DIARRHEA

Neutropenia

• Severe and life-threatening neutropenia, including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil, and leucovorin and in combination with fluorouracil and leucovorin. Withhold ONIVYDE for absolute neutrophil count below 1500/mm³ or neutropenic fever. Monitor blood cell counts periodically during treatment.

Diarrhea

• Severe and life-threatening diarrhea has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil, and leucovorin and in combination with fluorouracil and leucovorin. Do not administer ONIVYDE to patients with bowel obstruction. Withhold ONIVYDE for diarrhea of Grade 2-4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.

See Important Safety Information continued in this article.

When patients receive the ONIVYDE regimen, Blue ensures they have the tools they need should adverse events arise. She explains that for potential gastrointestinal side effects like cramping, nausea and diarrhea, she educates on how the treatment plan includes proactively managing these impacts and on the importance of staying hydrated.

Another important aspect of treatment is setting expectations around next steps if the treatment plan would require changes in order to avoid uncertainty along the way. Blue explains, “There’s no one-size-fits-all approach. We don't know how people will respond, and sometimes it’s more of an art than a science. It’s important to set expectations around what adverse events may occur and when a dose modification or second-line treatment regimen should be explored. I want to ensure patients don’t feel surprised.”

Another tool Blue and her team provide is a handbook to track side effects that also provides tips to help manage the side effects, including guidance on when to call the care team. She points out that this approach has helped some of her patients identify and manage side effects before they become too severe, which can impact daily life and, in some cases, lead to hospitalizations or treatment discontinuation.

Checking in

As the treatment journey progresses, Blue continues to ensure patient preferences are at the forefront. “Some patients may want to be highly involved and review imaging, and some may not be comfortable with that level of detail. Some may be very portal-savvy and want to share updates in this way. It’s all about meeting people where they are and adapting to their needs.”

While some patients may be an open book, some may hesitate to share how they’re doing, as they could have a perception that sharing details may impact their treatment plan. Dynamics between the family and patient can also add a layer of difficulty to these conversations. Sometimes, if Blue suspects that a patient is holding back on sharing how they’ve been doing on treatment in front of their loved ones, she may ask them to leave the room to speak freely.

For Blue, it’s important to get genuine updates to ensure symptoms are being managed appropriately and adjustments can be made. This is where having a solid foundation of trust is key – when patients know you care about them on a personal level, they’re more likely to share openly and be open to your suggestions. They will trust you understand their treatment goals.

“While pancreatic cancer is a challenging diagnosis,” Blue explains, “We can provide patient directed care when we get to know patients, educate them based on what they wish to know, and advocate for their needs across the multidisciplinary team. Successful outcomes for me are based on the patient’s ability to live life on their own terms.”

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ONIVYDE is contraindicated in patients who have experienced a severe hypersensitivity reaction or anaphylaxis to ONIVYDE or irinotecan HCl.

WARNINGS AND PRECAUTIONS

Severe Neutropenia: ONIVYDE can cause severe or life-threatening neutropenia and fatal neutropenic sepsis. In NAPOLI 3, Grade 3 and 4 neutropenia occurred in 26% of patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) and fatal neutropenic fever in 0.3% of patients. In NAPOLI 3, the incidence of Grade 3 or 4 neutropenia was similar among Asian patients [6 of 20 (30%)] compared to White patients [76 of 289 (26%)]. Neutropenic fever/neutropenic sepsis was reported in 5% of Asian patients (1 of 20) compared to 2.3% of White patients (7 of 306). In NAPOLI-1, Grade 3 and 4 neutropenia occurred in 20% of patients receiving ONIVYDE in combination with fluorouracil and leucovorin (ONIVYDE/FU/LV). Neutropenic sepsis occurred in 3% and fatal neutropenic sepsis in 0.8%. In NAPOLI-1, the incidence of Grade 3 or 4 neutropenia was higher among Asian patients [18 of 33 (55%)] compared to White patients [13 of 73 (18%)]. Neutropenic fever/neutropenic sepsis was reported in 6% of Asian patients compared to 1% of White patients.

Monitor complete blood cell counts on Days 1 and 8 of every cycle and more frequently if clinically indicated. Withhold ONIVYDE if the absolute neutrophil count (ANC) is below 1500/mm³ or if neutropenic fever occurs. Resume ONIVYDE when the ANC is 1500/mm³ or above. Reduce ONIVYDE dose for Grade 3-4 neutropenia or neutropenic fever following recovery in subsequent cycles.

Severe Diarrhea: In NAPOLI 3, Grade 3 and 4 diarrhea (early-onset [within 24 hours of chemotherapy] and late-onset [more than 24 hours following chemotherapy]) occurred in 20% receiving NALIRIFOX. In NAPOLI-1, Grade 3 or 4 diarrhea occurred in 13% receiving ONIVYDE/FU/LV. The incidence of Grade 3 or 4 late-onset diarrhea was 9% in patients receiving ONIVYDE/FU/LV. The incidence of Grade 3 or 4 early-onset diarrhea was 3% in patients receiving ONIVYDE/FU/LV.

To reduce the risk of severe diarrhea, patients should stop lactose-containing products, eat a low-fat diet, and maintain hydration during treatment with ONIVYDE. Withhold ONIVYDE for Grade 2-4 diarrhea. Local institutional guidelines should be followed for the treatment of diarrhea that does not improve within 48 hours and may include the addition of diphenoxylate hydrochloride plus atropine sulfate or octreotide. Following recovery to Grade 1 diarrhea, resume ONIVYDE at a reduced dose.

Interstitial Lung Disease (ILD): ONIVYDE can cause severe and fatal ILD. Postmarketing cases of severe and fatal ILD have been reported with ONIVYDE. Risk factors include pre-existing lung disease, use of pneumotoxic medicinal products, colony stimulating factors or having previously received radiation therapy. Patients with risk factors should be closely monitored for respiratory symptoms before and during ONIVYDE therapy. Withhold ONIVYDE in patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue ONIVYDE in patients with a confirmed diagnosis of ILD.

Severe Hypersensitivity Reaction: Irinotecan, including ONIVYDE, can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue ONIVYDE in patients who experience a severe hypersensitivity reaction.

Embryo-Fetal Toxicity: Based on animal data with irinotecan HCl and the mechanism of action of ONIVYDE, ONIVYDE can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during and for 7 months after the last dose of ONIVYDE treatment.

ADVERSE REACTIONS FOR NALIRIFOX

• The most common adverse reactions (≥20%) of NALIRIFOX were diarrhea (72%), fatigue (62%), nausea (59%), vomiting (40%), decreased appetite (37%), abdominal pain (35%), mucosal inflammation (28%), constipation (25%), and weight decreased (22%).
• Permanent discontinuation of ONIVYDE due to an adverse reaction occurred in 17% of patients. Adverse reactions that resulted in permanent discontinuation of ONIVYDE in ≥1% of patients included neutropenia, thrombocytopenia, diarrhea, fatigue, infections, and cerebrovascular accident.
• Dosage reduction of ONIVYDE due to an adverse reaction occurred in 52% of patients. Adverse reactions that required dosage reduction in ≥1% of patients included anemia, decreased appetite, diarrhea, fatigue, febrile neutropenia, hypokalemia, liver function test abnormalities, nausea, mucosal inflammation, neutropenia, peripheral neuropathy, vomiting, thrombocytopenia, and weight decreased.
• Dosage interruptions of ONIVYDE due to an adverse reaction occurred in 1.9% of patients. Adverse reactions which required dosage interruption in ≥0.5% of patients included hypersensitivity and infusion-related reaction.
• The most common laboratory abnormalities (≥10% Grade 3 or 4) were decreased neutrophils (26%), decreased potassium (22%), decreased lymphocytes (11%), and decreased hemoglobin (10%).

ADVERSE REACTIONS FOR ONIVYDE/FU/LV

• The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%).
• Adverse reactions led to permanent discontinuation of ONIVYDE in 11% of patients receiving ONIVYDE/FU/LV; the most frequent adverse reactions resulting in discontinuation of ONIVYDE were diarrhea, vomiting, and sepsis.
• Dose reductions of ONIVYDE for adverse reactions occurred in 33% of patients receiving ONIVYDE/FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia.
• ONIVYDE was withheld or delayed for adverse reactions in 62% of patients receiving ONIVYDE/FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia.
• The most common severe laboratory abnormalities (≥10% Grade 3 or 4) were lymphopenia and neutropenia.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of ONIVYDE:

• Hypersensitivity (including anaphylactic reaction and angioedema).

DRUG INTERACTIONS

• Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of ONIVYDE.
• Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy.

USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data with irinotecan HCl and the mechanism of action of ONIVYDE, ONIVYDE can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women. Advise pregnant women of the potential risk to a fetus.
• Lactation: Advise nursing women not to breastfeed during and for 1 month after the last dose of ONIVYDE.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including BOXED WARNING, for ONIVYDE.

ONIVYDE is a registered trademark of Ipsen Biopharm Ltd.
©2025 Ipsen Biopharmaceuticals, Inc. All rights reserved.  January 2025 ONV-US-005447