Managing Adverse Events in Patients Taking Abemaciclib

As abemaciclib (Verzenio) has emerged as a promising agent for patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, the oncology nurse is now a key factor for these patients, according to Paula Fulgham, RN, OCN.

“If they leave with (an oral) medication, they don’t know how to take the drug, the side effects and what to expect, and they’re going to be at home (without medical advisement. It’s not like they are coming in every 3 weeks for chemo and we can coach them and guide them as they go along,” said Fulgham, who is chief nursing officer at the Cancer Center of Kansas in Wichita.

“These patients are now going to be in the driver’s seat,” she added. “Understanding how these drugs work and the side effects profile, and what to educate the patients with early on is so important.”

At the 2nd Annual School of Nursing Oncology, held Aug. 3-4 in Chicago, Fulgham offered an overview of abemaciclib regimens, and their associated adverse events (AEs) to review practical considerations for nurses to use.

In the randomized, double-blind phase III MONARCH 2 trial, women who recurred or progressed on or after endocrine therapy received abemaciclib plus fulvestrant (Faslodex). Overall, 86% of patients experienced diarrhea with a median onset occurring 6 days after treatment started.

With this, Fulgham recommended for patients to have an over-the-counter antidiarrheal medication on hand before symptoms begin, and to know who and when to call when symptoms get out of control to ensure treatment continuation. She noted that it is up to the oncology nurse to understand the physiology of these patients and the AE profile of the drug to help determine whether a dose modification is necessary to resolve symptoms.

Additional AEs that occurred in the MONARCH 2 trial were nausea (45%), abdominal pain (35%), vomiting (26%), and stomatitis (15%). Additionally, fatigue (46%), peripheral edema (12%), and pyrexia (11%) of all grades were experienced.

Nine percent of patients had to discontinue treatment due to an AE compared with 3% of patients who were treated with fulvestrant alone. Of these, 43% of patients required a dose reduction due to an AE.

All-grade neutropenia occurred in 46% of patients, with death occurring in < 1% of patients due to neutropenia sepsis. Febrile neutropenia occurred in < 1% of patients. Fulgham noted that for patients who develop grade 3/4 AEs, dosage may be reduced, interrupted, or delayed.

Fulgham recommended for oncology nurses to provide patients with appropriate instructions that can be easily referenced at home. A sheet that goes through the basics, such as avoiding foods that interfere with the CYP3 pathway, would be more helpful to patients than a lengthy package insert.

Lastly, she stressed the importance of establishing an action plan that includes specific dosage times with patients before they start taking abemaciclib.

“Looking at the patient overall you want to know where their baseline is and how to monitor these patients as they go through the treatment,” Fulgham said. “We’ve had a great increase in our phone calls because nurses now see patients who are not coming in for chemotherapy regularly. Usually patients would discuss side effects at their follow-up appointments. These patients start these oral oncolytic they do have questions and monitoring. It’s important for nurses to understand when they discuss with the patients.”

Reference

Fulgham P. A CDK4&6 inhibitor for women with HR+, HER2-, MBC: Including those with concerning clinical characteristics. Presented at: the 2nd Annual School of Nursing Oncology; Aug. 3-4, 2018; Chicago.