Scott Soefje, PharmD, MBA, BCOP
New agents and formulations have been added to the CINV armamentarium; however, unless patients are encouraged to discuss the problem with their clinicians, their CINV may go unmanaged, causing even greater problems down the road.
“Patients come in with a perspective, that I feel like I have to change,” noted Brandi Riber, RN, a chemotherapy nurse with Florida Cancer Specialists in Fort Myers. “Patients come in expecting, ‘I am going to get chemo, I am going to be sick, I am going to throw up,’ but that’s not the case.”
A recent survey of 400 adult patients receiving chemotherapy, conducted by Wakefield Research on behalf of the Hematology/Oncology Pharmacy Association (HOPA) and Eisai, Inc, bears this out, finding that 83% of patients may be experiencing CINV unnecessarily.
Riber, a breast cancer survivor herself, understands only too well the fear patients feel about CINV—a fear which may intensify when they are at home, away from the security of their healthcare team: “I was a nurse when I started my treatment, and I still was fearful.”
“When delayed CINV is not prevented,” Riber continued, “the patient can experience a lot more nausea and vomiting, and this leads to further complications that we have to manage.”
Recently-Approved CINV Treatment OptionsMore than half of patients undergoing emetogenic chemotherapy may experience delayed-phase CINV, (occurring 25-120 hours after chemotherapy initiation), even when they are prescribed a 5-HT3 receptor anatagonist and a corticosteroid.
Last September, the FDA approved single-dose rolapitant (Varubi; Tesaro), for use in combination with other antiemetic agents in adults for the prevention of delayed-phase nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy, including, but not limited to HEC.
The FDA’s approval was based on data from several phase III trials of rolapitant involving more than 2500 patients receiving various emetogenic chemotherapy agents, including cisplatin, carboplatin, and anthracycline/cyclophosphamide–based regimens.
The data showed that adding rolapitant to a 5-HT3 antagonist and dexamethasone was superior to those agents alone in preventing delayed CINV in patients receiving chemotherapy regimens that were moderately or highly emetogenic.
Rolapitant is administered as a single dose (two, 90-mg tablets) prior to chemotherapy in combination with a 5-HT3 receptor antagonist and dexamethasone.
“I’ve found that patients are compliant with it,” said Riber. “We’ve had patients who have had great success in decreasing their nausea during a really highly emetogenic regimen.”
In July of last year, the FDA granted the 5-HT3 antagonist granisetron (Heron Therapeutics) a priority review designation with a decision expected shortly, and on February 4 of this year, fosaprepitant dimeglumine (Emend for injection; Merck) received FDA approval as a single dose in combination with other antiemetic agents for the prevention of delayed CINV following moderately emetogenic chemotherapy (MEC).
The FDA approval is primarily based on the phase III MK-0517-031 study, in which adding single-dose fosaprepitant to ondansetron and dexamethasone induced a complete response (CR) during the delayed phase in nearly 80% of patients receiving MEC. The CR rate with fosaprepitant was about 15% higher than the rate with ondansetron and dexamethasone alone.
Improving the CINV DialogueExperts agree that even with additional treatments, educating patients and making sure that they feel comfortable discussing CINV with their healthcare team is essential.
HOPA President Scott Soefje, PharmD, MBA, BCOP, noted that although the research literature indicates that CINV should be controlled in 80% to 90% of patients, what he found so surprising about the patient survey was that “even in this day and age, patients thought they had to live with nausea and vomiting if they had it. When 83% of patients say ‘that is just something that I thought I had to live with,’ to me that’s concerning and troubling—we’re not doing a very good job of getting the message out there.”
“Then what we found as we dug deeper… not only were patients suffering with [CINV], they were not telling practitioners ... they are suffering in silence,” Soefje continued.
With that in mind, HOPA, in conjunction with Eisai, is introducing the “Time to Talk CINV” campaign to develop new resources for pharmacists to help educate patients and their caregivers about CINV prevention. Soefje said that the tools developed through this campaign, which will launch formally at the HOPA annual meeting this March, will be valuable to physicians and nurses as well.
Soefje explained that physicians, nurses, and pharmacists form the triad that really impacts patient care:
“We believe that the team approach brings different aspects. If you talk to nurses and pharmacists, you will hear stories constantly about how a patient will tell a nurse or pharmacist something that they would never tell their doctor.”
“The literature will tell you that a patient with cancer hears somewhere between 10 and 30 percent of what they’re told in any session,” Soefje continued, a finding that underscores the need for all three practitioners to drive the patient education messages about CINV home:
“You put all that together, and a lot of times, you’ll have a patient who is very well-informed.”
Riber concurs: “Patients need that village to help them through it.”