Palonosetron HCL Is a Preferred Treatment for Moderately Emetogenic Chemotherapies

CINV is also associated with increased healthcare costs because of depression, unplanned office visits, hydration therapy, and prolonged hospitalization. Thus, the prevention and control of CINV are vital in the treatment and management of patients with cancer.

Aloxi® (palonosetron HCl) injection is indicated for pediatric (older than one month) and adult patients receiving moderately emetogenic cancer (MEC) and highly emetogenic cancer (HEC) chemotherapy. The recommended dose for adults is 0.25 mg infused over 30 seconds beginning approximately 30 minutes before the start of chemotherapy, and the recommended dose for pediatric patients (one month to 17 years) is 20 micrograms per kilogram (maximum 1.5 mg) infused over 15 minutes beginning approximately 30 minutes before the start of chemotherapy.

During a product theater at the 42nd Annual Congress in Denver, CO (http://congress.ons.org/), Jennifer Webster, MN, RN, AOCN®, from Georgia Cancer Specialists in Atlanta, discussed the nurse’s role in treating and managing patients with CINV who are receiving palonosetron HCl.

According to Webster, “70%–80% of patients receiving chemotherapy experience nausea and/or vomiting,” and she noted that the AE is very feared and distressing among patients. Although vomiting is physiologically the “worse” symptom (because the potential for dehydration and cardiac arrhythmias), Webster said that patients are more “bothered” by nausea, but it is a subjective experience and difficult to measure. “For many of our patients, the nausea is of concern and the vomiting can be a relief,” she explained.

“Think how socially isolating it is to have CINV,” Webster said, noting that many activities involve food, such as friendly gatherings, birthdays, and parties. “People cannot participate in our food rituals if they are not feeling well,” she said.

With HEC, patients have a 90% chance or higher of developing CINV, whereas those receiving MEC have a 30%–90% chance of developing CINV. Acute CINV occurs within the first 24 hours after treatment, with maximal intensity between five to six hours after treatment, whereas delayed CINV occurs in the first six to seven days after treatment, with maximal intensity between 48–72 hours after treatment. Breakthrough CINV occurs despite appropriate prophylactic treatment and can require rescue with antiemetic agents.

Webster noted patients who are more at risk of experiencing CINV are those who are younger, are female, had emesis during pregnancy, do not drink alcohol often, have motion sickness, have high anxiety or depression, or had previous CINV.

The U.S. Food and Drug Administration’s approval of palonosetron HCl was based on the results of three phase III studies and one phase II study.

Webster specifically discussed the pivotal, phase III study that compared palonosetron HCl with ondansetron following MEC. Patients received palonosetron HCl 0.25 mg (n = 189), palonosetron HCl 0.75 mg (n = 189), or ondansetron 32 mg (n = 185). The primary endpoint was complete response (CR), defined as no emetic episodes and no use of rescue medication during the acute phase (0–24 hours). “I like that the bar is high,” Webster said. “This is what we should be aiming for: no nausea and vomiting.”

Patients in the study were receiving cyclophosphamide (63%), doxorubicin (48%), cisplatin (18%), methotrexate (16%), or carboplatin (12%). Most patients in the trial had breast, lung, colorectal, or bladder cancers. Most were female (72%), and close to half were chemotherapy-naïve (42%).

Palonosetron HCl 0.25 mg had higher CR rates than ondansetron in the acute setting (81% versus 69%; p =0.009), as well as in the delayed setting (74% versus 55%; p < 0.001). Palonosetron HCl also demonstrated sustained prevention of MEC during the first five days of treatment compared to ondansetron:

• Day 1: 60% versus 57%; p = not significant (NS)
• Day 2: 60% versus 48%; p = 0.003
• Day 3: 65% versus 50%; p = 0.003
• Day 4: 73% versus 60%; p = 0.009
• Day 5: 78% versus 69%; p = NS

The study was designed as a noninferiority study, but it turned out to be statistically significantly superior, Webster said.

The most common AEs associated with palonosetron HCl were headache (n = 9; 4.8%), constipation (n = 3; 1.6%), and dizziness (n = 1; 0.5%).

Palonosetron HCl has a warning for hypersensitivity reactions and serotonin syndrome.

Palonosetron HCl is a preferred 5-HT₃ receptor antagonist for the use in MEC by the National Comprehensive Cancer Network and the American Society of Clinical Oncology.

“Oncology nurses are patient advocates,” Webster said, and nurses should assess patients, ensure adherence, monitor and manage symptoms, educate and communicate with patients, and maintain knowledge of evidence-based guidelines related to care.

Refer to the prescribing information and important safety information for palonosetron HCl for more information.

This program was supported by Eisai, Inc.