Patients with nasopharyngeal carcinoma (NPC) treated with concurrent chemoradiotherapy who received fosaprepitant every week were less likely to experience vomiting and had greater quality of life than those who received fosaprepitant every three weeks, according to the findings of a new study.
However, researchers also found that participants experienced no significant difference in their cumulative risk of vomiting or the need of rescue therapy (medication to relieve nausea and vomiting) whether they were treated with fosaprepitant weekly or every three weeks, according to the study published on July 27 in the journal JAMA Network Open.
The randomized clinical trial of 100 patients, with a mean age of 46.6 years and of whom 83% were male, ran from November 2020 to November 2022 at Sun Yat-sen University Cancer Center in China and was sponsored by Sun Yat-sen University, according to the trial’s listing on clinicaltrials.gov.
It has been 15 years since the 2008 approval by the Food and Drug Administration (FDA) of injectable Emend (fosaprepitant dimeglumine) as part of a three-day combination treatment regimen to prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV) for patients who received highly emetogenic chemotherapy (HEC). In 2016 single-dose injectable Emend, when combined with other drugs treating nausea and vomiting, was approved by the FDA to prevent delayed CINV in patients who’d received moderately emetogenic chemotherapy (MEC).
“Unlike substantial evidence in the prevention of chemotherapy-induced nausea and vomiting (CINV), research in the prevention of nausea and vomiting caused by concurrent chemoradiotherapy (CCRT) is currently lacking,” Sun Yat-Sen University researchers wrote in the JAMA Network Open study, which they posited was to their knowledge, “the first study to assess the efficacy and safety of fosaprepitant during combined radiotherapy-HEC.”
Participants were patients with previously untreated, histologically confirmed stage 2 to 4 nonkeratinizing NPC who had achieved CINV control, defined in the study as no vomiting or need of rescue therapy in the first 120 hours following the initiation of chemotherapy using a fosaprepitant-based regimen after two to three cycles of induction chemotherapy and were scheduled to receive intensity-modulated radiation therapy (IMRT) and concomitant treatment with the chemotherapy cisplatin every three weeks.
As a type of head and neck cancer, NPC starts in the nasopharynx, described on the American Cancer Society’s website as “the upper part of the throat behind the nose and near the base of skull.”
There is less than one case of NPC per 100,000 people each year throughout most of the world, including in the United States, according to the American Cancer Society, which noted that NPC is more common in parts of South Asia, the Middle East, Africa and among native people in the Arctic, with up to 25 to 30 cases per 100,000 men and 15 to 20 cases per 100,000 women in areas of China.
The study’s primary endpoint of complete response (no vomiting or rescue therapy during CCRT) was reached by 20.4% of patients receiving weekly fosaprepitant and 12.5% of patients who received fosaprepitant every three weeks.
In the first 21 days of the study, 52% of patients who received weekly fosaprepitant did not experience vomiting, as opposed to 28% of patients who received fosaprepitant every three weeks. During the overall, 56-day period, 38% of patients on weekly fosaprepitant did not vomit, compared to 14% of patients on triweekly fosaprepitant.
Ninety-eight percent of patients who received weekly fosaprepitant experienced either no nausea or mild nausea with little to no interreference with daily activities, versus 78% of patients receiving triweekly fosaprepitant, during the first 21 days, with 92% and 72% of patients, respectively, experiencing no clinically significant nausea during the 56 total days.
Regarding quality of life, participants receiving fosaprepitant on a weekly basis “experienced less fatigue, nausea and vomiting, dyspnea (labored breathing), insomnia, and appetite loss and presented with better role function and emotional function compared with those who received fosaprepitant every three weeks,” the authors wrote. “As for the symptoms and functions of the head and neck, patients receiving weekly fosaprepitant were found to have significantly less problems regarding pain, swallowing, sense, teeth, xerostomia (dry mouth), sticky saliva, coughing, feeling ill and nutritional supplements.”
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