A.P. Pharma Announces Positive APF530 Patient-Satisfaction Data from Phase 3 Study in Patients with Chemotherapy-Induced Nausea and Vomiting
- Poster at the
"Delayed-onset nausea and vomiting remains a major issue associated with many cancer treatment options, which can affect a patient's quality of life as well as his or her ability to sustain the recommended potentially lifesaving chemotherapy regimen," said Rebecca A. Clark-Snow, RN, BSN, OCN, clinical nurse coordinator and chair of the
The study found patient satisfaction between patients administered APF530 and palonosetron to prevent CINV following MEC or HEC were comparable, with no statistically significant differences. The severity of nausea experienced by patients in the study was also comparable with no statistically significant differences. These findings held for subgroups of patients regardless of whether, or not, they had previously received chemotherapy treatment. The study also showed that for each day of a 5-day period there were no statistically significant differences between APF530 and palonosetron in patient satisfaction and severity of nausea.
"These data indicate that APF530 has the potential to provide both comparable antiemetic effects and patient satisfaction results to palonosetron," said
A.P. Pharma's pivotal Phase 3 clinical trial was a multicenter, randomized, observer-blind, actively-controlled, double-dummy, parallel group study that compared the efficacy of APF530 with palonosetron. The trial stratified patients into two groups, one receiving moderately and the other receiving highly emetogenic chemotherapeutic agents in accordance with the Hesketh algorithm, which assigns emetogenic levels based on the chemotherapy agent, drug dosage and combinations employed. In each group, the patients were randomized to receive in the first chemotherapy treatment cycle either APF530 high dose (10 mg granisetron), APF530 low dose (5 mg granisetron) or the currently approved dose of palonosetron. Patients used a daily diary to record severity of nausea, vomiting/retching episodes, use of rescue medication, and satisfaction with nausea/vomiting control over a 5-day period following chemotherapy.
Prevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an antiemetic, typically administered just prior to chemotherapy.
Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning that more than 90% of patients experience CINV, if they do not receive an antiemetic. Acute-onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed-onset CINV occurs more than 24 hours after treatment and may persist for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy.
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A.P. Pharma, Inc.
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