PATIENT EXPERIENCE WITH FENTANYL EFFERVESCENT BUCCAL TABLETS: INTERIM ANALYSIS OF A LONG-TERM STUDY IN PATIENTS WITH CANCER-RELATED BREAKTHROUGH PAIN

2.50
Hdl Handle:
http://hdl.handle.net/10755/165154
Category:
Abstract
Type:
Presentation
Title:
PATIENT EXPERIENCE WITH FENTANYL EFFERVESCENT BUCCAL TABLETS: INTERIM ANALYSIS OF A LONG-TERM STUDY IN PATIENTS WITH CANCER-RELATED BREAKTHROUGH PAIN
Author(s):
Rhiner, Michelle; Kerr, Chantal; Lamarre, Donalyn; Messina, John; Slatkin, Neal
Author Details:
Michelle Rhiner, RN, MSN, NP, ACHPN, Manager/Clinical Coordinator, City of Hope Cancer Center, UCLA, Duarte, California, USA, email: MRhiner@coh.org; Chantal Kerr; Donalyn Lamarre; John Messina; Neal Slatkin
Abstract:
Topic: Breakthrough pain (BTP) is reported by 50-90% of cancer patients and can significantly affect quality of life and functional status. Episodes of BTP often peak within minutes, thus, analgesics with a rapid onset of effect may improve outcomes. Fentanyl effervescent buccal tablets (FEBT) enhance the rate and efficiency of fentanyl absorption through the buccal mucosa, which is intended to provide rapid-onset analgesia. Purpose: This study evaluated the long-term safety of FEBT in opioid-tolerant patients with cancer-related BTP. Results reported here represent a planned interim analysis. Framework: The evaluation of long-term safety and tolerability of any drug taken chronically is important. Methods: Patients eligible for this open-label, multicenter study were receiving stable doses of around-the-clock opioids for baseline pain and supplemental opioids for BTP. Patients who had participated in a previous FEBT efficacy study enrolled directly into the long-term (1-year) phase; new patients entered a titration phase to determine an effective FEBT dose before entering the long-term phase. Enrollment is planned for approximately 500 patients. As of July 29, 2005, 158 patients (aged 24 to 95 years) had received FEBT (100 - 800 micrograms) and had data on titration and adverse events (AEs). Findings: Patients experienced 3.0 +/- 1.7 BTP episodes per day and received a mean FEBT dose per BTP episode of 514.8 micrograms (mean exposure=84.4 days). Dose adjustments were required by 15.5% of patients (13.2% of patients required an increase in dose). The proportion of patients at each FEBT dose was 6% at 100 micrograms, 16% at 200 micrograms, 21% at 400 micrograms, 26% at 600 micrograms, and 31% at 800 micrograms. The most common AEs were nausea (35%), vomiting (20%), dizziness (20%), fatigue (15%), headache (12%), and anemia (11%). The majority of AEs (67%) were mild or moderate; 20% of patients discontinued because of AEs. The most frequent reasons for discontinuation were uncontrolled persistent cancer pain, metastatic lung cancer, and nausea (each 2%). Twenty-four deaths occurred; all were attributed to cancer-related pathology or the progression of cancer. These data suggest that FEBT are well-tolerated by opioid-tolerant patients with cancer-related BTP and that few patients require dose increases after titration to maintain control of BTP.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2006
Conference Name:
31st Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Boston, Massachusetts, USA
Sponsors:
Funding Sources: Cephalon, Inc., Frazer, PA.
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titlePATIENT EXPERIENCE WITH FENTANYL EFFERVESCENT BUCCAL TABLETS: INTERIM ANALYSIS OF A LONG-TERM STUDY IN PATIENTS WITH CANCER-RELATED BREAKTHROUGH PAINen_GB
dc.contributor.authorRhiner, Michelleen_US
dc.contributor.authorKerr, Chantalen_US
dc.contributor.authorLamarre, Donalynen_US
dc.contributor.authorMessina, Johnen_US
dc.contributor.authorSlatkin, Nealen_US
dc.author.detailsMichelle Rhiner, RN, MSN, NP, ACHPN, Manager/Clinical Coordinator, City of Hope Cancer Center, UCLA, Duarte, California, USA, email: MRhiner@coh.org; Chantal Kerr; Donalyn Lamarre; John Messina; Neal Slatkinen_US
dc.identifier.urihttp://hdl.handle.net/10755/165154-
dc.description.abstractTopic: Breakthrough pain (BTP) is reported by 50-90% of cancer patients and can significantly affect quality of life and functional status. Episodes of BTP often peak within minutes, thus, analgesics with a rapid onset of effect may improve outcomes. Fentanyl effervescent buccal tablets (FEBT) enhance the rate and efficiency of fentanyl absorption through the buccal mucosa, which is intended to provide rapid-onset analgesia. Purpose: This study evaluated the long-term safety of FEBT in opioid-tolerant patients with cancer-related BTP. Results reported here represent a planned interim analysis. Framework: The evaluation of long-term safety and tolerability of any drug taken chronically is important. Methods: Patients eligible for this open-label, multicenter study were receiving stable doses of around-the-clock opioids for baseline pain and supplemental opioids for BTP. Patients who had participated in a previous FEBT efficacy study enrolled directly into the long-term (1-year) phase; new patients entered a titration phase to determine an effective FEBT dose before entering the long-term phase. Enrollment is planned for approximately 500 patients. As of July 29, 2005, 158 patients (aged 24 to 95 years) had received FEBT (100 - 800 micrograms) and had data on titration and adverse events (AEs). Findings: Patients experienced 3.0 +/- 1.7 BTP episodes per day and received a mean FEBT dose per BTP episode of 514.8 micrograms (mean exposure=84.4 days). Dose adjustments were required by 15.5% of patients (13.2% of patients required an increase in dose). The proportion of patients at each FEBT dose was 6% at 100 micrograms, 16% at 200 micrograms, 21% at 400 micrograms, 26% at 600 micrograms, and 31% at 800 micrograms. The most common AEs were nausea (35%), vomiting (20%), dizziness (20%), fatigue (15%), headache (12%), and anemia (11%). The majority of AEs (67%) were mild or moderate; 20% of patients discontinued because of AEs. The most frequent reasons for discontinuation were uncontrolled persistent cancer pain, metastatic lung cancer, and nausea (each 2%). Twenty-four deaths occurred; all were attributed to cancer-related pathology or the progression of cancer. These data suggest that FEBT are well-tolerated by opioid-tolerant patients with cancer-related BTP and that few patients require dose increases after titration to maintain control of BTP.en_GB
dc.date.available2011-10-27T12:13:29Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:13:29Z-
dc.conference.date2006en_US
dc.conference.name31st Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationBoston, Massachusetts, USAen_US
dc.description.sponsorshipFunding Sources: Cephalon, Inc., Frazer, PA.-
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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