Nurse Management Issues During a Randomized Phase III Study of Patients with Metastatic Melanoma Using Histamine Dihydrochloride and Interleukin-2

2.50
Hdl Handle:
http://hdl.handle.net/10755/164626
Category:
Abstract
Type:
Presentation
Title:
Nurse Management Issues During a Randomized Phase III Study of Patients with Metastatic Melanoma Using Histamine Dihydrochloride and Interleukin-2
Author(s):
Stover, Lori
Author Details:
Lori Stover, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA
Abstract:
Background: High-dose IL-2 in metastatic melanoma (MM) requires inpatient hospitalization and side effects can be life threatening. Current efforts to prolong survival and to improve upon patient quality of life (QOL) while receiving IL-2 include investigating outpatient regimens in combination with other agents. Histamine dihydrochloride (Ceplene) is being investigated as a potential adjuvant therapy to IL-2 in MM and other cancers. Histamine potentiates cytokine therapies by inhibiting the production and release of free radicals from phagocytes and thus may protect NK cells and T cells from free radical-induced apoptosis. Methods & Results: In a recently completed randomized, multicenter phase III study in 305 MM patients, IL-2 (9 MIU/m2, bid, sc, days 1-2, weeks 1, 3; and 2 MIU/m2, bid, sc, days 1-5, weeks 2, 4) was administered with or without histamine (1.0 mg, bid, sc, days 1-5, weeks 1-4) for four weeks of a six-week cycle. Both study drugs in the following regimen were administered in an outpatient at-home setting. Before each cycle, patients completed a QOL survey. Some of the important nurse management issues in this study included patient education, study drug administration, and side-effect management. The first dose of treatment regimen was administered in the physician's office, and patients and/or caregivers were trained to administer histamine by slow s.c. injection over 10-20 minutes to minimize acute reactions. Due to the large number of injections associated with this regimen, patients were instructed to rotate injection sites to minimize formation of IL-2- related s.c. nodules. Most common side effects associated with histamine administration were transient and included facial and upper truncal flushing, hypotension, dizziness, palpitations, headache, and rhinitis; in most cases medical intervention was not required. Treatment with IL-2 and histamine significantly improved overall survival for patients with MM and baseline liver metastases compared to patients treated with IL-2 only (median, 154 days to 283 days, adjusted p = 0.008). The addition of subcutaneous histamine to IL-2 treatment did not adversely affect QOL. Conclusions: Histamine may be safely administered in conjunction with low-dose IL-2 and does not adversely affect QOL. Education of patients and caregivers in injection technique and effective toxicity management are essential during administration of this regimen.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2002
Conference Name:
27th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Washington, D.C., USA
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.titleNurse Management Issues During a Randomized Phase III Study of Patients with Metastatic Melanoma Using Histamine Dihydrochloride and Interleukin-2en_GB
dc.contributor.authorStover, Lorien_US
dc.author.detailsLori Stover, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USAen_US
dc.identifier.urihttp://hdl.handle.net/10755/164626-
dc.description.abstractBackground: High-dose IL-2 in metastatic melanoma (MM) requires inpatient hospitalization and side effects can be life threatening. Current efforts to prolong survival and to improve upon patient quality of life (QOL) while receiving IL-2 include investigating outpatient regimens in combination with other agents. Histamine dihydrochloride (Ceplene) is being investigated as a potential adjuvant therapy to IL-2 in MM and other cancers. Histamine potentiates cytokine therapies by inhibiting the production and release of free radicals from phagocytes and thus may protect NK cells and T cells from free radical-induced apoptosis. Methods & Results: In a recently completed randomized, multicenter phase III study in 305 MM patients, IL-2 (9 MIU/m2, bid, sc, days 1-2, weeks 1, 3; and 2 MIU/m2, bid, sc, days 1-5, weeks 2, 4) was administered with or without histamine (1.0 mg, bid, sc, days 1-5, weeks 1-4) for four weeks of a six-week cycle. Both study drugs in the following regimen were administered in an outpatient at-home setting. Before each cycle, patients completed a QOL survey. Some of the important nurse management issues in this study included patient education, study drug administration, and side-effect management. The first dose of treatment regimen was administered in the physician's office, and patients and/or caregivers were trained to administer histamine by slow s.c. injection over 10-20 minutes to minimize acute reactions. Due to the large number of injections associated with this regimen, patients were instructed to rotate injection sites to minimize formation of IL-2- related s.c. nodules. Most common side effects associated with histamine administration were transient and included facial and upper truncal flushing, hypotension, dizziness, palpitations, headache, and rhinitis; in most cases medical intervention was not required. Treatment with IL-2 and histamine significantly improved overall survival for patients with MM and baseline liver metastases compared to patients treated with IL-2 only (median, 154 days to 283 days, adjusted p = 0.008). The addition of subcutaneous histamine to IL-2 treatment did not adversely affect QOL. Conclusions: Histamine may be safely administered in conjunction with low-dose IL-2 and does not adversely affect QOL. Education of patients and caregivers in injection technique and effective toxicity management are essential during administration of this regimen.en_GB
dc.date.available2011-10-27T12:04:07Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:04:07Z-
dc.conference.date2002en_US
dc.conference.name27th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationWashington, D.C., USAen_US
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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