Nursing s Role in the Management of New Oral Chemotherapy Agents

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1 Nursing s Role in the Management of New Oral Chemotherapy Agents Mechelle Barrick BSN, RN, OCN, CCRP Clinical Research Nurse Coordinator Greater Baltimore Medical Center mbarrick@gbmc.org

2 THE NURSES ROLE FACING NEW CHALLENGES Oral Chemotherapy Drugs Who will teach the patients? What do we need to know? What does the patient need to know? How do we accomplish this is our various settings?

3 WHAT WE NEED TO KNOW Only 30% of oral medications are taken correctly WHY? Drug related side effects Cost of medication Lack of education Drug to drug interactions Other factors How Can We Impact This?

4 WHAT PATIENTS NEED TO The quick lesson: KNOW Medication name Dosage and schedule Safety issues Side effects How to manages side effects Who to call

5 HOW CAN THIS BE ACCOMPLISHED? Our roles vary by setting How can we teach patients when we see them after the fact? Educate ourselves Have appropriate patient literature Have access to patient resource programs

6 Update: New Oral Medications Lenalidomide or Revlimid Sunitinib Malate or Sutent Sorafenib Tosylate or Nexavar

7 Lenalidomide or Revlimid Other names: CC-5013 Pharmaceutical Company: Celgene Corporation FDA Approval: Transfusion Dependent Myelodysplastic Syndrome (MDS), associated with a deletion 5q cytogenetic abnormality Action: Immunomodulatory drug IMiDs (Thalidomide analog) Inhibition of Tumor Necrosis Factor (TNF): TNF increases the number of adhesion molecules on endothelial cells allowing for bonding of tumor cells resulting in metastasis Inhibits TNF with a greater affinity than thalidomide Anti-angiogenesis properties: Decreases Vascular Endothelial Growth Factor (VEGF) and Interleukin-6 (IL-6) Stimulates T-cells activity (enhances natural immune system) and increases activity of Natural Killer (NK) cells

8 Lenalidomide Dosage Schedule: 10 mg orally daily Take with a large glass of water with or without food Plasma concentrations reached in to 1.5 hours Available: 5 and 10 mg capsules Drug Interactions: None known renal excretion Common Side effects: Pruritis, Rash, Fatigue, Diarrhea, Constipation, Nausea Serious Concerns: Potential for Human Birth Defects DVT and PE: prophylaxis is recommended (i.e. Aspirin, Heparin, Lovenox) Neutropenia and Thrombocytopenia * dose dependent

9 Lenalidomide Nursing: RevAssist SM or Restricted distribution program: Prescribers and patients must be registered and agree to all program requirements Monitor CBC frequently Prophylaxis for DVT / PE potential Studies of Clinical Response:*not approved in MM MDS-03 Study: N=148 Open-label study Transfusion independence: 67% of patients, with median time to response of 4.1 weeks MM-010 Study: N=351 (Decadron + Revlimid versus Decadron) Response rates: 58% vs. 22% Medium time to recurrence 1 year vs. 5 months CR + ncr 17% vs. 4% Future Applications: Multiple Myeloma (25 mg dosing)

10 Sunitinib Malate or Sutent Other names: SU11248 Pharmaceutical Company: Pfizer Pharmaceuticals FDA Approval: Metastatic Renal Cell Carcinoma (MRCC) and Imatinib Resistant Gastrointestinal Stromal Tumor (GIST) Action: Small molecule Multi kinase inhibitor targeting several receptor tyrosine kinases (RTK) including: Vascular Endothelial Growth Factor Receptor (VEGFR) Platelet Derived Growth Factor Receptor (PDGFR) RTK are responsible for a wide variety of cellular activity including cell proliferation, differentiation, motility, and death. Upregulation of RTK s results in TUMOR GROWTH.

11 Sunitinib Malate Dosage Schedule: 50 mg orally daily for 4 weeks on / 2 weeks off Take with or without food Plasma concentrations reached in 6 to 12 hours Dose modification in 12.5 mg increments Available: 12.5 mg, 25 mg and 50 mg tablets Drug Interactions: Metabolized by cytochrome P450 enzyme CYP3A4 CYP3A4 inhibitors will increase concentrations of Sutent CYP3A4 inducers will decrease concentrations of Sutent Common Side Effects: Fatigue, Rash, Skin discoloration (yellow/orange), Hand-food reactions, Epitaxis, Diarrhea, Abdominal pain, Nausea, Mucositis, Anorexia, Serious Concerns: Decreases in left ventricular ejection function (LVEF) Tumor hemorrhage in GIST (3%) Hypertension, Neutropenia

12 Sunitinib Malate Nursing: First Resource Monitor CBC and Chemistries with each cycle Monitor for skin changes: color, cracking, rash, dryness, blistering Assess con-medications for possible interactions Studies of Clinical Response: GIST: N=312 patients: Sutent (n=201) versus Placebo (n=105) Time to Tumor Progression (TTP): 27.3 weeks vs. 6.4 weeks Progression Free Survival (PFS): 24.1 weeks vs. 6.0 weeks MRCC: Data from 2 single arm studies of 169 patients Objective Response Rate: 26% to 37% Duration of Response: 27 to 54 weeks Future Applications: Current trials in NSCLC, MBC, Liver Cancer

13 Sorafenib Tosylate or Nexavar Other names: BAY Pharmaceutical Company: Manufactured by Bayer HealthCare and Marketed by Onyx Pharmaceuticals FDA Approval: Metastatic Renal Cell Carcinoma Action: Small molecule Multikinase inhibitor blocking the ability of tumor cells to proliferate Targets VEGF and PDGFR Blocks the process of angiogenesis Effectively blocks the Raf /MEK / ERK signaling pathways The ability of the drug to block multiple signaling pathways allows for greater cell kill

14 Sorafenib Tosylate Dosage Schedule: 400 mg orally twice a day with treatment ongoing until no clinical benefit or toxicity Take WITHOUT food (1 hour before or 2 hours after) * High fat meals alter the bio-availability (By 26%) Plasma concentrations reached in 3 hours Drug Interactions: Metabolized by UGT1A1 and CYP3A4 pathways Monitor when used with CYP3A4 inhibitors & inducers Common Side effects: Diarrhea, Rash, Hand-foot syndrome, Fatigue, Alopecia Serious Concerns: Hypertension, Cardiac Ischemia (2.9%) Hemorrhage (2% with one fatal incident): patients on Coumadin should be monitored

15 Sorafenib Tosylate Nursing: REACH Program or Monitor Blood pressure weekly for the first 6 weeks of treatment Monitor PT in those individuals on Coumadin Monitor for hand-foot syndrome Studies of Clinical Response: N= 903 patients: Nexavar (n= 451) versus Placebo (n= 452) Progression Free Survival (PFS): 6 months vs. 3 months Overall Survival (OS): 28% reduction in mortality on Nexavar Future Applications: Clinical trials include Metastatic Melanoma, Colon, Liver, NSCLC, Gastric cancer and Lymphoma

16 Summary As the use of oral medications increases, nurses must be pro-active in learning about their application Nurses must take every opportunity to assess what patients know and provide them with information to maintain compliance with therapy Education is a team (Patient + Nurse + Doctor) responsibility