Pharmacy & Therapeutics - October 2008 - (Page PP2)

PRODUCT PROFILER: Granisetron Transdermal Delivery System Sancuso® (Granisetron Transdermal Delivery System) A New Formulation for Chemotherapy-Induced Nausea and Vomiting INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and most dreaded side effects reported by cancer patients.1 Other common adverse effects (AEs) of chemotherapeutic agents include hair loss, malaise, fatigue, diarrhea, dehydration, neutropenia, fever, systemic infections, and thrombocytopenia.2 Although some of these AEs cannot be prevented, those that can, such as CINV, should be aggressively prevented and managed. According to the American Cancer Society, the leading sites of new cancer cases and death in the U.S. for men are the prostate gland, lung and bronchus, colon and rectum, urinary bladder, and non-Hodgkin’s lymphoma.3 The leading sites for women are the breast, lung and bronchus, colon and rectum, uterine corpus, and non-Hodgkin’s lymphoma.3 Chemotherapy agents commonly employed to combat these disease are often highly emetogenic, such as cisplatin. In the U.S., breast cancer is the most common indication for chemotherapy among women.4 However, the chemotherapeutic agents commonly employed to treat breast cancer are also the leading cause of serious drug-related AEs among these women.4 Although the efficacy of chemotherapeutic agents used to treat breast cancer has been well documented in numerous clinical trials, toxicities of cancer chemotherapy are the most important factors limiting its use.2 In placebo-controlled trials, 98% of patients receiving cisplatin, a widely used chemotherapeutic agent, had emesis within 24 hours after drug administration at a dose of 50 to 120 mg/m2.5 In another trial, nausea and vomiting symptoms with cisplatin therapy were greatest at 48 to 72 hours, with a median of two emetic episodes per patient.5 Classification CINV can be divided into three types: acute, delayed, and anticipatory.5 • Acute nausea or vomiting is defined as occurring within 24 hours after chemotherapy administration.5 • Delayed nausea or vomiting occurs at least 24 hours after the administration of chemotherapy, and it may last for more than 120 hours.5 • Anticipatory vomiting is a learned or conditional response that typically occurs when nausea and 2 vomiting have been poorly controlled with previous chemotherapy. 5 It affects patients before acute chemotherapy-related symptoms are expected to occur, either before, during, or after chemotherapy administration.5 Anticipatory nausea or vomiting is best treated with behavioral interventions and other nonpharmacological approaches rather than with pharmacological therapy.5 Medical Complications Severe nausea and vomiting can result in many complications, such as dehydration, malnutrition, metabolic disturbances (i.e., metabolic alkalosis, hyponatremia, hypochloremia, and hypokalemia), and aspiration pneumonia, all of which can become lifethreatening.5 Patients experiencing vomiting may also rupture their esophagus (Boerhaave’s syndrome), or they may have a linear mucosal tear (Mallory–Weiss syndrome) in the region of the cardioesophageal junction, which may result in the vomiting of blood.5 A population-based assessment of adverse effects related to toxicity from chemotherapy in older women with breast cancer revealed that 178 of 4,134 women receiving chemotherapy within six months of their diagnosis (4.3%) were hospitalized for dehydration, compared with 486 of 30,926 women who did not receive chemotherapy (1.6%).2 All of these sequelae can result in a patient’s inability to tolerate subsequent doses of the chemotherapeutic agent or in the patient’s refusal of further treatment altogether.6 In one study, failure to control these side effects resulted in 25% to 50% of chemotherapy patients delaying or refusing possible lifesaving antineoplastic therapy.7 The problem is particularly severe with cisplatin. Another single-blind, randomized crossover trial, conducted by Chua et al., compared older oral CINV agents (tropisetron plus dexamethasone vs. a combination of metoclopramide, dexamethasone, and diphenhydramine) in Chinese patients with naso pharyngeal carcinoma who were scheduled to receive high-dose cisplatin.8 The patients were hospitalized for the first two days of the six-day treatment period. The investigators found that patient compliance with a multiple-dose schedule of the oral antiemetic treatments decreased by an average of 24% after the

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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