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Oral Oncology Drugs by gregory Warren, mD, and Wenhui Zhu, mD, phD g gregory Warren, mD W Wenhui Zhu, mD, phD I T H B E T T E r of the genetic, genomic and molecular changes of cancer, targeted therapy has become the next generation of cancer treatment. It is hoped that targeted therapy will provide effective treatment for cancer and make the once uniformly lethal disease a manageable chronic problem such as diabetes and hypertension. Many newly approved and in-development targeted oncology drugs are oral pills. Since the approval of imatinib for CML in 2001, there are 29 new oral oncology drugs approved by the Food and Drug Administration. Oral oncology drugs have created a major shift in the administration of cancer treatments from directly observed intravenous therapy to self-administered oral therapy. The delivery of intravenous chemotherapy typically involves a prescription from the physician, the double-checking of drug dose, preparation of the drug by the pharmacist and administration of the drug by the chemotherapy nurse in the office with direct observation during the entire treatment course. During this process, the drug dose and dose adjustment needed for critical organ (cardiac, renal and hepatic) function compromises are confirmed by both the physician and pharmacist. You know for sure the patient is receiving the scheduled treatment. Any acute reactions are addressed before the patient goes home. The use of oral oncology drugs looks very similar. The physician writes a prescription and the specialty pharmacy UNdErSTANdING mails the medicine to the patient — or the patient picks up the medicine from a retail pharmacy — and takes it at home. Many patients prefer an oral pill to intravenous therapy due to the convenience. Targeted oral drugs generally have a wider therapeutic index and therefore are safer to use than conventional cytotoxic drugs. They do not have the classical side effects of chemotherapy such as hair loss, nausea and vomiting. However, the safe and effective administration of oral oncology drugs requires careful consideration of many issues that are not so relevant to intravenous chemotherapy. The physician is the only person to make sure the drug dose is correct. You have much less control of many factors, which may prevent the patient getting the pill on time, and you do not know if the patient is taking the medicine correctly. Oral oncology drugs are more susceptible to drug-drug interactions and food effects than conventional chemotherapy agents. They have unique side effects such as skin rashes, hypertension, bleeding, endocrine abnormality, dyslipidemia and liver function abnormalities. In the future, many of these drugs may be combined, further complicating the dosage and monitoring of the patient. The American Society of Clinical Oncology (ASCO) and the Quality Oncology Practice Initiative (QOPI), provide useful guidelines for the use of oral oncology drugs. QOPI includes patient education parameters regarding food and drug interactions, how to handle missed doses, potential side effects and many other topics. The important issues are summarized below. the plan. Document and give the patient a plan before the start of oral chemotherapy. The plan should include the purpose of treatment, the dose and safe handling of the oral chemotherapy drug, days and duration of treatment, laboratory and toxicity monitoring, frequency of office visit and contact information. Educate the patient about food restrictions. the drug dose. Pay special attention to the patient's renal, hepatic and cardiac functions, and adjust drug dose as needed. Drug interactions. Review the patient's medication list, including over the counter supplements. Check major drug interaction to minimize drug-drug interactions. Symptoms. Assess and address symptoms and toxicity with each visit or contact following the start of therapy. adherence. Check for adherence to the plan. All oncologists are encouraged to become familiar with the guidelines and make sure a mechanism is in place in their practice for the safe and effective use of oral oncology drugs. With careful planning, patient education and close follow up from a dedicated oncology team including physicians, nurses, pharmacists and social workers, oral chemotherapy will be a safe, effective and more convenient treatment for many cancer patients. Dr. Gregory Warren and Dr. Wenhui Zhu are medical oncologists/hematologists on the Medical Staff at University Hospitals Seidman Cancer Center at Southwest General. ■ NovEmBEr /dECEmBEr ■ mdNEWS.Com ■ MD News Cleveland/Akron/Canton | 37