Consideration of Evidence on Antiemetic Drugs for Nausea and Vomiting Associated with Chemotherapy or Radiation Therapy in Adults. Technology Assessment Report

摘要

Nausea and vomiting are common symptoms in cancer patients undergoing chemotherapy and radiation therapy. In some cases, failure to control nausea and vomiting in cancer patients may result in reduced nutritional status and quality of life, and may prompt the refusal of continuing chemotherapeutic and radiation therapy cycles. The benefits and harms of antiemetic regimens including a 5-hydroxytryptamine-3 (5-HT3) antagonist and a corticosteroid, with and without aprepitant, have been researched in many clinical studies. However, these antiemetic regimens need to be evaluated in the context of the specific programmatic interests of Centers for Medicare & Medicaid Services in terms of all-oral regimens compared with one another, all-oral regimens compared to all-injectable regimens, and mixed oral compared with injectable regimens. Additionally, the applicability of the evidence to patients age 65 and older needs to be determined. This report compares the benefits and harms of antiemetic regimens that consist of a 5-HT3 antagonist plus a corticosteroid, with or without aprepitant, given to prevent and/or treat nausea and/or vomiting caused by emetogenic anticancer chemotherapy and/or radiation, and is based on a systematic review of the literature. The approach, methodology, and criteria used were agreed upon by consensus of staff at the Oregon Evidence-based Practice Center (EPC), Centers for Medicare & Medicaid Services (CMS), and the Agency for Healthcare Research and Quality (AHRQ). We assessed the internal validity (quality) of all studies based on predefined criteria. We graded the overall strength of evidence based on the guidance established for the Evidence-based Practice Center Program of AHRQ. The composite outcomes of total control (no emetic events, no rescue medication, none to mild nausea) and complete response (no emetic events, no rescue medication) were preferred to the individual outcomes of no emesis and no nausea. Applicability of the evidence was considered, with particular attention paid to whether the evidence was applicable to patients 65 years of age and older. Quantitative analyses were conducted where possible using Stats Direct (version 2.7.7, 9/13/2009). Random-effects models were used to estimate pooled relative risks and their 95% confidence intervals.