Congress Abstracts 2004

82

ASSESSING AND MANAGING POSSIBLE SIDE EFFECTS OF AVASTIN^®: A NURSE’S EXPERIENCE DURING THE PHASE II AND III CLINICAL TRIALS FOR COLORECTAL CANCER. Wanda Honeycutt, RN, BSN, Sherri Haley, RN, Roxanne Truax, RN, BSN, OCN^®, and Shawna Savage, RN, BSN, Duke Comprehensive Cancer Center, Durham, NC.

Avastin^® (RhuMAB VEGF) is a novel monoclonal antibody that is an anti-angiogenic agent.

Avastin^® has been tested in clinical trials for several tumor types. At Duke University Medical Center, an NCI-designated comprehensive cancer center, we participated in phase II and phase III clinical trials studying the combination of standard chemotherapy with and without Avastin^® for the treatment of metastatic colorectal cancer. Information was recently released from a 900-patient phase III randomized double-blind placebo-controlled study that demonstrated the addition of Avastin^® to standard chemotherapy significantly improved the overall survival, time to progression, and tumor response rate for newly diagnosed metastatic colorectal cancer patients. In this study, the only adverse event noted more frequently in the patients receiving Avastin^® was hypertension.

In the phase I and phase II clinical trials, several signal adverse events were identified that were possibly related to Avastin^®: hypertension, proteinuria, thrombosis, bleeding, and infusion reactions. Throughout these clinical trials, clinical research nurses assessed and managed the possible side effects of this new treatment. Education materials were developed for both nurses and patients. Nursing documentation tools and patient diaries promoted the accurate assessment of side effects. Protocol specific guidelines were implemented to assess and treat side effects.

Helping nurses to understand how to properly assess and manage side effects of Avastin^® will help to ensure quality care for this patient population.

The purpose of this presentation is to describe the nursing role in identification and management of Avastin^®-related side effects. Education materials, side effect monitoring tools, and patient outcomes will be presented.