Congress Abstracts 2006

4

SKIN REACTIONS ASSOCIATED WITH ORAL REVLIMID (LENALIDOMIDE) IN AL AMYLOIDOSIS (ALA); PATIENT TEACHING ENCOURAGING PROMPT REPORTING, AND CLINICAL ASSESSMENT AND MANAGEMENT OF SKIN REACTIONS CAN IMPACT PATIENT OUTCOMES. Kathleen Finn, RNC, ANP, MN, AOCN^®, Boston University Medical Center, Boston, MA; and Salli Fennessey, BS, CCRP, David Seldin, MD, Vaishali Sanchorawala, MD, Anthony Shelton, BS, Sandy Allten, RN, OCN^®, CCRP, and Carol Antonelli, CCRP, Boston Medical Center, Boston, MA.

Skin reactions associated with Revlimid^® in ALA can be effectively treated with prompt management using over-the-counter (OTC) antihistamines and steroid creams. Oncology nurses involved with clinical studies have a unique opportunity to observe adverse events and a responsibility to share their observations to positively impact patient care.

We intend to describe skin reactions, using photographs, associated with Revlimid^® and the effectiveness of our management.

Patients with ALA participated in our Phase II trial. Initial treatment began with Revlimid^® 15-25mg/d for 21 days of a 28-day cycle. 28 patients completed at least one cycle. We observed Grade 1-3 rashes in 14 patients (50%). Of these, 12 developed a rash within the first 28 days. Rashes were typically maculopapular eruptions occurring frequently on the extremities, but also on face and trunk. Pruritis accompanied rash in 57% (8/14) of patients. Scalp itch occurred in 29% (8/28) of all patients. Duration of rash ranged from 1-22 days (median=8days). Patient teaching encouraged prompt reporting of skin reactions. Diphenhydramine (25-50mg q6hrs) and topical OTC steroids was used to treat rashes and scalp itch. Prophylactic diphenhydramine was used with rechallenging doses of Revlimid^® and, in some cases, subsequent cycles. Rash grades and Revlimid^® dose modifications are described in the table below. 10/12 patients continued Revlimid^® with 2 discontinuing due to persistent Grade-3 rash.

Interventions for Non-desquamating rash using the NCI Common Terminology Criteria of Adverse Events (CTCAE) v3 are outlined below. Photographs will be utilized to demonstrate the rashes experienced.

* Diphenhydramine given at first sign of rash/itch, topical steroids added if no improvement within 24hrs

Grade 1-2: 65%(9/14); * and continue Revlimid^®

Grade 3: 21%(3/21); * and hold Revlimid^®; if < Gr 2 by Day-21 start subsequent cycle at next lower dose

Persistent Grade 3; 14%(2/14); * and discontinue Revlimid^® permanently

Managing adverse events can be clinically challenging because of the delicate balance between maximizing therapy duration while minimizing severity of side effects. In our trial, effective patient teaching methods led to prompt recognition of skin reactions by patients and initiation of effective treatment, allowing most patients to continue Revlimid^® therapy.