RSNA 2005 

Abstract Archives of the RSNA, 2005


LPB11-05

Amifostine as a Radioprotectant for Breast Cancer Patients with Implants Who Undergo Radiation Therapy: A Pilot Study

Scientific Posters

Presented on November 27, 2005
Presented as part of LPB11: Radiation Oncology and Radiobiology (Breast Cancer)

Participants

Susan McCloskey, Presenter: Nothing to Disclose
Leslie E. Botnick MD, Abstract Co-Author: Nothing to Disclose
May Lin Tao MD, Abstract Co-Author: Nothing to Disclose

DISCLOSURE

S.M.,L.E.B.,M.T.: Partial grant from: Medlmmune.

ABSTRACT

Purpose/Objective: Breast cancer patients who have breast implants for augmentation or reconstruction and undergo breast/chest wall irradiation are at increased risk for capsular contracture. Our study objectives were 1. to assess the frequency and severity of acute toxicities associated with subcutaneous (s.c.) administration of amifostine in this population 2. to examine preliminarily the effect of s.c. amifostine in reducing the incidence of capsular fibrosis and related complications. Materials/Methods: Patients with Stage 0-III breast cancer undergoing irradiation with either a pre-existing breast implant in an intact breast or an expander placed for breast reconstruction were eligible. Five hundred milligrams of amifostine, diluted in 2.5 mL normal saline, was injected s.c. in two injections (injection sites rotated), 30-60 minutes before each radiation fraction. We used the NCI Common Terminology Criteria for Adverse Events to evaluate acute toxicities. Patients were assessed at 6 and 12 months from completion of radiation therapy for skin and soft tissue toxicity using RTOG and Baker grading scales as well as a two-item patient self assessment questionnaire. Results: From January 2002 to August 2004, twenty-five patients were enrolled. Seven had pre-existing breast implants (AUG) and 18 had expanders for breast reconstruction (RECON). Sixteen (64%) enrolled patients completed at least 2/3rds of the planned course. Reasons for discontinuation were generalized pruritis and/ or rash (3), nausea (3), low grade fever and localized rash (2), pain at injection site (2), and bruising at injection site (1, who was diagnosed with acute leukemia). Ten (36%) patients had any grade 2/3 acute toxicity: fatigue in 5 (20%), nausea/ vomiting in 4 (16%), generalized pruritis or rash in 4 (16%), fever in 3 (12%), pain at injection site in 2 (8%), hypotension in 1 (4%), and local skin reaction in 1 (4%). No patient had a grade 4 acute toxicity. Of the 25 patients enrolled, 23 completed radiation ≥1 year ago; 20 (87%) returned for follow-up and 18 had documented Baker grades. Of the 20 who returned for follow-up, 7 (35%) had a capsulectomy for poor outcome. Of the 18 with documented Baker grades, 10 (56%) had a Baker grade 3 or 4 capsular contracture. Patients who had RECON compared to those who had AUG had a higher but not statistically significant rate of capsulectomy (43% vs 17%, p=0.24) and a similar likelihood of Baker grade 3 or 4 contracture (58% vs 50%, p=0.74). Twelve of the 20 patients completed at least 2/3rds of the planned course of amifostine. Of these 12, 3 (25%) had a capsulectomy and 7 (58%) developed a Baker grade 3 or 4. Patients who did not complete at least 2/3rds of the planned course of amifostine (N=8) had a higher but not statistically significant rate of capsulectomy compared to those who did (50% vs. 25%, p=0.25) and a similar likelihood of Baker grade 3 or 4 contracture (50% vs. 58%, p=0.74). Sixteen patients completed a 1 year self assessment. Of 11 patients who completed at least 2/3rds course, on a scale from 1 to 7 with 7 being excellent, 64% rated physical comfort 7 and 55% rated overall appearance 7. Among the 5 patients who completed <2/3rds course, 40% rated physical comfort 7 (p=0.38) while 60% (p=0.84) rated overall appearance 7. Conclusions: Tolerance of s.c. amifostine was fair in this breast cancer population. Patients who have pre-existing implants may have a better outcome after radiation therapy than those patients who have implants placed for reconstruction. Amifostine may reduce the rate of poor outcomes, such as capsulectomy. Larger numbers and longer follow-up are needed to substantiate findings.

Cite This Abstract

McCloskey, S, Botnick, L, Tao, M, Amifostine as a Radioprotectant for Breast Cancer Patients with Implants Who Undergo Radiation Therapy: A Pilot Study.  Radiological Society of North America 2005 Scientific Assembly and Annual Meeting, November 27 - December 2, 2005 ,Chicago IL. http://archive.rsna.org/2005/4420784.html