Test Predicts Breast Cancer Recurrence

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SABCS: Test Predicts Breast-Cancer Recurrence

By Charlene Laino

SAN ANTONIO, TX -- December 8, 2003 -- A new multi-gene real time-

polymerase chain reaction (RT-PCR) assay can help physicians to

decide whether patients with newly diagnosed breast cancer should

undergo chemotherapy, researchers reported here December 4th at the

26th Annual San Breast Cancer Symposium.

In a blinded study, the test -- which looks for the presence of 16

oncogenes and 5 reference genes -- accurately predicted the

likelihood that cancer would recur if chemotherapy were not given in

over 600 women, said Norman Wolmark, MD, Chair of the National

Surgical Adjuvant Breast and Bowel Project and the department of

Human Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania,

United States.

" This tool gives considerably more information than standard measures

of determining recurrence, such as age and tumor size, " Dr. Wolmark

said. " Women and their physicians can then use this information to

decide whether they should have chemotherapy. All eligible patients

should get it. "

For the study, the researchers analyzed tissue samples collected from

668 women with newly diagnosed Stage I or II, node-negative, estrogen-

receptor-positive breast cancer, and who were treated with tamoxifen

in the 1980s.

Ribonucleic acid was extracted from 3 10-micron sections without

dissection or from 6 10-micron sections of grossly dissected tumor.

Expression was quantified for the 21 genes using RT-PCR in a 384 well

format on the ABI 7900 real-time thermal cycler.

Depending on the expression of the genes, the women were assigned a

recurrence score of 1 to 100 and classified as being at low, medium

or high risk of recurrence.

At a mean follow-up of 10.9 years, the recurrence score accurately

predicted the risk of recurrence, Dr. Wolmark said. Women in the low-

risk category (with a recurrence score of 0 to 17) had only a 6.8%

chance of having a recurrence, the study showed. Cancer recurred,

however, in over 30% of women who had a recurrence score of over 30,

and therefore fell into the high-risk category. " This was highly

significant, with 9 zeros after the decimal point, " he said.

The study also showed that clinical characteristics such as patient

age (P = .084) and tumor size (P = .231) did not provide significant

additional information, compared with recurrence score, Dr. Wolmark

said. " While tumor grade is more accurate, we asked highly qualified

pathologists to grade a series of tumors, and there was only 43%

agreement, " he added. " So clearly that is not a reliable means of

predicting recurrence. "

Genomic Health, which makes the test, expects it to be available in

early 2004. The price has not yet been determined.

[study Title: Multi-Gene RT-PCR Assay for Predicting Recurrence in

Node Negative Breast Cancer Patients NSABP Studies B-20 and B-14.

Abstract 16]

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