Main Line Hospitals

Participate in Groundbreaking Breast Cancer Trial

Women who are newly diagnosed with early stage breast cancer may be eligible for a promising study to determine whether genetic profiling can be used to trailer their treatment.

WYNNEWOOD, Pa (September 2006)- The cancer programs at the Main Line Health hospitals of Lankenau, Bryn Mawr and Paoli are among five institutions in the five-county Philadelphia region participating in a clinical trial, launched last spring by the National Cancer Institute (NCI) and the National Institutes of Health (NIH), in what the NCI and NIH characterize as potentially the beginning of a new era in cancer treatment.

The study is called TAILORx, or Trial Assigning Individualized Options for Treatment (Rx).  By using genetic profiling of the patient's tumor, the study hopes to identify which breast cancers are likely to recur, thereby influencing treatment.

"The study is an innovative clinical trial that will potentially increase the ability of physicians to define the prognosis for a given patient and individualize breast cancer care,"  said Paul Gilman, MD, division chief of Hematology/Oncology at Lankenau Hospital and section chief of Medical Oncology for Main Line Health. "This knowledge will guide which patients may not need systemic chemotherapy, or identify those who do require such treatment."

Currently, oncologists assess factors such as tumor size and lymph node involvement to determine the cancer's stage and how it should be treated.  Most women with early stage breast cancer have a combination of treatments-surgery to remove the tumor, followed by radiation and hormonal therapy.  Although chemotherapy is also usually recommended, research has not demonstrated that it benefits all recipients equally.

"It will be exciting if the study proves that women in the moderate risk groups who receive hormone therapy alone do as well as women who receive chemo and hormone therapy, " said Maureen O'Connell, RN, administrator of Main Line Health's Community Clinical Oncology Program (CCOP), which participates in NCI-supported research projects.  "Up until now, patients have generally been advised to have more aggressive treatment based on their clinical status.  This study is a whole new way of thinking about treating patients."

A total of 10,046 women age 18 to 75 will be enrolled in TAILORx at 900 sites nationwide.  The goal at Main Line Health is to have 50 patients enrolled this year through Lankenau, Bryn Mawr, and Paoli Hospitals.

To be eligible for the study, women must have a diagnosis of estrogen- or progesterone-positive, Her2/neu negative cancer that has not spread to the lymph nodes and can be surgically removed.  (According to the NCI, over expression of the Her2/neu gene carries a poorer prognosis.)  More than half of the 212,920 expected breast cancer cases this year would qualify.  Once enrolled, the women will be studied for 10 years, with an additional follow-up of up to 20 years after the initial therapy.

Genetic screening of tumor specimens conducted over the last two years by Genomic Health, Inc., a California company, indicates that 29 percent of patients likely will not have a recurrence of breast cancer, with or without chemotherapy, while 27 percent have a higher likelihood of recurrence and may benefit from chemotherapy.

The big question mark for researchers in the trial is the 44 percent in the middle.  The study is targeting these patients in an attempt to determine which of them will benefit from chemotherapy and thus spare women from chemotherapy that is not likely to be of substantial benefit.

"For those women whose tumors show genetic results placing them in the moderate (middle) group, this trial is going to be a landmark," said O'Connell.  "We want to find the most appropriate and effective treatment.  Who would not want to spare anyone from unnecessary chemotherapy?"

Following surgery to remove the primary tumor, study participants will be classified into three groups:

• Participants with the lowest scores on the genetic test will receive hormonal therapy alone.
• Participants with the highest scores will receive the standard of care-chemotherapy plus hormonal therapy.
• Participants who fall in the targeted middle group will be randomly assigned to receive hormonal therapy with chemotherapy or hormonal therapy alone.

In addition, patients in all groups who have had breast-conservation surgery will receive radiation treatments.  For information on the TAILORx study at Main Line Health, call 610-645-2649.

Published:6-27-2008