Three-Week Course of Breast Radiation May Be as Effective as Conventional Five to Seven Week Course for Early Breast Cancers, Says U.S. Study

/PRNewswire/ -- According to a study presented November 4, 2009, at the 51st Annual Meeting of the American Society for Radiation Oncology (ASTRO), a shortened, more intensive course of radiation given to the whole breast, along with an extra dose of radiation given to the surgical bed of the tumor (concomitant boost), has been shown to result in excellent local control at a median follow up of two years after treatment with no significant side effects.

"The observations to date suggest that a three-week course of radiation therapy with concomitant boost results in outcomes comparable to that of a five to seven week course for early stage-breast cancers. Additional studies with a larger body of data and longer follow-up period will help establish whether this type of radiation treatment should be routinely used," Manjeet Chadha, M.D., lead author of the study and a radiation oncologist at the Beth Israel Medical Center in New York, said.

This shorter treatment, called accelerated hypofractionated whole breast irradiation, is an especially attractive option because women can receive a full course of radiation therapy in half the time -- three weeks of daily treatments vs. five to seven weeks. In addition, the cost of this treatment is lower relative to the cost of the standard whole breast radiation and is also less expensive than other new approaches, such as partial breast irradiation (breast brachytherapy).

"Studies from Europe and Canada have used accelerated schedules for breast radiation therapy with favorable results reported on longer follow up. In the U.S., however, there is limited data on this topic," Dr. Chadha said. "Additionally, the radiation therapy technique used in our study is different from previously published experiences. For each patient, we developed a conformal, personalized plan using three-dimensional dosimetry data derived from the patient specific CT scan images. Radiation treatment was delivered to the whole breast using an accelerated hypofractionated schedule, with the simultaneous delivery of a boost dose given to the precise location from which the tumor was removed."

Many women with early-stage breast cancer undergo breast conserving therapy. Typically, this means they first have surgery to remove the visible cancer (a lumpectomy), and then receive a course of radiation therapy to kill any microscopic cancer cells that may remain. The standard whole breast radiation treatment takes 15 to 30 minutes every day, Monday through Friday, for five to seven weeks.

Beginning in June 2004, researchers studied 112 women with early-stage breast cancer who received accelerated hypofractionated whole breast irradiation plus concomitant boost. The results were reported on 105 patients who had completed therapy and had a minimum six-month follow up. The patient group had small breast tumors that had not spread to the lymph nodes. Women with early-stage breast cancer who received chemotherapy or underwent radiation to the lymph nodes were excluded from the study. Patients were followed at regular intervals after completion of treatment.

Findings show that the cancer did not return to the original site or to the surrounding region in these women. The median follow-up of the study was two years. Survival was greater than 95 percent for patients with five years of follow up. The study also shows there were no significant physical or cosmetic side effects from the radiation treatment.

In an era of personalized care, Dr. Chadha emphasizes, "Women with early-stage breast cancer interested in this shorter course should ask their radiation oncologists about this option to evaluate whether it is suitable for their individual case."

For more information on radiation therapy for breast cancer, visit www.rtanswers.org.

The abstract, "Results using 3-week Accelerated Whole Breast (WB) Radiation Therapy (RT) and Concomitant Boost for Early-stage Node Negative Breast Cancer," will be presented at a scientific session at 11:30 a.m. on Wednesday, November 4. To speak to the lead author of the study, Manjeet Chadha, M.D., please call Beth Bukata or Nicole Napoli November 1-4, 2009, in the ASTRO Press Room at McCormick Place West at 312-791-7005 or 312-791-7006. You may also e-mail them at bethb@astro.org or nicolen@astro.org.

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FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

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