plus 1, Problems mount for hospital - Regina Leader-Post

Problems mount for hospital - Regina Leader-Post

Posted: 25 Feb 2010 08:24 AM PST

Windsor's Hotel-Dieu Grace Hospital is investigating serious errors in reports prepared by a pathologist who was suspended in January.

The pathology review, which began last November, overlaps with recent revelations that Hotel-Dieu surgeon Dr. Barbara Heartwell performed at least two mastectomies on women who did not have breast cancer -- Janice Laporte and Laurie Johnston.

At a news conference Wednesday afternoon, Hotel-Dieu officials said five of Heartwell's cases have been affected by errors in pathology reports.

The 2001 mastectomy performed on Laporte, who had a benign lump in her breast, was not the result of the suspended pathologist's errors.

Hotel-Dieu now has two major investigations underway: a pathology review and a review of Heartwell's past cases.

The pathologist did work all three area hospitals. It was not immediately clear if the 2009 mastectomy performed on Johnston was related to pathology mistakes.

In a statement issued late Tuesday night, Hotel-Dieu said Heartwell has volunteered to temporarily stop performing surgeries after hospital officials found out through the media about a 2001 case in which "a patient was tragically harmed."

Laporte's case came to light days after Hotel-Dieu admitted Heartwell misread a pathology report last fall and performed a mastectomy on another woman, Laurie Johnston, who was cancer-free.

Hotel-Dieu's interim chief of staff, Dr. Kevin Tracey, said Heartwell's withdrawal from the OR is "in the best interests of our patients" as the investigation into the cases continues.

Heartwell has never had a formal complaint filed with the College of Physicians and Surgeons of Ontario, which regulates doctors. It could be a year before Heartwell has a disciplinary hearing of her own.

The surgical safety checklist that was rolled out this week by the Ontario Ministry of Health is designed to prevent precisely the kind of mistakes that allowed the unnecessary mastectomies, health officials said Wednesday.

Just over a year in the making, the 32-point list will become mandatory April 1.

"I think when something like this happens it is incumbent upon all of us who are involved in the health system to look and see what lessons can be learned," Ontario Minister of Health Deb Matthews said Wednesday.

Windsor Star

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Genomic Health (GHDX) Announces Results of Oncotype DX Breast Cancer ... - StreetInsider.com

Posted: 26 Feb 2010 05:31 AM PST

February 26, 2010 8:36 AM EST

Genomic Health, Inc. (NASDAQ: GHDX) today announced results from an analysis demonstrating that the Oncotype DX breast cancer test has similar clinical relevance in estrogen receptor-positive, early-stage breast cancer patients in Asia Pacific (AP) countries as it does in a comparable U.S.-based patient population. The analysis showed that this advanced diagnostic test consistently identified more than 50 percent of hormone receptor positive early-stage breast cancer patients in AP countries as having low Recurrence Scores, similar to what has been shown in U.S. and European clinical studies evaluating the Oncotype DX breast cancer test. These results were presented in a poster presentation at the Organisation for Oncology and Translational Research (OOTR) 6th Annual Conference in Kyoto, Japan, on February 26.

The Oncotype DX breast cancer test measures the expression of 21 genes of an individual breast cancer tumor to generate a Recurrence Score that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage patients. As of February 2010, more than 8,000 physicians have used the Oncotype DX test for more than 135,000 breast cancer patients in more than 50 countries. The test was launched in the United States in 2004 where it has since been widely adopted for treating early-stage breast cancer, and is available worldwide.

"We believe these new findings, coupled with results from the multi-center Japanese validation study presented last April at the 2009 Kyoto Breast Cancer Consensus Conference, confirm the significant clinical benefit Oncotype DX provides in breast cancer treatment planning for early-stage breast cancer patients in Asia Pacific countries," said Calvin Chao, M.D., Medical Director, Genomic Health. "We believe these data support our efforts to expand the use of Oncotype DX throughout this important region of the world."

For this analysis, researchers at Genomic Health's CLIA (Clinical Laboratory Improvement Amendments) certified, CAP (College of American Pathologists) accredited laboratory analyzed tumor samples from 546 AP patients located in Japan, Taiwan, Hong Kong, Singapore, Thailand, India, Australia, and New Zealand. The tumor samples were submitted by physicians between 2006 and 2009. The AP Recurrence Score results, when compared to U.S. scores, showed a similar distribution of Recurrence Scores -- low Recurrence Score group (51 percent AP, versus 54 percent U.S.), intermediate Recurrence Score group (33 percent AP, versus 34 percent U.S.) and high Recurrence Score group (16 percent AP, versus 13 percent U.S.). These findings were consistent with results from numerous U.S. and international validation and confirmatory studies evaluating Oncotype DX, despite observed differences in practice pattern management of early-stage breast cancer.