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"Ultrastaging" May Be Predictive, But Is Definitely Expensive, in Early Stage Cervical Cancer: Presented at SGO

By Karla Harby

MIAMI BEACH, FL -- March 28, 2005 -- Using advanced technology to detect micrometastases that cannot be diagnosed using standard histological methods -- a procedure called "ultrastaging" -- appears predictive in early stage cervical cancer. But the high cost of the technology is likely to limit its use to research protocols.

Jacob Tangir, MD, Resident at the Yale University School of Medicine, New Haven, Connecticut, and an oncologist in private practice, presented his findings here on March 23 at the 2005 Annual Meeting on Women's Cancer of the Society of Gynecologic Oncologists.

The investigators performed a case-controlled study based on chart reviews. They identified 21 patients diagnosed with early stage cervical cancer (FIGO stages IA2-IB2), treated at Yale from 1985 through 2001, whose lymph nodes were diagnosed as free of metastases by standard histological methods at the time of surgery. Among these they found 13 patients whose disease had recurred, and 8 patients whose disease had not recurred, which they used as controls. The mean follow-up time was 41.7 months.

The researchers obtained lymph node tissue from the archives for all patients and prepared new slices for analysis. These were immunostained using commercial monoclonal antibodies against pan-cytokeratins, as well as being subjected to standard histological analysis.

None of the 8 patients in the control group showed evidence of micrometastases, Dr. Tangir said, compared with 5 (38.5%) of the patients who experienced disease recurrence. Except for median age, there were no other differences between the two patient groups. They estimated odds ratio to be 10.0 (95% confidence interval of 0.5 to 215.0).

Michael Gold, MD, Assistant Professor of Obstetrics and Gynecology at the University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, served as Discussant for the paper in this session.

"Ultrastaging is an expensive and time-consuming proposition," he told the audience. He calculated that if 10 to 25 lymph nodes per patient are analyzed, and if advanced immunohistochemistry costs US$48.50 per slide, then it would cost US$23,267 to US$58,167 per patient with micrometastases who is identified. Overall, including the analysis of patients who are free of the disease, the procedure would cost US$3,490 to US$8,725 per patient, he said.

Dr. Tangir replied that streamlined techniques could reduce the costs somewhat, by allowing for the analysis of fewer samples. But he agreed that "we cannot use this at the present time" in normal clinical practice. He added that if a sentinel node approach -- in which only lymph nodes that are key to the malignancy are sampled -- can be developed, this would also reduce costs.


[Presentation title: Clinical Implications of Pelvic Lymph Node Micrometastasis in Early Stage Cervical Cancer. Abstract 65]

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