NCCN Outcomes Databases Track Guidelines Compliance

HOLLYWOOD, Florida—An important part of the cancer guidelines effort by the National Comprehensive Cancer Network (NCCN), a coalition of 19 major US cancer centers, is to monitor concordance with the guidelines through the use of outcomes databases. Results from the breast cancer and non-Hodgkin’s lymphoma databases were presented during the NCCN’s Seventh Annual Conference.

The breast cancer database includes 7,623 women. "To my knowledge, this is the largest prospective, comprehensive database on primary breast cancer patients in the world," said Richard L. Theriault, DO, MBA, professor of medicine, Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center.

The patients all had newly diagnosed breast cancer treated at 11 NCCN centers from July 1, 1997, through October 16, 2001: 65% were 59 years of age or younger; 85 patients were under age 30, and 254 were older than age 80. Most patients (89.43%) had stage 0-II disease.

Dr. Theriault reported a sharp increase in the use of sentinel lymph node biopsy: from about 13% for stage I-II disease in 1997 to 69% in 1999.

Member institutions had a high rate of breast-conserving surgery for stage I-II disease, but with substantial variability among centers. The breast-conserving surgery rate was 69% for stage I disease (range, 55% to 82%) and 48% for stage II disease (range, 34% to 64%), he said.

Most (88%) stage I-II patients treated with breast-conserving surgery underwent axillary lymph node dissection, and 94% received radiation therapy. Radiation therapy was more likely to be omitted in women who were elderly (greater than 80 years of age).

Adjuvant Chemotherapy

In concordance with the guidelines, about 90% of NCCN institution patients with stage II disease and 75% with stage I disease received adjuvant chemotherapy with an anthracycline-based regimen—Adriamycin/cyclophosphamide (AC) or AC/taxane.

Nearly all stage IIIA patients received adjuvant chemotherapy. However, the rate of neoadjuvant anthracycline-based chemotherapy (76%) was less frequent than recommended. "For me, coming from M.D. Anderson, the fact that these patients are not getting neoadjuvant chemotherapy is beyond belief," Dr. Theriault said.

The rate of axillary lymph node dissection for DCIS patients who underwent breast-conserving procedures was 16%. "However," Dr. Theriault said, "the percentage of women who have mastectomy and lymph node surgery (at least a sampling of lymph nodes) is very high, about 70%."

Postsurgery Radiation Therapy

Only 74% of patients with breast-conserving surgery for DCIS received postsurgical radiation therapy. "We need to find out why 26% of these patients are not getting radiation therapy," Dr. Theriault said.

The rate of postmastectomy radiation therapy in women with high-risk disease also needs improvement. "High-risk postmastectomy patients are not receiving radiation as frequently as we would like," Dr. Theriault said. Of those with four or more positive nodes, 86% received radiation therapy, and the rate was 77% in those with tumors greater than 5 cm or with positive margins.

About 95% of women with small, well-differentiated tumors with relatively benign features received adjuvant hormonal therapy. "A lot of patients are getting tamoxifen [Nolvadex] now, even with small, well-differentiated tumors. It’s difficult to know if this is done in the adjuvant setting or as a chemoprevention strategy," he said.

Finally, Dr. Theriault noted, a change in the 1999 guidelines has not been widely adapted. The NCCN removed the age requirement for chemotherapy/hormonal therapy in ER-positive tumors. That change has resulted in a drop in concordance from 86% before 1999 to 54%.

Non-Hodgkin’s Lymphoma

M. Alma Rodriguez, MD, associate professor of medicine and associate internist in the Department of Lymphoma/Myeloma, M.D. Anderson Cancer Center, reported preliminary information on a database of 208 patients.

The five centers participating in this outcomes database are M.D. Anderson Cancer Center, City of Hope Cancer Center, Dana-Farber Cancer Institute, Fox Chase Cancer Center, and Roswell Park Cancer Institute. The report included data on mantle cell, follicular cell, and large cell lymphomas.

The patients’ median age was 55, with about the same number of men and women. There were similar numbers of large cell and follicular cell lymphoma patients, with a much smaller number in the mantle cell lymphoma category. Slightly over half of the patients were newly diagnosed and untreated.

There was equal stage distribution in the large cell lymphoma group. The majority of follicular cell patients were in stages III and IV, and most in the mantle cell group were in stage IV. The majority of patients had no significant comorbidities.

Among those with diffuse large cell lymphoma, very few patients received no therapy. Two received only treatment with either immunotherapy or radioactive immunotherapy. The majority received chemotherapy in various combinations. Only a small subset received chemotherapy alone.

Of the patients with follicular cell lymphoma, Dr. Rodriguez said, "a subset with limited-stage disease received radiation therapy only, and looking at the advanced-stage patients, the majority received chemotherapy combination regimens, with very few getting chemotherapy alone."

She noted that a small subset in this group received transplantation. "We found that patients are being transplanted fairly early on in the course of their illness," she said

In summary, she noted the wide variability in treatment choices among the participating NCCN institutions. "Immunotherapy seems to be playing an increasingly large role since the approval of rituximab [Rituxan]," she said.