Cancer 1996 Jun 1;77(11):2267-74

A prognostic index for ductal carcinoma in situ of the breast.

Silverstein MJ, Lagios MD, Craig PH, Waisman JR, Lewinsky BS, Colburn WJ, Poller DN

Division of Surgical Oncology, Breast Center, Van Nuys, California 91405, USA.

BACKGROUND. There is controversy and confusion regarding therapy for patients with ductal carcinoma in situ (DCIS) of the breast. The Van Nuys Prognostic Index (VNPI) was developed to aid in the complex treatment selection process. METHODS. The VNPI combines three significant predictors of local recurrence: tumor size, margin width, and pathologic classification. Scores of 1 (best) to 3 (worst) were assigned for each of the 3 predictors and then totaled to give an overall VNPI score ranging from 3 to 9. Three hundred thirty-three patients with pure DCIS treated with breast preservation (195 by excision only and 138 by excision plus radiation therapy) were studied with detection of local recurrence as the end point. RESULTS. There was no statistical difference in the 8 year local recurrence free survival in patients with VNPI scores of 3 or 4, regardless of whether or not radiation therapy was used (100% vs. 97%). Patients with VNPI scores of 5, 6, or 7 received a statistically significant 17% local recurrence free survival benefit when treated with radiation therapy (85% vs. 68%). Patients with scores of 8 or 9, although showing the greatest relative benefit from radiation therapy, experienced local recurrence rates in excess of 60% at 8 years. CONCLUSIONS. DCIS patients with VNPI scores of 3 or 4 can be considered for treatment with excision only. Patients with intermediate scores (5, 6, or 7) show a 17% decrease in local recurrence rates with radiation therapy. Patients with VNPI scores of 8 or 9 exhibit extremely high local recurrence rates, regardless of irradiation, and should be considered for mastectomy.

Lancet 1995 May 6;345(8958):1154-7

Prognostic classification of breast ductal carcinoma-in-situ.

Silverstein MJ, Poller DN, Waisman JR, Colburn WJ, Barth A, Gierson ED, Lewinsky B, Gamagami P, Slamon DJ

Gloucestershire Royal Hospital, UK.

We present a new prognostic classification designated the Van Nuys classification for ductal carcinoma-in-situ (DCIS). The classification combines high nuclear grade and comedo-type necrosis to predict clinical recurrence. Three groups of DCIS patients were defined by the presence or absence of high nuclear grade and comedo-type necrosis: 1--non-high-grade DCIS without comedo-type necrosis, 2--non-high-grade DCIS with comedo-type necrosis, 3--high-grade DCIS with or without comedo-type necrosis. There were 31 local recurrences in 238 patients after breast-conservation surgery 3.8% (3/80) in group 1, 11.1% (10/90) in group 2, and 26.5% (18/68) in group 3. The 8-year actuarial disease-free survivals were 93%, 84%, and 61%, respectively (all p < or = 0.05). The Van Nuys classification defines three distinct and easily recognizable groups, each of which has a different likelihood of local recurrence if treated with breast conservation.

Surg Oncol Clin N Am 1997 Apr;6(2):385-92

Ductal carcinoma in situ. The success of breast conservation therapy: a shared experience of two single institutional nonrandomized prospective studies.

Lagios MD, Silverstein MJ

Breast Cancer Consultation Service, St. Mary's Medical Center, San Francisco, USA.

A combined database of 342 patients with DCIS treated by lumpectomy alone versus lumpectomy and radiation therapy with a median 82-month follow-up is summarized in this joint study. Reproducible subtype classification and common methods of mammographic-pathologic correlation and complete tissue processing are unique features of this database, and they permit outcome to be analyzed by pathologic subtype, size, and margin status. Striking differences are noted in local control rates analyzed by subtype, which were largely independent of irradiation. Analysis of local recurrence-free survival restricted to those cases with a 10 mm or larger free margin width revealed no significant differences between the irradiated and nonirradiated groups. The local recurrence rates were 5% in those treated by lumpectomy alone and 4.5% in those treated by lumpectomy and irradiation.. Although differences in local recurrence rates for DCIS with a 10 mm plus free margin, with or without irradiation, were noted, they were not large. For DCIS patients with adequate (10 mm or more) or intermediate (1-9 mm) margin width, there was a reduction in local recurrence limited to the high-grade subtype (group III) with radiation therapy; an absolute 8% reduction for those with adequate margins and 11% for those with intermediate margins, but the difference was significant only for the latter group. However, no significant differences were noted for the lower grade DCIS subtypes (groups I and II). For DCIS patients with inadequate margins (i.e., less than 1 mm), irradiation provided no benefit for local control. We conclude that an adequate surgical excision for DCIS, defined as a free margin of 10 mm or more, largely makes moot the question of local control related to pathologic subtype and treatment modality. Specifically, adequately excised high-grade (group III) DCIS received a benefit for local control from radiation therapy of only 8% within the median follow-up period. This difference is not significant. The impact of DCIS size or extent on local recurrence is much smaller than margin width.. Significant differences achieved by radiation therapy were demonstrable only for the smallest size group (15 mm or less) in the high-grade subtype (group III). Differences in local recurrence rates for low and intermediate subtypes (group I and II) based on radiation therapy could not be demonstrated within the three size categories used in the study. We conclude that although adequate margins are more difficult to achieve for larger or more extensive DCIS, size alone is not a prohibition to breast conservation.