rhuMAb HER2 is well tolerated and clinically active in patients with HER2-overexpressing metastatic breast cancers that had received extensive prior therapy. This is evidence that targeting growth factor receptors can cause regression of human cancer and justifies further evaluation of this agent.

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Primary breast carcinomas from 192 patients treated between 1955 and 1965 for medullary carcinoma or duct carcinoma with medullary features were reviewed and reclassified using strictly defined pathologic criteria. Tumors that fulfilled requirements for medullary carcinoma were identified in 5 7 patients. Another 79 tumors that varied slightly from these criteria were termed "atypical" medullary carcinoma and 56 were chqracterized as nonmedullary carcinoma. When compared with the patients with nonmedullary infiltrating duct carcinoma, patients with medullary carcinoma had a significantly higher survival rate at 10 years, (84% vs. 63%), similar frequency of axillary lymph node metastases, and a more favorable prognosis when nodal metastases were present. Within the medullary carcinoma group, patients had a significantly better survival rate if their primary tumors were smaller than 3 cm in diameter. The average size of medullary carcinomas was 1.9 t m and that of nonmedullary carcinomas, 4.0 cm. Bilaterality was not more common in patients with medullary carcinoma, but the interval between diagnosis of the tumors w a s twice as long when one lesion was medullary (8.8 years) than when both were infiltrating duct carcinomas (4.6 years). Bilaterality was significantly more common among patients with medullary carcinoma who had B positive family history. The medullary lesion was most often the second one to be diagnosed. The 79 patients with atypical medullary carcinoma had a 10-year survival rate of 74%. Patients in this group whose tumors had a sparse lymphoid infiltrate had a relatively poor prognosis. Intraductal carcinoma at the periphery of the lesion was not associated with a less favorable prognosis. It was concluded that intraductal carcinoma was consistent with the diagnosis of medullary carcinoma if all other criteria for the diagnosis were satisfied. With these exceptions we were unable to draw any firm conclusions about favorable or unfavorable effects of other morphologic features on survival in the group with atypical medullary carcinoma. Until further study of this group reveals that some or all of the lesions form a distinct clinicopathologic entity they are best included under the heading of infiltrating duct carcinoma. When the criteria described in this report were used, medullary carcinoma proved to be a specific lesion associated with a significantly better prognosis than ordinary infiltrating duct carcinoma.Cancer 40:1365-1385, 1977 EDULLARY CARCINOMA IS AN INFREQUENT M type of mammary duct carcinoma usually considered to have a better prognosis than the common forms of infiltrating duct carcinoma. l q z o * z~z z Some authors have questioned this conclusion regarding prognosis or have ex-

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Objective To develop and evaluate a Localized Scleroderma (LS) Skin Severity Index (LoSSI) and global assessments’ clinimetric property and effect on quality of life (QOL). Methods A 3-phase study was conducted. The first phase involved 15 patients with LS and 14 examiners who assessed LoSSI [surface area (SA), erythema (ER), skin thickness (ST), and new lesion/extension (N/E)] twice for inter/intrarater reliability. Patient global assessment of disease severity (PtGA-S) and Children’s Dermatology Life Quality Index (CDLQI) were collected for intrarater reliability evaluation. The second phase was aimed to develop clinical determinants for physician global assessment of disease activity (PhysGA-A) and to assess its content validity. The third phase involved 2 examiners assessing LoSSI and PhysGA-A on 27 patients. Effect of training on improving reliability/validity and sensitivity to change of the LoSSI and PhysGA-A was determined. Results Interrater reliability was excellent for ER [intraclass correlation coefficient (ICC) 0.71], ST (ICC 0.70), LoSSI (ICC 0.80), and PhysGA-A (ICC 0.90) but poor for SA (ICC 0.35); thus, LoSSI was modified to mLoSSI. Examiners’ experience did not affect the scores, but training/practice improved reliability. Intrarater reliability was excellent for ER, ST, and LoSSI (Spearman’s rho = 0.71–0.89) and moderate for SA. PtGA-S and CDLQI showed good intrarater agreement (ICC 0.63 and 0.80). mLoSSI correlated moderately with PhysGA-A and PtGA-S. Both mLoSSI and PhysGA-A were sensitive to change following therapy. Conclusion mLoSSI and PhysGA-A are reliable and valid tools for assessing LS disease severity and show high sensitivity to detect change over time. These tools are feasible for use in routine clinical practice. They should be considered for inclusion in a core set of LS outcome measures for clinical trials.

Despite the widespread use of radiation therapy to treat breast carcinoma, angiosarcomas arising in the field of radiation therapy are rare. The authors studied three patients with cutaneous angiosarcoma and four patients with atypical vascular lesions (AVL). All had breast conserving surgery, axillary lymph node dissection, and radiation therapy for breast carcinoma. Six patients received conventional high energy postoperative doses of external beam radiation therapy to the breast. Details of radiation therapy were not available for one angiosarcoma patient. Angiosarcoma was diagnosed 3.5 years, 3.7 years, and 5.25 years after radiotherapy. The three angiosarcomas were multifocal or diffuse and high grade, with solid cellular foci located mainly in the dermis. In three patients AVL presented as discrete skin nodules (2 unifocal and 1 multifocal) and in one patient as a breast mass. The four AVL consisted of focal proliferation of dilated vascular spaces lined predominantly by a single layer of plump and sometimes hyperchromatic endothelial cells. After two angiosarcoma patients underwent mastectomy, one died 10 months after diagnosis with recurrent local angiosarcoma and the other is alive without angiosarcoma 2 months after diagnosis. One angiosarcoma patient died of unrelated causes 2 weeks after diagnosis. One AVL patient developed a second cutaneous AVL in the axillary region 17 months after excision of an AVL from the same area. None of the AVL patients has developed angiosarcoma or recurrent mammary carcinoma. They remain well 10 months, 18 months, 7 years and 7 months, and 10 years, respectively, after initial local excision. The authors conclude that cutaneous angiosarcoma and unusual benign cutaneous vascular lesions can develop within the field of radiation therapy for breast cancer. Unlike other radiation therapy-induced sarcomas, cutaneous angiosarcoma often occurs within a short time interval after radiotherapy. It is important to distinguish AVL from angiosarcoma. Longer follow-up will be necessary to fully characterize the prognostic importance of atypical vascular lesions, but currently there is no evidence that they represent a precursor to radiation-induced angiosarcoma.

ObjectiveTo evaluate the factors affecting the identification and accuracy of the sentinel node in breast cancer in a single institutional experience. Summary Background DataFew of the many published feasibility studies of lymphatic mapping for breast cancer have adequate numbers to assess in detail the factors affecting failed and falsely negative mapping procedures. MethodsFive hundred consecutive sentinel lymph node biopsies were performed using isosulfan blue dye and technetium-labeled sulfur colloid. A planned conventional axillary dissection was performed in 104 cases. ResultsSentinel nodes were identified in 458 of 492 (92%) ConclusionsSentinel node biopsy in patients with early breast cancer is a safe and effective alternative to routine axillary dissection for patients with negative nodes. Because of a small but definite rate of false-negative results, this procedure is most valuable in patients with a low risk of axillary nodal metastases. Both blue dye and radioisotope should be used to maximize the yield and accuracy of successful localizations.The histologic status of the axillary nodes remains the single best predictor of survival in patients with breast cancer.' The sentinel node is defined as the first lymph node in a regional lymphatic basin that receives lymph flow from a primary tumor. Several investigators have confirmed the hypothesis that lymphatic drainage of a breast cancer can be identified and traced to the sentinel node during surgery, and that the histologic status of the sentinel node accurately predicts the pathologic status of the entire axilla.8 The aim of this study was to evaluate in detail a single institutional experience in establishing and developing lymphatic mapping for breast cancer. Particular focus was on unsuccessful mapping procedures, the relative value of blue dye and radioisotope in localizing the sentinel node, false-negative results, and patients with positive nodal disease.