NILM Pap slides from women 30 years of age and older with positive high-risk HPV DNA. Focused rescreening prior to report issuance, an enhanced quality control measure.

OBJECTIVES: Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations specify that at least 10% of negative Papanicolaou (Pap) slides be rescreened as a quality control (QC) measure. With incorporation of human papillomavirus (HPV) DNA testing into screening guidelines for women aged 30 years or older, a population of patients exists who are HPV positive as well as negative for intraepithelial lesion or malignancy (NILM). METHODS: In this 9-month retrospective review with follow-up, 26,501 women 30 years of age and older underwent liquid-based Pap screening with concomitant high-risk HPV DNA testing at CellNetix Pathology and Laboratories, Seattle, WA. Of these women, 1,096 (4.1%) were originally interpreted by cytotechnologists as NILM with HPV DNA positivity. RESULTS: On rescreening, 13.9% (152/1,096) of patients were upgraded to atypical squamous cells and higher, with 2.8% being upgraded to low-grade squamous intraepithelial lesion (LSIL) and higher. Historical routine QC measures from the same period showed that 0.3% of cases were upgraded to LSIL and higher, representing a statistically significant increase in the detection of cases with LSIL and higher (χ(2) two-tailed P < .0001). CONCLUSIONS: Focused rescreening of this enriched subpopulation of patients who are NILM and high-risk HPV DNA positive enhances QC. An inherent potential bias in study design is recognized because results of DNA testing were, by definition, known at the time of rescreening result interpretations.

Focused rescreening of NILM Pap slides from women ≥ 30 years of age with positive high risk HPV DNA: an enhanced quality control measure.

CLIA 88 regulations specify that at least 10% of negative for intraepithelial lesion or malignancy (NILM) Paps be rescreened as a means of quality control (QC). With the incorporation of HPV DNA testing into American Society for Colposcopy and Cervical Pathology guidelines for women ≥ 30 years of age, a population of NILM patients with positive HPV results exists. Slides from this cohort were rescreened to judge the value of focused QC. Three hundred and eighty-six consecutive, NILM, HCII+, Paps (SurePath and ThinPrep, September 2009 to December 2009) from women aged ≥ 30 were retrieved from the CellNetix files. These slides were rescreened by cytotechnologists. Slides rescreened as atypical squamous cells (ASC) or higher by cytotechnologists were viewed by cytopathologists (CDS/RJT) who assigned a final interpretation. Of the 386 rescreened cases, 50 (12.9%) were placed in categories of ASC or higher, and 11 (2.9%) were interpreted as LSIL or above. By comparison, routine QC (including random, FocalPoint enriched, and historically high risk cases) was performed on a total of 20,580 Paps (21% of 99,501 annual cases). Concomitant routine QC revealed that 2.1% (427/20,580) were upgraded to ASC or higher and 0.3% (52/20,580) were upgraded to LSIL or higher. Focused rescreening of NILM cases with positive HPV DNA resulted in the detection of approximately ten times more SIL cases than did routine QC Pap slide review at CellNetix. Focused rescreening of this patient set may enhance QC in cytopathology laboratories performing liquid-based Paps. An inherent potential bias in study design is recognized, as results of DNA testing were by definition known at the time of rescreen.

Impact and outcomes of routine microstaging of sentinel lymph nodes in breast cancer: significance of the pN0(i+) and pN1mi categories.

BACKGROUND: In 2003, the American Joint Committee on Cancer (AJCC) initiated the 6th edition staging criteria, including pN0(i+) and pN1mi categories for breast cancer. However, the clinical significance of these categories is debated in the literature. METHODS: A prospective registry was used to identify patients staged with sentinel lymph node (SLN) biopsy. SLN evaluation included routine serial sectioning and immunohistochemical stains. SLN biopsies performed before January 2003 were restaged according to the AJCC's 6th edition criteria. RESULTS: Of 954 SLN biopsies identified, on review, 491 N0i-, 86 N0i+, 73 N1mi, 146 N1a, 29 N2a, and 11 N3a patients were available for analysis with a median follow-up of 45.4 months. Significant prognostic and therapeutic differences existed between the groups. Differences in overall survival (OS) and recurrence-free survival (RFS) were only noted when the size of the metastases reached the N1a level. There were no statistically significant differences in OS or RFS between N0(i-) and N0(i+) or N1mi disease. Cases that were N0(i+) or N1mi were more likely to have other poor prognostic factors and to receive more aggressive therapy. CONCLUSION: SLN biopsy allows a more sensitive evaluation of lymph nodes for metastatic cells. This has led to the increased identification of very small axillary metastases. While the new microstaging categories are not yet clearly associated with a significantly decreased OS or DFS in this series, they are associated with other poor prognostic factors and more local/regional and systemic therapy. Further analysis of the microstaging categories is needed.

Accuracy of intraoperative imprint cytology of sentinel lymph nodes in breast cancer.

BACKGROUND: In breast cancer treatment, immediate completion of axillary lymph node dissection (ALND) can be performed if the intraoperative sentinel lymph node (SLN) examination is positive. This study evaluates the accuracy of intraoperative imprint cytology (IC) for detecting SLN metastases. METHODS: Pathology reports from 385 SLN biopsy examinations were reviewed retrospectively. The SLNs were serially sectioned perpendicular to the long axis and IC was performed intraoperatively. The SLNs then were formalin-fixed for permanent sections. Final pathology was compared with the intraoperative IC results. RESULTS: The sensitivities for IC detection of N0(i+) (n = 36), N1mi (n = 24), and N1a-3a (n = 65) metastases were 0%, 4%, and 74%, respectively. The specificity was 100%. CONCLUSIONS: Final pathology identified 89 (23%) patients with N1 or greater disease. IC allowed 49 (55%) of these patients to undergo synchronous completion of ALND. No unnecessary completion ALNDs were performed. The sensitivity of IC decreased with decreasing size of the metastasis.