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Purpose To assess the accuracy of preoperative sonographic staging for prediction of limited axillary disease (LAD, one or two metastatic lymph nodes) and to identify factors associated with high prediction–pathology concordance in patients with early-stage breast cancer meeting the Z0011 criteria. Materials and Methods Patients treated between January 2015 and January 2020 were included in this retrospective, multicentric analysis of prospectively acquired service databases. The accuracy of LAD prediction was assessed separately for patients with one and two suspicious lymph nodes on preoperative sonography. Test validity outcomes for LAD prediction were calculated for both groups, and a multivariate model was used to identify factors associated with high accuracy of LAD prediction. Results Of 2059 enrolled patients, 1513 underwent sentinel node biopsy, 436 primary and 110 secondary axillary dissection. For LAD prediction in patients with one suspicious lymph node on preoperative ultrasound, sensitivity was 92% (95% CI 87–95%), negative predictive value (NPV) was 92% (95% CI 87–95%), and the false-negative rate (FNR) was 8% (95% CI 5–13%). For patients with two preoperatively suspicious nodes, the sensitivity, NPV, and FNR were 89% (95% CI 84–93%), 73% (62–83%), and 11% (95% CI 7–16%), respectively. On multivariate analysis, the number of suspicious lymph nodes was associated inversely with correct LAD prediction ([OR 0.01 (95% CI 0.01–0.93), p ≤ 0.01]. Conclusions Sonographic axillary staging in patients with one metastatic lymph node predicted by preoperative ultrasound showed high accuracy and a false-negative rate comparable to sentinel node biopsy for prediction of limited axillary disease.

6067 Background: The objective of this study was to compare laparoscopy and laparotomy for comprehensive surgical staging of early ovarian cancer in terms of efficacy and oncologic safety. Methods: Patients who had laparoscopic staging for early stage (I/II) ovarian cancer between 01/2000 and 10/2018 at the participating sites (Gynecologic comprehensive cancer centers with respective expertise in minimal invasive surgery) were included in this retrospective case-control study. The control group consisted of all patients treated via laparotomy during the study period. Clinical data were abstracted from medical record and recent follow up information were obtained. Comparisons were made between patients regarding surgical parameters and oncologic outcome and multivariate models were used to identify factors independently associated with disease recurrence. Results: Among 313 patients, staging was performed via laparoscopy in 208 (66 %) patients and via laparotomy in 105 (34 %) patients. Patients staged laparoscopically were younger (median 52 (15-86) vs. 59 (17-92) vears, p≤0.01) and had a lower BMI (24.4 (16.5-46.8) vs. 26 (15.5-53.8), p≤0.01). Regarding surgical parameters, duration of surgery was longer (291 (159-778) vs. 277 (159-690) minutes, p≤0.01), postoperative hospitalization was shorter (7 (0-27) vs. 9 (0-92) days, p≤0.01) and postoperative complications were lower in the laparoscopy group. On univariate analysis there were no differences in rates of tumor stage according to FIGO, intraoperative rupture of ovarian cysts (14 % vs. 13 %, p=0.87), number of lymph nodes removed (24 (0-89) vs. 22 (0-96), p=0.81) or any recurrence of disease (14 % vs. 16 %, p=0.52). At a median follow-up of 46 months (0-227), there were no differences in DFS and OS by surgical technique (5yr DFS 82 % (SE 0.04) vs. 83 % (SE 0.05), p=0.43; OS 91 % (SE 0.03) vs. 87 % (SE 0.04), p=0.87). On multivariate analysis route of surgery was not associated with an increased risk of recurrence. Conclusions: According to this preliminary analysis, laparoscopic surgical staging in patients with early ovarian cancer seems to be adequate and safe, but a longer follow-up and prospective data are needed to enhance evidence on oncologic outcomes.

Background Axillary staging is an integral part of the preoperative work-up in patients with breast cancer. Given the increasing number of patients treated with neoadjuvant chemotherapy (NC) and current guidelines to perform sentinel-node biopsy after the completion of neoadjuvant chemotherapy, axillary staging has gained more importance. Beside the prediction of nodal involvement, correct prediction of nodal stage is crucial in order to select respective treatment for the patients. Materials and Methods Patients treated for primary breast cancer from 01/2013 to 01/2018 and received preoperative sonografic axillary staging and surgery were identified from the breast databases of two large volume hospitals. In case of sonografic suspicion of nodal involvement an axillary biopsy was performed. Accuracy of axillary staging was examined regarding the concordance between prediction of nodal involvement and nodal (N) stage with final pathology. A multivariate model was used to identify factors associated with a high accuracy of axillary sonografic staging. Results Among 2220 patients, 112 were excluded due to incomplete clinical data or axillary surgery after completion of neoadjuvant chemotherapy leaving 2108 patients for final analysis. 1535 (73 %) showed a N0 stage on final pathology. Accuracy of axillary staging regarding prediction of nodal involvement was 92 % (1929/2108) with a sensitivity of 80 % and a specificity of 96 %, a positive predictive value of 88 % and a negative predictive of 93 %. Prediction of nodal stage was correct in 1894 of 2018 cases (90 %). Concordance between sonografic prediction of N stage and final pathology decreased with higher nodal stages (N0 - 91 %, N1 84 %, N2 81 %, N3 68 %) and was higher in node negative patients (91 %) compared to node positive patients (86 %; p ≤ 0.05). On multivariate analysis the presence of nodal involvement was the only factor associated with concordance of axillary staging and pathologic nodal stage (OR 0.11 (95 %CI 0.08 - 0.16) p ≤ 0.01). Conclusion In this large population of patients with primary breast cancer, we showed a high accuracy of preoperative axillary staging with respect to nodal involvement and prediction of respective N stage. With a negative predictive value of 93 % regarding node negativity, axillary staging showed accurate outcomes but improvements in sensitivity are necessary in oder to compete with sentinel node biopsy. Citation Format: Julia Caroline Radosa, Martin Deeken, Lisa Stotz, Sarah Huwer, Carolin Müller, Rosemarie Weinmann, Christoph G Radosa, Marc P Radosa, Stefan Wagenpfeil, Erich-Franz Solomayer. Can preoperative axillary staging replace sentinel node biopsy? Comparison of preoperative axillary and final histologic nodal findings in 2108 patients with primary breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-02-11.

e17052 Background: Early ovarian malignancies (eOM) are often diagnosed incidentally in the course of diagnostic minimal invasive surgery or laparoscopy for preoperative suspected benign indications. To what extent initial minimal-invasive staging matches final FIGO stage following definite surgery is controversially discussed and current literature on this question is sparse. The aim of this study was to assess accuracy of laparoscopic staging of eOM with regard to final FIGO stage. Methods: We retrospectively identified all patients treated for eOM between 01/2000 and 10/2018. Participating sites were Gynecologic comprehensive cancer centers with great expertise in minimal invasive surgery. Inclusion criteria were no preoperative suspicion of advanced malignancy, initial staging laparoscopy, completion of surgical treatment via laparotomy and complete follow-up data. Clinical data and outcomes were abstracted from the medical record. Rate of upstaging and distinct causes were assessed and initial and definite FIGO stage and 3-year disease free (DFS) and overall survival (OS) were compared with regard to the incidence of upstaging. Results: 107 patients with eOM were included in the final analysis. In 72 (67 %) patients primary laparoscopic staging was concordant with final staging. 35 (33 %) cases were upstaged after the second operation. Regarding the cause for upstaging 4 (11 %) were upstaged because of infiltration of the contralateral ovarian capsule, 16 (46 %) because of peritoneal infiltrates and in 15 (43 %) patients an iatrogenic rupture of the ovarian tumor occurred during laparotomy. 21 (60 %) cases were upstaged within FIGO stage I and 14 (40 %) cases from stage I to II. Comparison of 3-year DFS and OS showed no differences regarding upstaging. Conclusions: In this population of patients with eOM, staging laparoscopy performed by specialized laparoscopic oncologic surgeons showed a sufficient accuracy with no case of upstaging to advanced FIGO stages. Regarding oncologic safety laparoscopic staging showed no impact on 3-year DFS and OS.