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PURPOSE The aim of the current work was to clarify whether a preoperative lymphoscintigraphy (LSG) enhances staging accuracy of sentinel lymph node biopsy (SLNB). PATIENTS AND METHODS In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. As the false-negative rate of SLNB correlates with the number of resected sentinel lymph nodes (SLNs), our primary end point was the mean number of histologically detected SLNs per patient. One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG. Stratified one-sided 95% CI for the difference (without LSG − with LSG) in the mean number of histologically detected SLNs had to be greater than −0.27 (10% noninferiority margin). Stratification was performed according to tumor focality and trial site. Additional predefined secondary end points (rates of node-positive patients and of completion axillary lymph node dissection) were analyzed to rule out differences in the reliable detection of nodal metastases. RESULTS Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers. Modified intention-to-treat analysis (n = 1,163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI, −0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences. CONCLUSION We show that SLNB is equally effective irrespective of the surgeon’s knowledge of preoperative LSG results. SLNB without LSG will speed up the preoperative workflow and reduce cost.

555 Background: It is not clear whether SLNB performed with LSG is necessary to reliably detect sentinel lymph nodes (SLN) in breast cancer. The omission of LSG might offer an accelerated preoperative workflow, cost reduction, and the opportunity for developing innovative, safe detection strategies. Methods: Patients with cN0 early breast cancer or extensive/high grade DCIS received standard radiolabeled colloid LSG and SLNB. Patients were randomized 1:1 to either conducting SLNB with the performing surgeon knowing the preoperative LSG pictures and results or without knowledge of the LSG results. Since the false negative rate (FNR) of SLNB correlates with the number of harvested SLN, our primary endpoint was the average number of histologically detected SLN per patient in both treatment arms in a non-inferiority design. An average number of 2.7 SLN with a standard deviation of 1.8 was assumed. LSG of all patients were collected postoperatively for central review. Results: Between May 2014 and October 2015 n = 1198 patients were randomized in 23 participating breast centers. Baseline characteristics were well-balanced between the treatment arms. Modified intention-to-treat analysis (n = 1163) confirmed the omission of LSG. The average number of histologically detected SLN was 2.207 with LSG and 2.258 without. The range for the one-sided 95% CI for the difference between the arms was (-0.18, +infinity), i.e. above the pre-specified non-inferiority margin of -0.27. Secondary endpoints were analyzed to rule out differences in reliable detection of nodal metastases. Rates of nodal positive disease as identified by SLNB (Odds ratio (OR) 1.005, 95%CI (0.759, 1.33), p = 0.972) and rates of completion axillary dissection (OR 0.984, 95% CI (0.567, 1.71), p = 0.954) in the two treatment arms and in specific subgroups showed no statistically significant differences. Conclusions: Our results support the hypothesis that SLNB is equally effective irrespective of the knowledge of preoperative LSG results. We therefore suggest performing SLNB without LSG to accelerate the preoperative workflow, reduce costs, and improve the comfort for the patients. Clinical trial information: NCT02481128.

525 Background: Chemotherapy induced alopecia (CIA) is a distressing side effect for women with breast cancer (BC) undergoing chemotherapy (CT). Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Observational studies show a positive effect of scalp cooling to reduce hair loss, but randomized trials until recently have been lacking. Methods: In our monocentric prospective randomized trial patients with early BC undergoing (neo)adjuvant CT were 1:1 randomized to either scalp cooling (CAP) or not (noCAP). All patients received 18 to 24 weeks of anthracycline (A) and/or taxane (T)-based CT. The DigniCap System was used for scalp cooling. The primary endpoint was patient reported rate of alopecia according to the Dean Scale (Grade 0: no hair loss, grade 1: > 0 - 25%; grade 2: > 25 - 50%; grade 3: > 50 - 75%; grade 4: > 75%). Hair preservation was defined as hair loss £ grade 2. Secondary endpoints were rate of alopecia determined by nursing staff and an independent and blinded evaluator, rate of wig/scarf use as well as quality of life. Results: From August 2014 until January 2016 seventy-nine patients were included (41 CAP and 38 noCAP). The drop-out rate was 32% in the CAP arm and 34% in the noCAP arm. Main reasons for drop out were hair loss, adverse events (CAP) and randomization into control arm. At the time of this analysis all patients had completed CT. Hair preservation was observed in 39% of patients in the CAP arm versus 0% in the No CAP arm (p < 0.001). There was a strong concordance between patients and staff evaluation (weighted Cohen's Kappa = 0.92). Wig/scarf use was significantly less frequent in the CAP group (36% vs 92% at home, p < 0.001; 64% vs 91% outside, p < 0.001). We did not observe any differences in hair preservation between A-based and non A-based regimens. Conclusions: Our prospective randomized trial shows that scalp cooling is effective in preventing CIA in a relevant number of patients. This option should be made available for patients undergoing T+/-A-based (neo)adjuvant chemotherapy for EBC.

11012 Background: To prospectively assess the prognostic value of CTC counts at baseline and after one cycle of therapy and their kinetics for response, progression-free (PFS), and overall survival (OS) in MBC. Methods: MBC patients underwent CTC enumeration (CellSearch, Veridex) at baseline (CTCBL), after one cycle of a new line of therapy (CTC1C), and at progression (CTCPD). CTC status was classified as negative (neg (−)) or positive (pos (+)) for KIN) from CTCBL to CTC1C were classified as favorable if CTCs remained neg (neg>neg) or became neg (pos>neg), or as unfavorable (neg>pos or pos>pos). Tumor response was assessed every 2–3 months using RECIST criteria. CTC status and kinetics were associated with outcome using log-rank and Fisher’s exact tests. Results: Of 326 patients enrolled (median age (range) at first diagnosis: 50 (23–81) years), 115/326 (35%) were CTCBL+, 51/162 (31%) were CTC1C+, and 39/108 (36%) were CTCPD+. Median follow-up was 15.9 months (mos). Median PFS and OS were significantly reduced in CTCBL+ compared to CTCBL− patients (PFS, 4.3 vs. 7.1 mos, p = .019; OS, 15.0 mos vs. not reached (nr), p 1C+ compared to CTC1C− patients (p KIN were predictive of progressive disease as best response (neg>neg, 33%; pos>neg, 38%; pos>pos, 60%; neg>pos, 75%; p = .040). PFS and OS for patients with unfavorable CTCKIN were significantly shorter than for favorable CTCKIN (PFS, 3.7 vs. 6.8 mos, p at baseline, CTC after one cycle and CTC kinetics are highly predictive of outcome in MBC. Serial CTC enumeration could serve as a useful adjunct to standard diagnostic tests in tailoring therapy. Further details of CTCPD will be presented at the meeting. Clinical trial information: S-295/2009.