Background The continuum of anti-HER2 agents is regarded as a standard strategy for HER2 positive metastatic breast cancer patients who had progressed disease with anti-HER2 agent- containing treatments. However, there has been lack of data on which agents should be continued and how long continuous anti-HER2 therapies would be effective. This study was aimed to evaluate the efficacy of lapatinib plus vinorelbine in HER2 positive metastatic breast cancer patients who had progressed on both trastuzumab and lapatinib treatments. Methods A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n=75; laptinib, 1000mg daily ; vinorelbine 20mg/m2 D1,D8 q3w) or vinorelbine alone (V) (n=74; 30mg/m2 D1,D8 q3w). The stratification factors were followings; 1) visceral metastasis, 2) previous response to lapatinib treatment, CR+PR vs. SD ≥ 12 weeks. The primary endpoint was progression free survival (PFS) rate at 18 weeks. The secondary endpoints were objective response rate (ORR), PFS, and overall survival (OS). Results : Both arms were well balanced in various clinical factors. The median number of previous anti-HER2 therapies were 2 (range 2-5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (44.0% vs 36.5%, p=0.44). ORR was 19.7% in LV arm and 16.9% in V arm (p=0.881). PFS and OS did not differ between two arms (LV vs V; median PFS, 16weeks vs 12 weeks, HR= 0.86, 95% CI 0.61-1.22, p=0.41; median OS, 15.0 months vs 18.9 months, HR= 1.07, 95% CI 0.72-1.58, p=0.72). In subgroup analysis, there was no difference in PFS and OS between two arms according to previous response to lapatinib (median PFS, CR+PR vs. SD ≥ 12 weeks, 12.1weeks vs.17.4 weeks; HR= 1.242, 95% CI 0.881-1.751, p=0.215; median OS, 14.9 months vs. 19.4 months; HR= 1.179, 95% CI 0.797-1.744, p=0.41). Most common adverse events in both arms were neutropenia which was more often observed in V arm (55% vs 73%, p=0.03). Overall, the profiles of adverse events were similar in both arms and all were manageable. Conclusion Lapatinib plus vinorelbine treatment was tolerable, however, it did not demonstrate the clinical benefits compared to vinorelbine alone in HER2 positive metastatic breast cancer patients after progression on both trastuzumab and lapatinib. Citation Format: Sim SH, Park IH, Jung KH, Kim S-B, Ahn J-H, Lee K-H, Im S-A, Im Y-H, Park YH, Sohn JH, Kim YJ, Lee S, Kim H-J, Chae YS, Park K-H, Nam B-H, Lee KS, Ro J. Randomized phase II study of lapatinib plus vinorelbine versus vinorelbine in patients with HER2 positive metastatic breast cancer progressed after lapatinib and trastuzumab treatment [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-23.
Background: Ki-67 has been increasingly used as a prognostic marker in spite of debates on the evaluation methods and inconsistent results on its clinical values. CKAP2 is a microtubule-associated protein which plays key roles in microtubule assembly and disassembly. In the present study, the clinical significance of CKAP2-positive cells was evaluated and compared with the results of Ki-67 positive cells. Methods: A total of 579 early breast cancer patients who underwent surgery at the National Cancer Center Hospital between 2001 and 2005 were accrued. The proliferation activity was measured by CKAP2-positive cell count (CPCC) and Ki-67 labeling index (Ki-67 LI) using CKAP2 and Ki-67 antibodies, respectively, by immunohistochemcial staining on FFPE tumor tissue. The correlation of CPCC or Ki-67 LI with recurrence free survival (RFS) was analyzed. The immunofluorescent staining was performed on HeLa cells after synchronization by double thymidine block to compare the patterns between CKAP2 and Ki-67. Results: The CPCC (median, 8 with the range of 0- 170) and Ki-67 LI (median, 10.2 with the range of 0%- 91.7%) were highly correlated (R = 0.754, P < 0.001). While CPCC was marginally significant in multivariate analysis for RFS in all cases, it was a significant variable for RFS in the subset analysis with HER2-negative luminal breast cancer patients (HR, 3.154; 95% CI, 1.154-10.693; P = 0.027). On the contrary, Ki-67 LI failed to show any correlation with RFS in all or any subgroups. In the analysis on HeLa cells, CKAP2 staining was more specific to cells in metaphase than Ki-67 staining. Conclusions: CPCC can be an independent prognostic factor specifically in a HER2-negative luminal type of breast cancer. In addition, CPCC appears to be superior to Ki-67 LI as a survival indicator which may be related to the restricted expression pattern of CKAP2 in metaphase cells. Further study is warranted. Citation Format: Sim SH, Bae C-D, Kwon Y, Park IH, Lee KS, Jung S-Y, Lee S, Kang H-S, Lee ES, Kim H-S, Hong K-M, Ro J. CKAP2 (cytoskeleton associated protein 2) is a new prognostic marker in HER2-negative luminal breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-08-25.
INTRODUCTION Axillary sentinel lymph node (SLN) biopsy is a standard method for axillary nodal staging in the treatment of breast cancer. However, along with the trends to SLN performed only without additional axillary lymph node dissection, it's time to be considered omission of SLN for selective patients. We developed a prediction model to assess the negative probability of sentinel lymph node metastasis, specifically focus on the patients with clinical T1 breast cancer. METHODS and MATERIALS The study group consisted of 513 consecutive patients with clinical T1 breast cancer, who had undergone primary surgery between 2007 and 2012. The clinicopathologic factors and imaging modalities including breast ultrasound (US), magnetic resonance imaging (MRI), chest computed tomography (CT), and positron emission tomography (PET) were evaluated. Patients who fulfilled our inclusion criteria were randomized into experimental and validation set by 3:1 ratio. In the experimental group (n = 256), multivariate logistic regression analysis was used to analyze the association of each variable with the likelihood of SLN metastases. A prediction model was developed based on the patients in the experimental group and was validated with internal patient cohorts. RESULTS Of the 513 patients, 119 (23.1%) were found to have SLN metastases. In univariate analysis, presence of lymphovascular invasion (P < 0.001) and suspicious finding of preoperative image studies (US, PET, and MRI, P < 0.001) were independent positive predictors of SLN metastases. In multivariate analysis of experimental group, estrogen receptor status (P = 0.012), presence of lymphatic invasion (P < 0.001), and suspicious finding of preoperative image studies (US, PET, and MRI, P < 0.001) were each associated with involvement of SLN. A prediction model based on this analysis consists of 9 rows including 6 variables (age, estrogen receptor status, presence of lymphatic invasion, and results of preoperative US, PET or CT, MRI). The sum of assigned points for all six variables made corresponding value of negative probability of SLN metastasis. The accuracy of prediction model applied to the validation group, as measured by the area under the receiver operating curve was 0.789. CONCLUSIONS The prediction model developed here may be a useful tool to assess SLN involvement for clinical T1 breast cancer patients. And prospective study for additional validation of the prediction model is currently in preparation, exploring the possibility of SLN biopsy omission. Citation Format: Cho JN, Song EJ, Lee MH, Jung S-Y, Lee S, Kang H-S, Sim SH, Park IH, Lee KS, Kim YJ, Kim S-K, Kwon Y, Nam B-H, Lee ES. Development of prediction model for omission of sentinel lymph node biopsy in T1 breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-01-12.
Purpose This study aimed to evaluated the identification rate and operation time of sentinel lymph node biopsy (SLNB) by a multimodal fluorescent-radioactive system (MFS) using a mixture of indocyanine green (ICG), radioisotope (RI) compared with the RI alone in advanced breast cancer patients with neoadjuvant therapy. Methods In this phase II randomized study, we enrolled 65 patients with advanced breast cancer with neoadjuvant therapy. Then, they received SLNB with either MFS or RI. We compared the identification rate, operation time of SLNB and number of sentinel lymph nodes. We also evaluated the safety. We analyzed the data of 65 patients for interim analysis. Results The mean age of the MFS group and RI group was 51.7 and 45.9 years (p=0.024), respectively. There were no differences in histopathological characteristics, including tumor size, node positivity, and hormone receptor status between two groups. The radiologic study showed the clinically complete response in axillary lymph nodes after neoadjuvant therapy. In MFS group, sentinel lymph nodes (SLNs) were identified in 30 patients and we could not identify the SLNs in one patient. In RI group, we identified the SLNs in 33 patients and also could not identify them in one patient. (p=0.947). The average numbers of SLNs in the MFS and RI group were similar. (2.32±1.10 vs. 2.18 ± 1.57, respectively; p=0.668) The operation time of SLNB was similar in the each group (11.65 ± 6.49 vs. 9.47 ± 6.26, respectively, p= 0.174) There were no complication, including allergic reactions, skin staining or necrosis. Conclusions This study is the randomized trial that compared MFS using ICG and RI and the conventional RI method for SLNB in the advanced breast cancer with neoadjuvant therapy. The multimodal fluorescent-radioactive system is a feasible and safe method for SLNB for the breast cancer patients with neoadjuvant therapy. We will evaluate the 130 patients for final analysis. Citation Format: Lee S, Jung S-Y, Kim S-K, Lee ES, Lee MH, Park SJ, Kang H-S, Lee KS, Park IH, Sim SH, Kim Y, Kwon Y, Joo J, Kang SH. Clinical application of multimodal fluorescent-radioactive system in advanced breast cancer patients with neoadjuvant therapy; interim analysis for 65 patients [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-01-15.
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