Background We investigated the real-life effectiveness and safety of vedolizumab maintenance treatment among Korean patients with Crohn’s disease (CD) or ulcerative colitis (UC) who previously failed anti-tumour necrosis factor (anti-TNF) therapy. Methods Adult patients with CD or UC who have previously failed anti-TNF therapy and received vedolizumab were prospectively enrolled from 16 hospitals in Korea. The primary outcome was clinical remission at week 54. Clinical remission was defined as a Crohn’s disease activity index (CDAI) <150 and a partial Mayo score ≤2 with a combined rectal bleeding and stool frequency subscore ≤1. We also analyzed factors associated with clinical remission at week 54. Results Between August 2017 to July 2020, a total of 165 patients (81 with CD and 84 with UC) received vedolizumab therapy, of whom 154 patients (93.3%) (75 with CD and 79 with UC) received vedolizumab maintenance therapy (Table 1). Clinical remission and response rates at week 54 were 22.2% and 24.1% among patients with CD and 41.4% and 45.7% among patients with UC, respectively (Figure 1A and 1B). Among 70 patients with UC with baseline Mayo endoscopic subscore ≥2, endoscopic remission (Mayo endoscopic subscore ≤1) at week 54 was observed in 19 patients (27.1%). Out of 50 patients with CD with ulcers in baseline endoscopy, 2 patients (4%) showed a disappearance of ulcers at week 54 (Figure 1C). In the multivariable analysis, age at baseline (adjusted odds ration [aOR] 1.065, 95% confidence interval [CI] 1.003–1.131, P=0.041) and Mayo endoscopic subscore at baseline (aOR 0.141, 95% CI 0.026–0.746, P=0.021) were significantly associated with clinical remission at week 54 among patients with UC (Table 2). No factors were found to be associated with clinical remission at week 54 among patients with CD. Among patients who experienced one or more adverse events (n=134, 81.2%), serious adverse events occurred in 82 patients (49.7%) (Table 3). Disease exacerbation was the most common adverse events (n=89, 53.9%). Conclusion The real-life effectiveness of vedolizumab maintenance treatment for Korean patients with UC who failed anti-TNF therapy was generally similar with the outcomes reported from the previous Western studies. A substantial proportion of patients with CD experienced a loss of response during the first year of treatment. Less severe disease at baseline was associated with clinical remission at 1 year of vedolizumab therapy among patients with UC.
Background If the size of the tumor is large, neoadjuvant systemic therapy (NST) is performed to reduce the size of the tumor and to conserve the breast. It is known that magnetic resonance imaging is more accurate than mammography (MMG) or ultrasonography (USG) in determining the area of residual cancer in breast-conserving surgery (BSG) after NST. However, there are some problems when performing BCS using MRI. Because the posture of MRI test is different from the posture at surgery, it is difficult to accurately mark the area of the tumor observed in MRI. Neoadjuvant systemic therapy reduces tumor size and often makes it difficult to detect the original tumor area on preoperative MRI. Even if the tumor is not visible in the image, the cancer cells may remain, so it is important to accurately indicate the extent of the initial tumor and remove it. Until now, however, there has been no way to accurately mark past breast tumors in the breast. We have developed a breast surgical guide (BSG) that can mark a range of tumor directly on the breast using three-dimensional printing technology based on supine MRI. This study analyzed the results of patients who underwent BCS using a 3D printing breast surgical guide (3D-BSG) based on supine MRI. Methods This trial was designed as a prospective single-institution cohort study. Our study protocol was approved by the Institutional Review Board of Asan Medical Center, Seoul, Korea (IRB No. 2016-1237). Patients who were expected to undergo BCS after NST were enrolled in this study and supine MRI was performed before and after NST. From MRI images, morphological shapes of breasts and tumors were modeled. The prepared digital model was saved in stereolithography file format and then exported to a 3D printer. 3D-BSG is designed to be able to mark the skin and attach the dye injecting column to mark the around the tumor. The breast tissue was removed with blue dye on the basis of the border. To obtain tumor free margin, intraoperative frozen sections were identified in several cavities and re-excision was performed if tumor positive. Results Between January 2016 and May 2017, 50 patients were enrolled in the study. BCS was applied to 40 patients, except for those who were rejected or mastectomy. Complete remission was observed in 15 patients after NST. Four patients had tumor positive on resection margins on frozen biopsy during operation, two with IDC and two with DCIS. Re-excision was performed in these patients and tumor negative margin was confirmed in all patients in the final pathology results. The median size of the long axis of the tumor was 1.7 cm (range, 0.5 to 4.5 cm) and the median size of the long axis of the removed breast tissue was 5.1 cm (range, 2.3 to 8.1 cm). The distance between tumor and resection margin was 1.2 cm (range, 0.1 to 4.8 cm).. Conclusions In BCS, the application of the supine MRI based 3D-BSG showed low rates of positive margins. Unlike conventional localization techniques, application of 3D-BSG does not cause pain to the patient, has no radiation exposure, and has no time required for the localization procedure, so it will be helpful for patients in BCS in the future. Citation Format: Ko B, Kim N, Seo J, Kim H, Gong G, Kim S, Son B, Ahn SH. Application of supine MRI-based 3D printing breast surgical guide for precision breast-conserving surgery [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 P3-13-01.
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