International Multicenter
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2021 ◽  
pp. JCO.21.01839
Mary F. Mulcahy ◽  
Armeen Mahvash ◽  
Marc Pracht ◽  
Amir H. Montazeri ◽  
Steve Bandula ◽  

PURPOSE To study the impact of transarterial Yttrium-90 radioembolization (TARE) in combination with second-line systemic chemotherapy for colorectal liver metastases (CLM). METHODS In this international, multicenter, open-label phase III trial, patients with CLM who progressed on oxaliplatin- or irinotecan-based first-line therapy were randomly assigned 1:1 to receive second-line chemotherapy with or without TARE. The two primary end points were progression-free survival (PFS) and hepatic PFS (hPFS), assessed by blinded independent central review. Random assignment was performed using a web- or voice-based system stratified by unilobar or bilobar disease, oxaliplatin- or irinotecan-based first-line chemotherapy, and KRAS mutation status. RESULTS Four hundred twenty-eight patients from 95 centers in North America, Europe, and Asia were randomly assigned to chemotherapy with or without TARE; this represents the intention-to-treat population and included 215 patients in the TARE plus chemotherapy group and 213 patients in the chemotherapy alone group. The hazard ratio (HR) for PFS was 0.69 (95% CI, 0.54 to 0.88; 1-sided P = .0013), with a median PFS of 8.0 (95% CI, 7.2 to 9.2) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. The HR for hPFS was 0.59 (95% CI, 0.46 to 0.77; 1-sided P < .0001), with a median hPFS of 9.1 (95% CI, 7.8 to 9.7) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. Objective response rates were 34.0% (95% CI, 28.0 to 40.5) and 21.1% (95% CI, 16.2 to 27.1; 1-sided P = .0019) for the TARE and chemotherapy groups, respectively. Median overall survival was 14.0 (95% CI, 11.8 to 15.5) and 14.4 months (95% CI, 12.8 to 16.4; 1-sided P = .7229) with a HR of 1.07 (95% CI, 0.86 to 1.32) for TARE and chemotherapy groups, respectively. Grade 3 adverse events were reported more frequently with TARE (68.4% v 49.3%). Both groups received full chemotherapy dose intensity. CONCLUSION The addition of TARE to systemic therapy for second-line CLM led to longer PFS and hPFS. Further subset analyses are needed to better define the ideal patient population that would benefit from TARE.

Breast Care ◽  
2021 ◽  
pp. 1-15
Guldeniz Karadeniz Cakmak

<b><i>Background:</i></b> Oncoplastic breast conserving surgery (OBCS), which is the current procedure of choice for eligible BC patients, describes a philosophy that prioritizes oncologic and cosmetic outcomes. However, knowledge gaps regarding training, acceptance, and practice preclude standardization and make it difficult to design algorithmic guidelines to optimize individualized management in the era of precision medicine. <b><i>Summary:</i></b> The harmony between patient expectations and oncologic goals creates the state of the art of OBCS. Nevertheless, to achieve these goals, multidisciplinary approach is a must. Surgical decisions require a comprehensive evaluation including patient factors, tumor biology, genetics, technical considerations, and adjunct therapies. Moreover, the quality-of-life (QOL) issues should be considered as the highest level of priority with a shared decision making instituted on realistic discussions with the patient. <b><i>Key messages:</i></b> The standardization in OBCS should be initiated via defining a breast surgeon who should gain theorical and practical competence on techniques via national or international educational programs. The algorithmic patient assessment with appropriate documentation before and after surgery should be established. A simple and safe global lexicon should be designed regarding techniques to be proposed and quality metrics to be considered. Additionally, international multicenter prospective trials should be instituted to overcome knowledge gaps. It is evident that OBCS is the perfect union of science with art. Nevertheless, at the very end, the question is not the nature of the surgeon/artist who would be the extremist, the innovator, or the conservative, but the patient’s satisfaction, prognosis, and QOL that conclude the cascade of state of the art of OBCS.

2021 ◽  
Vol 12 ◽  
Laura M. Scorr ◽  
Stewart A. Factor ◽  
Sahyli Perez Parra ◽  
Rachel Kaye ◽  
Randal C. Paniello ◽  

Objective: The goal of this study is to better characterize the phenotypic heterogeneity of oromandibular dystonia (OMD) for the purpose of facilitating early diagnosis.Methods: First, we provide a comprehensive summary of the literature encompassing 1,121 cases. Next, we describe the clinical features of 727 OMD subjects enrolled by the Dystonia Coalition (DC), an international multicenter cohort. Finally, we summarize clinical features and treatment outcomes from cross-sectional analysis of 172 OMD subjects from two expert centers.Results: In all cohorts, typical age at onset was in the 50s and 70% of cases were female. The Dystonia Coalition cohort revealed perioral musculature was involved most commonly (85%), followed by jaw (61%) and tongue (17%). OMD more commonly appeared as part of a segmental dystonia (43%), and less commonly focal (39%) or generalized (10%). OMD was found to be associated with impaired quality of life, independent of disease severity. On average, social anxiety (LSA score: 33 ± 28) was more common than depression (BDI II score: 9.7 ± 7.8). In the expert center cohorts, botulinum toxin injections improved symptom severity by more than 50% in ~80% of subjects, regardless of etiology.Conclusions: This comprehensive description of OMD cases has revealed novel insights into the most common OMD phenotypes, pattern of dystonia distribution, associated psychiatric disturbances, and effect on QoL. We hope these findings will improve clinical recognition to aid in timely diagnosis and inform treatment strategies.

2021 ◽  
Vol 13 (9) ◽  
pp. 416-425
Ioannis S Papanikolaou ◽  
Georgios Tziatzios ◽  
Alexandros Chatzidakis ◽  
Antonio Facciorusso ◽  
Stefano Francesco Crinò ◽  

2021 ◽  
pp. jnumed.121.262561
Benedikt M. Schaarschmidt ◽  
Moritz Wildgruber ◽  
Roman Kloeckner ◽  
James Nie ◽  
Verena Steinle ◽  

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