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Original Article:
The efficacy and safety of trifluridine/tipiracil plus bevacizumab compared with trifluridine/tipiracil monotherapy for metastatic colorectal cancer: A meta-analysis
Yutong Ge, Dongying Gu, Xiaowei Wei
Digit Med
2022, 8:7 (21 April 2022)
DOI
:10.4103/digm.digm_44_21
Background:
Some small sample size studies have yielded slightly inconsistent results for comparing the efficacy and toxicity of trifluridine/tipiracil (TAS-102) with or without bevacizumab. This meta-analysis aims to further investigate the additive effect and safety profile of bevacizumab when combined with TAS-102 in patients receiving a salvage-line treatment for metastatic colorectal cancer (mCRC).
Methods:
A systematic literature search was conducted using PubMed, Web of Science, Cochrane Library, and some oncological conferences by the end of February 2021. No restrictions were placed on the searches. Two reviewers independently performed the retrieval and selection according to the “Patient, Intervention, Comparison, Outcome, Study design” principle. The outcome endpoints included overall survival (OS), progression-free survival (PFS), disease control rate (DCR), and adverse events (AEs).
Results:
Six controlled trials which recruited 435 refractory mCRC patients were ultimately taken in. Our results suggested that the regimen of TAS-102 plus bevacizumab had a significant advantage in OS, PFS, and DCR over TAS-102 alone (hazard ratio (HR) = 0.43, 95% confidence interval (CI): 0.27–0.67,
P
< 0.001; HR = 0.48, 95% CI: 0.39–0.59,
P
< 0.001; OR = 3.19, 95% CI: 1.56–6.50,
P
= 0.001; respectively). In general, the incidence of AEs was slightly but not obviously higher in the combination therapy group than the monotherapy group (OR = 1.08; 95% CI: 0.89–1.30;
P
= 0.458). However, the most frequent grade 3 or worse AE was neutropenia (OR = 2.32; 95% CI: 1.53–3.52;
P
< 0.001) which was higher in the TAS-102 plus bevacizumab group. Meanwhile, the morbidity of anemia (OR = 0.43; 95% CI: 0.22–0.83;
P
= 0.013) was significantly higher in TAS-102 monotherapy group.
Conclusion:
TAS-102 plus bevacizumab has promising activity with a manageable safety profile in a salvage-line treatment for mCRC who are refractory or intolerant to standard chemotherapy.
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Original Article:
The UpSMART Accelerator: driving digital innovation to change the conduct of early phase cancer medicine trials
Butt Fouziah, Stephenson Laura, Agnelli Luca, Villalobos Alberu Xenia, Carter Louise, Chown Rachel, De Braud Filippo, Damian Silvia, Dienstmann Rodrigo, Formica Elisabetta, Garralda Elena, Graham Donna M, Graley Andrew, Landers Dónal, O'Regan Paul, Patil Akshita, Regan Aoife, Royle Jennifer K, Stevenson Julie, Walker Alison, Dive Caroline, Hughes Andrew
Digit Med
2022, 8:1 (25 January 2022)
DOI
:10.4103/digm.digm_3_21
Digitalizing clinical trials provide an opportunity to address challenges faced in the Phase I trial settings, where near real-time data capture and data interpretation are prerequisites for iterative decision-making to rapidly adapt trial designs based on emerging insights. Although digital technologies have driven significant improvements in many businesses and organizations, the adoption of digital technologies in clinical trials has been slow. In recognition of this lag, the UpSMART consortium, a 5-year funded program (2020–2024), has been established in Europe between the UK, Spain, and Italy to embrace digital technologies and drive benefits to patients. The consortium, led by the Cancer Research UK Manchester Institute Cancer Biomarker Centre, aims to 'digitalize' Experimental Cancer Medicine Centres in the UK and Early Drug Development Units in Spain and Italy by open-sourcing and sharing digital healthcare products between participating centers across the consortium. The goal is to optimize data capture and interpretation thus accelerating Phase I clinical research to ultimately benefit patients by allowing faster access to tomorrow's medicines.
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Original Article:
Clinical application of digital design combined with personalized three-dimensional printing technology in the treatment of deep oromaxillofacial-cervical tumors
Zhichen Guo, Chenxi Li, Bin Ling, Zhongcheng Gong
Digit Med
2021, 7:3 (7 December 2021)
DOI
:10.4103/digm.digm_27_21
Background and Purpose:
The emergence of digitalized technology has greatly promoted the progress of craniomaxillofacial and head and neck surgery. This present study aimed to explore and describe the advantages of digital design combined with personalized three-dimensional (3D) printing technology in the treatment of deep oromaxillofacial-cervical tumors.
Patients and Methods:
Nine patients with deep tumor of oral and maxillofacial and neck region admitted to Xinjiang Medical University Affiliated First Hospital from June 2017 to March 2021 were all treated by the digitalized surgery. Preoperatively, radiological examination including computed tomography (CT) angiography, plain and enhanced CT scan, and magnetic resonance imaging were performed in all patients. The software packaged of MIMICS, 3-matic and MAYA was cooperatively used to offer 3D modeling and create 3D texturing for morphological and functional reconstruction. The application effect was assessed by analyzing the relevant data and every patient followed up regularly after the operation.
Results:
The reconstructed images were acquired through computer-aided three-dimension reconstruction, as well as the navigated devices were established through 3D printing. There were totally nine patients including 4 males and 5 females with a mean age of 48.5 years old, whose tumor size ranged from 1.5 cm × 2.2 cm to 3.5 cm × 4.2 cm. The analysis of data also showed that five cases were characterized by oromaxillofacial osseous defect, 2 primary lesions were adjacent to bone and 2 were noncontacted with bone; the location of 7 cases were closely next to blood vessels of oral-maxillofacial-cervical region, while 2 were contactless.
Conclusions:
Although the tumors occurred in the deeply maxillofacial area are difficult to resect due to several complex anatomical and functional subunits in this area, digital design combined with 3D technology is a promising tool to provide precise diagnosis with an accurately targeted treatment for maxillofacial deep tumor. The preoperative design and the combined navigation technology can further improve the accuracy and safety for curing deep maxillofacial and neck tumors.
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Original Article:
Magnetic resonance imaging texture analysis of unilateral lateral pterygoid myospasm in patients with temporomandibular joint disorders: A pilot study
Chenxi Li, Xu Liu, Baihetinuer Muhetaer, Sakendeke Jumatai, Zhongcheng Gong
Digit Med
2021, 7:2 (7 December 2021)
DOI
:10.4103/digm.digm_31_21
Background and Purpose:
Lots of clinical observations have found that there is a close relationship between the pathological changes of lateral pterygoid muscle (LPM) and temporomandibular disc displacement. On medical images, unfortunately, these occult dysfunctions of LPM could scarcely be detected by naked eyes. As the presence of intrinsic properties of the human body, textural feature is capable to effectively discover the subtle functional changes of involved tissues. This study aimed to evaluate the lateral pterygoid myospasm in patients with temporomandibular joint disorders (TMD) applying magnetic resonance imaging (MRI) texture analysis.
Patients and Methods:
From December 2019 to October 2020, totally nine patients suffered from unilateral spasm of LPM (which is a subtype of TMD) were evaluated by MRI, who were consecutively recruited from Xinjiang Medical University Affiliated First Hospital. Gray-level co-occurrence matrix method was used to analyze the textural features of MRI T2-weighted images with the maximum area of LPM scanned at axial (closed-mouth) plane. Independent samples
t
-test was performed to compare the relevant parameters of bilateral LPMs (healthy- and affected-side of one individual self-controlled trial).
Results:
There were no statistically significant values between the two sides of angular second moment, inversed differential moment, and entropy (
P
> 0.05). The contrast of the healthy-side (267.983 ± 45.952) was significantly higher than that of the affected-side (210.003 ± 29.613) (
P
< 0.05); and the autocorrelation of the healthy-side (4.536 ± 0.819) was significantly lower than that of the affected-side (6.563 ± 1.653) (
P
< 0.05).
Conclusion:
The texture contrast and autocorrelation have certain clinical meanings of diagnosis since they could identify the altered status of LPM, and could be considered as the efficient imaging biomarkers to assess LPM changes in patients with TMD.
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Original Article:
Efficacy of clear aligners on mandibular molar distalization: A retrospective study
Jie Han, Nan Ning, Hongjiang Du, Mengqi Zhou, Chaoying Cai, Yaya Hong, Yi Zhou, Xuepeng Chen
Digit Med
2021, 7:1 (7 December 2021)
DOI
:10.4103/digm.digm_30_21
Background:
Clear aligners (CAs) can distalize mandibular molars. The present study aimed to study the efficiency and influencing the factors of CAs for mandibular molar distalization and to provide guidance for clinical design.
Materials and Methods:
The present study evaluated 32 adult orthodontic patients who needed mandibular molar distalization and were treated with CAs between September 2018 and September 2020 at the school of medicine. The cone-beam computed tomography images of T
0
(before orthodontic treatment) and T
1
(after mandibular molars were fully distalized) were collected, and the actual movements of mandibular molars were measured and compared with the expected movements. The efficiency of mandibular molar distalization during treatment was comprehensively evaluated, and the relevant factors were analyzed.
Results:
For mandibular first molar distalization, the average efficiency of the crown was 67.19% 9swn. 13%, and that of the root was 37.87% 7stn. 72%. There was a significant difference between the achieved movement amount and the expected amount (
P
< 0.05). For mandibular second molars, the average efficiency of the crown was 58.47% 7swn. 07%, and that of the root was 57.03% 3stn. 48%. There was a statistically significant difference between the achieved movement amount and the expected amount (
P
< 0.05). There was a significant negative correlation between the expected movement and the efficiency of the crown.
Conclusions:
CAs can achieve mandibular molar distalization, and the movement pattern of molars is mainly a tipping movement. To accomplish bodily movement, overcorrection should be fully considered. In addition, it is suggested that close attention should be given to observing root movement during molar distalization.
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