Prospective randomized controlled trial.
Compare range of motion (ROM) and adjacent segment degeneration (ASD) following cervical disc arthroplasty (CDA) versus anterior cervical discectomy and ...fusion (ACDF) at 20-year follow-up.
Anterior cervical discectomy and fusion is the standard of treatment for single-level cervical disc degeneration causing radiculopathy. CDA is claimed to reduce shear strain, and adjacent-level ROM changes are hypothesized to hasten ASD with ACDF.
This study collected data on 47 patients randomized to ACDF or CDA. Lateral cervical spine radiographs were evaluated preoperatively, postoperatively, and at 20 years for alignment, ROM, ASD, and heterotopic ossification.
Eighty-two percent (18/22) of CDA patients and 84% (21/25) of ACDF patients followed up at 20 years. At 20 years, total cervical (C2-C7) ROM was statistically different between the CDA and fusion groups (47.8° vs . 33.4°, P =0.005). Total cervical ROM was not significantly different between preoperative and 20-year periods following CDA (45.6° vs . 47.4°, P =0.772) or ACDF (40.6° vs . 33.0°, P =0.192). Differences in postoperative and 20-year index-level ROM following CDA were not significant (10.1° vs . 10.2°, P =0.952). Final ASD grading was statistically lower following CDA versus ACDF at both adjacent levels ( P <0.005). Twenty-year adjacent-level ossification development was increased following ACDF versus CDA ( P <0.001). Polyethylene mean thickness decreased from 9.4 mm immediately postoperatively to 9.1 mm at 20-year follow up ( P =0.013). Differences in adjacent-level ROM from preoperative to 20-year follow-up in both the ACDF and CDA groups did not meet statistical significance ( P >0.05).
Cervical disc arthroplasty maintains index-level and total cervical ROM with very long-term follow-up. Total cervical ROM was higher at 20 years in CDA relative to ACDF. CDA results in lower rates of ASD and adjacent-level ossification development than ACDF.
Background
The American Society of Breast Surgeons recommends genetic testing (GT) for all women with breast cancer (BC), but implementation and uptake of GT has not been well-described.
Methods
A ...retrospective chart review was performed for newly diagnosed BC patients or patients with a newly identified recurrence of BC seen in a multidisciplinary clinic (MDBC) who were offered genetic counseling (GC) and GT.
Results
The 138 women attending the MDBC had a median age of 54 years and comprised non-Hispanic whites (46%), Asians (28%), Hispanics (17%), blacks (4%), and other (5%). Of the 105 (76%) patients without prior GT, 100 (95%) accepted GC, with 93 (93%) of these 100 patients undergoing GT. The patients meeting the National Comprehensive Cancer Network (NCCN) guidelines for GT were more likely to undergo GT. Testing was performed with a 67- to 84-gene panel, together with an 8- to 9-gene STAT panel if needed. Among 120 patients with reports available, including 33 patients previously tested, 15 (12%) were positive (1
BLM
, 1
BRCA1
, 3
BRCA2
, 1
BRIP1
, 1
CFTR
, 1
CHEK2
, 1
MUTYH
, 1
PALB2
, 1
PRSS1
, 1
RAD50
, 1
RET,
and 2
TP53
), 44 (37%) were negative, and 61 (51%) had an uncertain variant. The median time to STAT results (
n
= 50) was 8 days. The STAT results were available before surgery for 47 (98%) of the 48 STAT patients undergoing surgery.
Conclusions
New BC patients attending the MDBC demonstrated high rates of acceptance of GC and GT. The combination of GC and GT can offer timely information critical to patient risk assessment and treatment planning.
Purpose
This systematic review and meta-analysis aimed to evaluate the efficacy of Mepitel film in preventing or treating acute radiation dermatitis (RD) in patients with breast cancer in randomized ...controlled trials (RCTs).
Methods
Embase, APA PsychInfo, Journals@Ovid Full Text, Ovid MEDLINE, PubMed, and Cochrane Trials were searched until December 12, 2022, to identify RCTs on the use of Mepitel film for preventing or treating acute RD from breast cancer radiotherapy. Per-protocol analysis was used to compare outcomes, calculate pooled effect sizes, odds ratio (OR), and 95% confidence intervals (CI), and to create forest plots using random effects analysis in RevMan 5.4.
Results
Three RCTs were included in this review. Mepitel film significantly reduced the incidence of grade 3 RD (OR 0.15 95% CI 0.06, 0.37,
p
<0.0001) and grade 2 or 3 RD (OR 0.16 95% CI 0.04, 0.65,
p
=0.01) as scored on either the CTCAE or the RTOG scale. Additionally, Mepitel film significantly reduced RISRAS mean scores assessed by patients and combined researcher and patient (standardized mean difference (SMD) -7.59, 95% CI -14.42, -0.76,
p
=0.03; SMD -15.36, 95% CI -30.01, -0.71
p
=0.04) but not the researcher component of the assessment tool (SMD -17.55, 95% CI -36.94, 1.84,
p
=0.08).
Conclusion
Mepitel film reduced the incidence of acute RD and improved patient-reported outcomes with minimal side effects, the main one being itchiness. Future research should assess the feasibility of Mepitel film with respect to specific patient-reported outcomes such as health-related quality of life issues associated with its use.
Purpose
The primary objective is to systematically review primary studies, such as randomized control trials (RCTs), feasibility, exploratory, and case studies; and the secondary objective is to ...evaluate all secondary articles, such as reviews, guidelines, and editorials, relevant to the use of StrataXRT for the prevention and/or management of radiation dermatitis (RD) in cancer patients.
Methods
A literature search was conducted up to February 26, 2023, for articles investigating the use of StrataXRT for the prevention and treatment of RD, in the following databases: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar. The keywords “StrataXRT”, “dermatitis”, “radiotherapy”, and “radiation” were used to identify relevant articles.
Results
Twenty-seven articles from 2018 to 2022 were identified to fulfill the inclusion criteria of this review, of which nine are primary studies and 18 are secondary papers. Significant heterogeneity was observed in the current literature studying the effects of StrataXRT, making it difficult to make cross-trial comparisons. There is a suggestion of the efficacy of StrataXRT in the prevention and treatment of RD.
Conclusion
The findings of this review recommend further adequately powered RCTs with robust methodology including patient and clinician assessments to determine the efficacy of StrataXRT in preventing and treating RD. This is essential to improve the quality of life of patients and identify which groups of patients would benefit most from StrataXRT.
As stereotactic body radiation therapy (SBRT) becomes widely available for early-stage non-small cell lung cancer (NSCLC), there may be concerns in the surgical community that SBRT is being offered ...for patients with operable tumors, even though surgery is standard of care. We evaluated the trends in SBRT and surgery over time for patients with NSCLC.
The National Cancer Database was queried for patients with node-negative NSCLC ≤5 cm from 2004 to 2016. The relationships between definitive local treatment modalities and year were analyzed using a multinomial regression model while controlling for other covariates.
Among the 202,367 patients who met the inclusion criteria, there was a steady decrease in mean tumor size in all treatment modalities, from 2.44 cm (SD=1.08) to 2.25 cm (SD=1.00) over the study period. In the multinomial model, the probability of receiving lobectomy demonstrated a slight decline from 58% (2004) to 53% (2016). The use of SBRT increased from 1% to 20%, while patients receiving no therapy declined from 27% to 16%. The likelihood of SBRT increased with year of diagnosis (P<0.0001) and decreasing tumor size (P<0.0001), compared with lobectomy. Age, race, income, facility, and Charlson-Deyo score were also associated with treatment modality.
The mean tumor size of early-stage NSCLC decreased over the study period for all treatment modalities. SBRT use has increased, mostly among older patients with smaller tumors and Charlson-Deyo scores ≥3. The increase in SBRT contributed to the significant decline in patients who had no therapy.
Purpose To evaluate whether morphologic characteristics of rotator cuff tear have prognostic value in determining symptomatic structural failure of arthroscopic rotator cuff repair independent of age ...or gender. Methods Arthroscopic rotator cuff repair cases performed by five fellowship-trained surgeons at our institution from 2006 to 2013 were retrospectively reviewed. Data extraction included demographics, comorbidities, repair technique, clinical examination, and radiographic findings. Failure in symptomatic patients was defined as structural defect on postoperative magnetic resonance imaging or pseudoparalysis on examination. Failures were age and gender matched with successful repairs in a 1:2 ratio. Results A total of 30 failures and 60 controls were identified. Supraspinatus atrophy ( P = .03) and tear size (18.3 mm failures v 13.9 mm controls; P = .02) were significant risk factors for failure, as was the presence of an infraspinatus tear greater than 10 mm (62% v 17%, P < .01). Single-row repair ( P = .06) and simple suture configuration ( P = .17) were more common but similar between groups. Diabetes mellitus and active tobacco use were not significantly associated with increased failure risk but psychiatric medication use was more frequent in the failure group. Conclusions This study confirms previous suspicions that tear size and fatty infiltration are associated with failure of arthroscopic rotator cuff repair but independent of age or gender in symptomatic patients. There is also a quantitative cutoff on magnetic resonance imaging for the size of infraspinatus involvement that can be used clinically as a predicting factor. Although reported in the literature, smoking and diabetes were not associated with failure. Level of Evidence Level III, retrospective case control.
Purpose
To evaluate the overall efficacy of StrataXRT, a topical gel dressing, in preventing acute radiation dermatitis (RD) in breast cancer patients undergoing radiotherapy (RT).
Methods
A ...systematic search was conducted on April 25, 2023 in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Randomized controlled trials (RCTs) assessing the effectiveness of StrataXRT in preventing acute RD in breast cancer patients undergoing adjuvant RT to the breast or chest wall with or without regional nodes were included. Pooled incidence odds ratio (OR) and 95% confidence interval (CI) were calculated using a random-effects model, with analysis and forest plots generated in RevMan v5.4.
Results
The analysis included three RCTs with a total of 189 patients assessed using per-protocol analysis. Two RCTs compared StrataXRT to standard of care, while the third compared it with Mepitel film and was reported separately. In the former RCTs, the odds ratio (OR) for developing acute grade 3 RD favored StrataXRT at 0.05 (95% CI, 0.01-0.22;
P
< 0.0001). The OR for developing acute grades 2–3 RD was 0.32 (95% CI, 0.03-3.18;
P
= 0.33). The RCT comparing StrataXRT with Mepitel film showed insignificant ORs for grade 3 and grades 2-3 RD. One RCT reported significantly lower erythema index (
P
= 0.008) and melanin index (
P
= 0.015) in StrataXRT patients. The use of StrataXRT did not raise additional safety concerns.
Conclusion
StrataXRT may help prevent severe acute RD in breast cancer RT patients. Further high quality, large-scale studies are needed to confirm these findings.
Stereotactic radiosurgery (SRS) for operative brain metastasis (BrM) is usually administered 1 to 6 weeks after resection. Preoperative versus postoperative timing of SRS delivery related to surgery ...remains a critical question, as a pattern of failure is the development of leptomeningeal disease (LMD) in as many as 35% of patients who undergo postoperative SRS or the occurrence of radiation necrosis. As they await level I clinical data from ongoing trials, the authors aimed to bridge the gap by comparing postoperative with simulated preoperative single-fraction SRS dosimetry plans for patients with surgically resected BrM.
The authors queried their institutional database to retrospectively identify patients who underwent postoperative Gamma Knife SRS (GKSRS) after resection of BrM between January 2014 and January 2021. Exclusion criteria were prior radiation delivered to the lesion, age < 18 years, and prior diagnosis of LMD. Once identified, a simulated preoperative SRS plan was designed to treat the unresected BrM and compared with the standard postoperative treatment delivered to the resection cavity per Radiation Therapy Oncology Group (RTOG) 90-05 guidelines. Numerous comparisons between preoperative and postoperative GKSRS treatment parameters were then made using paired statistical analyses.
The authors' cohort included 45 patients with a median age of 59 years who were treated with GKSRS after resection of a BrM. Primary cancer origins included colorectal cancer (27%), non-small cell lung cancer (22%), breast cancer (11%), melanoma (11%), and others (29%). The mean tumor and cavity volumes were 15.06 cm3 and 12.61 cm3, respectively. In a paired comparison, there was no significant difference in the planned treatment volumes between the two groups. When the authors compared the volume of surrounding brain that received 12 Gy or more (V12Gy), an important predictor of radiation necrosis, 64% of patient plans in the postoperative SRS group (29/45, p = 0.008) recorded greater V12 volumes. Preoperative plans were more conformal (p < 0.001) and exhibited sharper dose drop-off at the lesion margins (p = 0.0018) when compared with postoperative plans.
Comparison of simulated preoperative and delivered postoperative SRS plans administered to the BrM or resection cavity suggested that preoperative SRS allows for more highly conformal lesional coverage and sharper dose drop-off compared with postoperative plans. Furthermore, V12Gy was lower in the presurgical GKSRS plans, which may account for the decreased incidence of radiation necrosis seen in prior retrospective studies.