Purpose To report the anatomic and functional results of primary vitrectomy without scleral buckling for the treatment of pseudophakic rhegmatogenous retinal detachment (PsRD). Design Prospective, ...nonrandomized surgical technique study. Methods One hundred eyes of 98 patients with PsRD were operated by vitrectomy alone. Internal subretinal fluid drainage, cryocoagulation and/or endolaser and fluid–air exchange with sulfur hexafluoride 20% was applied in all cases. The preoperative and postoperative characteristics were analyzed. Main outcome measures were anatomic success rates after initial surgical intervention and after reoperation for primary failures, visual outcome at the last follow-up visit, and complications. Results Mean follow-up ± standard deviation (SD) was 12 ± 6.3 months (range, seven to 36 months). Mean final visual acuity ± SD was 0.42 ± 0.45 logarithm of the minimum angle of resolution (logMAR) compared with 0.95 ± 0.73 logMAR before surgery ( P < .01). Mean number ± SD of retinal breaks found before surgery was 1.36 ± 1.12 (range, zero to five), and an additional 1.58 ± 2.26 (range, zero to 15) retinal breaks were found during surgery. The retina was reattached successfully after a single surgery in 92 eyes (92%). Recurrence of retinal detachment occurred in eight eyes (8%), caused by proliferative vitreoretinopathy in six eyes (75%) and by new breaks in two eyes (25%). Final anatomic reattachment was obtained in these cases after a mean of 1.75 subsequent operations. Three eyes required permanent silicone oil tamponade so that final anatomic success was achieved in 97 eyes (97%). The most common postoperative complication was ocular hypertonia of more than 21 mm Hg, observed in 36 (36%) eyes, which was managed successfully. Conclusions Primary vitrectomy without scleral buckling provides a high anatomic success rate in eyes with PsRD and is associated with few complications.
Objective:
The objective of this systematic analysis was to perform a qualitative and quantitative synthesis of the literature concerning salivary and serum leptin variations in patients with chronic ...periodontitis (CP) compared with healthy subjects. Saliva leptin concentration analysis could be a relevant and non-invasive biological test for the evaluation of periodontal disease in both medical and clinical trials, beyond the clinical and radiographic elements.
Material and Method:
Querying the PubMed and Web of Science databases identified articles that met our inclusion criteria. Quantitative analysis of the literature data was performed with the Review Manager 5.3 software.
Results:
The qualitative analysis included 14 articles and showed a decrease of salivary leptin (5 studies out of 5) and an increase of serum leptin (11 of 12 studies) in patients with CP compared to unaffected subjects of CP. Quantitative analysis was performed on 4 trials. For salivary leptin, we confirmed a decrease in its level in patients with CP with a standardized mean difference (SMD) of −2.27, 95% CI −2.68, −1.86. The difference was highly significant but we detected a very important heterogeneity in this dataset (
I
2
= 94%). For serum leptin, we also confirmed an increase in its rate in patients with CP with an SMD of 2.18, 95% CI 1.75, 2.61. The difference was highly significant but the heterogeneity measured in this dataset was also too high (
I
2
= 95%). Conclusion: The current level of evidence was insufficient to assert an increase in serum leptin and a decrease in salivary leptin in CP patients compared to healthy controls due to a great heterogeneity of the values measured in the studies.
Primary surgery is usually the mainstay treatment in early-stage oropharyngeal and oral cavity cancer. Typically, neck surgery is performed. Negative tumor margins are recommended (> 5 mm). If ...feasible, re-resection of any positive margin is preferred. Otherwise, postoperative radiotherapy is required. Adjuvant postoperative radiotherapy can be limited to the primary site for patients with pT1-T2 tumors and negative neck exploration. Currently, both fractionated external beam radiotherapy and brachytherapy can have a role in the postoperative management of early-stage oropharyngeal and oral cavity cancer with high risk margins. Another possible alternative could be postoperative stereotactic body radiotherapy (SBRT). The aim of this study is to evaluate postoperative SBRT in the treatment of early-stage oropharyngeal and oral cavity cancer with high risk margins.
The STEREO POSTOP study is a national, open-label, non-randomized phase II trial within the GORTEC network. Patients with early-stage oropharyngeal and oral cavity cancers with high risk margins indicating the need for postoperative radiation are eligible for enrollment. SBRT consists of a total dose of 36 Gy in 6 fractions over 2 weeks. The primary endpoint is severe late toxicity defined as 2-year toxicity of grade ≥ 3 according to CTCAE V4.03 classification. The secondary endpoints include acute toxicity (≤ 3 months), local and locoregional control, disease-free and overall survival, quality of life of patients, nutritional impact and predictive factors of toxicity. The experimental design chosen is a one-step Fleming plan design without interim analysis as the primary endpoint will be evaluated at a 2-year follow-up. Ninety patients will be recruited. The study was started in January 2018 with a 4-year enrollment period and an estimated completion in January 2024.
This study is the first prospective trial to evaluate head and neck cancer postoperative SBRT in the setting of early-stage oropharyngeal and oral cavity cancers with high risk margins. SBRT is an attractive option because it delivers a highly conformal dose of radiation in a limited number of fractions (like brachytherapy but with less contraindication), with steep dose gradients resulting in reduced normal tissue irradiation and with a short overall treatment time.
Clinicaltrials.gov : NCT03401840 , registered on 17-1-2018. Identifier in French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID - RCB 2017-A02058-45, registered on July 2017. Protocol version: Version 3 dated from 25th November 2019.
Patients surgically treated for oral cancer are affected by several underestimated deglutition disorders risk factors. This study aims to characterize the level of these food oral processing (FOP) ...impairments in a group of patients treated by surgery for tongue cancer. Twenty-seven consecutive patients surgically treated for tongue cancer were evaluated concerning their chewing capacity (Mastication-test), and responded to questions concerning their capacity to bite, chew and manipulate food with their tongue, and their quality of life. According to the Mastication-test, 16 patients suffered total FOP incapacities (TI group), characterized by high tumor stage, invasive carcinological surgery and necessity of reconstructive surgery; 12 patients were partially or not impaired (PI/NI-group). Tongue movement score and number of dental units were lower in the TI group than in the PI/NI-group. Subjective FOP criteria were clearly impaired in the TI group and correlated with a poor oral health-related quality of life. One year after surgery, there is a decrease in BMI for TI group patients while the PI group patients had a significant increase in BMI. All patients surgically treated for oral cancer suffered FOP impairments, but not with the same severity. Totally impaired subjects are at higher risk from long-term malnutrition. Functional evaluation of FOP should form part of the post-operative follow-up for all patients suffering from tongue cancer, using a quick combined evaluation of chewing efficiency, oral health quality of life and nutritional status.
Background
Presently, there are few published reports on postoperative radiation therapy for oropharyngeal and oral cavity cancers treated with IMRT/VMAT technique. This study aimed to assess the ...oncological outcomes of this population treated with postoperative VMAT in our institution, with a focus on loco-regional patterns of failure.
Material and methods
Between 2011 and 2019, 167 patients were included (40% of oropharyngeal cancers, and 60% of oral cavity cancers). The median age was 60 years. There was 64.2% of stage IV cancers. All patients had both T and N surgery. 34% had a R1 margin, 42% had perineural invasion. 72% had a positive neck dissection and 42% extranodal extension (ENE). All patients were treated with VMAT with simultaneous integrated boost with three dose levels: 66Gy in case of R1 margin and/or ENE, 59.4-60Gy on the tumor bed, and 54Gy on the prophylactic areas. Concomittant cisplatin was administrated concomitantly when feasible in case of R1 and/or ENE.
Results
The 1- and 2-year loco-regional control rates were 88.6% and 85.6% respectively. Higher tumor stage (T3/T4), the presence of PNI, and time from surgery >45 days were significant predictive factors of worse loco-regional control in multivariate analysis (p=0.02, p=0.04, and p=0.02). There were 17 local recurrences: 11 (64%) were considered as infield, 4 (24%) as marginal, and 2 (12%) as outfield. There were 9 regional recurrences only, 8 (89%) were considered as infield, and 1 (11%) as outfield. The 1- and 2-year disease-free survival (DFS) rates were 78.9% and 71.8% respectively. The 1- and 2-year overall survival (OS) rates were 88.6% and 80% respectively. Higher tumor stage (T3/T4) and the presence of ENE were the two prognostic factors significantly associated with worse DFS and OS in multivariate analysis.
Conclusion
Our outcomes for postoperative VMAT for oral cavity and oropharyngeal cancers are encouraging, with high rates of loco-regional control. However, the management of ENE still seems challenging.
Introduction While studies have extensively examined the clinical and pharmacokinetic correlates of drug-drug interactions (DDIs) with antiretroviral therapy (ART), less is known about DDIs from the ...perspective of people living with HIV (PLHIV). Among an international sample of PLHIV, we examined experiences, concerns and challenges regarding DDIs. Methods Data came from an international, web-based survey that was conducted among adult PLHIV aged ≥18 years who were receiving ART during 2019 (Positive Perspectives Wave 2, n=2389). Data were analyzed using descriptive statistics and with a special focus on the Asian region comprising participants from China, Taiwan, Japan, and South Korea (n=230). Multivariable analyses were performed using pooled data from all 2389 participants. Statistical significance was at p<0.05. Results Overall, 59.1% (136/230) of Asian participants were concerned about the risk of DDIs, 58.3% (134/230) were concerned about having to take more medicines as they grew older, and 25.9% (44/170) of those who had ever switched ART attributed it to DDIs, higher than every other geographical region except North America. Among Asian participants, 86.0% (43/50) of those aged ≥50 years reported having ever been diagnosed with a non-HIV comorbidity versus 60.0% (108/180) aged <50 years (p=0.001). Within the pooled sample, adults aged ≥50 years were more likely to perceive the need to reduce DDIs as a current treatment priority, than younger adults (adjusted prevalence ratio, APR=1.14; 95% CI: 1.02–1.27). The percentage of the entire population that ever switched ART because of DDIs ranged from 10.6% (148/1402) among those receiving treatment for HIV only, to 26.4% (14/53) among those receiving treatment for ≥7 conditions (including HIV). Conclusions Older adults reported more comorbidities than younger ones, and the probability of having switched ART because of DDIs increased with increasing concurrent treatments. Providing simpler regimens may help reduce the risk of DDIs. Healthcare providers can improve PLHIV’s health-related quality of life by delivering person-centered care.
Isosulfan blue dye peripheral injection is used in preoperative sentinel lymph node (SLN) identification alone or, to increase sensitivity, in conjunction with radiocolloid mapping. However, ...isosulfan blue dye has certain drawbacks and limitations.
This study assesses the authors' experience of SLN biopsy using only radiocolloid tracer.
Between 2000 and 2008, 218 patients underwent SLN biopsy with radiocolloid mapping, preoperative localization by lymphoscintigraphy and intraoperative confirmation by gamma probe in primary malignant cutaneous melanoma.
Mean Breslow index was 2.1 mm. The SLN biopsy success rate was above 98% at all sites and 87% in head and neck locations. The 5-year overall survival rate was 90% and that of 5-year disease-free survival was 80%. False-negative rate, with a mean follow-up time of 41 months, was 5.5%.
Sentinel lymph node biopsy can be successfully performed in patients with melanoma using only radiocolloid tracer without blue dye staining. In circumstances where blue dye cannot be used such as head and neck tumors, allergic reactions and pregnancy, radiocolloid tracer mapping alone is not a loss of chance for patients with melanoma.
Lymphangioma is a benign vascular malformation of the lymphatic vessels. In 90% of cases it is diagnosed during the first 2 years of life. As seen in 75% of cases, the head and neck region are the ...preferred location. This report represents an original case of lymphatic malformation (LM) in a 15-year-old patient discovered during an unscheduled postoperative symptomatology of third molar germectomies. Two biopsies, one non-contributory, were required to make the diagnosis. Lymphangiomas are classified as LM. They are usually non-regressive. Their etiology remains controversial.
BACKGROUND:A calcium alginate dressing (ALGINATE) and negative pressure wound therapy (NPWT) are frequently used to treat wounds which heal by secondary intention. This trial compared the healing ...efficacy and safety of these 2 treatments.
METHODS:This randomized, non-inferiority trial enrolled patients who underwent skin excision (>30 cm), which was left open to heal by secondary intention. They received ALGINATE or NPWT by a centralized randomization. Follow-up was performed weekly until optimal granulation tissue was obtained. The primary outcome was time to obtain optimal granulation tissue for a split thickness skin graft take (non-inferiority margin4 days). Secondary outcomes were occurrence of adverse events (AEs) and impact of the treatments on the patient’s daily life.
RESULTS:ALGINATE and NPWT were applied to 47 and 48 patients, respectively. The mean time to optimal granulation was 19.98 days (95% CI, 17.7–22.3) with ALGINATE and 20.54 (95% CI, 17.6–23.5) with NPWT. Between group difference was −0.56 days (95% CI −4.22 to 3.10). The non-inferiority of ALGINATE versus NPWT was demonstrated. No AE related to the treatment occurred with ALGINATE versus 14 AEs with NPWT. There was no difference in the impact of the treatments on the patient’s daily life.
CONCLUSION:This trial demonstrates that ALGINATE has a similar healing efficacy to that of NPWT and that is markedly better with regard to patient safety.
•The STEREOPOSTOP-GORTEC-2017–03 phase 2 trial evaluates postoperative SBRT in case of high risk margins for pT1-T2/N0 oropharyngeal and oral cavity tumors.•On the 10 first patients treated on ...Novalis, adding non-coplanar arcs resulted in better dosimetric outcomes.•Acute toxicity appears acceptable.•The most common acute toxicity was grade 2 and 3 mucositis.
The STEREO POSTOP GORTEC 2017–03 phase 2 trial (NCT03401840) evaluates postoperative stereotactic body radiotherapy (SBRT) in case of high-risk margins for pT1-T2/N0 oropharyngeal and oral cavity tumors. The present ancillary study aimed to compare the dosimetric impact of adding non-coplanar arcs to the volumetric modulated arc therapy (VMAT) technique and to evaluate acute toxicities on the first patients included in this trial.
Ten patients were included. Patients were treated with Novalis TX®. The total dose was 36 Gy (100 % isodose line) in 6 fractions, treated every other day. Two treatment plans were created for each patient: one plan using 2 coplanar arcs only (VMATc) and one plan using coplanar and 3 non-coplanar arcs (VMATc + nc). Acute toxicity was evaluated according to NCI CTCAE criteria V4.03.
Median age was 62 years. Localization of tumor was the mobile tongue for 6 patients, floor of mouth for 2, cheek for 1, and gingiva for 1. Six patients had pT2N0 tumors (AJCC 7th edition) and 4 had pT1N0. Mean CTV and PTV volumes were 36.4 and 56.1 cc respectively. Mean PTV coverage by the 36 Gy isodose was 98.2 % for both techniques (p = ns), with comparable conformity indexes (1.1 for VMATc vs 1.07 for VMATc + nc; p = 0.23). VMATc + nc had a significantly better gradient index (3.45 vs 2.97; p = 0.01), resulting in a significantly better sparing of most organs at risk. For example, mean Dmean to the oral cavity, lips, and homolateral parotid were respectively of 16.8 Gy, 11.1 Gy, and 10.4 Gy for VMATc vs 14.8 Gy (p = 0.005), 8.1 Gy (p = 0.001), 6.5 Gy (p = 0.04) for VMATc + nc. No grade ≥ 4 or higher acute toxicity was reported. The most common acute toxicity was grade ≥ 2 mucositis.
VMATc + nc had better dosimetric outcomes than VMATc and has become the standard technique for patients treated in the STEREO POSTOP GORTEC 2017–03 trial (NCT03401840) in our institution. Acute toxicity appears acceptable.
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